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Meghan Markle interview resurfaces suicidality screening debate
An eye-opening moment during March 7’s Meghan Markle/Prince Harry interview with Oprah Winfrey was Markle’s admission that, before the royal couple moved from the U.K., she was suicidal and had nowhere to turn for help.
For health care practitioners, this has resurfaced the debate over universal suicidality screening and discussion about what should happen when patients screen positive.
The American Psychiatric Association reports suicide is the 10th leading cause of death in the United States, but the second leading cause of death in people age 10-34 years old.
The latest data from the Centers for Disease Control and Prevention show that, in 2019, suicide rates dropped for the first time in 14 years. However, it is widely expected that, in the face of the COVID-19 pandemic and its associated isolation, loneliness, and stress, the next round of data will show a surge in suicide deaths.
, chair of the APA’s Committee on Women’s Mental Health.
“I can see it in my office. People who didn’t necessarily complain about anxiety and depression before or who had been stable for many years are decompensating now,” Dr. De Faria said in an interview.
Although other parts of the interview may have been controversial, said Dr. De Faria, Markle’s disclosure has opened up a much-needed discussion.
“I’m all for people talking about mental health, and I commend [Markle] for sharing her struggle and putting it out there,” she added.
In a perfect world, she noted, there would be universal suicide screening by all medical professionals.
However, Dr. De Faria, associate clinical professor of psychiatry, University of Florida, Gainesville, acknowledged that from a resource standpoint this is not a pragmatic solution.
Primary care physicians are often the frontline defense for suicide prevention, noted Mona Masood, DO, a Philadelphia-area psychiatrist and founder and chief organizer of the Physician Support Line, a free mental health hotline exclusively for doctors staffed by volunteer psychiatrists.
“I believe our general practitioner colleagues, our family medicine colleagues are the ones who are going to be seeing the majority of mental health concerns or illnesses because of the stigma that is often there from seeing a psychiatrist,” Dr. Masood said in an interview.
Dr. De Faria noted that the Patient Health Questionnaire-2 (PHQ-2) for mental health offers a simple screen that includes two key questions. It asks: Over the last 2 weeks, how often have you been bothered by the following problems?
- Little interest or pleasure in doing things.
- Feeling down, depressed, or hopeless.
However, both Dr. De Faria and Dr. Masood emphasized that individualized follow-up questions and follow-up care are equally important.
Unlike Dr. De Faria, who prefers universal screening but understands the challenges of implementing it, Dr. Masood favors targeted screening.
“For physicians, the whole point of what we do is to save lives. To talk to somebody about the complete opposite and to ask, ‘Are you planning on ending your life?’ is very jarring. But for the patient, that may be their only outlet. A primary care provider may be the only professional that they talk to about their mental health,” said Dr. Masood.
Patients can easily say “no” to suicidal ideation questions from a general screen, but targeted, probing questions let patients know that they’re being heard and seen beyond their physical examination, she added.
She also suggested that clinicians ask open-ended questions of those patients who are struggling.
Dr. Masood noted that having a plan in place before screening a patient is especially key.
“I’d argue that one of the subconscious reasons why so many doctors do not ask the question [about suicidality] is because if you ask it, you have to be ready for the answer and to know what you’d do,” she said.
All primary care physicians should have “mental health professionals as resources in your back pocket” in order to have a referral ready to give to patients in need, she said.
“Outside of your clinic time, have a rapport with your local psychiatrist or therapist and know where to send someone who is suicidal,” Dr. Masood said. “Know what is in your local area so you’ll already know how to implement your plan.”
Dr. Masood also recommended:
- Informing staff about protocols for patients with suicidal thoughts who need to go to the hospital for evaluation.
- Creating a safe space in the clinic/office, such as an unused exam room, where patients can wait for next steps.
- Having staff inform a patient’s emergency contact about the situation.
- Trying for a “warm handoff,” where the emergency contact takes the patient to the nearest crisis center and having staff call ahead to let them know to expect the patient.
- If the patient has no emergency contact, following your state’s involuntary crisis response protocol, which involves calling 911 for emergency services.
In addition, the APA’s suicide prevention page includes a long list of helpful resources for patients, families, and physicians.
A version of this article first appeared on Medscape.com.
An eye-opening moment during March 7’s Meghan Markle/Prince Harry interview with Oprah Winfrey was Markle’s admission that, before the royal couple moved from the U.K., she was suicidal and had nowhere to turn for help.
For health care practitioners, this has resurfaced the debate over universal suicidality screening and discussion about what should happen when patients screen positive.
