Mental Health

Pradeep Bansal considered the five capsules he was about to swallow. Together they made up a 25-mg dose of a substance that, in another setting, could have landed him in federal prison.

The substance was psilocybin, the active ingredient in magic mushrooms. To be more exact, it was a synthetic form of psilocybin called COMP360, made to pharmaceutical standards by a company called COMPASS Pathways. He was taking it as part of an Food and Drug Administration–approved clinical study on mental health therapy for people with cancer.

Dr. Bansal, a New York gastroenterologist, was far more comfortable giving medical treatment than receiving it. But he was getting used to it.

He had already been through surgery and a number of other treatments to address the physical aspects of his cancer. The psilocybin was to address the mental aspects – the crushing anxiety and depression that had stuck with him after his diagnosis.

Dr. Bansal did not arrive at this moment lightly.

“I was extremely skeptical going into this process,” said Dr. Bansal, who during a long medical career had looked with distrust and even disdain at alternative therapies.

“I don’t have much patience for holistic medicine, homeopathy, acupuncture, or alternative medicines with claims of spiritual upliftment or altered states of mind.”

But Bansal had done his homework on psilocybin and was impressed.

People with late-stage cancer and other serious health conditions who got psilocybin-assisted psychotherapy had “significant decreases” in anxiety and depression as long as 12 months after the treatment, according to studies published in 2011, 2014, and 2016.

One study from Johns Hopkins University tracked the effects of a single guided dose of psilocybin in terminal cancer patients with anxiety and depression. More than 80% had a “significant decrease” in symptoms – even 6 months after treatment – with more than 60% of the group remaining in the normal mood range.

For the study Dr. Bansal joined, there had been weeks of screening and consultation and preparation in a strictly controlled scientific trial.

And yet, even with all that he had learned, even with his psychiatrist-guide by his side, he was afraid. Afraid of what he might experience under the powerful effects of psilocybin. And afraid that this was all a misguided waste of time – that his mental angst would still be there when it was all over.

He knew that psilocybin, like other psychedelic substances, could take you on a “trip” – could remove you, at least for a time, from normal conscious experience.

Maybe he would feel “funny,” he thought. Maybe he would have some hallucinations. But how would that change the reality of his cancer? How would it lift the black dread and anxiety he felt about his future?
 

Stuck in a dark place

Dr. Bansal had first noticed blood in his urine – a lot of it – in September 2019. 

Two months later, doctors diagnosed cancer in his right kidney. He would need surgery to remove the kidney and surrounding lymph nodes (an operation called radical nephrectomy).

It was a shock, said Dr. Bansal. But the diagnosis and the surgery happened so quickly that he hardly had time to think. And treatment results seemed good. The cancer was only in stage I and the CT scans showed no signs of cancer after surgery.

“We were so relieved. Everyone was so happy,” Dr. Bansal said. “They didn’t even give me chemotherapy after surgery because it seemed so early.”

But a routine scan in June 2020 revealed more cancer in his lung. Within a couple of months, it was in his bladder too.

“It was devastating,” Dr. Bansal said. “I went from thinking I was healthy again to stage IV cancer.”

As doctors scheduled surgery to remove part of his lung, Dr. Bansal started on painful immunotherapy (BCG therapy) for his bladder.

At this point, from a psychological standpoint, Dr. Bansal was reeling. As a doctor, he knew all too well the meaning of stage IV cancer.

With two adult children and a grandchild on the way, Dr. Bansal had been looking forward to retirement with his wife of almost 40 years. “Suddenly, I wasn’t sure I was going to last that long,” Bansal recalled. “I was in a very dark place. I was very anxious, very depressed from lack of sleep.”

He saw a therapist about his cancer diagnosis and maintained his regular meditation practice at home. He hired a personal trainer and tried to focus on any good news that he got about his treatment.

Those things helped, but not enough.

The basic facts were inescapable. His cancer might end everything. He couldn’t stop thinking about it. And then he couldn’t stop thinking about how he couldn’t stop thinking about it.

If the worst happened, he didn’t want to spend his last days in a state of such relentless existential angst. And it wasn’t just for himself. He wanted to be strong and mentally present for his family and his loved ones and his patients.

As he searched for something to ease his mental anguish, Dr. Bansal recalled some psychedelic research on end-of-life anxiety and depression that he’d read about in Michael Pollan’s book on psychedelics, “How to Change Your Mind” (New York, Penguin Press, 2018).

The studies were small and the research was new, but Dr. Bansal was impressed enough with the results to take a chance. He called a lead researcher of one of the studies, a fellow New York doctor, and eventually found himself accepted into a new study.
 

Starting the journey

By the time Dr. Bansal arrived at the Bill Richards Center for Healing at the Aquilino Cancer Center in Rockville, Md., he had already been through weeks of screening.

The main requirements for the study were a cancer diagnosis and a measurable level of depression. But study participants also had to be physically fit enough to handle the medication, and psychologically free from a personal or family history of psychosis or schizophrenia. (The study also required participants to slowly wean themselves from medications like SSRIs for depression or antianxiety medications under the strict supervision of a qualified doctor.)

Dr. Bansal’s week of treatment began almost immediately on arrival at Aquilino. Everything was carefully choreographed but not rushed. From Monday to Wednesday, doctors followed his physical health with exams, ECGs, and blood work. And most importantly, they began to prepare him for the “dosing session” on Thursday when he would take the psilocybin.

This is the careful crafting of “set and setting” stressed in so many psychedelic therapies. “Set” refers to your mindset going into the drug experience. “Setting” is the space and people around you when the drug sends you into an altered state of consciousness.

Dr. Bansal met several times with at least three therapists in the days leading up to his dosing. He attended 4-plus hours of therapist-led group sessions with other people who would get a dosing on the same day. Together, they talked about what to expect during the experience and what to do in the face of fear or panic. 

He connected with a therapist who would be his personal guide. Dr. Bansal’s therapist was a military psychiatrist with over 30 years’ experience.

“He was there with me from day 1, and so we established a relationship,” Dr. Bansal said.

“He asked me a lot of personal background history – you know, my religious convictions, aspirations, all those things.”

“Trust and let go,” was a kind of mantra for the treatment repeated by his guide and other doctors.

For Dr. Bansal, a doctor and scientist accustomed to using hard facts rather than touchy-feely slogans to navigate the care of patients, it was an adjustment, to say the least.

But he did his best to set aside his doubts and embrace the journey he was about to take.
 

The day of the trip

Thursday morning finally arrived. The setting of the dosing room was warm and welcoming, more like a cozy home study than a hospital room.

This matters more than you might think. First, because it’s important that you feel safe, open, and comfortable enough to let go and enter into a therapeutic process. But also because though rare, it’s possible – especially with psilocybin – for people to lose track of where they are and what they’re doing and put themselves or others in danger.

The dose, 25 mg, had been carefully calibrated to induce a psychedelic experience sufficient for therapy. Much less than that, say 10 mg, isn’t enough for most people to enter this state. A double dose, 50 mg, though not physically unsafe, may leave you too incoherent to have the useful insights key to therapeutic value.

A doctor, the lead investigator of the study, brought the five capsules into the room in an intricately carved crucible with a small ceremonial cup that held the water with which to take it.

“It was very solemn,” Dr. Bansal said. “He sat down with me in a very calming way.”

The doctor said: “Don’t worry about it. Just trust and let go.”

And that’s just what he did.

Dr. Bansal swallowed the capsules and lay down. The doctor quietly left the room so that Dr. Bansal and his psychiatrist guide could begin their session together.

Special eye shades kept him in the pitch dark whether his eyes were open or closed. Headphones streamed a curated musical playlist – much of it Western classical like Strauss, Bach, Mozart, and Beethoven – but also modern electronica and other music from cultures around the globe.

Dr. Bansal would remain here, with his therapist-guide by his side, in largely this same position, for the next 7-and-a-half hours.

It took about 45 minutes for the medication to kick in.
 

The investigator

The doctor who brought the capsules into the dosing room was Manish Agrawal, MD, codirector of clinical research at the Aquilino Cancer Center and lead investigator of the study.

Dr. Agrawal trained at the National Cancer Institute and practiced for many years as an oncologist before developing an interest in psychedelic therapies. It was his work with cancer patients that drew him to psychedelics in the first place.

He had seen too many of his patients mentally wrecked by a cancer diagnosis, and he often felt helpless to comfort them.

“You take care of the physical aspects of the cancer, right? You talk about side effects and recommend another scan to look for recurrence.”

“But what about the psychological effects?”

They can be very serious and too often go ignored, said Dr. Agrawal. Your plans for the future suddenly become moot. You may be concerned about your ability to work or worried about the pain and suffering and financial strain that might be ahead for both you and your family. And to top it all off, you’re staring into the face of your own mortality.

So it’s no wonder, said Dr. Agrawal, that many people develop clinical levels of anxiety and depression after a cancer diagnosis.

Like Dr. Bansal, Dr. Agrawal had been impressed by early studies on psilocybin-assisted therapies for end-of-life anxiety and depression. He had tried other approaches – support groups, one-on-one therapy, religious counselors, psychiatrist-prescribed medication – but he was never really happy with the results.

To Dr. Agrawal, psilocybin-assisted therapy was the first thing that looked like it could really make a difference.

And so after his psychedelic certification at the California Institute of Integral Studies, Dr. Agrawal was determined to change his approach.

The result was the Bill Richards Center for Healing at Aquilino Cancer Center, built specifically to study psychedelic-assisted therapies for psychological distress in people with cancer. The mission of the center is to help develop safe, FDA-approved psychedelic therapies for the mental health of cancer patients, and, once approved, provide a state-of-the-art facility and staff to administer those treatments.
 

A trip into the unknown

Back in the dosing room, Dr. Bansal was starting to feel the effects of the medication. As the psilocybin kicked in, spectacular images swirled.

“It was as if a million stained glass windows had suddenly come to life and were dancing in front of my vision,” Dr. Bansal said.

There were moving landscapes and intricate swirling patterns and massive stages in the sky where he saw orchestras playing the music he was hearing.

Dr. Bansal saw himself being crushed by a huge machine and buried, dead, in the Earth. He died and returned to life several times, glided over the top of New York City with the skyscrapers just below him, and took in the vision of the entire universe.

“I saw this expanse of the sky that was limitless. And there was this prehistoric reptile creature that spanned galaxies in the sky ahead of me who was dying. I said: ‘My God, the universe is dying,’ but then after a few moments, the universe came to life again in a burst of stars exploding.”

All the while, Dr. Bansal said, he was well aware that it was simply his mind creating these images, thoughts, and ideas. He knew he was in a safe room wearing eyeshades and headphones.

And yet, he says, it felt true. “The images and feelings are so powerful that you cannot help but believe they are in some way a part of reality.”

“At one point, I saw this giant Ferris wheel coming towards me and it was full of giant crabs, clicking and clacking their pincers. And my brain told me: ‘That’s my cancer!’ ”

Dr. Bansal was terrified. But he and his therapist had arranged a system of signals before the session. “If I was feeling afraid, I would hold his hand and if I had other issues, I would raise my hand. If I was feeling good, I would give him a thumbs up.”

Dr. Bansal reached out to his therapist and grasped his hand. “I said, ‘My cancer is coming at me!’ ”

His therapist was clear about what to do: Stand firm and walk toward it.

“That’s what they tell you: If you see anything frightening, you face it. And that’s the whole point of this exercise. And so, I stood and walked forward, and it just blew off in a puff of smoke.”
 

A state of peace

Around 3 hours into the experience, Dr. Bansal started to feel an immense sense of peace, happiness, and even comfort.

“I felt like I was watching a movie or a multidimensional slideshow. I was also a part of the movie. I felt like I could tell my mind what I wanted to see, and it would show it to me. It’s almost like you can mold your own visions. It was mystical.”

After about 8 hours, as the effects of the drug wore off, Dr. Bansal removed his eyeshades and headphones. He was completely drained.

“Even though I was lying down on my back for 7 hours, I felt like I had been run over by a truck. I was exhausted beyond belief physically and mentally.”

This was partly because of the fact that he hadn’t eaten much during the session. But mostly, said Dr. Bansal, it was because of the searing emotional intensity of the experience.
 

After the journey

It’s hard to put into words, said Dr. Bansal, what this treatment has done for his life. He feels as if he has stumbled onto something very precious that had been right in front of him all along. He wrote of his change in perspective almost obsessively in his journal in the days and weeks after treatment. One passage reads:

“It seems that, as time is passing on, I’m becoming more relaxed and hopeful, more calm, and at peace. Family has become even more important to me now. Money, politics, material gains, alcohol, seem less important.”

And yet there was nothing “easy” about the experience. In fact, in some ways the experience demanded more from him. “I feel I need to be more compassionate and considerate – less irritable and angry, more understanding of others’ needs. I feel I need to be a better human being, a better patient, a better father, and a better doctor for my patients.”

The experience, he said, gave him something far more important than mere ease. It gave him a sense of meaning.

From his journal:

“I died, and I was reborn. If I survived this, then I can face anything and anybody in the cosmic scheme. I can become part of it.

“How many sorrows in the universe? My cancer is nothing. Life does not end with the end of life. What was will be again. Eternally.”

That’s not an unusual response, according to the namesake of the Bill Richards Center for Healing. Bill Richards, PhD, has worked in the world of psychedelic-assisted psychotherapy since 1963.

A psychologist with decades of experience, Dr. Richards and colleagues figure that, with few possible exceptions, he has helped treat more people with psychedelic therapies than anyone alive in Western medicine today. At Aquilino, he works directly with patients and oversees the therapy protocol that goes along with the psilocybin dosing sessions.

“It’s inspiring,” Dr. Richards said.

“You meet someone who’s very depressed and scared and isolating from family and having all kinds of physical complaints. And a few days later, you talk to the same person and they have a whole new lease on life.”

And the positive effects can extend deep into the family system, he said.

After psilocybin treatment, said Dr. Richards, the person with cancer can become a kind of social worker for the family. They’re often far better able to talk about death and loss and even money and family issues than their loved ones. It’s not uncommon after treatment to see the resolution of years-old resentments or grievances that have dogged a family for many years.

Plus, said Dr. Richards, the cancer patient often ends up as a kind model to other family members for how to approach death. “They can demonstrate how to live fully – right to the last breath – which is a real gift because those relatives and loved ones have to die someday too, you know.”

At 80 years old, Dr. Richards is still in active practice and hopes to spend the rest of his days working with people in end-of-life care.
 

After the experience

Psychedelic-assisted therapy does not end with the dosing session. Integration sessions, where you discuss what happened during the dosing session, are a key part of most treatments.

The goal is to help participants absorb and “integrate” their experience. It typically happens over two or more sessions of 60-90 minutes with a therapist. In some cases, the therapist may invite a significant other to join in the integration process.

Dr. Agrawal’s trial at the Bill Richards center added something new: group therapy. Not only did Dr. Bansal meet with his therapist, he also met with a group of three other people in the trial who had their dosing the same day.

The point, said Dr. Agrawal, is to try and determine the effect of the group on the therapy. After their private dosing sessions, they come back together to discuss their experiences.

“After the psilocybin, they feel like they’ve been to war together,” Dr. Agrawal said. “There is this profound openness and connection. They feel able to share things with each other that they wouldn’t with other people.”

It will take some time to figure out how the group affects the overall outcome, but Dr. Bansal thinks it was integral to the success of his treatment.

In fact, he continues to meet regularly with his therapy group, even though it’s long since past the requirements of the study.
 

Pradeep 2.0

Dr. Bansal still has tough days with his cancer. Recently, immunotherapy treatment for his bladder caused side effects – pain, bleeding, fever, and chills – for most of the night. He felt like he was “passing razor blades” when he peed.

“And yet it was somehow okay,” he said. “It was only pain.”

“It’s as if there is a part of me that is watching myself objectively, going through the painful process of treatments saying: ‘It’s all right. I will be with you through this journey, through this experience. Don’t worry.’”

Months after taking that one dose, Dr. Bansal still calls it as “the single most powerful experience of my life.”

The change in his mental outlook, Dr. Bansal said, was profound, particularly in regard to his cancer.

“I understood that I still had cancer and that it could kill me in a few weeks, or months, or years. But my perspective had shifted.”

Dr. Bansal was as surprised as anyone. “Had somebody told me going into this that I would come out a transformed being or a person with a completely different perspective on life, I would never have believed it.”

He even named his new outlook. “I call it Pradeep 2.0.”

A version of this article first appeared on WebMD.com.

Pradeep Bansal considered the five capsules he was about to swallow. Together they made up a 25-mg dose of a substance that, in another setting, could have landed him in federal prison.

The substance was psilocybin, the active ingredient in magic mushrooms. To be more exact, it was a synthetic form of psilocybin called COMP360, made to pharmaceutical standards by a company called COMPASS Pathways. He was taking it as part of an Food and Drug Administration–approved clinical study on mental health therapy for people with cancer.

Dr. Bansal, a New York gastroenterologist, was far more comfortable giving medical treatment than receiving it. But he was getting used to it.

He had already been through surgery and a number of other treatments to address the physical aspects of his cancer. The psilocybin was to address the mental aspects – the crushing anxiety and depression that had stuck with him after his diagnosis.

Dr. Bansal did not arrive at this moment lightly.

“I was extremely skeptical going into this process,” said Dr. Bansal, who during a long medical career had looked with distrust and even disdain at alternative therapies.

“I don’t have much patience for holistic medicine, homeopathy, acupuncture, or alternative medicines with claims of spiritual upliftment or altered states of mind.”

But Bansal had done his homework on psilocybin and was impressed.

People with late-stage cancer and other serious health conditions who got psilocybin-assisted psychotherapy had “significant decreases” in anxiety and depression as long as 12 months after the treatment, according to studies published in 2011, 2014, and 2016.

One study from Johns Hopkins University tracked the effects of a single guided dose of psilocybin in terminal cancer patients with anxiety and depression. More than 80% had a “significant decrease” in symptoms – even 6 months after treatment – with more than 60% of the group remaining in the normal mood range.

For the study Dr. Bansal joined, there had been weeks of screening and consultation and preparation in a strictly controlled scientific trial.

And yet, even with all that he had learned, even with his psychiatrist-guide by his side, he was afraid. Afraid of what he might experience under the powerful effects of psilocybin. And afraid that this was all a misguided waste of time – that his mental angst would still be there when it was all over.

He knew that psilocybin, like other psychedelic substances, could take you on a “trip” – could remove you, at least for a time, from normal conscious experience.

Maybe he would feel “funny,” he thought. Maybe he would have some hallucinations. But how would that change the reality of his cancer? How would it lift the black dread and anxiety he felt about his future?
 

Stuck in a dark place

Dr. Bansal had first noticed blood in his urine – a lot of it – in September 2019. 

Two months later, doctors diagnosed cancer in his right kidney. He would need surgery to remove the kidney and surrounding lymph nodes (an operation called radical nephrectomy).

It was a shock, said Dr. Bansal. But the diagnosis and the surgery happened so quickly that he hardly had time to think. And treatment results seemed good. The cancer was only in stage I and the CT scans showed no signs of cancer after surgery.

“We were so relieved. Everyone was so happy,” Dr. Bansal said. “They didn’t even give me chemotherapy after surgery because it seemed so early.”

But a routine scan in June 2020 revealed more cancer in his lung. Within a couple of months, it was in his bladder too.

“It was devastating,” Dr. Bansal said. “I went from thinking I was healthy again to stage IV cancer.”

As doctors scheduled surgery to remove part of his lung, Dr. Bansal started on painful immunotherapy (BCG therapy) for his bladder.

At this point, from a psychological standpoint, Dr. Bansal was reeling. As a doctor, he knew all too well the meaning of stage IV cancer.

With two adult children and a grandchild on the way, Dr. Bansal had been looking forward to retirement with his wife of almost 40 years. “Suddenly, I wasn’t sure I was going to last that long,” Bansal recalled. “I was in a very dark place. I was very anxious, very depressed from lack of sleep.”

He saw a therapist about his cancer diagnosis and maintained his regular meditation practice at home. He hired a personal trainer and tried to focus on any good news that he got about his treatment.

Those things helped, but not enough.

The basic facts were inescapable. His cancer might end everything. He couldn’t stop thinking about it. And then he couldn’t stop thinking about how he couldn’t stop thinking about it.

If the worst happened, he didn’t want to spend his last days in a state of such relentless existential angst. And it wasn’t just for himself. He wanted to be strong and mentally present for his family and his loved ones and his patients.

As he searched for something to ease his mental anguish, Dr. Bansal recalled some psychedelic research on end-of-life anxiety and depression that he’d read about in Michael Pollan’s book on psychedelics, “How to Change Your Mind” (New York, Penguin Press, 2018).

The studies were small and the research was new, but Dr. Bansal was impressed enough with the results to take a chance. He called a lead researcher of one of the studies, a fellow New York doctor, and eventually found himself accepted into a new study.
 

Starting the journey

By the time Dr. Bansal arrived at the Bill Richards Center for Healing at the Aquilino Cancer Center in Rockville, Md., he had already been through weeks of screening.

The main requirements for the study were a cancer diagnosis and a measurable level of depression. But study participants also had to be physically fit enough to handle the medication, and psychologically free from a personal or family history of psychosis or schizophrenia. (The study also required participants to slowly wean themselves from medications like SSRIs for depression or antianxiety medications under the strict supervision of a qualified doctor.)

Dr. Bansal’s week of treatment began almost immediately on arrival at Aquilino. Everything was carefully choreographed but not rushed. From Monday to Wednesday, doctors followed his physical health with exams, ECGs, and blood work. And most importantly, they began to prepare him for the “dosing session” on Thursday when he would take the psilocybin.

This is the careful crafting of “set and setting” stressed in so many psychedelic therapies. “Set” refers to your mindset going into the drug experience. “Setting” is the space and people around you when the drug sends you into an altered state of consciousness.

Dr. Bansal met several times with at least three therapists in the days leading up to his dosing. He attended 4-plus hours of therapist-led group sessions with other people who would get a dosing on the same day. Together, they talked about what to expect during the experience and what to do in the face of fear or panic. 

He connected with a therapist who would be his personal guide. Dr. Bansal’s therapist was a military psychiatrist with over 30 years’ experience.

“He was there with me from day 1, and so we established a relationship,” Dr. Bansal said.

“He asked me a lot of personal background history – you know, my religious convictions, aspirations, all those things.”

“Trust and let go,” was a kind of mantra for the treatment repeated by his guide and other doctors.

For Dr. Bansal, a doctor and scientist accustomed to using hard facts rather than touchy-feely slogans to navigate the care of patients, it was an adjustment, to say the least.

But he did his best to set aside his doubts and embrace the journey he was about to take.
 

The day of the trip

Thursday morning finally arrived. The setting of the dosing room was warm and welcoming, more like a cozy home study than a hospital room.

This matters more than you might think. First, because it’s important that you feel safe, open, and comfortable enough to let go and enter into a therapeutic process. But also because though rare, it’s possible – especially with psilocybin – for people to lose track of where they are and what they’re doing and put themselves or others in danger.

The dose, 25 mg, had been carefully calibrated to induce a psychedelic experience sufficient for therapy. Much less than that, say 10 mg, isn’t enough for most people to enter this state. A double dose, 50 mg, though not physically unsafe, may leave you too incoherent to have the useful insights key to therapeutic value.

A doctor, the lead investigator of the study, brought the five capsules into the room in an intricately carved crucible with a small ceremonial cup that held the water with which to take it.

“It was very solemn,” Dr. Bansal said. “He sat down with me in a very calming way.”

The doctor said: “Don’t worry about it. Just trust and let go.”

And that’s just what he did.

Dr. Bansal swallowed the capsules and lay down. The doctor quietly left the room so that Dr. Bansal and his psychiatrist guide could begin their session together.

Special eye shades kept him in the pitch dark whether his eyes were open or closed. Headphones streamed a curated musical playlist – much of it Western classical like Strauss, Bach, Mozart, and Beethoven – but also modern electronica and other music from cultures around the globe.

Dr. Bansal would remain here, with his therapist-guide by his side, in largely this same position, for the next 7-and-a-half hours.

It took about 45 minutes for the medication to kick in.
 

The investigator

The doctor who brought the capsules into the dosing room was Manish Agrawal, MD, codirector of clinical research at the Aquilino Cancer Center and lead investigator of the study.

Dr. Agrawal trained at the National Cancer Institute and practiced for many years as an oncologist before developing an interest in psychedelic therapies. It was his work with cancer patients that drew him to psychedelics in the first place.

He had seen too many of his patients mentally wrecked by a cancer diagnosis, and he often felt helpless to comfort them.

“You take care of the physical aspects of the cancer, right? You talk about side effects and recommend another scan to look for recurrence.”

“But what about the psychological effects?”

They can be very serious and too often go ignored, said Dr. Agrawal. Your plans for the future suddenly become moot. You may be concerned about your ability to work or worried about the pain and suffering and financial strain that might be ahead for both you and your family. And to top it all off, you’re staring into the face of your own mortality.

So it’s no wonder, said Dr. Agrawal, that many people develop clinical levels of anxiety and depression after a cancer diagnosis.

Like Dr. Bansal, Dr. Agrawal had been impressed by early studies on psilocybin-assisted therapies for end-of-life anxiety and depression. He had tried other approaches – support groups, one-on-one therapy, religious counselors, psychiatrist-prescribed medication – but he was never really happy with the results.

To Dr. Agrawal, psilocybin-assisted therapy was the first thing that looked like it could really make a difference.

And so after his psychedelic certification at the California Institute of Integral Studies, Dr. Agrawal was determined to change his approach.

The result was the Bill Richards Center for Healing at Aquilino Cancer Center, built specifically to study psychedelic-assisted therapies for psychological distress in people with cancer. The mission of the center is to help develop safe, FDA-approved psychedelic therapies for the mental health of cancer patients, and, once approved, provide a state-of-the-art facility and staff to administer those treatments.
 

A trip into the unknown

Back in the dosing room, Dr. Bansal was starting to feel the effects of the medication. As the psilocybin kicked in, spectacular images swirled.

“It was as if a million stained glass windows had suddenly come to life and were dancing in front of my vision,” Dr. Bansal said.

There were moving landscapes and intricate swirling patterns and massive stages in the sky where he saw orchestras playing the music he was hearing.

Dr. Bansal saw himself being crushed by a huge machine and buried, dead, in the Earth. He died and returned to life several times, glided over the top of New York City with the skyscrapers just below him, and took in the vision of the entire universe.

“I saw this expanse of the sky that was limitless. And there was this prehistoric reptile creature that spanned galaxies in the sky ahead of me who was dying. I said: ‘My God, the universe is dying,’ but then after a few moments, the universe came to life again in a burst of stars exploding.”

All the while, Dr. Bansal said, he was well aware that it was simply his mind creating these images, thoughts, and ideas. He knew he was in a safe room wearing eyeshades and headphones.

And yet, he says, it felt true. “The images and feelings are so powerful that you cannot help but believe they are in some way a part of reality.”

“At one point, I saw this giant Ferris wheel coming towards me and it was full of giant crabs, clicking and clacking their pincers. And my brain told me: ‘That’s my cancer!’ ”

Dr. Bansal was terrified. But he and his therapist had arranged a system of signals before the session. “If I was feeling afraid, I would hold his hand and if I had other issues, I would raise my hand. If I was feeling good, I would give him a thumbs up.”

Dr. Bansal reached out to his therapist and grasped his hand. “I said, ‘My cancer is coming at me!’ ”

His therapist was clear about what to do: Stand firm and walk toward it.

“That’s what they tell you: If you see anything frightening, you face it. And that’s the whole point of this exercise. And so, I stood and walked forward, and it just blew off in a puff of smoke.”
 

A state of peace

Around 3 hours into the experience, Dr. Bansal started to feel an immense sense of peace, happiness, and even comfort.

“I felt like I was watching a movie or a multidimensional slideshow. I was also a part of the movie. I felt like I could tell my mind what I wanted to see, and it would show it to me. It’s almost like you can mold your own visions. It was mystical.”

After about 8 hours, as the effects of the drug wore off, Dr. Bansal removed his eyeshades and headphones. He was completely drained.

“Even though I was lying down on my back for 7 hours, I felt like I had been run over by a truck. I was exhausted beyond belief physically and mentally.”

This was partly because of the fact that he hadn’t eaten much during the session. But mostly, said Dr. Bansal, it was because of the searing emotional intensity of the experience.
 

After the journey

It’s hard to put into words, said Dr. Bansal, what this treatment has done for his life. He feels as if he has stumbled onto something very precious that had been right in front of him all along. He wrote of his change in perspective almost obsessively in his journal in the days and weeks after treatment. One passage reads:

“It seems that, as time is passing on, I’m becoming more relaxed and hopeful, more calm, and at peace. Family has become even more important to me now. Money, politics, material gains, alcohol, seem less important.”

And yet there was nothing “easy” about the experience. In fact, in some ways the experience demanded more from him. “I feel I need to be more compassionate and considerate – less irritable and angry, more understanding of others’ needs. I feel I need to be a better human being, a better patient, a better father, and a better doctor for my patients.”

The experience, he said, gave him something far more important than mere ease. It gave him a sense of meaning.

From his journal:

“I died, and I was reborn. If I survived this, then I can face anything and anybody in the cosmic scheme. I can become part of it.

“How many sorrows in the universe? My cancer is nothing. Life does not end with the end of life. What was will be again. Eternally.”

That’s not an unusual response, according to the namesake of the Bill Richards Center for Healing. Bill Richards, PhD, has worked in the world of psychedelic-assisted psychotherapy since 1963.

A psychologist with decades of experience, Dr. Richards and colleagues figure that, with few possible exceptions, he has helped treat more people with psychedelic therapies than anyone alive in Western medicine today. At Aquilino, he works directly with patients and oversees the therapy protocol that goes along with the psilocybin dosing sessions.

“It’s inspiring,” Dr. Richards said.

“You meet someone who’s very depressed and scared and isolating from family and having all kinds of physical complaints. And a few days later, you talk to the same person and they have a whole new lease on life.”

And the positive effects can extend deep into the family system, he said.

After psilocybin treatment, said Dr. Richards, the person with cancer can become a kind of social worker for the family. They’re often far better able to talk about death and loss and even money and family issues than their loved ones. It’s not uncommon after treatment to see the resolution of years-old resentments or grievances that have dogged a family for many years.

Plus, said Dr. Richards, the cancer patient often ends up as a kind model to other family members for how to approach death. “They can demonstrate how to live fully – right to the last breath – which is a real gift because those relatives and loved ones have to die someday too, you know.”

At 80 years old, Dr. Richards is still in active practice and hopes to spend the rest of his days working with people in end-of-life care.
 

After the experience

Psychedelic-assisted therapy does not end with the dosing session. Integration sessions, where you discuss what happened during the dosing session, are a key part of most treatments.

The goal is to help participants absorb and “integrate” their experience. It typically happens over two or more sessions of 60-90 minutes with a therapist. In some cases, the therapist may invite a significant other to join in the integration process.

Dr. Agrawal’s trial at the Bill Richards center added something new: group therapy. Not only did Dr. Bansal meet with his therapist, he also met with a group of three other people in the trial who had their dosing the same day.

The point, said Dr. Agrawal, is to try and determine the effect of the group on the therapy. After their private dosing sessions, they come back together to discuss their experiences.

“After the psilocybin, they feel like they’ve been to war together,” Dr. Agrawal said. “There is this profound openness and connection. They feel able to share things with each other that they wouldn’t with other people.”

It will take some time to figure out how the group affects the overall outcome, but Dr. Bansal thinks it was integral to the success of his treatment.

In fact, he continues to meet regularly with his therapy group, even though it’s long since past the requirements of the study.
 

Pradeep 2.0

Dr. Bansal still has tough days with his cancer. Recently, immunotherapy treatment for his bladder caused side effects – pain, bleeding, fever, and chills – for most of the night. He felt like he was “passing razor blades” when he peed.

“And yet it was somehow okay,” he said. “It was only pain.”

“It’s as if there is a part of me that is watching myself objectively, going through the painful process of treatments saying: ‘It’s all right. I will be with you through this journey, through this experience. Don’t worry.’”

Months after taking that one dose, Dr. Bansal still calls it as “the single most powerful experience of my life.”

The change in his mental outlook, Dr. Bansal said, was profound, particularly in regard to his cancer.

“I understood that I still had cancer and that it could kill me in a few weeks, or months, or years. But my perspective had shifted.”

Dr. Bansal was as surprised as anyone. “Had somebody told me going into this that I would come out a transformed being or a person with a completely different perspective on life, I would never have believed it.”

He even named his new outlook. “I call it Pradeep 2.0.”

A version of this article first appeared on WebMD.com.

Pradeep Bansal considered the five capsules he was about to swallow. Together they made up a 25-mg dose of a substance that, in another setting, could have landed him in federal prison.

The substance was psilocybin, the active ingredient in magic mushrooms. To be more exact, it was a synthetic form of psilocybin called COMP360, made to pharmaceutical standards by a company called COMPASS Pathways. He was taking it as part of an Food and Drug Administration–approved clinical study on mental health therapy for people with cancer.

Dr. Bansal, a New York gastroenterologist, was far more comfortable giving medical treatment than receiving it. But he was getting used to it.

He had already been through surgery and a number of other treatments to address the physical aspects of his cancer. The psilocybin was to address the mental aspects – the crushing anxiety and depression that had stuck with him after his diagnosis.

Dr. Bansal did not arrive at this moment lightly.

“I was extremely skeptical going into this process,” said Dr. Bansal, who during a long medical career had looked with distrust and even disdain at alternative therapies.

“I don’t have much patience for holistic medicine, homeopathy, acupuncture, or alternative medicines with claims of spiritual upliftment or altered states of mind.”

But Bansal had done his homework on psilocybin and was impressed.

People with late-stage cancer and other serious health conditions who got psilocybin-assisted psychotherapy had “significant decreases” in anxiety and depression as long as 12 months after the treatment, according to studies published in 2011, 2014, and 2016.

One study from Johns Hopkins University tracked the effects of a single guided dose of psilocybin in terminal cancer patients with anxiety and depression. More than 80% had a “significant decrease” in symptoms – even 6 months after treatment – with more than 60% of the group remaining in the normal mood range.

For the study Dr. Bansal joined, there had been weeks of screening and consultation and preparation in a strictly controlled scientific trial.

And yet, even with all that he had learned, even with his psychiatrist-guide by his side, he was afraid. Afraid of what he might experience under the powerful effects of psilocybin. And afraid that this was all a misguided waste of time – that his mental angst would still be there when it was all over.

He knew that psilocybin, like other psychedelic substances, could take you on a “trip” – could remove you, at least for a time, from normal conscious experience.

Maybe he would feel “funny,” he thought. Maybe he would have some hallucinations. But how would that change the reality of his cancer? How would it lift the black dread and anxiety he felt about his future?
 

Stuck in a dark place

Dr. Bansal had first noticed blood in his urine – a lot of it – in September 2019. 

Two months later, doctors diagnosed cancer in his right kidney. He would need surgery to remove the kidney and surrounding lymph nodes (an operation called radical nephrectomy).

It was a shock, said Dr. Bansal. But the diagnosis and the surgery happened so quickly that he hardly had time to think. And treatment results seemed good. The cancer was only in stage I and the CT scans showed no signs of cancer after surgery.

“We were so relieved. Everyone was so happy,” Dr. Bansal said. “They didn’t even give me chemotherapy after surgery because it seemed so early.”

But a routine scan in June 2020 revealed more cancer in his lung. Within a couple of months, it was in his bladder too.

“It was devastating,” Dr. Bansal said. “I went from thinking I was healthy again to stage IV cancer.”

As doctors scheduled surgery to remove part of his lung, Dr. Bansal started on painful immunotherapy (BCG therapy) for his bladder.

At this point, from a psychological standpoint, Dr. Bansal was reeling. As a doctor, he knew all too well the meaning of stage IV cancer.

With two adult children and a grandchild on the way, Dr. Bansal had been looking forward to retirement with his wife of almost 40 years. “Suddenly, I wasn’t sure I was going to last that long,” Bansal recalled. “I was in a very dark place. I was very anxious, very depressed from lack of sleep.”

He saw a therapist about his cancer diagnosis and maintained his regular meditation practice at home. He hired a personal trainer and tried to focus on any good news that he got about his treatment.

Those things helped, but not enough.

The basic facts were inescapable. His cancer might end everything. He couldn’t stop thinking about it. And then he couldn’t stop thinking about how he couldn’t stop thinking about it.

If the worst happened, he didn’t want to spend his last days in a state of such relentless existential angst. And it wasn’t just for himself. He wanted to be strong and mentally present for his family and his loved ones and his patients.

As he searched for something to ease his mental anguish, Dr. Bansal recalled some psychedelic research on end-of-life anxiety and depression that he’d read about in Michael Pollan’s book on psychedelics, “How to Change Your Mind” (New York, Penguin Press, 2018).

The studies were small and the research was new, but Dr. Bansal was impressed enough with the results to take a chance. He called a lead researcher of one of the studies, a fellow New York doctor, and eventually found himself accepted into a new study.
 

Starting the journey

By the time Dr. Bansal arrived at the Bill Richards Center for Healing at the Aquilino Cancer Center in Rockville, Md., he had already been through weeks of screening.

The main requirements for the study were a cancer diagnosis and a measurable level of depression. But study participants also had to be physically fit enough to handle the medication, and psychologically free from a personal or family history of psychosis or schizophrenia. (The study also required participants to slowly wean themselves from medications like SSRIs for depression or antianxiety medications under the strict supervision of a qualified doctor.)

Dr. Bansal’s week of treatment began almost immediately on arrival at Aquilino. Everything was carefully choreographed but not rushed. From Monday to Wednesday, doctors followed his physical health with exams, ECGs, and blood work. And most importantly, they began to prepare him for the “dosing session” on Thursday when he would take the psilocybin.

This is the careful crafting of “set and setting” stressed in so many psychedelic therapies. “Set” refers to your mindset going into the drug experience. “Setting” is the space and people around you when the drug sends you into an altered state of consciousness.

Dr. Bansal met several times with at least three therapists in the days leading up to his dosing. He attended 4-plus hours of therapist-led group sessions with other people who would get a dosing on the same day. Together, they talked about what to expect during the experience and what to do in the face of fear or panic. 

He connected with a therapist who would be his personal guide. Dr. Bansal’s therapist was a military psychiatrist with over 30 years’ experience.

“He was there with me from day 1, and so we established a relationship,” Dr. Bansal said.

“He asked me a lot of personal background history – you know, my religious convictions, aspirations, all those things.”

“Trust and let go,” was a kind of mantra for the treatment repeated by his guide and other doctors.

For Dr. Bansal, a doctor and scientist accustomed to using hard facts rather than touchy-feely slogans to navigate the care of patients, it was an adjustment, to say the least.

But he did his best to set aside his doubts and embrace the journey he was about to take.
 

The day of the trip

Thursday morning finally arrived. The setting of the dosing room was warm and welcoming, more like a cozy home study than a hospital room.

This matters more than you might think. First, because it’s important that you feel safe, open, and comfortable enough to let go and enter into a therapeutic process. But also because though rare, it’s possible – especially with psilocybin – for people to lose track of where they are and what they’re doing and put themselves or others in danger.

The dose, 25 mg, had been carefully calibrated to induce a psychedelic experience sufficient for therapy. Much less than that, say 10 mg, isn’t enough for most people to enter this state. A double dose, 50 mg, though not physically unsafe, may leave you too incoherent to have the useful insights key to therapeutic value.

A doctor, the lead investigator of the study, brought the five capsules into the room in an intricately carved crucible with a small ceremonial cup that held the water with which to take it.

“It was very solemn,” Dr. Bansal said. “He sat down with me in a very calming way.”

The doctor said: “Don’t worry about it. Just trust and let go.”

And that’s just what he did.

Dr. Bansal swallowed the capsules and lay down. The doctor quietly left the room so that Dr. Bansal and his psychiatrist guide could begin their session together.

Special eye shades kept him in the pitch dark whether his eyes were open or closed. Headphones streamed a curated musical playlist – much of it Western classical like Strauss, Bach, Mozart, and Beethoven – but also modern electronica and other music from cultures around the globe.

Dr. Bansal would remain here, with his therapist-guide by his side, in largely this same position, for the next 7-and-a-half hours.

It took about 45 minutes for the medication to kick in.
 

The investigator

The doctor who brought the capsules into the dosing room was Manish Agrawal, MD, codirector of clinical research at the Aquilino Cancer Center and lead investigator of the study.

Dr. Agrawal trained at the National Cancer Institute and practiced for many years as an oncologist before developing an interest in psychedelic therapies. It was his work with cancer patients that drew him to psychedelics in the first place.

He had seen too many of his patients mentally wrecked by a cancer diagnosis, and he often felt helpless to comfort them.

“You take care of the physical aspects of the cancer, right? You talk about side effects and recommend another scan to look for recurrence.”

“But what about the psychological effects?”

They can be very serious and too often go ignored, said Dr. Agrawal. Your plans for the future suddenly become moot. You may be concerned about your ability to work or worried about the pain and suffering and financial strain that might be ahead for both you and your family. And to top it all off, you’re staring into the face of your own mortality.

So it’s no wonder, said Dr. Agrawal, that many people develop clinical levels of anxiety and depression after a cancer diagnosis.

Like Dr. Bansal, Dr. Agrawal had been impressed by early studies on psilocybin-assisted therapies for end-of-life anxiety and depression. He had tried other approaches – support groups, one-on-one therapy, religious counselors, psychiatrist-prescribed medication – but he was never really happy with the results.

To Dr. Agrawal, psilocybin-assisted therapy was the first thing that looked like it could really make a difference.

And so after his psychedelic certification at the California Institute of Integral Studies, Dr. Agrawal was determined to change his approach.

The result was the Bill Richards Center for Healing at Aquilino Cancer Center, built specifically to study psychedelic-assisted therapies for psychological distress in people with cancer. The mission of the center is to help develop safe, FDA-approved psychedelic therapies for the mental health of cancer patients, and, once approved, provide a state-of-the-art facility and staff to administer those treatments.
 

A trip into the unknown

Back in the dosing room, Dr. Bansal was starting to feel the effects of the medication. As the psilocybin kicked in, spectacular images swirled.

“It was as if a million stained glass windows had suddenly come to life and were dancing in front of my vision,” Dr. Bansal said.

There were moving landscapes and intricate swirling patterns and massive stages in the sky where he saw orchestras playing the music he was hearing.

Dr. Bansal saw himself being crushed by a huge machine and buried, dead, in the Earth. He died and returned to life several times, glided over the top of New York City with the skyscrapers just below him, and took in the vision of the entire universe.

“I saw this expanse of the sky that was limitless. And there was this prehistoric reptile creature that spanned galaxies in the sky ahead of me who was dying. I said: ‘My God, the universe is dying,’ but then after a few moments, the universe came to life again in a burst of stars exploding.”

All the while, Dr. Bansal said, he was well aware that it was simply his mind creating these images, thoughts, and ideas. He knew he was in a safe room wearing eyeshades and headphones.

And yet, he says, it felt true. “The images and feelings are so powerful that you cannot help but believe they are in some way a part of reality.”

“At one point, I saw this giant Ferris wheel coming towards me and it was full of giant crabs, clicking and clacking their pincers. And my brain told me: ‘That’s my cancer!’ ”

Dr. Bansal was terrified. But he and his therapist had arranged a system of signals before the session. “If I was feeling afraid, I would hold his hand and if I had other issues, I would raise my hand. If I was feeling good, I would give him a thumbs up.”

Dr. Bansal reached out to his therapist and grasped his hand. “I said, ‘My cancer is coming at me!’ ”

His therapist was clear about what to do: Stand firm and walk toward it.

“That’s what they tell you: If you see anything frightening, you face it. And that’s the whole point of this exercise. And so, I stood and walked forward, and it just blew off in a puff of smoke.”
 

A state of peace

Around 3 hours into the experience, Dr. Bansal started to feel an immense sense of peace, happiness, and even comfort.

“I felt like I was watching a movie or a multidimensional slideshow. I was also a part of the movie. I felt like I could tell my mind what I wanted to see, and it would show it to me. It’s almost like you can mold your own visions. It was mystical.”

After about 8 hours, as the effects of the drug wore off, Dr. Bansal removed his eyeshades and headphones. He was completely drained.

“Even though I was lying down on my back for 7 hours, I felt like I had been run over by a truck. I was exhausted beyond belief physically and mentally.”

This was partly because of the fact that he hadn’t eaten much during the session. But mostly, said Dr. Bansal, it was because of the searing emotional intensity of the experience.
 

After the journey

It’s hard to put into words, said Dr. Bansal, what this treatment has done for his life. He feels as if he has stumbled onto something very precious that had been right in front of him all along. He wrote of his change in perspective almost obsessively in his journal in the days and weeks after treatment. One passage reads:

“It seems that, as time is passing on, I’m becoming more relaxed and hopeful, more calm, and at peace. Family has become even more important to me now. Money, politics, material gains, alcohol, seem less important.”

And yet there was nothing “easy” about the experience. In fact, in some ways the experience demanded more from him. “I feel I need to be more compassionate and considerate – less irritable and angry, more understanding of others’ needs. I feel I need to be a better human being, a better patient, a better father, and a better doctor for my patients.”

The experience, he said, gave him something far more important than mere ease. It gave him a sense of meaning.

From his journal:

“I died, and I was reborn. If I survived this, then I can face anything and anybody in the cosmic scheme. I can become part of it.

“How many sorrows in the universe? My cancer is nothing. Life does not end with the end of life. What was will be again. Eternally.”

That’s not an unusual response, according to the namesake of the Bill Richards Center for Healing. Bill Richards, PhD, has worked in the world of psychedelic-assisted psychotherapy since 1963.

A psychologist with decades of experience, Dr. Richards and colleagues figure that, with few possible exceptions, he has helped treat more people with psychedelic therapies than anyone alive in Western medicine today. At Aquilino, he works directly with patients and oversees the therapy protocol that goes along with the psilocybin dosing sessions.

“It’s inspiring,” Dr. Richards said.

“You meet someone who’s very depressed and scared and isolating from family and having all kinds of physical complaints. And a few days later, you talk to the same person and they have a whole new lease on life.”

And the positive effects can extend deep into the family system, he said.

After psilocybin treatment, said Dr. Richards, the person with cancer can become a kind of social worker for the family. They’re often far better able to talk about death and loss and even money and family issues than their loved ones. It’s not uncommon after treatment to see the resolution of years-old resentments or grievances that have dogged a family for many years.

Plus, said Dr. Richards, the cancer patient often ends up as a kind model to other family members for how to approach death. “They can demonstrate how to live fully – right to the last breath – which is a real gift because those relatives and loved ones have to die someday too, you know.”

At 80 years old, Dr. Richards is still in active practice and hopes to spend the rest of his days working with people in end-of-life care.
 

After the experience

Psychedelic-assisted therapy does not end with the dosing session. Integration sessions, where you discuss what happened during the dosing session, are a key part of most treatments.

The goal is to help participants absorb and “integrate” their experience. It typically happens over two or more sessions of 60-90 minutes with a therapist. In some cases, the therapist may invite a significant other to join in the integration process.

Dr. Agrawal’s trial at the Bill Richards center added something new: group therapy. Not only did Dr. Bansal meet with his therapist, he also met with a group of three other people in the trial who had their dosing the same day.

The point, said Dr. Agrawal, is to try and determine the effect of the group on the therapy. After their private dosing sessions, they come back together to discuss their experiences.

“After the psilocybin, they feel like they’ve been to war together,” Dr. Agrawal said. “There is this profound openness and connection. They feel able to share things with each other that they wouldn’t with other people.”

It will take some time to figure out how the group affects the overall outcome, but Dr. Bansal thinks it was integral to the success of his treatment.

In fact, he continues to meet regularly with his therapy group, even though it’s long since past the requirements of the study.
 

Pradeep 2.0

Dr. Bansal still has tough days with his cancer. Recently, immunotherapy treatment for his bladder caused side effects – pain, bleeding, fever, and chills – for most of the night. He felt like he was “passing razor blades” when he peed.

“And yet it was somehow okay,” he said. “It was only pain.”

“It’s as if there is a part of me that is watching myself objectively, going through the painful process of treatments saying: ‘It’s all right. I will be with you through this journey, through this experience. Don’t worry.’”

Months after taking that one dose, Dr. Bansal still calls it as “the single most powerful experience of my life.”

The change in his mental outlook, Dr. Bansal said, was profound, particularly in regard to his cancer.

“I understood that I still had cancer and that it could kill me in a few weeks, or months, or years. But my perspective had shifted.”

Dr. Bansal was as surprised as anyone. “Had somebody told me going into this that I would come out a transformed being or a person with a completely different perspective on life, I would never have believed it.”

He even named his new outlook. “I call it Pradeep 2.0.”

A version of this article first appeared on WebMD.com.

A specialty group is asking federal and state governments to preserve and expand access to telehealth services for children with developmental and behavioral problems.

Citing the success during the COVID-19 pandemic of telehealth for these patients, the Society for Developmental and Behavioral Pediatrics (SDBP) has issued a position statement in its official journal calling for continued use of video and telephone for home-based diagnostic assessments, medication management follow-ups, and therapeutic interventions for children  with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental conditions.

“Telehealth offers plenty of opportunities for quick check-ins. It can offer some crisis management opportunities ... to address a parent’s concern about challenging behaviors or navigating school system issues or developmental needs,” lead author Robert D. Keder, MD, assistant professor of pediatrics at University of Connecticut, Farmington, and cochair of SDBP’s Advocacy Committee, told this news organization.

“The video visit does really offer us so much more. It’s so enriching and lets us as providers meet the child in their natural home environment. The real magic of a video visit is we haven’t done house calls as a medical society for decades. But now, literally, the power of telehealth lets us do a house call.”

In the face of the pandemic, emergency government policies allowed care to continue remotely via telehealth, including video and phone calls. The policies have allowed patients to have video visits in their own home, lifted provider licensure requirements for visits across state lines, and allowed reimbursement not only for video visits but also for telephone encounters.

As a result, the field of developmental and behavioral pediatrics (DBP) has recognized telehealth as a viable and useful model of care for children with neurodevelopmental disorders, said Neelkamal Soares, MD, a member of the society’s board and a coauthor of the position paper.

“Telehealth has been helpful in mitigating barriers families often face when attending in-person visits,” such as the lack of transportation and child care, missed work hours, and other issues, said Dr. Soares, professor of pediatric and adolescent medicine at Western Michigan University Stryker in Kalamazoo. At the same time, the growth in the use of the technology has highlighted additional obstacles to equitable access to care, including broadband connectivity, digital literacy, and the availability of interpretation and sign language services, he said.

Dr. Keder said telehealth has enabled him to better help with behavior management by observing children where they are most comfortable. Remote visits also allow him to consider information such as furniture arrangements and how that can affect the patient’s living conditions, and also sibling interactions, learning and homework, eating, and sleep.

Telemedicine conferences enable DBP specialists to facilitate care collaboration with different members of the patient’s care team. Consent from a family and a click of a button allows for therapists, early intervention specialists, teachers, school nurses, or even primary care providers the capacity to participate in a telehealth visit, he said.

Dr. Keder said the future of telehealth is uncertain. The policies from the pandemic may expire in the near term and vary from state to state. The goal of the policy statement is to advocate for legislation and policies that support ongoing, equitable, home-based telehealth care for patients seen by DBP providers while ensuring equitable access to DBP in general.

Kate Benton, PhD, a clinical psychologist with Lurie Children’s Hospital at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., said the society has done an excellent job of explaining the need to maintain telehealth in light of the shortage of pediatricians, clinical psychologists, and other professionals in the field.

“Telehealth has opened new avenues for these patients who otherwise have difficulty seeing specialists. This is a population of children who without telehealth have significant challenges in getting access to care,” she said.

Wendy Fournier, mother of an autistic child and president of the National Autism Association, said telehealth can be beneficial for some individuals with the disorder.

“There are many aspects of in-person doctor visits that can be overwhelming, including bright lights, many people talking, waiting for the doctor, being comfortable with the doctor’s touch, etc.,” Ms. Fournier said in an interview. “All of these things can cause sensory and emotional dysregulation leading to overwhelming anxiety and fear.”

Visits to the doctor can be especially difficult for people who are nonverbal and unable to express their discomfort, said. 

“At my daughter’s last medical appointment, she could not stay in the exam room and pulled me out the door. Thankfully, we have an understanding and compassionate physician who finished our appointment in our car. I believe that telehealth visits should remain available as a necessary and vital accommodation for people with disabilities,” Ms. Fournier said.
 

False equivalence?

Dr. Soares said researchers have attempted to assess the evidence of telehealth benefits in such situations as ADHD, cognitive behavioral therapy, and parent training. 

“There is a paucity of published studies that specifically look at different conditions and compare in-person to telehealth visits, but these are ongoing in autism diagnostics and other areas by several SDBP members,” he said. “Stay tuned.”

Dr. Keder added that telehealth will never replace in-person visits, but the availability of this new option gives developmental pediatricians flexibility in strategies in treating and evaluating patients.

“Both are helpful and viable models. In the pandemic, we were forced out of necessity to embrace telehealth,” he said. “Because of this, we are seeing the power and benefits telehealth offers. Now many families like a mixture of alternating in person with telehealth visits.”

The policy statement cites research that finds patients are highly satisfied with telehealth and that telehealth may cost less than in-office visits.

The report stresses that equitable access to devices needed for telehealth visits is a concern because there is disproportionate access to required technology, especially in rural and underserved communities. The Federal Communications Commission has provided grants to eligible families to offset the cost, in part, for a laptop, desktop computer, or tablet. However, more is still needed, the group said.

The position paper calls for:

• Equitable access to the infrastructure and technology for telehealth, including greater access to broadband services in rural and underserved areas.
• Increased access to devices needed to connect children with neurodevelopmental disorders with critical health care services.
• Reimbursement of interpretation services for the people who are deaf and/or have limited English proficiency.
• Mitigation of geographic barriers to accessing DBP care.
• Permitting patients to access telehealth from their home or whichever physical location provides opportunities for safe and timely care, especially for established patients.
• Ensuring more engagement by state medical licensing boards to join the Interstate Medical Licensing Compact to provide care by telehealth when there is already an insufficient geographic distribution of that type of provider in a state, as is being conducted in the field of psychology.
• Ensuring ongoing reimbursement.
• Parity in reimbursement for telehealth in-person visits.
• Increased funding for research looking into outcomes, quality, and effectiveness of telehealth services at the federal and state levels.

“Our organization can work with families to educate lawmakers, insurance administrators, and organizational leaders about the value that telehealth holds in the care of their child and family,” Dr. Soares said. “We can also conduct research to add to the evidence based around the topic to further the science around telehealth outcomes and equivalency to in-person settings.”

“With the current workforce shortage in DBP and behavioral health it is more critical than ever to maintain access to care,” Dr. Keder added. “The pandemic has provided an opportunity to better harness the amazing power of telehealth to allow for access to equitable care for families. We hope that this statement moves legislators, leaders, and voters to continue to advocate for ongoing telehealth at both the state, federal, and organizational levels.”

Dr. Benton, Dr. Keder, and Dr. Soares have disclosed no financial conflicts of interest.

A version of this article first appeared on Medscape.com.

A specialty group is asking federal and state governments to preserve and expand access to telehealth services for children with developmental and behavioral problems.

Citing the success during the COVID-19 pandemic of telehealth for these patients, the Society for Developmental and Behavioral Pediatrics (SDBP) has issued a position statement in its official journal calling for continued use of video and telephone for home-based diagnostic assessments, medication management follow-ups, and therapeutic interventions for children  with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental conditions.

“Telehealth offers plenty of opportunities for quick check-ins. It can offer some crisis management opportunities ... to address a parent’s concern about challenging behaviors or navigating school system issues or developmental needs,” lead author Robert D. Keder, MD, assistant professor of pediatrics at University of Connecticut, Farmington, and cochair of SDBP’s Advocacy Committee, told this news organization.

“The video visit does really offer us so much more. It’s so enriching and lets us as providers meet the child in their natural home environment. The real magic of a video visit is we haven’t done house calls as a medical society for decades. But now, literally, the power of telehealth lets us do a house call.”

In the face of the pandemic, emergency government policies allowed care to continue remotely via telehealth, including video and phone calls. The policies have allowed patients to have video visits in their own home, lifted provider licensure requirements for visits across state lines, and allowed reimbursement not only for video visits but also for telephone encounters.

As a result, the field of developmental and behavioral pediatrics (DBP) has recognized telehealth as a viable and useful model of care for children with neurodevelopmental disorders, said Neelkamal Soares, MD, a member of the society’s board and a coauthor of the position paper.

“Telehealth has been helpful in mitigating barriers families often face when attending in-person visits,” such as the lack of transportation and child care, missed work hours, and other issues, said Dr. Soares, professor of pediatric and adolescent medicine at Western Michigan University Stryker in Kalamazoo. At the same time, the growth in the use of the technology has highlighted additional obstacles to equitable access to care, including broadband connectivity, digital literacy, and the availability of interpretation and sign language services, he said.

Dr. Keder said telehealth has enabled him to better help with behavior management by observing children where they are most comfortable. Remote visits also allow him to consider information such as furniture arrangements and how that can affect the patient’s living conditions, and also sibling interactions, learning and homework, eating, and sleep.

Telemedicine conferences enable DBP specialists to facilitate care collaboration with different members of the patient’s care team. Consent from a family and a click of a button allows for therapists, early intervention specialists, teachers, school nurses, or even primary care providers the capacity to participate in a telehealth visit, he said.

Dr. Keder said the future of telehealth is uncertain. The policies from the pandemic may expire in the near term and vary from state to state. The goal of the policy statement is to advocate for legislation and policies that support ongoing, equitable, home-based telehealth care for patients seen by DBP providers while ensuring equitable access to DBP in general.

Kate Benton, PhD, a clinical psychologist with Lurie Children’s Hospital at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., said the society has done an excellent job of explaining the need to maintain telehealth in light of the shortage of pediatricians, clinical psychologists, and other professionals in the field.

“Telehealth has opened new avenues for these patients who otherwise have difficulty seeing specialists. This is a population of children who without telehealth have significant challenges in getting access to care,” she said.

Wendy Fournier, mother of an autistic child and president of the National Autism Association, said telehealth can be beneficial for some individuals with the disorder.

“There are many aspects of in-person doctor visits that can be overwhelming, including bright lights, many people talking, waiting for the doctor, being comfortable with the doctor’s touch, etc.,” Ms. Fournier said in an interview. “All of these things can cause sensory and emotional dysregulation leading to overwhelming anxiety and fear.”

Visits to the doctor can be especially difficult for people who are nonverbal and unable to express their discomfort, said. 

“At my daughter’s last medical appointment, she could not stay in the exam room and pulled me out the door. Thankfully, we have an understanding and compassionate physician who finished our appointment in our car. I believe that telehealth visits should remain available as a necessary and vital accommodation for people with disabilities,” Ms. Fournier said.
 

False equivalence?

Dr. Soares said researchers have attempted to assess the evidence of telehealth benefits in such situations as ADHD, cognitive behavioral therapy, and parent training. 

“There is a paucity of published studies that specifically look at different conditions and compare in-person to telehealth visits, but these are ongoing in autism diagnostics and other areas by several SDBP members,” he said. “Stay tuned.”

Dr. Keder added that telehealth will never replace in-person visits, but the availability of this new option gives developmental pediatricians flexibility in strategies in treating and evaluating patients.

“Both are helpful and viable models. In the pandemic, we were forced out of necessity to embrace telehealth,” he said. “Because of this, we are seeing the power and benefits telehealth offers. Now many families like a mixture of alternating in person with telehealth visits.”

The policy statement cites research that finds patients are highly satisfied with telehealth and that telehealth may cost less than in-office visits.

The report stresses that equitable access to devices needed for telehealth visits is a concern because there is disproportionate access to required technology, especially in rural and underserved communities. The Federal Communications Commission has provided grants to eligible families to offset the cost, in part, for a laptop, desktop computer, or tablet. However, more is still needed, the group said.

The position paper calls for:

• Equitable access to the infrastructure and technology for telehealth, including greater access to broadband services in rural and underserved areas.
• Increased access to devices needed to connect children with neurodevelopmental disorders with critical health care services.
• Reimbursement of interpretation services for the people who are deaf and/or have limited English proficiency.
• Mitigation of geographic barriers to accessing DBP care.
• Permitting patients to access telehealth from their home or whichever physical location provides opportunities for safe and timely care, especially for established patients.
• Ensuring more engagement by state medical licensing boards to join the Interstate Medical Licensing Compact to provide care by telehealth when there is already an insufficient geographic distribution of that type of provider in a state, as is being conducted in the field of psychology.
• Ensuring ongoing reimbursement.
• Parity in reimbursement for telehealth in-person visits.
• Increased funding for research looking into outcomes, quality, and effectiveness of telehealth services at the federal and state levels.

“Our organization can work with families to educate lawmakers, insurance administrators, and organizational leaders about the value that telehealth holds in the care of their child and family,” Dr. Soares said. “We can also conduct research to add to the evidence based around the topic to further the science around telehealth outcomes and equivalency to in-person settings.”

“With the current workforce shortage in DBP and behavioral health it is more critical than ever to maintain access to care,” Dr. Keder added. “The pandemic has provided an opportunity to better harness the amazing power of telehealth to allow for access to equitable care for families. We hope that this statement moves legislators, leaders, and voters to continue to advocate for ongoing telehealth at both the state, federal, and organizational levels.”

Dr. Benton, Dr. Keder, and Dr. Soares have disclosed no financial conflicts of interest.

A version of this article first appeared on Medscape.com.

A specialty group is asking federal and state governments to preserve and expand access to telehealth services for children with developmental and behavioral problems.

Citing the success during the COVID-19 pandemic of telehealth for these patients, the Society for Developmental and Behavioral Pediatrics (SDBP) has issued a position statement in its official journal calling for continued use of video and telephone for home-based diagnostic assessments, medication management follow-ups, and therapeutic interventions for children  with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental conditions.

“Telehealth offers plenty of opportunities for quick check-ins. It can offer some crisis management opportunities ... to address a parent’s concern about challenging behaviors or navigating school system issues or developmental needs,” lead author Robert D. Keder, MD, assistant professor of pediatrics at University of Connecticut, Farmington, and cochair of SDBP’s Advocacy Committee, told this news organization.

“The video visit does really offer us so much more. It’s so enriching and lets us as providers meet the child in their natural home environment. The real magic of a video visit is we haven’t done house calls as a medical society for decades. But now, literally, the power of telehealth lets us do a house call.”

In the face of the pandemic, emergency government policies allowed care to continue remotely via telehealth, including video and phone calls. The policies have allowed patients to have video visits in their own home, lifted provider licensure requirements for visits across state lines, and allowed reimbursement not only for video visits but also for telephone encounters.

As a result, the field of developmental and behavioral pediatrics (DBP) has recognized telehealth as a viable and useful model of care for children with neurodevelopmental disorders, said Neelkamal Soares, MD, a member of the society’s board and a coauthor of the position paper.

“Telehealth has been helpful in mitigating barriers families often face when attending in-person visits,” such as the lack of transportation and child care, missed work hours, and other issues, said Dr. Soares, professor of pediatric and adolescent medicine at Western Michigan University Stryker in Kalamazoo. At the same time, the growth in the use of the technology has highlighted additional obstacles to equitable access to care, including broadband connectivity, digital literacy, and the availability of interpretation and sign language services, he said.

Dr. Keder said telehealth has enabled him to better help with behavior management by observing children where they are most comfortable. Remote visits also allow him to consider information such as furniture arrangements and how that can affect the patient’s living conditions, and also sibling interactions, learning and homework, eating, and sleep.

Telemedicine conferences enable DBP specialists to facilitate care collaboration with different members of the patient’s care team. Consent from a family and a click of a button allows for therapists, early intervention specialists, teachers, school nurses, or even primary care providers the capacity to participate in a telehealth visit, he said.

Dr. Keder said the future of telehealth is uncertain. The policies from the pandemic may expire in the near term and vary from state to state. The goal of the policy statement is to advocate for legislation and policies that support ongoing, equitable, home-based telehealth care for patients seen by DBP providers while ensuring equitable access to DBP in general.

Kate Benton, PhD, a clinical psychologist with Lurie Children’s Hospital at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., said the society has done an excellent job of explaining the need to maintain telehealth in light of the shortage of pediatricians, clinical psychologists, and other professionals in the field.

“Telehealth has opened new avenues for these patients who otherwise have difficulty seeing specialists. This is a population of children who without telehealth have significant challenges in getting access to care,” she said.

Wendy Fournier, mother of an autistic child and president of the National Autism Association, said telehealth can be beneficial for some individuals with the disorder.

“There are many aspects of in-person doctor visits that can be overwhelming, including bright lights, many people talking, waiting for the doctor, being comfortable with the doctor’s touch, etc.,” Ms. Fournier said in an interview. “All of these things can cause sensory and emotional dysregulation leading to overwhelming anxiety and fear.”

Visits to the doctor can be especially difficult for people who are nonverbal and unable to express their discomfort, said. 

“At my daughter’s last medical appointment, she could not stay in the exam room and pulled me out the door. Thankfully, we have an understanding and compassionate physician who finished our appointment in our car. I believe that telehealth visits should remain available as a necessary and vital accommodation for people with disabilities,” Ms. Fournier said.
 

False equivalence?

Dr. Soares said researchers have attempted to assess the evidence of telehealth benefits in such situations as ADHD, cognitive behavioral therapy, and parent training. 

“There is a paucity of published studies that specifically look at different conditions and compare in-person to telehealth visits, but these are ongoing in autism diagnostics and other areas by several SDBP members,” he said. “Stay tuned.”

Dr. Keder added that telehealth will never replace in-person visits, but the availability of this new option gives developmental pediatricians flexibility in strategies in treating and evaluating patients.

“Both are helpful and viable models. In the pandemic, we were forced out of necessity to embrace telehealth,” he said. “Because of this, we are seeing the power and benefits telehealth offers. Now many families like a mixture of alternating in person with telehealth visits.”

The policy statement cites research that finds patients are highly satisfied with telehealth and that telehealth may cost less than in-office visits.

The report stresses that equitable access to devices needed for telehealth visits is a concern because there is disproportionate access to required technology, especially in rural and underserved communities. The Federal Communications Commission has provided grants to eligible families to offset the cost, in part, for a laptop, desktop computer, or tablet. However, more is still needed, the group said.

The position paper calls for:

• Equitable access to the infrastructure and technology for telehealth, including greater access to broadband services in rural and underserved areas.
• Increased access to devices needed to connect children with neurodevelopmental disorders with critical health care services.
• Reimbursement of interpretation services for the people who are deaf and/or have limited English proficiency.
• Mitigation of geographic barriers to accessing DBP care.
• Permitting patients to access telehealth from their home or whichever physical location provides opportunities for safe and timely care, especially for established patients.
• Ensuring more engagement by state medical licensing boards to join the Interstate Medical Licensing Compact to provide care by telehealth when there is already an insufficient geographic distribution of that type of provider in a state, as is being conducted in the field of psychology.
• Ensuring ongoing reimbursement.
• Parity in reimbursement for telehealth in-person visits.
• Increased funding for research looking into outcomes, quality, and effectiveness of telehealth services at the federal and state levels.

“Our organization can work with families to educate lawmakers, insurance administrators, and organizational leaders about the value that telehealth holds in the care of their child and family,” Dr. Soares said. “We can also conduct research to add to the evidence based around the topic to further the science around telehealth outcomes and equivalency to in-person settings.”

“With the current workforce shortage in DBP and behavioral health it is more critical than ever to maintain access to care,” Dr. Keder added. “The pandemic has provided an opportunity to better harness the amazing power of telehealth to allow for access to equitable care for families. We hope that this statement moves legislators, leaders, and voters to continue to advocate for ongoing telehealth at both the state, federal, and organizational levels.”

Dr. Benton, Dr. Keder, and Dr. Soares have disclosed no financial conflicts of interest.

A version of this article first appeared on Medscape.com.

Suicide is a national public health concern that affects thousands of US individuals and families, with repercussions that reverberate through entire communities. In 2019, there were 47,500 US deaths by suicide, which accounted for about 1 death every 11 minutes.¹ Suicide remains the tenth leading cause of death in the United States and has been part of the top 12 leading causes of death since 1975.² Unfortunately, this trend has worsened; suicide rates have increased by 35% from 1999 to 2018.³ One particularly vulnerable population is US veterans who accounted for 13.8% of all suicide deaths in 2018.⁴ Among veterans, the suicide death average increased from 16.6 per day in 2005 to 17.6 in 2018.⁴ Furthermore, veterans experiencing homelessness are 5 times more likely to attempt suicide and 2.5 times more likely to have suicidal ideation compared with veterans without a history of homelessness.⁴ Suicide is a significant issue among veterans experiencing homelessness: Veterans account for about 11% of the overall US homeless population.⁵

Recent data suggest opportunities for suicide risk assessment in the primary care setting. A study from the Veterans Health Administration (VHA) Office for Suicide Prevention found that in 2014 an average of 20 veterans died by suicide every day and 6 of the 20 (30%) on average used VHA services within the prior year.⁶ Similarly, a review of 40 studies on suicide found that 45% of suicide victims had contact with their primary care practitioner (PCP) within 1 month of suicide, and 75% of victims had contact within the year of suicide.⁷ An analysis of depression screening in 2008/2009 using Patient Health Questionnaire-2 (PHQ-2) or Patient Health Questionnaire-9 (PHQ-9) at 3 large western US Department of Veterans Affairs (VA) medical centers found that 55% were screened for depression.⁸ The VA has made suicide prevention a top priority and supports the established US goal of reducing annual suicide deaths by 20% by 2025.⁹ Given key opportunities for suicide risk assessment in the primary care setting, the VHA Office of Mental Health and Suicide Prevention implemented a national, standardized process for suicide risk assessment on October 1, 2018.^10,11

The VA approach to suicide screening, evaluation, and documentation has evolved over time. Between October 2018 and December 2020, the process was augmented to include 3 stages embedded into the electronic health record (EHR): a primary screen (PHQ-2 with Item 9 from the PHQ-9 [PHQ-2+I9]), a secondary screen (Columbia-Suicide Severity Rating Scale [C-SSRS]), and a tertiary screen (Comprehensive Suicide Risk Evaluation [CSRE]). The primary screen consisted of the depression screening using the PHQ-2 with the addition of I9 asking about suicidal ideation. The secondary screening, or C-SSRS, included 8 questions to elaborate on suicidal ideation, intent, plan, and any history of suicidal attempts or preparatory behaviors. The tertiary screen consisted of the CSRE, a questionnaire developed internally by the VA in 2018 to further evaluate the veteran’s suicidal thoughts, attempts, warning signs, risk factors, protective factors, and reasons for living. The goal of the screenings was to identify veterans at risk of suicide, assess risk severity, and to individually tailor risk mitigation strategies for safe disposition. These risk categories were developed by the regional Mental Illness Research, Education and Clinical Center, which suggested treatment strategies, such as hospitalization or close outpatient follow-up.^12,13

The Homeless Patient Aligned Care Team (HPACT) clinic at the West Los Angeles VA Medical Center (WLAVAMC) in California, one of the largest VA homeless clinics in the country and 1 of 7 national VA Office of Academic Affiliation Centers of Excellence in Primary Care Education training programs implemented the standardized tools for suicide risk screening and quality improvement (QI). The HPACT clinic is an interprofessional team, including primary care, mental health, social work, pharmacy, and peer support, that is adjacent to the WLAVAMC general primary care clinics. The team collaboratively addresses both medical and psychosocial needs of veterans with a focus on the Housing First Model, an approach that prioritizes ending homelessness while addressing all factors associated with veterans' health and well-being. After 1 year of stable housing, veterans graduate to the WLAVAMC general primary care clinics.

Given the vulnerability of veterans experiencing homelessness, the clinic leadership identified suicide risk screening as a high priority initiative and created a taskforce to oversee effective implementation of clinic screening efforts. An interprofessional team of nurse practitioners (NPs), pharmacists, physicians, psychologists, social workers (SWs), and trainees formed to improve screening efforts and use the QI principles to guide analysis and intervention. The team wrote the following SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) Aim statements: (1) ensure > 90% of eligible patients receive a primary screen; (2) ensure > 90% of positive primary I9 screens receive subsequent screenings within 24 hours; and (3) increase staff comfort and familiarity using the screening tools. This article examines the results of the screening initiative 1-year postimplementation, describes difficulties faced, and suggests strategies that might be used to overcome those challenges.

Methods

This QI analysis was exempt from institutional review board review. Prior to the standardized national suicide risk assessment rollout of October 1, 2018, the QI team met to review and understand the workflow to be implemented into the HPACT clinic. To describe the initial screening process, the new suicide risk assessment consisted of primary, secondary, and tertiary screens that would warrant subsequent intervention by clinicians if positive (Figure 1). The primary screen included the PHQ-2+I9 questionnaire (PHQ-2 for depression and I9 for suicidal ideation). If either were positive, follow-up questionnaires were required. Of note, patients with a prior depression diagnosis, cognitive impairment defined at a severity of moderate or greater based on clinician evaluation and judgement, or life expectancy < 6 months were exempt from screening because, by definition, they had theoretically already been screened and classified as under surveillance.

A positive I9 response prompted a secondary screen using C-SSRS. A positive secondary screen prompted a tertiary screen using CSRE. If the PHQ-2 screening was positive but I9 was negative, the standard follow-up depression clinical reminder was used. Any clinical staff member could perform the primary screen, including licensed vocational nurses (LVNs), registered nurses (RNs), and SWs in any setting (eg, emergency department, primary care, inpatient services). The secondary and tertiary screens required completion by a licensed clinician. RNs were able to perform the secondary screen but not the tertiary screen.

The HPACT clinic serves approximately 3000 patients by 50 staff and trainees divided into 2 teams. LVNs and RNs were tasked to conduct the primary screen as part of their initial clinic check-in. If the primary screen was positive for scheduled patients, LVNs notified a PCP to complete the secondary screen. For unscheduled patients, RNs conducted a primary screen and, if positive, a secondary screen. If the secondary screen was positive, a tertiary screen was performed by mental health practitioners or SWs, or PCPs if the former were unavailable. SWs, mental health practitioners, and PCPs were colocated in the clinic, which allowed for safe and convenient warm handoffs between clinicians.

Results

During the project year, the HPACT clinic had 2932 unique patients assigned to primary care. Of those veterans, 533 (18%) were exempt from screening by protocol. Of the remainder, staff screened 1876 (64%) of eligible veterans for suicide risk (Figure 2), which did not meet the SMART Aim of screening > 90% of eligible veterans. For the follow-up screens, using a QI dashboard designed for reviewing I9 and C-SSRS results, the QI team reviewed a convenience sample of 5 provider panels and identified 34 positive I9 screens. Twenty of those 34 patients (59%) received a C-SSRS within 24 hours of the positive I9, which did not meet the SMART Aim of ensuring > 90% of primary I9 screens had subsequent C-SSRS screening within 24 hours.

Of the veterans screened, 1,271 (43%) had their screening performed outside of the HPACT primary care team assigned, while 605 (21%) patients had their screening performed by an HPACT member. Most of the screening that occurred outside of the assigned primary care team occurred in other physical settings, including other VA facilities.

Of the 523 (18%) patients who were not screened, 331 (11%) patients had no visit to the HPACT clinic and 132 (5%) empaneled patients did not visit any VA site within the 1-year period. There were 192 (7%) patients who were not screened that had a visit to HPACT while 19 (1%) of those patients declined screening. A total of 184 (6%) patients were not screened and thus were considered true missed opportunities. This group of patients were eligible for screening but did not undergo screening in the HPACT clinic or any other VA setting despite visiting the VA.

Discussion

Though the QI project failed to meet the SMART Aim of ensuring > 90% of eligible patients received a primary screen for suicide risk and > 90% of positive primary I9 screens received subsequent screenings within 24 hours, the results highlight effective practices and barriers for implementation of wide-scale EHR-based interventions for suicide assessment. Most missed screening opportunities were due to patients being lost to follow-up over the duration of the project, which is a challenge faced in this patient population. A recent analysis of the national rollout of this screening program found that 95% of eligible veterans with a visit to the VA in the first year of the program received screening.¹⁴ In a post hoc analysis using the same eligibility criteria, the rate of screening for this project was 83%. Reflecting on the data from this national cohort compared with the HPACT clinic, this brings to light potential circumstances that may be unique to veterans experiencing homelessness compared with the general veteran population, for instance, the level of engagement may be lower among veterans experiencing homelessness, though this is beyond the scope of this article. Nonetheless, promoting interprofessional collaboration, visualizing effective process flows, establishing clear lines of communication and roles for involved staff, and opening avenues for continuous feedback and troubleshooting are all potentially effective interventions to improve suicide screening rates within the veteran population.

This HPACT clinic initiative aimed to determine how a new screening process would be implemented while identifying potential areas for improvement. Surprisingly, 43% of patients who were screened had their screening performed outside of the HPACT clinic, most often in the inpatient setting at other WLAVAMC clinics or other VA systems. It is possible that due to the nature of the patient population that the HPACT clinic serves with intensive service needs, these patients have wider geographic and clinical location use than most clinic populations due to the transient nature of patients with housing insecurity. What is encouraging, however, is that through this systemwide initiative, there is an impetus to screen veterans, regardless of who performs the screening. This is particularly meaningful given that rates of depression screening may be as low as 4% among PCPs.¹⁵ During implementation, the QI team learned that nearly 18% of the empaneled HPACT patients were exempt from screening. The exempt patients do not have an active clinical reminder for depression screens. Instead, these patients are receiving mental health surveillance and specialty treatment, during which continuous monitoring and assessment for suicidal ideation and risk of suicide are performed. Additionally, an EHR-based factor that also may limit appropriate follow-up and contribute to missed opportunities is that secondary and tertiary screens do not populate until the EHR was refreshed after positive primary screens, which introduces human error in a process that could be automated. Both RNs and PCPs may occasionally miss secondary and tertiary screens due to this issue, which continues to be a barrier. Given the high risk HPACT clinic population, the QI team encouraged staff members to frequently screen patients for suicidal ideation regardless of clinical reminders. A consideration for the future would be to identify optimal frequency for screening and to continue to validate assessment methods.

Limitations

Due to the limited sample size, findings cannot be generalized to all VA sites. The QI team used retrospective, administrative data. Additionally, since this is a primary care clinic focused on a specialized population, this result may not be generalizable to all primary care settings, other primary care populations, or even other homeless primary care clinics, though it may establish a benchmark when other clinics internally examine their data and processes.

Conclusions

Improving screening protocols can lead to identification of at-risk individuals who would not have otherwise been identified.^16,17 As the US continues to grapple with mental health and suicide, efforts toward addressing this important issue among veterans remains a top priority.

Acknowledgments

Thank you to the VAGLAHS Center of Excellence in Primary Care Education faculty and trainees, the HPACT staff, and the VA Informatics and Computing Infrastructure (VINCI) for data support.

Suicide is a national public health concern that affects thousands of US individuals and families, with repercussions that reverberate through entire communities. In 2019, there were 47,500 US deaths by suicide, which accounted for about 1 death every 11 minutes.¹ Suicide remains the tenth leading cause of death in the United States and has been part of the top 12 leading causes of death since 1975.² Unfortunately, this trend has worsened; suicide rates have increased by 35% from 1999 to 2018.³ One particularly vulnerable population is US veterans who accounted for 13.8% of all suicide deaths in 2018.⁴ Among veterans, the suicide death average increased from 16.6 per day in 2005 to 17.6 in 2018.⁴ Furthermore, veterans experiencing homelessness are 5 times more likely to attempt suicide and 2.5 times more likely to have suicidal ideation compared with veterans without a history of homelessness.⁴ Suicide is a significant issue among veterans experiencing homelessness: Veterans account for about 11% of the overall US homeless population.⁵

Recent data suggest opportunities for suicide risk assessment in the primary care setting. A study from the Veterans Health Administration (VHA) Office for Suicide Prevention found that in 2014 an average of 20 veterans died by suicide every day and 6 of the 20 (30%) on average used VHA services within the prior year.⁶ Similarly, a review of 40 studies on suicide found that 45% of suicide victims had contact with their primary care practitioner (PCP) within 1 month of suicide, and 75% of victims had contact within the year of suicide.⁷ An analysis of depression screening in 2008/2009 using Patient Health Questionnaire-2 (PHQ-2) or Patient Health Questionnaire-9 (PHQ-9) at 3 large western US Department of Veterans Affairs (VA) medical centers found that 55% were screened for depression.⁸ The VA has made suicide prevention a top priority and supports the established US goal of reducing annual suicide deaths by 20% by 2025.⁹ Given key opportunities for suicide risk assessment in the primary care setting, the VHA Office of Mental Health and Suicide Prevention implemented a national, standardized process for suicide risk assessment on October 1, 2018.^10,11

The VA approach to suicide screening, evaluation, and documentation has evolved over time. Between October 2018 and December 2020, the process was augmented to include 3 stages embedded into the electronic health record (EHR): a primary screen (PHQ-2 with Item 9 from the PHQ-9 [PHQ-2+I9]), a secondary screen (Columbia-Suicide Severity Rating Scale [C-SSRS]), and a tertiary screen (Comprehensive Suicide Risk Evaluation [CSRE]). The primary screen consisted of the depression screening using the PHQ-2 with the addition of I9 asking about suicidal ideation. The secondary screening, or C-SSRS, included 8 questions to elaborate on suicidal ideation, intent, plan, and any history of suicidal attempts or preparatory behaviors. The tertiary screen consisted of the CSRE, a questionnaire developed internally by the VA in 2018 to further evaluate the veteran’s suicidal thoughts, attempts, warning signs, risk factors, protective factors, and reasons for living. The goal of the screenings was to identify veterans at risk of suicide, assess risk severity, and to individually tailor risk mitigation strategies for safe disposition. These risk categories were developed by the regional Mental Illness Research, Education and Clinical Center, which suggested treatment strategies, such as hospitalization or close outpatient follow-up.^12,13

The Homeless Patient Aligned Care Team (HPACT) clinic at the West Los Angeles VA Medical Center (WLAVAMC) in California, one of the largest VA homeless clinics in the country and 1 of 7 national VA Office of Academic Affiliation Centers of Excellence in Primary Care Education training programs implemented the standardized tools for suicide risk screening and quality improvement (QI). The HPACT clinic is an interprofessional team, including primary care, mental health, social work, pharmacy, and peer support, that is adjacent to the WLAVAMC general primary care clinics. The team collaboratively addresses both medical and psychosocial needs of veterans with a focus on the Housing First Model, an approach that prioritizes ending homelessness while addressing all factors associated with veterans' health and well-being. After 1 year of stable housing, veterans graduate to the WLAVAMC general primary care clinics.

Given the vulnerability of veterans experiencing homelessness, the clinic leadership identified suicide risk screening as a high priority initiative and created a taskforce to oversee effective implementation of clinic screening efforts. An interprofessional team of nurse practitioners (NPs), pharmacists, physicians, psychologists, social workers (SWs), and trainees formed to improve screening efforts and use the QI principles to guide analysis and intervention. The team wrote the following SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) Aim statements: (1) ensure > 90% of eligible patients receive a primary screen; (2) ensure > 90% of positive primary I9 screens receive subsequent screenings within 24 hours; and (3) increase staff comfort and familiarity using the screening tools. This article examines the results of the screening initiative 1-year postimplementation, describes difficulties faced, and suggests strategies that might be used to overcome those challenges.

Methods

This QI analysis was exempt from institutional review board review. Prior to the standardized national suicide risk assessment rollout of October 1, 2018, the QI team met to review and understand the workflow to be implemented into the HPACT clinic. To describe the initial screening process, the new suicide risk assessment consisted of primary, secondary, and tertiary screens that would warrant subsequent intervention by clinicians if positive (Figure 1). The primary screen included the PHQ-2+I9 questionnaire (PHQ-2 for depression and I9 for suicidal ideation). If either were positive, follow-up questionnaires were required. Of note, patients with a prior depression diagnosis, cognitive impairment defined at a severity of moderate or greater based on clinician evaluation and judgement, or life expectancy < 6 months were exempt from screening because, by definition, they had theoretically already been screened and classified as under surveillance.

A positive I9 response prompted a secondary screen using C-SSRS. A positive secondary screen prompted a tertiary screen using CSRE. If the PHQ-2 screening was positive but I9 was negative, the standard follow-up depression clinical reminder was used. Any clinical staff member could perform the primary screen, including licensed vocational nurses (LVNs), registered nurses (RNs), and SWs in any setting (eg, emergency department, primary care, inpatient services). The secondary and tertiary screens required completion by a licensed clinician. RNs were able to perform the secondary screen but not the tertiary screen.

The HPACT clinic serves approximately 3000 patients by 50 staff and trainees divided into 2 teams. LVNs and RNs were tasked to conduct the primary screen as part of their initial clinic check-in. If the primary screen was positive for scheduled patients, LVNs notified a PCP to complete the secondary screen. For unscheduled patients, RNs conducted a primary screen and, if positive, a secondary screen. If the secondary screen was positive, a tertiary screen was performed by mental health practitioners or SWs, or PCPs if the former were unavailable. SWs, mental health practitioners, and PCPs were colocated in the clinic, which allowed for safe and convenient warm handoffs between clinicians.

Results

During the project year, the HPACT clinic had 2932 unique patients assigned to primary care. Of those veterans, 533 (18%) were exempt from screening by protocol. Of the remainder, staff screened 1876 (64%) of eligible veterans for suicide risk (Figure 2), which did not meet the SMART Aim of screening > 90% of eligible veterans. For the follow-up screens, using a QI dashboard designed for reviewing I9 and C-SSRS results, the QI team reviewed a convenience sample of 5 provider panels and identified 34 positive I9 screens. Twenty of those 34 patients (59%) received a C-SSRS within 24 hours of the positive I9, which did not meet the SMART Aim of ensuring > 90% of primary I9 screens had subsequent C-SSRS screening within 24 hours.

Of the veterans screened, 1,271 (43%) had their screening performed outside of the HPACT primary care team assigned, while 605 (21%) patients had their screening performed by an HPACT member. Most of the screening that occurred outside of the assigned primary care team occurred in other physical settings, including other VA facilities.

Of the 523 (18%) patients who were not screened, 331 (11%) patients had no visit to the HPACT clinic and 132 (5%) empaneled patients did not visit any VA site within the 1-year period. There were 192 (7%) patients who were not screened that had a visit to HPACT while 19 (1%) of those patients declined screening. A total of 184 (6%) patients were not screened and thus were considered true missed opportunities. This group of patients were eligible for screening but did not undergo screening in the HPACT clinic or any other VA setting despite visiting the VA.

Discussion

Though the QI project failed to meet the SMART Aim of ensuring > 90% of eligible patients received a primary screen for suicide risk and > 90% of positive primary I9 screens received subsequent screenings within 24 hours, the results highlight effective practices and barriers for implementation of wide-scale EHR-based interventions for suicide assessment. Most missed screening opportunities were due to patients being lost to follow-up over the duration of the project, which is a challenge faced in this patient population. A recent analysis of the national rollout of this screening program found that 95% of eligible veterans with a visit to the VA in the first year of the program received screening.¹⁴ In a post hoc analysis using the same eligibility criteria, the rate of screening for this project was 83%. Reflecting on the data from this national cohort compared with the HPACT clinic, this brings to light potential circumstances that may be unique to veterans experiencing homelessness compared with the general veteran population, for instance, the level of engagement may be lower among veterans experiencing homelessness, though this is beyond the scope of this article. Nonetheless, promoting interprofessional collaboration, visualizing effective process flows, establishing clear lines of communication and roles for involved staff, and opening avenues for continuous feedback and troubleshooting are all potentially effective interventions to improve suicide screening rates within the veteran population.

This HPACT clinic initiative aimed to determine how a new screening process would be implemented while identifying potential areas for improvement. Surprisingly, 43% of patients who were screened had their screening performed outside of the HPACT clinic, most often in the inpatient setting at other WLAVAMC clinics or other VA systems. It is possible that due to the nature of the patient population that the HPACT clinic serves with intensive service needs, these patients have wider geographic and clinical location use than most clinic populations due to the transient nature of patients with housing insecurity. What is encouraging, however, is that through this systemwide initiative, there is an impetus to screen veterans, regardless of who performs the screening. This is particularly meaningful given that rates of depression screening may be as low as 4% among PCPs.¹⁵ During implementation, the QI team learned that nearly 18% of the empaneled HPACT patients were exempt from screening. The exempt patients do not have an active clinical reminder for depression screens. Instead, these patients are receiving mental health surveillance and specialty treatment, during which continuous monitoring and assessment for suicidal ideation and risk of suicide are performed. Additionally, an EHR-based factor that also may limit appropriate follow-up and contribute to missed opportunities is that secondary and tertiary screens do not populate until the EHR was refreshed after positive primary screens, which introduces human error in a process that could be automated. Both RNs and PCPs may occasionally miss secondary and tertiary screens due to this issue, which continues to be a barrier. Given the high risk HPACT clinic population, the QI team encouraged staff members to frequently screen patients for suicidal ideation regardless of clinical reminders. A consideration for the future would be to identify optimal frequency for screening and to continue to validate assessment methods.

Limitations

Due to the limited sample size, findings cannot be generalized to all VA sites. The QI team used retrospective, administrative data. Additionally, since this is a primary care clinic focused on a specialized population, this result may not be generalizable to all primary care settings, other primary care populations, or even other homeless primary care clinics, though it may establish a benchmark when other clinics internally examine their data and processes.

Conclusions

Improving screening protocols can lead to identification of at-risk individuals who would not have otherwise been identified.^16,17 As the US continues to grapple with mental health and suicide, efforts toward addressing this important issue among veterans remains a top priority.

Acknowledgments

Thank you to the VAGLAHS Center of Excellence in Primary Care Education faculty and trainees, the HPACT staff, and the VA Informatics and Computing Infrastructure (VINCI) for data support.

Suicide is a national public health concern that affects thousands of US individuals and families, with repercussions that reverberate through entire communities. In 2019, there were 47,500 US deaths by suicide, which accounted for about 1 death every 11 minutes.¹ Suicide remains the tenth leading cause of death in the United States and has been part of the top 12 leading causes of death since 1975.² Unfortunately, this trend has worsened; suicide rates have increased by 35% from 1999 to 2018.³ One particularly vulnerable population is US veterans who accounted for 13.8% of all suicide deaths in 2018.⁴ Among veterans, the suicide death average increased from 16.6 per day in 2005 to 17.6 in 2018.⁴ Furthermore, veterans experiencing homelessness are 5 times more likely to attempt suicide and 2.5 times more likely to have suicidal ideation compared with veterans without a history of homelessness.⁴ Suicide is a significant issue among veterans experiencing homelessness: Veterans account for about 11% of the overall US homeless population.⁵

Recent data suggest opportunities for suicide risk assessment in the primary care setting. A study from the Veterans Health Administration (VHA) Office for Suicide Prevention found that in 2014 an average of 20 veterans died by suicide every day and 6 of the 20 (30%) on average used VHA services within the prior year.⁶ Similarly, a review of 40 studies on suicide found that 45% of suicide victims had contact with their primary care practitioner (PCP) within 1 month of suicide, and 75% of victims had contact within the year of suicide.⁷ An analysis of depression screening in 2008/2009 using Patient Health Questionnaire-2 (PHQ-2) or Patient Health Questionnaire-9 (PHQ-9) at 3 large western US Department of Veterans Affairs (VA) medical centers found that 55% were screened for depression.⁸ The VA has made suicide prevention a top priority and supports the established US goal of reducing annual suicide deaths by 20% by 2025.⁹ Given key opportunities for suicide risk assessment in the primary care setting, the VHA Office of Mental Health and Suicide Prevention implemented a national, standardized process for suicide risk assessment on October 1, 2018.^10,11

The VA approach to suicide screening, evaluation, and documentation has evolved over time. Between October 2018 and December 2020, the process was augmented to include 3 stages embedded into the electronic health record (EHR): a primary screen (PHQ-2 with Item 9 from the PHQ-9 [PHQ-2+I9]), a secondary screen (Columbia-Suicide Severity Rating Scale [C-SSRS]), and a tertiary screen (Comprehensive Suicide Risk Evaluation [CSRE]). The primary screen consisted of the depression screening using the PHQ-2 with the addition of I9 asking about suicidal ideation. The secondary screening, or C-SSRS, included 8 questions to elaborate on suicidal ideation, intent, plan, and any history of suicidal attempts or preparatory behaviors. The tertiary screen consisted of the CSRE, a questionnaire developed internally by the VA in 2018 to further evaluate the veteran’s suicidal thoughts, attempts, warning signs, risk factors, protective factors, and reasons for living. The goal of the screenings was to identify veterans at risk of suicide, assess risk severity, and to individually tailor risk mitigation strategies for safe disposition. These risk categories were developed by the regional Mental Illness Research, Education and Clinical Center, which suggested treatment strategies, such as hospitalization or close outpatient follow-up.^12,13

The Homeless Patient Aligned Care Team (HPACT) clinic at the West Los Angeles VA Medical Center (WLAVAMC) in California, one of the largest VA homeless clinics in the country and 1 of 7 national VA Office of Academic Affiliation Centers of Excellence in Primary Care Education training programs implemented the standardized tools for suicide risk screening and quality improvement (QI). The HPACT clinic is an interprofessional team, including primary care, mental health, social work, pharmacy, and peer support, that is adjacent to the WLAVAMC general primary care clinics. The team collaboratively addresses both medical and psychosocial needs of veterans with a focus on the Housing First Model, an approach that prioritizes ending homelessness while addressing all factors associated with veterans' health and well-being. After 1 year of stable housing, veterans graduate to the WLAVAMC general primary care clinics.

Given the vulnerability of veterans experiencing homelessness, the clinic leadership identified suicide risk screening as a high priority initiative and created a taskforce to oversee effective implementation of clinic screening efforts. An interprofessional team of nurse practitioners (NPs), pharmacists, physicians, psychologists, social workers (SWs), and trainees formed to improve screening efforts and use the QI principles to guide analysis and intervention. The team wrote the following SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) Aim statements: (1) ensure > 90% of eligible patients receive a primary screen; (2) ensure > 90% of positive primary I9 screens receive subsequent screenings within 24 hours; and (3) increase staff comfort and familiarity using the screening tools. This article examines the results of the screening initiative 1-year postimplementation, describes difficulties faced, and suggests strategies that might be used to overcome those challenges.

Methods

This QI analysis was exempt from institutional review board review. Prior to the standardized national suicide risk assessment rollout of October 1, 2018, the QI team met to review and understand the workflow to be implemented into the HPACT clinic. To describe the initial screening process, the new suicide risk assessment consisted of primary, secondary, and tertiary screens that would warrant subsequent intervention by clinicians if positive (Figure 1). The primary screen included the PHQ-2+I9 questionnaire (PHQ-2 for depression and I9 for suicidal ideation). If either were positive, follow-up questionnaires were required. Of note, patients with a prior depression diagnosis, cognitive impairment defined at a severity of moderate or greater based on clinician evaluation and judgement, or life expectancy < 6 months were exempt from screening because, by definition, they had theoretically already been screened and classified as under surveillance.

A positive I9 response prompted a secondary screen using C-SSRS. A positive secondary screen prompted a tertiary screen using CSRE. If the PHQ-2 screening was positive but I9 was negative, the standard follow-up depression clinical reminder was used. Any clinical staff member could perform the primary screen, including licensed vocational nurses (LVNs), registered nurses (RNs), and SWs in any setting (eg, emergency department, primary care, inpatient services). The secondary and tertiary screens required completion by a licensed clinician. RNs were able to perform the secondary screen but not the tertiary screen.

The HPACT clinic serves approximately 3000 patients by 50 staff and trainees divided into 2 teams. LVNs and RNs were tasked to conduct the primary screen as part of their initial clinic check-in. If the primary screen was positive for scheduled patients, LVNs notified a PCP to complete the secondary screen. For unscheduled patients, RNs conducted a primary screen and, if positive, a secondary screen. If the secondary screen was positive, a tertiary screen was performed by mental health practitioners or SWs, or PCPs if the former were unavailable. SWs, mental health practitioners, and PCPs were colocated in the clinic, which allowed for safe and convenient warm handoffs between clinicians.

Results

During the project year, the HPACT clinic had 2932 unique patients assigned to primary care. Of those veterans, 533 (18%) were exempt from screening by protocol. Of the remainder, staff screened 1876 (64%) of eligible veterans for suicide risk (Figure 2), which did not meet the SMART Aim of screening > 90% of eligible veterans. For the follow-up screens, using a QI dashboard designed for reviewing I9 and C-SSRS results, the QI team reviewed a convenience sample of 5 provider panels and identified 34 positive I9 screens. Twenty of those 34 patients (59%) received a C-SSRS within 24 hours of the positive I9, which did not meet the SMART Aim of ensuring > 90% of primary I9 screens had subsequent C-SSRS screening within 24 hours.

Of the veterans screened, 1,271 (43%) had their screening performed outside of the HPACT primary care team assigned, while 605 (21%) patients had their screening performed by an HPACT member. Most of the screening that occurred outside of the assigned primary care team occurred in other physical settings, including other VA facilities.

Of the 523 (18%) patients who were not screened, 331 (11%) patients had no visit to the HPACT clinic and 132 (5%) empaneled patients did not visit any VA site within the 1-year period. There were 192 (7%) patients who were not screened that had a visit to HPACT while 19 (1%) of those patients declined screening. A total of 184 (6%) patients were not screened and thus were considered true missed opportunities. This group of patients were eligible for screening but did not undergo screening in the HPACT clinic or any other VA setting despite visiting the VA.

Discussion

Though the QI project failed to meet the SMART Aim of ensuring > 90% of eligible patients received a primary screen for suicide risk and > 90% of positive primary I9 screens received subsequent screenings within 24 hours, the results highlight effective practices and barriers for implementation of wide-scale EHR-based interventions for suicide assessment. Most missed screening opportunities were due to patients being lost to follow-up over the duration of the project, which is a challenge faced in this patient population. A recent analysis of the national rollout of this screening program found that 95% of eligible veterans with a visit to the VA in the first year of the program received screening.¹⁴ In a post hoc analysis using the same eligibility criteria, the rate of screening for this project was 83%. Reflecting on the data from this national cohort compared with the HPACT clinic, this brings to light potential circumstances that may be unique to veterans experiencing homelessness compared with the general veteran population, for instance, the level of engagement may be lower among veterans experiencing homelessness, though this is beyond the scope of this article. Nonetheless, promoting interprofessional collaboration, visualizing effective process flows, establishing clear lines of communication and roles for involved staff, and opening avenues for continuous feedback and troubleshooting are all potentially effective interventions to improve suicide screening rates within the veteran population.

This HPACT clinic initiative aimed to determine how a new screening process would be implemented while identifying potential areas for improvement. Surprisingly, 43% of patients who were screened had their screening performed outside of the HPACT clinic, most often in the inpatient setting at other WLAVAMC clinics or other VA systems. It is possible that due to the nature of the patient population that the HPACT clinic serves with intensive service needs, these patients have wider geographic and clinical location use than most clinic populations due to the transient nature of patients with housing insecurity. What is encouraging, however, is that through this systemwide initiative, there is an impetus to screen veterans, regardless of who performs the screening. This is particularly meaningful given that rates of depression screening may be as low as 4% among PCPs.¹⁵ During implementation, the QI team learned that nearly 18% of the empaneled HPACT patients were exempt from screening. The exempt patients do not have an active clinical reminder for depression screens. Instead, these patients are receiving mental health surveillance and specialty treatment, during which continuous monitoring and assessment for suicidal ideation and risk of suicide are performed. Additionally, an EHR-based factor that also may limit appropriate follow-up and contribute to missed opportunities is that secondary and tertiary screens do not populate until the EHR was refreshed after positive primary screens, which introduces human error in a process that could be automated. Both RNs and PCPs may occasionally miss secondary and tertiary screens due to this issue, which continues to be a barrier. Given the high risk HPACT clinic population, the QI team encouraged staff members to frequently screen patients for suicidal ideation regardless of clinical reminders. A consideration for the future would be to identify optimal frequency for screening and to continue to validate assessment methods.

Limitations

Due to the limited sample size, findings cannot be generalized to all VA sites. The QI team used retrospective, administrative data. Additionally, since this is a primary care clinic focused on a specialized population, this result may not be generalizable to all primary care settings, other primary care populations, or even other homeless primary care clinics, though it may establish a benchmark when other clinics internally examine their data and processes.

Conclusions

Improving screening protocols can lead to identification of at-risk individuals who would not have otherwise been identified.^16,17 As the US continues to grapple with mental health and suicide, efforts toward addressing this important issue among veterans remains a top priority.

Acknowledgments

Thank you to the VAGLAHS Center of Excellence in Primary Care Education faculty and trainees, the HPACT staff, and the VA Informatics and Computing Infrastructure (VINCI) for data support.

Despite the success of several US Department of Veterans Affairs (VA) initiatives in facilitating psychosocial functioning, rehabilitation, and re-entry among veterans experiencing homelessness and/or interactions with the criminal justice system (ie, justice-involved veterans), suicide risk among these veterans remains a significant public health concern. Rates of suicide among veterans experiencing homelessness are more than double that of veterans with no history of homelessness.¹ Similarly, justice-involved veterans experience myriad mental health concerns, including elevated rates of psychiatric symptoms, suicidal thoughts, and self-directed violence relative to those with no history of criminal justice involvement.²

In addition, a bidirectional relationship between criminal justice involvement and homelessness, often called the “institutional circuit,” is well established. Criminal justice involvement can directly result in difficulty finding housing.³ For example, veterans may have their lease agreement denied based solely on their history of criminogenic behavior. Moreover, criminal justice involvement can indirectly impact a veteran’s ability to maintain housing. Indeed, justice-involved veterans can experience difficulty attaining and sustaining employment, which in turn can result in financial difficulties, including inability to afford rental or mortgage payments.

Similarly, those at risk for or experiencing housing instability may resort to criminogenic behavior to survive in the context of limited psychosocial resources.^4-6 For instance, a veteran experiencing homelessness may seek refuge from inclement weather in a heated apartment stairwell and subsequently be charged with trespassing. Similarly, these veterans also may resort to theft to eat or pay bills. To this end, homelessness and justice involvement are likely a deleterious cycle that is difficult for the veteran to escape.

Unfortunately, the concurrent impact of housing insecurity and criminal justice involvement often serves to further exacerbate mental health sequelae, including suicide risk (Figure).⁷ In addition to precipitating frustration and helplessness among veterans who are navigating these stressors, these social determinants of health can engender a perception that the veteran is a burden to those in their support system. For example, these veterans may depend on friends or family to procure housing or transportation assistance for a job, medical appointments, and court hearings.

Despite the success of several US Department of Veterans Affairs (VA) initiatives in facilitating psychosocial functioning, rehabilitation, and re-entry among veterans experiencing homelessness and/or interactions with the criminal justice system (ie, justice-involved veterans), suicide risk among these veterans remains a significant public health concern. Rates of suicide among veterans experiencing homelessness are more than double that of veterans with no history of homelessness.¹ Similarly, justice-involved veterans experience myriad mental health concerns, including elevated rates of psychiatric symptoms, suicidal thoughts, and self-directed violence relative to those with no history of criminal justice involvement.²

In addition, a bidirectional relationship between criminal justice involvement and homelessness, often called the “institutional circuit,” is well established. Criminal justice involvement can directly result in difficulty finding housing.³ For example, veterans may have their lease agreement denied based solely on their history of criminogenic behavior. Moreover, criminal justice involvement can indirectly impact a veteran’s ability to maintain housing. Indeed, justice-involved veterans can experience difficulty attaining and sustaining employment, which in turn can result in financial difficulties, including inability to afford rental or mortgage payments.

Similarly, those at risk for or experiencing housing instability may resort to criminogenic behavior to survive in the context of limited psychosocial resources.^4-6 For instance, a veteran experiencing homelessness may seek refuge from inclement weather in a heated apartment stairwell and subsequently be charged with trespassing. Similarly, these veterans also may resort to theft to eat or pay bills. To this end, homelessness and justice involvement are likely a deleterious cycle that is difficult for the veteran to escape.

Unfortunately, the concurrent impact of housing insecurity and criminal justice involvement often serves to further exacerbate mental health sequelae, including suicide risk (Figure).⁷ In addition to precipitating frustration and helplessness among veterans who are navigating these stressors, these social determinants of health can engender a perception that the veteran is a burden to those in their support system. For example, these veterans may depend on friends or family to procure housing or transportation assistance for a job, medical appointments, and court hearings.

Despite the success of several US Department of Veterans Affairs (VA) initiatives in facilitating psychosocial functioning, rehabilitation, and re-entry among veterans experiencing homelessness and/or interactions with the criminal justice system (ie, justice-involved veterans), suicide risk among these veterans remains a significant public health concern. Rates of suicide among veterans experiencing homelessness are more than double that of veterans with no history of homelessness.¹ Similarly, justice-involved veterans experience myriad mental health concerns, including elevated rates of psychiatric symptoms, suicidal thoughts, and self-directed violence relative to those with no history of criminal justice involvement.²

In addition, a bidirectional relationship between criminal justice involvement and homelessness, often called the “institutional circuit,” is well established. Criminal justice involvement can directly result in difficulty finding housing.³ For example, veterans may have their lease agreement denied based solely on their history of criminogenic behavior. Moreover, criminal justice involvement can indirectly impact a veteran’s ability to maintain housing. Indeed, justice-involved veterans can experience difficulty attaining and sustaining employment, which in turn can result in financial difficulties, including inability to afford rental or mortgage payments.

Similarly, those at risk for or experiencing housing instability may resort to criminogenic behavior to survive in the context of limited psychosocial resources.^4-6 For instance, a veteran experiencing homelessness may seek refuge from inclement weather in a heated apartment stairwell and subsequently be charged with trespassing. Similarly, these veterans also may resort to theft to eat or pay bills. To this end, homelessness and justice involvement are likely a deleterious cycle that is difficult for the veteran to escape.

Unfortunately, the concurrent impact of housing insecurity and criminal justice involvement often serves to further exacerbate mental health sequelae, including suicide risk (Figure).⁷ In addition to precipitating frustration and helplessness among veterans who are navigating these stressors, these social determinants of health can engender a perception that the veteran is a burden to those in their support system. For example, these veterans may depend on friends or family to procure housing or transportation assistance for a job, medical appointments, and court hearings.

Early interventions that focus on clinical case management and psychiatric care, and not necessarily on individual psychotherapy, are effective for young patients with borderline personality disorder (BPD), new research suggests.

Findings from the Monitoring Outcomes of Borderline Personality Disorder in Youth (MOBY) trial also showed improved psychosocial functioning and reduced suicide ideation with these therapies.

The results suggest that, contrary to common belief, psychotherapy is not the only effective approach for early BPD, lead author Andrew M. Chanen, PhD, director of clinical programs and services and head of personality disorder research at Orygen, Melbourne, told this news organization.

“We can say that early diagnosis and early treatment is effective, and the treatment doesn’t need to involve individual psychotherapy but does need to involve clinical case management and psychiatric care,” said Dr. Chanen, a professorial fellow at the Centre for Youth Mental Health, University of Melbourne.

The findings were published online in JAMA Psychiatry.
 

Extreme sensitivity

Patients with BPD have “extreme sensitivity to interpersonal slights” and often exhibit intense and volatile emotions and impulsive behavior, Dr. Chanen noted. Many will self-harm, abuse drugs, or attempt suicide; the suicide rate among patients with BPD is 8%-10%.

The condition is typically diagnosed in puberty or early adulthood, affecting about 3% of young people and a little more than 1% of adults.

Because of their aggression and interpersonal difficulties, patients with BPD are often discriminated against by health professionals and end up not getting treated, said Dr. Chanen.

Those who are treated often receive individual psychotherapy, such as dialectical behavior therapy (DBT). That type of therapy, which teaches healthy ways to cope with stress and regulate emotions, is very effective, Dr. Chanen said.

The MOBY trial examined three treatment approaches: the Helping Young People Early (HYPE) model, HYPE combined with weekly “befriending,” and a general youth mental health service (YMHS) model combined with befriending.

A key element of HYPE is cognitive analytic therapy, a psychotherapy program focused on understanding problematic self-management and interpersonal relationship patterns. The model includes clinical case management, such as attending to housing, vocational and educational issues, other mental health needs, and physical health needs.

In the second model, the psychotherapy of the HYPE program was replaced with befriending, which involves chatting with a patient about neutral topics such as sports and avoiding emotionally loaded topics such as interpersonal problems.

For YMHS plus befriending, experts trained in treating young people, but not specialized in treating BPD, were involved in managing patients.

‘High satisfaction’

Researchers randomly assigned 139 participants aged 15-25 years (80.6% women; mean age, 19.1 years) with BPD to one of the treatment arms. Of these, 128 (92.1%) were included in the intent-to-treat analysis.

The primary endpoint was psychosocial functioning, as measured by the Inventory of Interpersonal Problems Circumplex Version and the Social Adjustment Scale–Self-Report. Secondary endpoints included suicidal ideation, suicide attempts, nonsuicidal self-injury, depression, substance use, and treatment satisfaction.

The investigators reported group averages, but the study’s noninferiority design did not allow for determining if one treatment had superior efficacy.

All groups improved significantly on the primary endpoint. At 12 months, there was a mean 28.91-point (23.8%) drop in interpersonal problems and a mean 0.55-point (19.3%) drop in social adjustment scores.

For secondary outcomes, mean improvements at 12 months ranged from 40.7% (17.64 points) on the depression scale to 52.7% (6.22 points) for suicide ideation.

“The only area where the treatment didn’t really have an impact was substance use,” said Dr. Chanen. “Satisfaction was high for all three interventions throughout the study, and it’s hard to improve on high satisfaction.”

‘Turns things upside down’

That patients across all groups had marked and sustained improvements “in ways you wouldn’t expect for BPD” supports the conclusion that the interventions had a true effect, Dr. Chanen said.

The results suggest early diagnosis and “a not very complicated treatment [will] drastically improve the lives of these young people,” he added.

They also imply there are effective alternatives to psychotherapy, which many individuals in the field insist is the only way to treat BPD. “This study turns things upside down and says actually it’s not. It’s the basics of treatment that are important,” Dr. Chanen said.

When a patient presents at the emergency department following a severe overdose, “it’s a reflex” for clinicians to refer that person to a psychotherapy program. “The problem is, these programs are not plentiful enough to be able to service the needs of this group,” Dr. Chanen noted.

On the other hand, the skills for clinical case management and psychiatric care “are available throughout the mental health systems,” he added.

The researchers are planning another analysis to determine whether age and sex predict better outcomes in these patients with BPD.
 

Unique contribution

Commenting for this news organization, John M. Oldham, MD, distinguished emeritus professor, Baylor College of Medicine, Houston, said a “unique and important contribution” of the study is the focus on early intervention.

“The general standard approach in psychiatry and the diagnostic world has been to not even consider anything until after somebody is 18 years of age, which is a mistake because these kids can become quite impaired earlier than that,” he said.

Dr. Oldham, who was not involved with the research, chaired the American Psychiatric Association workgroup that developed the 2001 evidence-based practice guideline for treating BPD, which recommended psychotherapy as the primary treatment. The guideline was last updated in 2005 – and another update is currently being developed, he noted.

There is an emerging trend toward “good psychiatric management” that focuses on level of functioning rather than on a specific strategy requiring a certificate of training that “not many people out there have,” said Dr. Oldham.

“You’re not going to make much headway with these kids if you’re going to be searching around for a DBT-certified therapist. What you need is to bring them in, get them to trust you, and in a sense be a kind of overall behavioral medicine navigator for them,” he added.

Dr. Oldham noted that, although the primary study outcome improved between 19% and 24%, “that means three-quarters of the people didn’t improve.”

He also pointed out this was only a 1-year trial. “Sometimes treatment for people with a personality disorder such as borderline takes a lot longer than that,” Dr. Oldham concluded.

The trial was funded by the National Health and Medical Research Council. Dr. Chanen reports receiving grants from the Australian government’s National Health and Medical Research Council during the conduct of the study and other support from the Helping Young People Early (HYPE) translational program outside the submitted work. He and another investigator cofounded and lead the HYPE clinical program, a government-funded program with continuous support, and the HYPE translational program, a not-for-profit training program. Dr. Oldham reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Early interventions that focus on clinical case management and psychiatric care, and not necessarily on individual psychotherapy, are effective for young patients with borderline personality disorder (BPD), new research suggests.

Findings from the Monitoring Outcomes of Borderline Personality Disorder in Youth (MOBY) trial also showed improved psychosocial functioning and reduced suicide ideation with these therapies.

The results suggest that, contrary to common belief, psychotherapy is not the only effective approach for early BPD, lead author Andrew M. Chanen, PhD, director of clinical programs and services and head of personality disorder research at Orygen, Melbourne, told this news organization.

“We can say that early diagnosis and early treatment is effective, and the treatment doesn’t need to involve individual psychotherapy but does need to involve clinical case management and psychiatric care,” said Dr. Chanen, a professorial fellow at the Centre for Youth Mental Health, University of Melbourne.

The findings were published online in JAMA Psychiatry.
 

Extreme sensitivity

Patients with BPD have “extreme sensitivity to interpersonal slights” and often exhibit intense and volatile emotions and impulsive behavior, Dr. Chanen noted. Many will self-harm, abuse drugs, or attempt suicide; the suicide rate among patients with BPD is 8%-10%.

The condition is typically diagnosed in puberty or early adulthood, affecting about 3% of young people and a little more than 1% of adults.

Because of their aggression and interpersonal difficulties, patients with BPD are often discriminated against by health professionals and end up not getting treated, said Dr. Chanen.

Those who are treated often receive individual psychotherapy, such as dialectical behavior therapy (DBT). That type of therapy, which teaches healthy ways to cope with stress and regulate emotions, is very effective, Dr. Chanen said.

The MOBY trial examined three treatment approaches: the Helping Young People Early (HYPE) model, HYPE combined with weekly “befriending,” and a general youth mental health service (YMHS) model combined with befriending.

A key element of HYPE is cognitive analytic therapy, a psychotherapy program focused on understanding problematic self-management and interpersonal relationship patterns. The model includes clinical case management, such as attending to housing, vocational and educational issues, other mental health needs, and physical health needs.

In the second model, the psychotherapy of the HYPE program was replaced with befriending, which involves chatting with a patient about neutral topics such as sports and avoiding emotionally loaded topics such as interpersonal problems.

For YMHS plus befriending, experts trained in treating young people, but not specialized in treating BPD, were involved in managing patients.

‘High satisfaction’

Researchers randomly assigned 139 participants aged 15-25 years (80.6% women; mean age, 19.1 years) with BPD to one of the treatment arms. Of these, 128 (92.1%) were included in the intent-to-treat analysis.

The primary endpoint was psychosocial functioning, as measured by the Inventory of Interpersonal Problems Circumplex Version and the Social Adjustment Scale–Self-Report. Secondary endpoints included suicidal ideation, suicide attempts, nonsuicidal self-injury, depression, substance use, and treatment satisfaction.

The investigators reported group averages, but the study’s noninferiority design did not allow for determining if one treatment had superior efficacy.

All groups improved significantly on the primary endpoint. At 12 months, there was a mean 28.91-point (23.8%) drop in interpersonal problems and a mean 0.55-point (19.3%) drop in social adjustment scores.

For secondary outcomes, mean improvements at 12 months ranged from 40.7% (17.64 points) on the depression scale to 52.7% (6.22 points) for suicide ideation.

“The only area where the treatment didn’t really have an impact was substance use,” said Dr. Chanen. “Satisfaction was high for all three interventions throughout the study, and it’s hard to improve on high satisfaction.”

‘Turns things upside down’

That patients across all groups had marked and sustained improvements “in ways you wouldn’t expect for BPD” supports the conclusion that the interventions had a true effect, Dr. Chanen said.

The results suggest early diagnosis and “a not very complicated treatment [will] drastically improve the lives of these young people,” he added.

They also imply there are effective alternatives to psychotherapy, which many individuals in the field insist is the only way to treat BPD. “This study turns things upside down and says actually it’s not. It’s the basics of treatment that are important,” Dr. Chanen said.

When a patient presents at the emergency department following a severe overdose, “it’s a reflex” for clinicians to refer that person to a psychotherapy program. “The problem is, these programs are not plentiful enough to be able to service the needs of this group,” Dr. Chanen noted.

On the other hand, the skills for clinical case management and psychiatric care “are available throughout the mental health systems,” he added.

The researchers are planning another analysis to determine whether age and sex predict better outcomes in these patients with BPD.
 

Unique contribution

Commenting for this news organization, John M. Oldham, MD, distinguished emeritus professor, Baylor College of Medicine, Houston, said a “unique and important contribution” of the study is the focus on early intervention.

“The general standard approach in psychiatry and the diagnostic world has been to not even consider anything until after somebody is 18 years of age, which is a mistake because these kids can become quite impaired earlier than that,” he said.

Dr. Oldham, who was not involved with the research, chaired the American Psychiatric Association workgroup that developed the 2001 evidence-based practice guideline for treating BPD, which recommended psychotherapy as the primary treatment. The guideline was last updated in 2005 – and another update is currently being developed, he noted.

There is an emerging trend toward “good psychiatric management” that focuses on level of functioning rather than on a specific strategy requiring a certificate of training that “not many people out there have,” said Dr. Oldham.

“You’re not going to make much headway with these kids if you’re going to be searching around for a DBT-certified therapist. What you need is to bring them in, get them to trust you, and in a sense be a kind of overall behavioral medicine navigator for them,” he added.

Dr. Oldham noted that, although the primary study outcome improved between 19% and 24%, “that means three-quarters of the people didn’t improve.”

He also pointed out this was only a 1-year trial. “Sometimes treatment for people with a personality disorder such as borderline takes a lot longer than that,” Dr. Oldham concluded.

The trial was funded by the National Health and Medical Research Council. Dr. Chanen reports receiving grants from the Australian government’s National Health and Medical Research Council during the conduct of the study and other support from the Helping Young People Early (HYPE) translational program outside the submitted work. He and another investigator cofounded and lead the HYPE clinical program, a government-funded program with continuous support, and the HYPE translational program, a not-for-profit training program. Dr. Oldham reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Early interventions that focus on clinical case management and psychiatric care, and not necessarily on individual psychotherapy, are effective for young patients with borderline personality disorder (BPD), new research suggests.

Findings from the Monitoring Outcomes of Borderline Personality Disorder in Youth (MOBY) trial also showed improved psychosocial functioning and reduced suicide ideation with these therapies.

The results suggest that, contrary to common belief, psychotherapy is not the only effective approach for early BPD, lead author Andrew M. Chanen, PhD, director of clinical programs and services and head of personality disorder research at Orygen, Melbourne, told this news organization.

“We can say that early diagnosis and early treatment is effective, and the treatment doesn’t need to involve individual psychotherapy but does need to involve clinical case management and psychiatric care,” said Dr. Chanen, a professorial fellow at the Centre for Youth Mental Health, University of Melbourne.

The findings were published online in JAMA Psychiatry.
 

Extreme sensitivity

Patients with BPD have “extreme sensitivity to interpersonal slights” and often exhibit intense and volatile emotions and impulsive behavior, Dr. Chanen noted. Many will self-harm, abuse drugs, or attempt suicide; the suicide rate among patients with BPD is 8%-10%.

The condition is typically diagnosed in puberty or early adulthood, affecting about 3% of young people and a little more than 1% of adults.

Because of their aggression and interpersonal difficulties, patients with BPD are often discriminated against by health professionals and end up not getting treated, said Dr. Chanen.

Those who are treated often receive individual psychotherapy, such as dialectical behavior therapy (DBT). That type of therapy, which teaches healthy ways to cope with stress and regulate emotions, is very effective, Dr. Chanen said.

The MOBY trial examined three treatment approaches: the Helping Young People Early (HYPE) model, HYPE combined with weekly “befriending,” and a general youth mental health service (YMHS) model combined with befriending.

A key element of HYPE is cognitive analytic therapy, a psychotherapy program focused on understanding problematic self-management and interpersonal relationship patterns. The model includes clinical case management, such as attending to housing, vocational and educational issues, other mental health needs, and physical health needs.

In the second model, the psychotherapy of the HYPE program was replaced with befriending, which involves chatting with a patient about neutral topics such as sports and avoiding emotionally loaded topics such as interpersonal problems.

For YMHS plus befriending, experts trained in treating young people, but not specialized in treating BPD, were involved in managing patients.

‘High satisfaction’

Researchers randomly assigned 139 participants aged 15-25 years (80.6% women; mean age, 19.1 years) with BPD to one of the treatment arms. Of these, 128 (92.1%) were included in the intent-to-treat analysis.

The primary endpoint was psychosocial functioning, as measured by the Inventory of Interpersonal Problems Circumplex Version and the Social Adjustment Scale–Self-Report. Secondary endpoints included suicidal ideation, suicide attempts, nonsuicidal self-injury, depression, substance use, and treatment satisfaction.

The investigators reported group averages, but the study’s noninferiority design did not allow for determining if one treatment had superior efficacy.

All groups improved significantly on the primary endpoint. At 12 months, there was a mean 28.91-point (23.8%) drop in interpersonal problems and a mean 0.55-point (19.3%) drop in social adjustment scores.

For secondary outcomes, mean improvements at 12 months ranged from 40.7% (17.64 points) on the depression scale to 52.7% (6.22 points) for suicide ideation.

“The only area where the treatment didn’t really have an impact was substance use,” said Dr. Chanen. “Satisfaction was high for all three interventions throughout the study, and it’s hard to improve on high satisfaction.”

‘Turns things upside down’

That patients across all groups had marked and sustained improvements “in ways you wouldn’t expect for BPD” supports the conclusion that the interventions had a true effect, Dr. Chanen said.

The results suggest early diagnosis and “a not very complicated treatment [will] drastically improve the lives of these young people,” he added.

They also imply there are effective alternatives to psychotherapy, which many individuals in the field insist is the only way to treat BPD. “This study turns things upside down and says actually it’s not. It’s the basics of treatment that are important,” Dr. Chanen said.

When a patient presents at the emergency department following a severe overdose, “it’s a reflex” for clinicians to refer that person to a psychotherapy program. “The problem is, these programs are not plentiful enough to be able to service the needs of this group,” Dr. Chanen noted.

On the other hand, the skills for clinical case management and psychiatric care “are available throughout the mental health systems,” he added.

The researchers are planning another analysis to determine whether age and sex predict better outcomes in these patients with BPD.
 

Unique contribution

Commenting for this news organization, John M. Oldham, MD, distinguished emeritus professor, Baylor College of Medicine, Houston, said a “unique and important contribution” of the study is the focus on early intervention.

“The general standard approach in psychiatry and the diagnostic world has been to not even consider anything until after somebody is 18 years of age, which is a mistake because these kids can become quite impaired earlier than that,” he said.

Dr. Oldham, who was not involved with the research, chaired the American Psychiatric Association workgroup that developed the 2001 evidence-based practice guideline for treating BPD, which recommended psychotherapy as the primary treatment. The guideline was last updated in 2005 – and another update is currently being developed, he noted.

There is an emerging trend toward “good psychiatric management” that focuses on level of functioning rather than on a specific strategy requiring a certificate of training that “not many people out there have,” said Dr. Oldham.

“You’re not going to make much headway with these kids if you’re going to be searching around for a DBT-certified therapist. What you need is to bring them in, get them to trust you, and in a sense be a kind of overall behavioral medicine navigator for them,” he added.

Dr. Oldham noted that, although the primary study outcome improved between 19% and 24%, “that means three-quarters of the people didn’t improve.”

He also pointed out this was only a 1-year trial. “Sometimes treatment for people with a personality disorder such as borderline takes a lot longer than that,” Dr. Oldham concluded.

The trial was funded by the National Health and Medical Research Council. Dr. Chanen reports receiving grants from the Australian government’s National Health and Medical Research Council during the conduct of the study and other support from the Helping Young People Early (HYPE) translational program outside the submitted work. He and another investigator cofounded and lead the HYPE clinical program, a government-funded program with continuous support, and the HYPE translational program, a not-for-profit training program. Dr. Oldham reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Adjunctive treatment with the novel oral medication REL-1017 (esmethadone) is effective in adults with major depressive disorder (MDD) who have failed other antidepressants, new research suggests.
 

REL-1017, from Relmada Therapeutics, is a novel N-methyl-D-aspartate receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiologic glutamatergic neurotransmission.

Jupiterimages/ThinkStock

Results from a phase 2a study showed rapid “therapeutic efficacy,” with a statistical difference by day 4, and the improvement was “robust,” with an effect size of 0.7 to 1. The positive outcome was also sustained for at least 1 week after treatment discontinuation, coinvestigator Paolo L. Manfredi, MD, chief scientific officer, Relmada Therapeutics, noted.

“Considering that the available traditional antidepressants have an average effect size around 0.3, this novel, potential rapid-acting antidepressant … holds great promise for millions of patients suffering from depression,” Dr. Manfredi told this news organization.

These results were obtained with a “very-well-tolerated once-daily oral NMDAR antagonist, without the dissociative effects seen with ketamine,” he added.

The findings were published online in the American Journal of Psychiatry.

‘Clear need’ for better therapies

It is estimated that more than half of patients with MDD fail to respond adequately following their first standard antidepressant treatment. In addition, responses are often delayed by 4-8 weeks after starting an antidepressant.

Therefore, there is a “clear need” to develop drugs for MDD that act quickly and with improved efficacy, the investigators note.

The phase 2a study of REL-1017 enrolled 62 adult patients (45% women) aged 18-65 years with moderate to severe MDD and no significant psychiatric comorbidity. All had failed to benefit from one to three standard antidepressant treatments in their current major depressive episode.

The researchers evaluated two doses of REL-1017 (25 mg and 50 mg once daily) vs. placebo given as adjunctive treatment. The assigned treatment lasted 7 days.

The primary study objectives were safety and tolerability. Results showed no serious adverse events (AEs), and no patients experienced treatment-emergent AEs that led to the stopping of treatment.

In addition, patients receiving the active drug experienced mild or moderate transient AEs comparable to placebo, with no opioid, dissociative, or psychotomimetic symptoms, or withdrawal effects when treatment ended.

The most common AEs reported were headache, constipation, nausea, and sleepiness.

Significant efficacy

The primary efficacy endpoint was the Montgomery–Åsberg Depression Scale (MADRS) score.

Mean MADRS score at baseline was 33.8 in the placebo group vs. 32.9 in the REL-1017 25-mg group and 35.2 in the REL-1017 50-mg group.

MADRS scores showed improvement on day 4 of treatment in both REL-1017 groups, and the improvement continued through day 7 (last dose) and day 14 (7 days after the last dose), with P ≤ .0308 and effect sizes ranging from 0.7 to 1.0.

Mean change from baseline in MADRS scores showed more improvement at the end of the dosing period for both dosing groups (–16.8 with 25 mg and –16.6 with 50 mg) vs. –8.8 with placebo.

Results of the other efficacy endpoints of Symptoms of Depression Questionnaire (SDQ) score and Clinical Global Impressions severity scale (CGI-S) and improvement scale (CGI-I) scores were similar to that of the MADRS.

Remission rates (defined as a MADRS score ≤10) on day 14, the last day of efficacy assessment, were 5% with placebo vs. 31% (P = .035) with REL-1017 25 mg and 39% (P = .01) with REL-1017 50 mg.

The number needed to treat to achieve remission on day 14 was four with the 25-mg dose and three with the 50-mg dose.

Phase 3 trials to confirm the efficacy and safety of REL-1017 are in progress, with topline results expected later this year, the investigators report.

The study was funded by Relmada Therapeutics. Dr. Manfredi has received personal fees from and/or held stock ownership in Relmada. Disclosures for the other investigators are fully listed in the original article.

A version of this article first appeared on Medscape.com.

Adjunctive treatment with the novel oral medication REL-1017 (esmethadone) is effective in adults with major depressive disorder (MDD) who have failed other antidepressants, new research suggests.
 

REL-1017, from Relmada Therapeutics, is a novel N-methyl-D-aspartate receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiologic glutamatergic neurotransmission.

Jupiterimages/ThinkStock

Results from a phase 2a study showed rapid “therapeutic efficacy,” with a statistical difference by day 4, and the improvement was “robust,” with an effect size of 0.7 to 1. The positive outcome was also sustained for at least 1 week after treatment discontinuation, coinvestigator Paolo L. Manfredi, MD, chief scientific officer, Relmada Therapeutics, noted.

“Considering that the available traditional antidepressants have an average effect size around 0.3, this novel, potential rapid-acting antidepressant … holds great promise for millions of patients suffering from depression,” Dr. Manfredi told this news organization.

These results were obtained with a “very-well-tolerated once-daily oral NMDAR antagonist, without the dissociative effects seen with ketamine,” he added.

The findings were published online in the American Journal of Psychiatry.

‘Clear need’ for better therapies

It is estimated that more than half of patients with MDD fail to respond adequately following their first standard antidepressant treatment. In addition, responses are often delayed by 4-8 weeks after starting an antidepressant.

Therefore, there is a “clear need” to develop drugs for MDD that act quickly and with improved efficacy, the investigators note.

The phase 2a study of REL-1017 enrolled 62 adult patients (45% women) aged 18-65 years with moderate to severe MDD and no significant psychiatric comorbidity. All had failed to benefit from one to three standard antidepressant treatments in their current major depressive episode.

The researchers evaluated two doses of REL-1017 (25 mg and 50 mg once daily) vs. placebo given as adjunctive treatment. The assigned treatment lasted 7 days.

The primary study objectives were safety and tolerability. Results showed no serious adverse events (AEs), and no patients experienced treatment-emergent AEs that led to the stopping of treatment.

In addition, patients receiving the active drug experienced mild or moderate transient AEs comparable to placebo, with no opioid, dissociative, or psychotomimetic symptoms, or withdrawal effects when treatment ended.

The most common AEs reported were headache, constipation, nausea, and sleepiness.

Significant efficacy

The primary efficacy endpoint was the Montgomery–Åsberg Depression Scale (MADRS) score.

Mean MADRS score at baseline was 33.8 in the placebo group vs. 32.9 in the REL-1017 25-mg group and 35.2 in the REL-1017 50-mg group.

MADRS scores showed improvement on day 4 of treatment in both REL-1017 groups, and the improvement continued through day 7 (last dose) and day 14 (7 days after the last dose), with P ≤ .0308 and effect sizes ranging from 0.7 to 1.0.

Mean change from baseline in MADRS scores showed more improvement at the end of the dosing period for both dosing groups (–16.8 with 25 mg and –16.6 with 50 mg) vs. –8.8 with placebo.

Results of the other efficacy endpoints of Symptoms of Depression Questionnaire (SDQ) score and Clinical Global Impressions severity scale (CGI-S) and improvement scale (CGI-I) scores were similar to that of the MADRS.

Remission rates (defined as a MADRS score ≤10) on day 14, the last day of efficacy assessment, were 5% with placebo vs. 31% (P = .035) with REL-1017 25 mg and 39% (P = .01) with REL-1017 50 mg.

The number needed to treat to achieve remission on day 14 was four with the 25-mg dose and three with the 50-mg dose.

Phase 3 trials to confirm the efficacy and safety of REL-1017 are in progress, with topline results expected later this year, the investigators report.

The study was funded by Relmada Therapeutics. Dr. Manfredi has received personal fees from and/or held stock ownership in Relmada. Disclosures for the other investigators are fully listed in the original article.

A version of this article first appeared on Medscape.com.

Adjunctive treatment with the novel oral medication REL-1017 (esmethadone) is effective in adults with major depressive disorder (MDD) who have failed other antidepressants, new research suggests.
 

REL-1017, from Relmada Therapeutics, is a novel N-methyl-D-aspartate receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiologic glutamatergic neurotransmission.

Jupiterimages/ThinkStock

Results from a phase 2a study showed rapid “therapeutic efficacy,” with a statistical difference by day 4, and the improvement was “robust,” with an effect size of 0.7 to 1. The positive outcome was also sustained for at least 1 week after treatment discontinuation, coinvestigator Paolo L. Manfredi, MD, chief scientific officer, Relmada Therapeutics, noted.

“Considering that the available traditional antidepressants have an average effect size around 0.3, this novel, potential rapid-acting antidepressant … holds great promise for millions of patients suffering from depression,” Dr. Manfredi told this news organization.

These results were obtained with a “very-well-tolerated once-daily oral NMDAR antagonist, without the dissociative effects seen with ketamine,” he added.

The findings were published online in the American Journal of Psychiatry.

‘Clear need’ for better therapies

It is estimated that more than half of patients with MDD fail to respond adequately following their first standard antidepressant treatment. In addition, responses are often delayed by 4-8 weeks after starting an antidepressant.

Therefore, there is a “clear need” to develop drugs for MDD that act quickly and with improved efficacy, the investigators note.

The phase 2a study of REL-1017 enrolled 62 adult patients (45% women) aged 18-65 years with moderate to severe MDD and no significant psychiatric comorbidity. All had failed to benefit from one to three standard antidepressant treatments in their current major depressive episode.

The researchers evaluated two doses of REL-1017 (25 mg and 50 mg once daily) vs. placebo given as adjunctive treatment. The assigned treatment lasted 7 days.

The primary study objectives were safety and tolerability. Results showed no serious adverse events (AEs), and no patients experienced treatment-emergent AEs that led to the stopping of treatment.

In addition, patients receiving the active drug experienced mild or moderate transient AEs comparable to placebo, with no opioid, dissociative, or psychotomimetic symptoms, or withdrawal effects when treatment ended.

The most common AEs reported were headache, constipation, nausea, and sleepiness.

Significant efficacy

The primary efficacy endpoint was the Montgomery–Åsberg Depression Scale (MADRS) score.

Mean MADRS score at baseline was 33.8 in the placebo group vs. 32.9 in the REL-1017 25-mg group and 35.2 in the REL-1017 50-mg group.

MADRS scores showed improvement on day 4 of treatment in both REL-1017 groups, and the improvement continued through day 7 (last dose) and day 14 (7 days after the last dose), with P ≤ .0308 and effect sizes ranging from 0.7 to 1.0.

Mean change from baseline in MADRS scores showed more improvement at the end of the dosing period for both dosing groups (–16.8 with 25 mg and –16.6 with 50 mg) vs. –8.8 with placebo.

Results of the other efficacy endpoints of Symptoms of Depression Questionnaire (SDQ) score and Clinical Global Impressions severity scale (CGI-S) and improvement scale (CGI-I) scores were similar to that of the MADRS.

Remission rates (defined as a MADRS score ≤10) on day 14, the last day of efficacy assessment, were 5% with placebo vs. 31% (P = .035) with REL-1017 25 mg and 39% (P = .01) with REL-1017 50 mg.

The number needed to treat to achieve remission on day 14 was four with the 25-mg dose and three with the 50-mg dose.

Phase 3 trials to confirm the efficacy and safety of REL-1017 are in progress, with topline results expected later this year, the investigators report.

The study was funded by Relmada Therapeutics. Dr. Manfredi has received personal fees from and/or held stock ownership in Relmada. Disclosures for the other investigators are fully listed in the original article.

A version of this article first appeared on Medscape.com.

I am a psychiatrist, which means I am a mental health professional, which means I work with people with mental illness. Sometimes people with mental health conditions who suffer from mental illness need to take a day off work – also called a mental health day – because they are too symptomatic to work, and sometimes people who don’t have a mental illness need to take a day off work, also called a mental health day, because they are feeling stressed.

Sometimes professional athletes don’t do things they agreed to do in their contracts because they realize that doing these things is very upsetting and will be detrimental to their mental health, or maybe they have a mental illness and doing these things will worsen their mental health condition, which is, in fact, a mental illness. Other times people with mental health conditions need to have pets travel with them because this mitigates the symptoms of their mental illness or perhaps it’s just good for their mental health. And finally, some people suffer from mental illnesses, or sometimes from learning problems, which are severe enough that a person with these conditions has a disability and needs special accommodations to function optimally in educational or occupational settings, or needs public financial support because their difficulties disable them to the point that they can’t work at all.

Is your head spinning yet? The point I am trying to make is that, as a profession, we have done an abysmal job of defining what we do, who we serve, and differentiating the fact that what someone with a psychiatric disorder needs to do to function or to alleviate emotional suffering may be entirely different from the things that everyone needs to do, regardless of whether they have a psychiatric disorder, to feel their emotional best.

The National Alliance on Mental Illness tells us that one in five Americans are suffering from a mental illness, while the Epidemiologic Catchment Area Program revealed that half of people will meet criteria for a mental illness at some point in their lives. We hear about “the mentally ill” constantly in the news – often in relation to mass shooters or homelessness – yet even psychiatrists might be pressed to define who exactly the “mentally ill” are. And how many of us could not somehow, at some time, find ourselves in 1 of the 157 disorders that DSM-5 lists – down from 365 disorders in the DSM-IV-TR?

Differentiating mental health from mental illness is just the beginning of our semantic confusion. As psychiatrists we treat major depression, and yet the illness “depression,” a syndromic constellation of symptoms, includes the key symptom of sadness. People often say they are “depressed” when they mean they are sad or demoralized, and yet, if their sadness persists in the absence of other symptoms, they may well want, or feel they “should” have medications, even in the absence of a disorder. And maybe those medications help them feel better, so that the presence or absence of a verified illness doesn’t really matter. But if the medications cause adverse reactions, then psychiatry might have done a better job by that person’s sadness. Melancholia, or perhaps any designation than “depression,” with its multiple meanings, might better serve our patients and our profession. This is only one example, as the number of people who tell me they have obsessive-compulsive disorder – or more often announce, “I’m OCD!” because they are well organized in a productive way is remarkable. And while I have treated only a few people who meet the criteria for narcissistic personality disorder, from general conversation it would seem that they are at every dinner table and by every water cooler.

Does it matter? A diagnostic lexicon can be so helpful when it guides treatment, provides a heterogeneous group of patients for research studies, and allows for an understanding of the etiology, course, and prognosis of a given condition. When someone is so depressed that they can’t get out of bed, or is so disorganized that they can’t perform their job and might cause a disturbance in their workplace, it is good to instruct them to take time off work and send them back well with a doctor’s note. But this is different from the person who doesn’t want to face a difficult situation, who simply doesn’t like their job or their boss, or who wants their pet declared an emotional support animal to avoid the fee the airlines charge to bring an animal on board if one does not have a psychiatric diagnosis. Sometimes these lines are blurry – if someone does not want to do something because it makes them anxious, does it matter how deep the pit in their stomach is, or if they are having full-blown panic attacks? When do we agree that their distress is reason to allow them to avoid responsibilities without repercussions versus a violation of their obligations and an infringement on others?

Diagnoses offer solace to some patients: There is a name for their suffering, available treatment, and often others with the same condition to look to for guidance and community. For others, a psychiatric diagnosis is a source of shame, a label they see as damaging to their character and sometimes to their careers – including in medicine – where we have been particularly unsympathetic to those who announce a psychiatric history.

In some cultures, the label itself decreases someone’s attractiveness as a potential marriage partner. We would all like to see the stigma of mental illness vanish, but we have a long way to go.

Psychiatric diagnoses move over time and with our politics and culture. This is good; we don’t hold on to what we learn to be untrue. But they may well add to issues of inequity. Those who can afford to pay for expensive educational assessments can request educational accommodations, including untimed standardized tests. This advantage may not be available to those without the resources to pay for these evaluations, and one might wonder why all comers can’t take untimed tests so as not to favor the privileged. Psychiatry has long been accused of diagnosing people of color with poor prognosis illnesses and women with conditions that imply emotional weakness.

While our diagnoses have clinical utility, it is unfortunate that they have come to be about reimbursement. A diagnosis needs to be assigned for insurers to pay for care, and so we create diagnostic categories to allow for treatment. Is this reasonable? Do we need to say that someone who is suffering after the death of a loved one has a mental illness in order to allow them to seek relief from their suffering? It leads us to believe that all suffering is about pathology, that we should expect pain-free emotional lives. Perhaps we need a diagnostic category of psychic pain, not otherwise specified, to allow for treatment for those who simply ache.

Mental illness is about interventions to alleviate the suffering of those with disorders. Mental health is about interventions that may benefit everyone, whether they suffer from a mental illness or not. Sleep, nutrition, exercise, sunlight, nature, entertainment and escape, yoga, meditation, vacations in beautiful places with loving people – these are things that potentially help us all whether we do or do not have an illness. With so much confusion about what it is we do, and about who “should” get help, who can get help, who might want help, and where they should go to seek help, perhaps it would be better if our lingo were more precise.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). The has a private practice and is assistant professor of psychiatry ad behavioral sciences at Johns Hopkins University, both in Baltimore. She has no disclosures.

I am a psychiatrist, which means I am a mental health professional, which means I work with people with mental illness. Sometimes people with mental health conditions who suffer from mental illness need to take a day off work – also called a mental health day – because they are too symptomatic to work, and sometimes people who don’t have a mental illness need to take a day off work, also called a mental health day, because they are feeling stressed.

Sometimes professional athletes don’t do things they agreed to do in their contracts because they realize that doing these things is very upsetting and will be detrimental to their mental health, or maybe they have a mental illness and doing these things will worsen their mental health condition, which is, in fact, a mental illness. Other times people with mental health conditions need to have pets travel with them because this mitigates the symptoms of their mental illness or perhaps it’s just good for their mental health. And finally, some people suffer from mental illnesses, or sometimes from learning problems, which are severe enough that a person with these conditions has a disability and needs special accommodations to function optimally in educational or occupational settings, or needs public financial support because their difficulties disable them to the point that they can’t work at all.

Is your head spinning yet? The point I am trying to make is that, as a profession, we have done an abysmal job of defining what we do, who we serve, and differentiating the fact that what someone with a psychiatric disorder needs to do to function or to alleviate emotional suffering may be entirely different from the things that everyone needs to do, regardless of whether they have a psychiatric disorder, to feel their emotional best.

The National Alliance on Mental Illness tells us that one in five Americans are suffering from a mental illness, while the Epidemiologic Catchment Area Program revealed that half of people will meet criteria for a mental illness at some point in their lives. We hear about “the mentally ill” constantly in the news – often in relation to mass shooters or homelessness – yet even psychiatrists might be pressed to define who exactly the “mentally ill” are. And how many of us could not somehow, at some time, find ourselves in 1 of the 157 disorders that DSM-5 lists – down from 365 disorders in the DSM-IV-TR?

Differentiating mental health from mental illness is just the beginning of our semantic confusion. As psychiatrists we treat major depression, and yet the illness “depression,” a syndromic constellation of symptoms, includes the key symptom of sadness. People often say they are “depressed” when they mean they are sad or demoralized, and yet, if their sadness persists in the absence of other symptoms, they may well want, or feel they “should” have medications, even in the absence of a disorder. And maybe those medications help them feel better, so that the presence or absence of a verified illness doesn’t really matter. But if the medications cause adverse reactions, then psychiatry might have done a better job by that person’s sadness. Melancholia, or perhaps any designation than “depression,” with its multiple meanings, might better serve our patients and our profession. This is only one example, as the number of people who tell me they have obsessive-compulsive disorder – or more often announce, “I’m OCD!” because they are well organized in a productive way is remarkable. And while I have treated only a few people who meet the criteria for narcissistic personality disorder, from general conversation it would seem that they are at every dinner table and by every water cooler.

Does it matter? A diagnostic lexicon can be so helpful when it guides treatment, provides a heterogeneous group of patients for research studies, and allows for an understanding of the etiology, course, and prognosis of a given condition. When someone is so depressed that they can’t get out of bed, or is so disorganized that they can’t perform their job and might cause a disturbance in their workplace, it is good to instruct them to take time off work and send them back well with a doctor’s note. But this is different from the person who doesn’t want to face a difficult situation, who simply doesn’t like their job or their boss, or who wants their pet declared an emotional support animal to avoid the fee the airlines charge to bring an animal on board if one does not have a psychiatric diagnosis. Sometimes these lines are blurry – if someone does not want to do something because it makes them anxious, does it matter how deep the pit in their stomach is, or if they are having full-blown panic attacks? When do we agree that their distress is reason to allow them to avoid responsibilities without repercussions versus a violation of their obligations and an infringement on others?

Diagnoses offer solace to some patients: There is a name for their suffering, available treatment, and often others with the same condition to look to for guidance and community. For others, a psychiatric diagnosis is a source of shame, a label they see as damaging to their character and sometimes to their careers – including in medicine – where we have been particularly unsympathetic to those who announce a psychiatric history.

In some cultures, the label itself decreases someone’s attractiveness as a potential marriage partner. We would all like to see the stigma of mental illness vanish, but we have a long way to go.

Psychiatric diagnoses move over time and with our politics and culture. This is good; we don’t hold on to what we learn to be untrue. But they may well add to issues of inequity. Those who can afford to pay for expensive educational assessments can request educational accommodations, including untimed standardized tests. This advantage may not be available to those without the resources to pay for these evaluations, and one might wonder why all comers can’t take untimed tests so as not to favor the privileged. Psychiatry has long been accused of diagnosing people of color with poor prognosis illnesses and women with conditions that imply emotional weakness.

While our diagnoses have clinical utility, it is unfortunate that they have come to be about reimbursement. A diagnosis needs to be assigned for insurers to pay for care, and so we create diagnostic categories to allow for treatment. Is this reasonable? Do we need to say that someone who is suffering after the death of a loved one has a mental illness in order to allow them to seek relief from their suffering? It leads us to believe that all suffering is about pathology, that we should expect pain-free emotional lives. Perhaps we need a diagnostic category of psychic pain, not otherwise specified, to allow for treatment for those who simply ache.

Mental illness is about interventions to alleviate the suffering of those with disorders. Mental health is about interventions that may benefit everyone, whether they suffer from a mental illness or not. Sleep, nutrition, exercise, sunlight, nature, entertainment and escape, yoga, meditation, vacations in beautiful places with loving people – these are things that potentially help us all whether we do or do not have an illness. With so much confusion about what it is we do, and about who “should” get help, who can get help, who might want help, and where they should go to seek help, perhaps it would be better if our lingo were more precise.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). The has a private practice and is assistant professor of psychiatry ad behavioral sciences at Johns Hopkins University, both in Baltimore. She has no disclosures.

I am a psychiatrist, which means I am a mental health professional, which means I work with people with mental illness. Sometimes people with mental health conditions who suffer from mental illness need to take a day off work – also called a mental health day – because they are too symptomatic to work, and sometimes people who don’t have a mental illness need to take a day off work, also called a mental health day, because they are feeling stressed.

Sometimes professional athletes don’t do things they agreed to do in their contracts because they realize that doing these things is very upsetting and will be detrimental to their mental health, or maybe they have a mental illness and doing these things will worsen their mental health condition, which is, in fact, a mental illness. Other times people with mental health conditions need to have pets travel with them because this mitigates the symptoms of their mental illness or perhaps it’s just good for their mental health. And finally, some people suffer from mental illnesses, or sometimes from learning problems, which are severe enough that a person with these conditions has a disability and needs special accommodations to function optimally in educational or occupational settings, or needs public financial support because their difficulties disable them to the point that they can’t work at all.

Is your head spinning yet? The point I am trying to make is that, as a profession, we have done an abysmal job of defining what we do, who we serve, and differentiating the fact that what someone with a psychiatric disorder needs to do to function or to alleviate emotional suffering may be entirely different from the things that everyone needs to do, regardless of whether they have a psychiatric disorder, to feel their emotional best.

The National Alliance on Mental Illness tells us that one in five Americans are suffering from a mental illness, while the Epidemiologic Catchment Area Program revealed that half of people will meet criteria for a mental illness at some point in their lives. We hear about “the mentally ill” constantly in the news – often in relation to mass shooters or homelessness – yet even psychiatrists might be pressed to define who exactly the “mentally ill” are. And how many of us could not somehow, at some time, find ourselves in 1 of the 157 disorders that DSM-5 lists – down from 365 disorders in the DSM-IV-TR?

Differentiating mental health from mental illness is just the beginning of our semantic confusion. As psychiatrists we treat major depression, and yet the illness “depression,” a syndromic constellation of symptoms, includes the key symptom of sadness. People often say they are “depressed” when they mean they are sad or demoralized, and yet, if their sadness persists in the absence of other symptoms, they may well want, or feel they “should” have medications, even in the absence of a disorder. And maybe those medications help them feel better, so that the presence or absence of a verified illness doesn’t really matter. But if the medications cause adverse reactions, then psychiatry might have done a better job by that person’s sadness. Melancholia, or perhaps any designation than “depression,” with its multiple meanings, might better serve our patients and our profession. This is only one example, as the number of people who tell me they have obsessive-compulsive disorder – or more often announce, “I’m OCD!” because they are well organized in a productive way is remarkable. And while I have treated only a few people who meet the criteria for narcissistic personality disorder, from general conversation it would seem that they are at every dinner table and by every water cooler.

Does it matter? A diagnostic lexicon can be so helpful when it guides treatment, provides a heterogeneous group of patients for research studies, and allows for an understanding of the etiology, course, and prognosis of a given condition. When someone is so depressed that they can’t get out of bed, or is so disorganized that they can’t perform their job and might cause a disturbance in their workplace, it is good to instruct them to take time off work and send them back well with a doctor’s note. But this is different from the person who doesn’t want to face a difficult situation, who simply doesn’t like their job or their boss, or who wants their pet declared an emotional support animal to avoid the fee the airlines charge to bring an animal on board if one does not have a psychiatric diagnosis. Sometimes these lines are blurry – if someone does not want to do something because it makes them anxious, does it matter how deep the pit in their stomach is, or if they are having full-blown panic attacks? When do we agree that their distress is reason to allow them to avoid responsibilities without repercussions versus a violation of their obligations and an infringement on others?

Diagnoses offer solace to some patients: There is a name for their suffering, available treatment, and often others with the same condition to look to for guidance and community. For others, a psychiatric diagnosis is a source of shame, a label they see as damaging to their character and sometimes to their careers – including in medicine – where we have been particularly unsympathetic to those who announce a psychiatric history.

In some cultures, the label itself decreases someone’s attractiveness as a potential marriage partner. We would all like to see the stigma of mental illness vanish, but we have a long way to go.

Psychiatric diagnoses move over time and with our politics and culture. This is good; we don’t hold on to what we learn to be untrue. But they may well add to issues of inequity. Those who can afford to pay for expensive educational assessments can request educational accommodations, including untimed standardized tests. This advantage may not be available to those without the resources to pay for these evaluations, and one might wonder why all comers can’t take untimed tests so as not to favor the privileged. Psychiatry has long been accused of diagnosing people of color with poor prognosis illnesses and women with conditions that imply emotional weakness.

While our diagnoses have clinical utility, it is unfortunate that they have come to be about reimbursement. A diagnosis needs to be assigned for insurers to pay for care, and so we create diagnostic categories to allow for treatment. Is this reasonable? Do we need to say that someone who is suffering after the death of a loved one has a mental illness in order to allow them to seek relief from their suffering? It leads us to believe that all suffering is about pathology, that we should expect pain-free emotional lives. Perhaps we need a diagnostic category of psychic pain, not otherwise specified, to allow for treatment for those who simply ache.

Mental illness is about interventions to alleviate the suffering of those with disorders. Mental health is about interventions that may benefit everyone, whether they suffer from a mental illness or not. Sleep, nutrition, exercise, sunlight, nature, entertainment and escape, yoga, meditation, vacations in beautiful places with loving people – these are things that potentially help us all whether we do or do not have an illness. With so much confusion about what it is we do, and about who “should” get help, who can get help, who might want help, and where they should go to seek help, perhaps it would be better if our lingo were more precise.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). The has a private practice and is assistant professor of psychiatry ad behavioral sciences at Johns Hopkins University, both in Baltimore. She has no disclosures.

As a physician first and a mental health clinician second, I hope to provide factual medical information on the Omicron variant to my patients, family members, and friends. I also try to remain curious instead of angry about why some choose not to vaccinate.

The most effective way to encourage people to obtain a vaccination is to use communication free of judgment and criticism, which allows a safe space for the unvaccinated to express their motivations and fears behind their current choice of not vaccinating and explore possible barriers to an alternative option that could lead to vaccination.

As an adult psychiatrist, ADHD specialist, and amateur COVID-19 expert, I’d like to offer 10 reasons why Omicron – which ironically means “small” in Latin, can still cause big destruction. Please share these 10 reasons with your patients.

• If you are not vaccinated, this virus will find you within the next few weeks and likely lead to severe symptoms.
• Long-haul symptoms from COVID-19 infection are still possible even for people who contract a milder case of the Omicron variant.
• The monoclonal antibody and antiviral treatments recently approved by the Food and Drug Administration for pre-exposure prevention of COVID-19 are limited. For many reasons, now is not the best time to play Russian roulette and intentionally get infected with a “mild” variant.
• There are not enough testing sites or over-the-counter rapid COVID tests available to keep up with the demand, and the latter are cost prohibitive for many people.
• Emergency care during the next few weeks for unforeseen non–COVID-related illnesses, such as a sudden heart attack or stroke, may be affected by the shortage of medical providers because of illness, quarantine, and burnout.
• There will be fewer first responders, including EMTs, police officers, and firefighters, because of COVID quarantines from illness and exposure.
• Although most Americans oppose temporary shutdowns, de facto shutdowns might be necessary because of the absence of healthy, COVID-negative individuals to maintain a functional society.
• Omicron math is deceiving, since the risk of hospitalization with Omicron appears to be far lower than with the Delta variant. However, the higher volume of infections with Omicron will offset the lower severity leading to comparable numbers of hospitalizations.
• Omicron has made it difficult for some schools to reopen after the holiday break, and reopening might become even more difficult as the surge progresses. Many schools already were in desperate need of substitute teachers, bus drivers, and additional staff necessary for COVID safety precautions before the emergence of the Omicron variant.
• And, for a less altruistic reason, as if the nine reasons above weren’t enough – if infections continue, especially among the unvaccinated – where the virus mutates the most – this can lead to a trifecta variant that not only evades the immune system and is highly infectious but causes severe disease in both the unvaccinated as well as the vaccinated.

Because of its extremely high transmissibility, the Omicron variant – layered atop Delta – presents great risk to us as a society. We must do all we can as clinicians to educate our patients so that they can protect themselves and their families.

Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.

As a physician first and a mental health clinician second, I hope to provide factual medical information on the Omicron variant to my patients, family members, and friends. I also try to remain curious instead of angry about why some choose not to vaccinate.

The most effective way to encourage people to obtain a vaccination is to use communication free of judgment and criticism, which allows a safe space for the unvaccinated to express their motivations and fears behind their current choice of not vaccinating and explore possible barriers to an alternative option that could lead to vaccination.

As an adult psychiatrist, ADHD specialist, and amateur COVID-19 expert, I’d like to offer 10 reasons why Omicron – which ironically means “small” in Latin, can still cause big destruction. Please share these 10 reasons with your patients.

• If you are not vaccinated, this virus will find you within the next few weeks and likely lead to severe symptoms.
• Long-haul symptoms from COVID-19 infection are still possible even for people who contract a milder case of the Omicron variant.
• The monoclonal antibody and antiviral treatments recently approved by the Food and Drug Administration for pre-exposure prevention of COVID-19 are limited. For many reasons, now is not the best time to play Russian roulette and intentionally get infected with a “mild” variant.
• There are not enough testing sites or over-the-counter rapid COVID tests available to keep up with the demand, and the latter are cost prohibitive for many people.
• Emergency care during the next few weeks for unforeseen non–COVID-related illnesses, such as a sudden heart attack or stroke, may be affected by the shortage of medical providers because of illness, quarantine, and burnout.
• There will be fewer first responders, including EMTs, police officers, and firefighters, because of COVID quarantines from illness and exposure.
• Although most Americans oppose temporary shutdowns, de facto shutdowns might be necessary because of the absence of healthy, COVID-negative individuals to maintain a functional society.
• Omicron math is deceiving, since the risk of hospitalization with Omicron appears to be far lower than with the Delta variant. However, the higher volume of infections with Omicron will offset the lower severity leading to comparable numbers of hospitalizations.
• Omicron has made it difficult for some schools to reopen after the holiday break, and reopening might become even more difficult as the surge progresses. Many schools already were in desperate need of substitute teachers, bus drivers, and additional staff necessary for COVID safety precautions before the emergence of the Omicron variant.
• And, for a less altruistic reason, as if the nine reasons above weren’t enough – if infections continue, especially among the unvaccinated – where the virus mutates the most – this can lead to a trifecta variant that not only evades the immune system and is highly infectious but causes severe disease in both the unvaccinated as well as the vaccinated.

Because of its extremely high transmissibility, the Omicron variant – layered atop Delta – presents great risk to us as a society. We must do all we can as clinicians to educate our patients so that they can protect themselves and their families.

Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.

As a physician first and a mental health clinician second, I hope to provide factual medical information on the Omicron variant to my patients, family members, and friends. I also try to remain curious instead of angry about why some choose not to vaccinate.

The most effective way to encourage people to obtain a vaccination is to use communication free of judgment and criticism, which allows a safe space for the unvaccinated to express their motivations and fears behind their current choice of not vaccinating and explore possible barriers to an alternative option that could lead to vaccination.

As an adult psychiatrist, ADHD specialist, and amateur COVID-19 expert, I’d like to offer 10 reasons why Omicron – which ironically means “small” in Latin, can still cause big destruction. Please share these 10 reasons with your patients.

• If you are not vaccinated, this virus will find you within the next few weeks and likely lead to severe symptoms.
• Long-haul symptoms from COVID-19 infection are still possible even for people who contract a milder case of the Omicron variant.
• The monoclonal antibody and antiviral treatments recently approved by the Food and Drug Administration for pre-exposure prevention of COVID-19 are limited. For many reasons, now is not the best time to play Russian roulette and intentionally get infected with a “mild” variant.
• There are not enough testing sites or over-the-counter rapid COVID tests available to keep up with the demand, and the latter are cost prohibitive for many people.
• Emergency care during the next few weeks for unforeseen non–COVID-related illnesses, such as a sudden heart attack or stroke, may be affected by the shortage of medical providers because of illness, quarantine, and burnout.
• There will be fewer first responders, including EMTs, police officers, and firefighters, because of COVID quarantines from illness and exposure.
• Although most Americans oppose temporary shutdowns, de facto shutdowns might be necessary because of the absence of healthy, COVID-negative individuals to maintain a functional society.
• Omicron math is deceiving, since the risk of hospitalization with Omicron appears to be far lower than with the Delta variant. However, the higher volume of infections with Omicron will offset the lower severity leading to comparable numbers of hospitalizations.
• Omicron has made it difficult for some schools to reopen after the holiday break, and reopening might become even more difficult as the surge progresses. Many schools already were in desperate need of substitute teachers, bus drivers, and additional staff necessary for COVID safety precautions before the emergence of the Omicron variant.
• And, for a less altruistic reason, as if the nine reasons above weren’t enough – if infections continue, especially among the unvaccinated – where the virus mutates the most – this can lead to a trifecta variant that not only evades the immune system and is highly infectious but causes severe disease in both the unvaccinated as well as the vaccinated.

Because of its extremely high transmissibility, the Omicron variant – layered atop Delta – presents great risk to us as a society. We must do all we can as clinicians to educate our patients so that they can protect themselves and their families.

Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.

The nation’s Surgeon General, Vice Admiral Vivek H. Murthy, MD, MBA, recently released an advisory report on the current state of youth mental health and recommendations to improve well-being. This action follows a number of emergency declarations that have been made by professional organizations such as the American Academy of Child and Adolescent Psychiatry (AACAP), the American Academy of Pediatrics (AAP), and other health care groups to raise awareness about the alarming increase of depression, suicide, anxiety, and other mental health problems in youth.

These reports can be helpful in focusing attention and resources for important public health problems. Many still reference the 1999 report from former Surgeon General David Satcher, MD, PhD, which offered a number of eye-opening statistics regarding the prevalence of mental health conditions and the amount of disability associated with them.

Sadly, the present report indicates that many of these indices have grown worse in the past 20 years. For example, the advisory notes that, even before COVID-19, fully half of female high school students reported persistent feelings of sadness or hopelessness (up 40% from 2009). The report then goes on to cite a number of studies documenting even further rises in youth mental health problems associated with the pandemic.

Most of the advisory, however, is devoted to actions that can be taken by different groups, including young people themselves, parents, educators, the government, and even social media and video game companies, to support mental health and well-being. Multiple online resources are provided at the end of each of these sections.

One of the segments is aimed at health care organizations and professionals. While first making a fairly sweeping statement that “our health care system today is not set up optimally to support the mental health and well-being of children and youth,” this part then outlines five broad recommendations that might help improve the fit. These include the following.

• Increase prevention efforts, such as coordination to enrichment programs and referrals for economic and legal supports for families in need.
• Screen routinely for mental health conditions and link those who screen in with appropriate care.
• Identify mental health needs in parents and caregivers such as depression and substance use that can have negative effects on children.
• Increase partnerships between health care groups and community organizations.
• Build multidisciplinary teams that are culturally appropriate and maximally engage children and caretakers in the decision-making process.

The current report is downloadable for free (see reference below) and it is certainly worthwhile for pediatricians to take a look. Dr. Murthy writes, regarding the current state of mental health, that “it would be a tragedy if we beat back one public health crisis only to allow another to grow in its place.”

The report also outlines specific areas where additional research is needed, such as data on racial and sexual minorities and research on innovative and scalable therapies. In addition to the online resources that are provided, the report is backed by over 250 references.

Since its release, the report has generally been well received, and, indeed, there is much to support. The well-known Child Mind Institute in New York tweeted that “this document is a wake-up call for the country and a long-overdue statement of leadership from the federal government.”

Many of the recommendations are admittedly somewhat commons sense, but there are some that are much less so. For example, one recommendation to youth themselves is to serve others – something that may first come across as counterintuitive but can indeed help children and adolescents develop a sense of purpose and self-worth. The call for pediatric health care professionals to screen parents in addition to the patients themselves will likely result in some debate as well. The recommendation to reduce access to lethal means, including the specific naming of firearms, is also a welcome addition. This report also rightly puts a spotlight on the role of societal factors such as racism and poverty in the development of mental health problems and in getting access to quality treatment.

Also worth noting is how much of the advisory examined the role of media in both the problem and the solution. While recognizing that technology, smartphones, and social media are here to stay, a number of suggestions were given to parents, media organizations, journalists, and entertainment companies to reduce the negative impacts these mediums can have. Explicitly recognized in the report is that “there can be tension between what’s best for the technology company and what’s best for the individual user or society.” Also acknowledged was that the link between media of various types and mental health is complex and inconsistent with there being a strong need for additional work in this area when it comes to academic research as well as product development within these companies themselves.

Yet while there is much to like about the advisory, there remain some areas that seem lacking. For example, the text about what causes mental health conditions gets a little dualistic in mentioning biological and environmental factors without much appreciation that these are hardly independent domains. Perhaps more substantially, there was surprisingly little airtime devoted to an enormous issue that underlies so many other challenges related to mental health care – namely an inadequate workforce that gets smaller by the minute. The topic was treated much too superficially with lots of vague calls to “expand” the workforce that lacked substance or detail.

Overall, however, the new Surgeon General’s Advisory is a welcome document that offers updated knowledge of our current challenges and provides practical responses that truly could make a difference. Now all we have to do is put these recommendations into action.

Dr. Rettew is a child and adolescent psychiatrist and medical director of Lane County Behavioral Health in Eugene, Ore. His latest book is “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood.” You can follow him on Twitter and Facebook @PediPsych.

Reference

“Protecting Youth Mental Health – The U.S. Surgeon General’s Advisory,” U.S. Department of Health & Human Services (2021).

The nation’s Surgeon General, Vice Admiral Vivek H. Murthy, MD, MBA, recently released an advisory report on the current state of youth mental health and recommendations to improve well-being. This action follows a number of emergency declarations that have been made by professional organizations such as the American Academy of Child and Adolescent Psychiatry (AACAP), the American Academy of Pediatrics (AAP), and other health care groups to raise awareness about the alarming increase of depression, suicide, anxiety, and other mental health problems in youth.

These reports can be helpful in focusing attention and resources for important public health problems. Many still reference the 1999 report from former Surgeon General David Satcher, MD, PhD, which offered a number of eye-opening statistics regarding the prevalence of mental health conditions and the amount of disability associated with them.

Sadly, the present report indicates that many of these indices have grown worse in the past 20 years. For example, the advisory notes that, even before COVID-19, fully half of female high school students reported persistent feelings of sadness or hopelessness (up 40% from 2009). The report then goes on to cite a number of studies documenting even further rises in youth mental health problems associated with the pandemic.

Most of the advisory, however, is devoted to actions that can be taken by different groups, including young people themselves, parents, educators, the government, and even social media and video game companies, to support mental health and well-being. Multiple online resources are provided at the end of each of these sections.

One of the segments is aimed at health care organizations and professionals. While first making a fairly sweeping statement that “our health care system today is not set up optimally to support the mental health and well-being of children and youth,” this part then outlines five broad recommendations that might help improve the fit. These include the following.

• Increase prevention efforts, such as coordination to enrichment programs and referrals for economic and legal supports for families in need.
• Screen routinely for mental health conditions and link those who screen in with appropriate care.
• Identify mental health needs in parents and caregivers such as depression and substance use that can have negative effects on children.
• Increase partnerships between health care groups and community organizations.
• Build multidisciplinary teams that are culturally appropriate and maximally engage children and caretakers in the decision-making process.

The current report is downloadable for free (see reference below) and it is certainly worthwhile for pediatricians to take a look. Dr. Murthy writes, regarding the current state of mental health, that “it would be a tragedy if we beat back one public health crisis only to allow another to grow in its place.”

The report also outlines specific areas where additional research is needed, such as data on racial and sexual minorities and research on innovative and scalable therapies. In addition to the online resources that are provided, the report is backed by over 250 references.

Since its release, the report has generally been well received, and, indeed, there is much to support. The well-known Child Mind Institute in New York tweeted that “this document is a wake-up call for the country and a long-overdue statement of leadership from the federal government.”

Many of the recommendations are admittedly somewhat commons sense, but there are some that are much less so. For example, one recommendation to youth themselves is to serve others – something that may first come across as counterintuitive but can indeed help children and adolescents develop a sense of purpose and self-worth. The call for pediatric health care professionals to screen parents in addition to the patients themselves will likely result in some debate as well. The recommendation to reduce access to lethal means, including the specific naming of firearms, is also a welcome addition. This report also rightly puts a spotlight on the role of societal factors such as racism and poverty in the development of mental health problems and in getting access to quality treatment.

Also worth noting is how much of the advisory examined the role of media in both the problem and the solution. While recognizing that technology, smartphones, and social media are here to stay, a number of suggestions were given to parents, media organizations, journalists, and entertainment companies to reduce the negative impacts these mediums can have. Explicitly recognized in the report is that “there can be tension between what’s best for the technology company and what’s best for the individual user or society.” Also acknowledged was that the link between media of various types and mental health is complex and inconsistent with there being a strong need for additional work in this area when it comes to academic research as well as product development within these companies themselves.

Yet while there is much to like about the advisory, there remain some areas that seem lacking. For example, the text about what causes mental health conditions gets a little dualistic in mentioning biological and environmental factors without much appreciation that these are hardly independent domains. Perhaps more substantially, there was surprisingly little airtime devoted to an enormous issue that underlies so many other challenges related to mental health care – namely an inadequate workforce that gets smaller by the minute. The topic was treated much too superficially with lots of vague calls to “expand” the workforce that lacked substance or detail.

Overall, however, the new Surgeon General’s Advisory is a welcome document that offers updated knowledge of our current challenges and provides practical responses that truly could make a difference. Now all we have to do is put these recommendations into action.

Dr. Rettew is a child and adolescent psychiatrist and medical director of Lane County Behavioral Health in Eugene, Ore. His latest book is “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood.” You can follow him on Twitter and Facebook @PediPsych.

Reference

“Protecting Youth Mental Health – The U.S. Surgeon General’s Advisory,” U.S. Department of Health & Human Services (2021).

The nation’s Surgeon General, Vice Admiral Vivek H. Murthy, MD, MBA, recently released an advisory report on the current state of youth mental health and recommendations to improve well-being. This action follows a number of emergency declarations that have been made by professional organizations such as the American Academy of Child and Adolescent Psychiatry (AACAP), the American Academy of Pediatrics (AAP), and other health care groups to raise awareness about the alarming increase of depression, suicide, anxiety, and other mental health problems in youth.

These reports can be helpful in focusing attention and resources for important public health problems. Many still reference the 1999 report from former Surgeon General David Satcher, MD, PhD, which offered a number of eye-opening statistics regarding the prevalence of mental health conditions and the amount of disability associated with them.

Sadly, the present report indicates that many of these indices have grown worse in the past 20 years. For example, the advisory notes that, even before COVID-19, fully half of female high school students reported persistent feelings of sadness or hopelessness (up 40% from 2009). The report then goes on to cite a number of studies documenting even further rises in youth mental health problems associated with the pandemic.

Most of the advisory, however, is devoted to actions that can be taken by different groups, including young people themselves, parents, educators, the government, and even social media and video game companies, to support mental health and well-being. Multiple online resources are provided at the end of each of these sections.

One of the segments is aimed at health care organizations and professionals. While first making a fairly sweeping statement that “our health care system today is not set up optimally to support the mental health and well-being of children and youth,” this part then outlines five broad recommendations that might help improve the fit. These include the following.

• Increase prevention efforts, such as coordination to enrichment programs and referrals for economic and legal supports for families in need.
• Screen routinely for mental health conditions and link those who screen in with appropriate care.
• Identify mental health needs in parents and caregivers such as depression and substance use that can have negative effects on children.
• Increase partnerships between health care groups and community organizations.
• Build multidisciplinary teams that are culturally appropriate and maximally engage children and caretakers in the decision-making process.

The current report is downloadable for free (see reference below) and it is certainly worthwhile for pediatricians to take a look. Dr. Murthy writes, regarding the current state of mental health, that “it would be a tragedy if we beat back one public health crisis only to allow another to grow in its place.”

The report also outlines specific areas where additional research is needed, such as data on racial and sexual minorities and research on innovative and scalable therapies. In addition to the online resources that are provided, the report is backed by over 250 references.

Since its release, the report has generally been well received, and, indeed, there is much to support. The well-known Child Mind Institute in New York tweeted that “this document is a wake-up call for the country and a long-overdue statement of leadership from the federal government.”

Many of the recommendations are admittedly somewhat commons sense, but there are some that are much less so. For example, one recommendation to youth themselves is to serve others – something that may first come across as counterintuitive but can indeed help children and adolescents develop a sense of purpose and self-worth. The call for pediatric health care professionals to screen parents in addition to the patients themselves will likely result in some debate as well. The recommendation to reduce access to lethal means, including the specific naming of firearms, is also a welcome addition. This report also rightly puts a spotlight on the role of societal factors such as racism and poverty in the development of mental health problems and in getting access to quality treatment.

Also worth noting is how much of the advisory examined the role of media in both the problem and the solution. While recognizing that technology, smartphones, and social media are here to stay, a number of suggestions were given to parents, media organizations, journalists, and entertainment companies to reduce the negative impacts these mediums can have. Explicitly recognized in the report is that “there can be tension between what’s best for the technology company and what’s best for the individual user or society.” Also acknowledged was that the link between media of various types and mental health is complex and inconsistent with there being a strong need for additional work in this area when it comes to academic research as well as product development within these companies themselves.

Yet while there is much to like about the advisory, there remain some areas that seem lacking. For example, the text about what causes mental health conditions gets a little dualistic in mentioning biological and environmental factors without much appreciation that these are hardly independent domains. Perhaps more substantially, there was surprisingly little airtime devoted to an enormous issue that underlies so many other challenges related to mental health care – namely an inadequate workforce that gets smaller by the minute. The topic was treated much too superficially with lots of vague calls to “expand” the workforce that lacked substance or detail.

Overall, however, the new Surgeon General’s Advisory is a welcome document that offers updated knowledge of our current challenges and provides practical responses that truly could make a difference. Now all we have to do is put these recommendations into action.

Dr. Rettew is a child and adolescent psychiatrist and medical director of Lane County Behavioral Health in Eugene, Ore. His latest book is “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood.” You can follow him on Twitter and Facebook @PediPsych.

Reference

“Protecting Youth Mental Health – The U.S. Surgeon General’s Advisory,” U.S. Department of Health & Human Services (2021).

Use of a leukotriene receptor antagonist (LTRA) for asthma management did not increase the risk of neuropsychiatric disease, based on data from more than 60,000 asthma patients.

Although LTRAs are established as an effective drug for asthma, the U.S. Food and Drug Administration warnings of the risk for neuropsychiatric (NP) drug reactions – including a boxed warning for montelukast (Singulair) – has raised concerns, writes Ji-Su Shim, MD, of Ewha Womans University, Seoul, South Korea, and colleagues.

However, evidence for such an association is limited, and previous studies have focused only on children and adolescents, and on a single LTRA (montelukast), the researchers say.

In a study published Dec. 1 in the Journal of Allergy and Clinical Immunology: In Practice, the researchers used a Korean national health insurance database to identify 61,571 adult patients with asthma aged 40 years and older between Jan. 2002 and Dec. 2015 with no history of LTRA use.

The patients underwent screening examinations between Jan. 2009 and Dec. 2010, which marked the start of a follow-up period ending on Dec. 31, 2015. The median age of the study population was 61 years, and the mean follow-up period for NPs or other outcomes was approximately 47.6 months for LTRA users and 46.5 months for nonusers. Overall, 11.1% of the study population used pranlukast (Onon), 11% used montelukast, and 0.24% used zafirlukast (Accolate).

A total of 12,168 patients took an LTRA during the follow-up period. The hazard ratio for newly diagnosed neuropsychiatric diseases was not significantly different between LTRA users and nonusers (hazard ratio, 1.01; P = .952) in an adjusted model that included age, sex, pack-years of smoking, alcohol use, physical activity, body mass index, comorbid conditions, other respiratory diseases, and use of other asthma medications.

The most common NPs were dementia, mood disorders, and panic disorders, and the prevalence of each was not significantly different between LTRA users and nonusers (75.4% vs. 76.1% for dementia, 12.7% vs. 12.8% for mood disorders, and 5.6% vs. 3.5% for panic disorders).

A subgroup analysis for associations between the duration of LTRA use and NP disease risk also showed no significant difference between LTRA users and nonusers.

“The mechanism of the development of NP symptoms by LTRAs has not been identified,” the researchers write in their discussion of the study findings. “Because most of NP side effects due to montelukast occur in few patients within 2 weeks of drug administration, it also may have relation with the presence of some genetic polymorphisms involving modification of the normal action or metabolism of LTRAs,” they explained.

The FDA’s boxed warning for montelukast noting the risk of serious mental health side effects has renewed interest in the relationship between NPs and LTRAs, the researchers noted. However, the current study findings support previous randomized controlled trials and larger studies, and the current warnings are based mainly on pharmacovigilance studies, case series, and case reports, they said.

The study findings were limited by several factors, including the retrospective design, the potential for misclassification of asthma diagnosis, the exclusion of temporary NP symptoms that might prompt LTRA discontinuation, and the inability to detect possible differences in ethnicities other than Korean, the researchers note.

However, the results suggest that adverse NP symptoms should not prevent physicians from prescribing LTRAs to selected patients with asthma. Instead, the physician should accompany the prescription with “a word of caution in case any mood changes might occur,” the investigators wrote.

“Further studies, such as randomized controlled trials, are needed to reveal the association between the use of LTRAs and the risk of NP events and/or diseases,” they concluded.

Potential genetic predisposition may drive cases

The relatively rare occurrence of NP symptoms in asthma patients using LTRAs has prompted questions from the medical community on whether the relationship really exists, writes Désirée Larenas-Linnemann, MD, of Médica Sur Clinical Foundation and Hospital, Mexico City, in an accompanying editorial ).

The current study provides information about medications and possible adverse drug reactions, but “great care should be taken in the interpretation of the results from such a study,” she notes. Limitations include not only the possible misclassification of asthma and the homogeneous study population, but also the fact that some NPs, such as dementia, are already common in older adults..

Dr. Larenas-Linnemann shared a story of one of her patients, a 2½-year-old boy who began exhibiting hyperactivity and other strange behaviors while on an LRTA. The toddler’s father had previously reported “horrible nightmares, strange thoughts, and to feel upset, unsecure until he suspended the medication.” Cases such as this support a potential genetic predisposition, with drug metabolism playing a role, and clinicians should take genetic backgrounds into account, she said.

“Even though the current study did not show an association between LTRA use or duration of exposure and the occurrence of NP diseases in Korean adults with asthma, this does not imply such a relationship might be present in other age groups (children-adolescents-adults up to 50 years) or in patients with a different genetic background,” she emphasized.

However, “In the meantime, although LTRA should continue to be prescribed if indicated, an index of suspicion for possible NP effects should be maintained,” Dr. Larenas-Linnemann concluded.

“This study is timely, since the boxed warning for montelukast was issued approximately 1 year ago by the FDA,” Thomas B. Casale, MD, of the University of South Florida, Tampa, said in an interview.

Dr. Casale said he was not surprised by the findings, “since most of the data implicating a potential link between the use of montelukast and neuropsychiatric disorders have not been particularly compelling,” and much of the current information comes from case reports and retrospective studies.

“Furthermore, the data appeared to be somewhat stronger in the pediatric population,” Dr. Casale noted. “This study focused on elderly patients (mean age 61) and included two other leukotriene modifiers. The number of patients receiving montelukast was small (56), which may have also confounded the results,” he noted.

As for clinical implications, “I don’t think this study will change practice,” Dr. Casale said. “As indicated, it is in an elderly population, included only a limited number of patients receiving montelukast, and was in a Korean cohort. All of these factors could have influenced the results,” and the data may not be generalizable to patients elsewhere, including the United States, he said. “Also, the study only included patients with asthma and in the United States; the approval for rhinitis is another important indication to study,” he noted.

Additional research is needed in the form of better prospective studies examining the potential link between montelukast and neuropsychiatric disorders in both the pediatric and adult populations having either asthma or rhinitis, Dr. Casale concluded.

The study received no outside funding. The researchers and Dr. Casale have disclosed no relevant financial relationships. Dr. Larenas-Linnemann disclosed personal fees from Allakos, Armstrong, AstraZeneca, Chiesi, DBV Technologies, Grünenthal, GSK, Mylan/Viatris, Menarini, MSD, Novartis, Pfizer, Sanofi, Siegfried, UCB, Alakos, Gossamer, and Carnot, and grants from Sanofi, AstraZeneca, Novartis, Circassia, UCB, GSK, and the Purina Institute.

A version of this article first appeared on Medscape.com.

Use of a leukotriene receptor antagonist (LTRA) for asthma management did not increase the risk of neuropsychiatric disease, based on data from more than 60,000 asthma patients.

Although LTRAs are established as an effective drug for asthma, the U.S. Food and Drug Administration warnings of the risk for neuropsychiatric (NP) drug reactions – including a boxed warning for montelukast (Singulair) – has raised concerns, writes Ji-Su Shim, MD, of Ewha Womans University, Seoul, South Korea, and colleagues.

However, evidence for such an association is limited, and previous studies have focused only on children and adolescents, and on a single LTRA (montelukast), the researchers say.

In a study published Dec. 1 in the Journal of Allergy and Clinical Immunology: In Practice, the researchers used a Korean national health insurance database to identify 61,571 adult patients with asthma aged 40 years and older between Jan. 2002 and Dec. 2015 with no history of LTRA use.

The patients underwent screening examinations between Jan. 2009 and Dec. 2010, which marked the start of a follow-up period ending on Dec. 31, 2015. The median age of the study population was 61 years, and the mean follow-up period for NPs or other outcomes was approximately 47.6 months for LTRA users and 46.5 months for nonusers. Overall, 11.1% of the study population used pranlukast (Onon), 11% used montelukast, and 0.24% used zafirlukast (Accolate).

A total of 12,168 patients took an LTRA during the follow-up period. The hazard ratio for newly diagnosed neuropsychiatric diseases was not significantly different between LTRA users and nonusers (hazard ratio, 1.01; P = .952) in an adjusted model that included age, sex, pack-years of smoking, alcohol use, physical activity, body mass index, comorbid conditions, other respiratory diseases, and use of other asthma medications.

The most common NPs were dementia, mood disorders, and panic disorders, and the prevalence of each was not significantly different between LTRA users and nonusers (75.4% vs. 76.1% for dementia, 12.7% vs. 12.8% for mood disorders, and 5.6% vs. 3.5% for panic disorders).

A subgroup analysis for associations between the duration of LTRA use and NP disease risk also showed no significant difference between LTRA users and nonusers.

“The mechanism of the development of NP symptoms by LTRAs has not been identified,” the researchers write in their discussion of the study findings. “Because most of NP side effects due to montelukast occur in few patients within 2 weeks of drug administration, it also may have relation with the presence of some genetic polymorphisms involving modification of the normal action or metabolism of LTRAs,” they explained.

The FDA’s boxed warning for montelukast noting the risk of serious mental health side effects has renewed interest in the relationship between NPs and LTRAs, the researchers noted. However, the current study findings support previous randomized controlled trials and larger studies, and the current warnings are based mainly on pharmacovigilance studies, case series, and case reports, they said.

The study findings were limited by several factors, including the retrospective design, the potential for misclassification of asthma diagnosis, the exclusion of temporary NP symptoms that might prompt LTRA discontinuation, and the inability to detect possible differences in ethnicities other than Korean, the researchers note.

However, the results suggest that adverse NP symptoms should not prevent physicians from prescribing LTRAs to selected patients with asthma. Instead, the physician should accompany the prescription with “a word of caution in case any mood changes might occur,” the investigators wrote.

“Further studies, such as randomized controlled trials, are needed to reveal the association between the use of LTRAs and the risk of NP events and/or diseases,” they concluded.

Potential genetic predisposition may drive cases

The relatively rare occurrence of NP symptoms in asthma patients using LTRAs has prompted questions from the medical community on whether the relationship really exists, writes Désirée Larenas-Linnemann, MD, of Médica Sur Clinical Foundation and Hospital, Mexico City, in an accompanying editorial ).

The current study provides information about medications and possible adverse drug reactions, but “great care should be taken in the interpretation of the results from such a study,” she notes. Limitations include not only the possible misclassification of asthma and the homogeneous study population, but also the fact that some NPs, such as dementia, are already common in older adults..

Dr. Larenas-Linnemann shared a story of one of her patients, a 2½-year-old boy who began exhibiting hyperactivity and other strange behaviors while on an LRTA. The toddler’s father had previously reported “horrible nightmares, strange thoughts, and to feel upset, unsecure until he suspended the medication.” Cases such as this support a potential genetic predisposition, with drug metabolism playing a role, and clinicians should take genetic backgrounds into account, she said.

“Even though the current study did not show an association between LTRA use or duration of exposure and the occurrence of NP diseases in Korean adults with asthma, this does not imply such a relationship might be present in other age groups (children-adolescents-adults up to 50 years) or in patients with a different genetic background,” she emphasized.

However, “In the meantime, although LTRA should continue to be prescribed if indicated, an index of suspicion for possible NP effects should be maintained,” Dr. Larenas-Linnemann concluded.

“This study is timely, since the boxed warning for montelukast was issued approximately 1 year ago by the FDA,” Thomas B. Casale, MD, of the University of South Florida, Tampa, said in an interview.

Dr. Casale said he was not surprised by the findings, “since most of the data implicating a potential link between the use of montelukast and neuropsychiatric disorders have not been particularly compelling,” and much of the current information comes from case reports and retrospective studies.

“Furthermore, the data appeared to be somewhat stronger in the pediatric population,” Dr. Casale noted. “This study focused on elderly patients (mean age 61) and included two other leukotriene modifiers. The number of patients receiving montelukast was small (56), which may have also confounded the results,” he noted.

As for clinical implications, “I don’t think this study will change practice,” Dr. Casale said. “As indicated, it is in an elderly population, included only a limited number of patients receiving montelukast, and was in a Korean cohort. All of these factors could have influenced the results,” and the data may not be generalizable to patients elsewhere, including the United States, he said. “Also, the study only included patients with asthma and in the United States; the approval for rhinitis is another important indication to study,” he noted.

Additional research is needed in the form of better prospective studies examining the potential link between montelukast and neuropsychiatric disorders in both the pediatric and adult populations having either asthma or rhinitis, Dr. Casale concluded.

The study received no outside funding. The researchers and Dr. Casale have disclosed no relevant financial relationships. Dr. Larenas-Linnemann disclosed personal fees from Allakos, Armstrong, AstraZeneca, Chiesi, DBV Technologies, Grünenthal, GSK, Mylan/Viatris, Menarini, MSD, Novartis, Pfizer, Sanofi, Siegfried, UCB, Alakos, Gossamer, and Carnot, and grants from Sanofi, AstraZeneca, Novartis, Circassia, UCB, GSK, and the Purina Institute.

A version of this article first appeared on Medscape.com.

Use of a leukotriene receptor antagonist (LTRA) for asthma management did not increase the risk of neuropsychiatric disease, based on data from more than 60,000 asthma patients.

Although LTRAs are established as an effective drug for asthma, the U.S. Food and Drug Administration warnings of the risk for neuropsychiatric (NP) drug reactions – including a boxed warning for montelukast (Singulair) – has raised concerns, writes Ji-Su Shim, MD, of Ewha Womans University, Seoul, South Korea, and colleagues.

However, evidence for such an association is limited, and previous studies have focused only on children and adolescents, and on a single LTRA (montelukast), the researchers say.

In a study published Dec. 1 in the Journal of Allergy and Clinical Immunology: In Practice, the researchers used a Korean national health insurance database to identify 61,571 adult patients with asthma aged 40 years and older between Jan. 2002 and Dec. 2015 with no history of LTRA use.

The patients underwent screening examinations between Jan. 2009 and Dec. 2010, which marked the start of a follow-up period ending on Dec. 31, 2015. The median age of the study population was 61 years, and the mean follow-up period for NPs or other outcomes was approximately 47.6 months for LTRA users and 46.5 months for nonusers. Overall, 11.1% of the study population used pranlukast (Onon), 11% used montelukast, and 0.24% used zafirlukast (Accolate).

A total of 12,168 patients took an LTRA during the follow-up period. The hazard ratio for newly diagnosed neuropsychiatric diseases was not significantly different between LTRA users and nonusers (hazard ratio, 1.01; P = .952) in an adjusted model that included age, sex, pack-years of smoking, alcohol use, physical activity, body mass index, comorbid conditions, other respiratory diseases, and use of other asthma medications.

The most common NPs were dementia, mood disorders, and panic disorders, and the prevalence of each was not significantly different between LTRA users and nonusers (75.4% vs. 76.1% for dementia, 12.7% vs. 12.8% for mood disorders, and 5.6% vs. 3.5% for panic disorders).

A subgroup analysis for associations between the duration of LTRA use and NP disease risk also showed no significant difference between LTRA users and nonusers.

“The mechanism of the development of NP symptoms by LTRAs has not been identified,” the researchers write in their discussion of the study findings. “Because most of NP side effects due to montelukast occur in few patients within 2 weeks of drug administration, it also may have relation with the presence of some genetic polymorphisms involving modification of the normal action or metabolism of LTRAs,” they explained.

The FDA’s boxed warning for montelukast noting the risk of serious mental health side effects has renewed interest in the relationship between NPs and LTRAs, the researchers noted. However, the current study findings support previous randomized controlled trials and larger studies, and the current warnings are based mainly on pharmacovigilance studies, case series, and case reports, they said.

The study findings were limited by several factors, including the retrospective design, the potential for misclassification of asthma diagnosis, the exclusion of temporary NP symptoms that might prompt LTRA discontinuation, and the inability to detect possible differences in ethnicities other than Korean, the researchers note.

However, the results suggest that adverse NP symptoms should not prevent physicians from prescribing LTRAs to selected patients with asthma. Instead, the physician should accompany the prescription with “a word of caution in case any mood changes might occur,” the investigators wrote.

“Further studies, such as randomized controlled trials, are needed to reveal the association between the use of LTRAs and the risk of NP events and/or diseases,” they concluded.

Potential genetic predisposition may drive cases

The relatively rare occurrence of NP symptoms in asthma patients using LTRAs has prompted questions from the medical community on whether the relationship really exists, writes Désirée Larenas-Linnemann, MD, of Médica Sur Clinical Foundation and Hospital, Mexico City, in an accompanying editorial ).

The current study provides information about medications and possible adverse drug reactions, but “great care should be taken in the interpretation of the results from such a study,” she notes. Limitations include not only the possible misclassification of asthma and the homogeneous study population, but also the fact that some NPs, such as dementia, are already common in older adults..

Dr. Larenas-Linnemann shared a story of one of her patients, a 2½-year-old boy who began exhibiting hyperactivity and other strange behaviors while on an LRTA. The toddler’s father had previously reported “horrible nightmares, strange thoughts, and to feel upset, unsecure until he suspended the medication.” Cases such as this support a potential genetic predisposition, with drug metabolism playing a role, and clinicians should take genetic backgrounds into account, she said.

“Even though the current study did not show an association between LTRA use or duration of exposure and the occurrence of NP diseases in Korean adults with asthma, this does not imply such a relationship might be present in other age groups (children-adolescents-adults up to 50 years) or in patients with a different genetic background,” she emphasized.

However, “In the meantime, although LTRA should continue to be prescribed if indicated, an index of suspicion for possible NP effects should be maintained,” Dr. Larenas-Linnemann concluded.

“This study is timely, since the boxed warning for montelukast was issued approximately 1 year ago by the FDA,” Thomas B. Casale, MD, of the University of South Florida, Tampa, said in an interview.

Dr. Casale said he was not surprised by the findings, “since most of the data implicating a potential link between the use of montelukast and neuropsychiatric disorders have not been particularly compelling,” and much of the current information comes from case reports and retrospective studies.

“Furthermore, the data appeared to be somewhat stronger in the pediatric population,” Dr. Casale noted. “This study focused on elderly patients (mean age 61) and included two other leukotriene modifiers. The number of patients receiving montelukast was small (56), which may have also confounded the results,” he noted.

As for clinical implications, “I don’t think this study will change practice,” Dr. Casale said. “As indicated, it is in an elderly population, included only a limited number of patients receiving montelukast, and was in a Korean cohort. All of these factors could have influenced the results,” and the data may not be generalizable to patients elsewhere, including the United States, he said. “Also, the study only included patients with asthma and in the United States; the approval for rhinitis is another important indication to study,” he noted.

Additional research is needed in the form of better prospective studies examining the potential link between montelukast and neuropsychiatric disorders in both the pediatric and adult populations having either asthma or rhinitis, Dr. Casale concluded.

The study received no outside funding. The researchers and Dr. Casale have disclosed no relevant financial relationships. Dr. Larenas-Linnemann disclosed personal fees from Allakos, Armstrong, AstraZeneca, Chiesi, DBV Technologies, Grünenthal, GSK, Mylan/Viatris, Menarini, MSD, Novartis, Pfizer, Sanofi, Siegfried, UCB, Alakos, Gossamer, and Carnot, and grants from Sanofi, AstraZeneca, Novartis, Circassia, UCB, GSK, and the Purina Institute.

A version of this article first appeared on Medscape.com.