The American Psychiatric Association reports suicide is the 10th leading cause of death in the United States, but the second leading cause of death in people age 10-34 years old.
The latest data from the Centers for Disease Control and Prevention show that, in 2019, suicide rates dropped for the first time in 14 years. However, it is widely expected that, in the face of the COVID-19 pandemic and its associated isolation, loneliness, and stress, the next round of data will show a surge in suicide deaths.
, chair of the APA’s Committee on Women’s Mental Health.
“I can see it in my office. People who didn’t necessarily complain about anxiety and depression before or who had been stable for many years are decompensating now,” Dr. De Faria said in an interview.
Although other parts of the interview may have been controversial, said Dr. De Faria, Markle’s disclosure has opened up a much-needed discussion.
“I’m all for people talking about mental health, and I commend [Markle] for sharing her struggle and putting it out there,” she added.
In a perfect world, she noted, there would be universal suicide screening by all medical professionals.
However, Dr. De Faria, associate clinical professor of psychiatry, University of Florida, Gainesville, acknowledged that from a resource standpoint this is not a pragmatic solution.
Primary care physicians are often the frontline defense for suicide prevention, noted Mona Masood, DO, a Philadelphia-area psychiatrist and founder and chief organizer of the Physician Support Line, a free mental health hotline exclusively for doctors staffed by volunteer psychiatrists.
“I believe our general practitioner colleagues, our family medicine colleagues are the ones who are going to be seeing the majority of mental health concerns or illnesses because of the stigma that is often there from seeing a psychiatrist,” Dr. Masood said in an interview.
Dr. De Faria noted that the Patient Health Questionnaire-2 (PHQ-2) for mental health offers a simple screen that includes two key questions. It asks: Over the last 2 weeks, how often have you been bothered by the following problems?
- Little interest or pleasure in doing things.
- Feeling down, depressed, or hopeless.
However, both Dr. De Faria and Dr. Masood emphasized that individualized follow-up questions and follow-up care are equally important.
Unlike Dr. De Faria, who prefers universal screening but understands the challenges of implementing it, Dr. Masood favors targeted screening.
“For physicians, the whole point of what we do is to save lives. To talk to somebody about the complete opposite and to ask, ‘Are you planning on ending your life?’ is very jarring. But for the patient, that may be their only outlet. A primary care provider may be the only professional that they talk to about their mental health,” said Dr. Masood.
Patients can easily say “no” to suicidal ideation questions from a general screen, but targeted, probing questions let patients know that they’re being heard and seen beyond their physical examination, she added.
She also suggested that clinicians ask open-ended questions of those patients who are struggling.
Dr. Masood noted that having a plan in place before screening a patient is especially key.
“I’d argue that one of the subconscious reasons why so many doctors do not ask the question [about suicidality] is because if you ask it, you have to be ready for the answer and to know what you’d do,” she said.
All primary care physicians should have “mental health professionals as resources in your back pocket” in order to have a referral ready to give to patients in need, she said.
“Outside of your clinic time, have a rapport with your local psychiatrist or therapist and know where to send someone who is suicidal,” Dr. Masood said. “Know what is in your local area so you’ll already know how to implement your plan.”
Dr. Masood also recommended:
- Informing staff about protocols for patients with suicidal thoughts who need to go to the hospital for evaluation.
- Creating a safe space in the clinic/office, such as an unused exam room, where patients can wait for next steps.
- Having staff inform a patient’s emergency contact about the situation.
- Trying for a “warm handoff,” where the emergency contact takes the patient to the nearest crisis center and having staff call ahead to let them know to expect the patient.
- If the patient has no emergency contact, following your state’s involuntary crisis response protocol, which involves calling 911 for emergency services.
In addition, the APA’s suicide prevention page includes a long list of helpful resources for patients, families, and physicians.
A version of this article first appeared on Medscape.com.
An eye-opening moment during March 7’s Meghan Markle/Prince Harry interview with Oprah Winfrey was Markle’s admission that, before the royal couple moved from the U.K., she was suicidal and had nowhere to turn for help.
For health care practitioners, this has resurfaced the debate over universal suicidality screening and discussion about what should happen when patients screen positive.
The American Psychiatric Association reports suicide is the 10th leading cause of death in the United States, but the second leading cause of death in people age 10-34 years old.
The latest data from the Centers for Disease Control and Prevention show that, in 2019, suicide rates dropped for the first time in 14 years. However, it is widely expected that, in the face of the COVID-19 pandemic and its associated isolation, loneliness, and stress, the next round of data will show a surge in suicide deaths.
, chair of the APA’s Committee on Women’s Mental Health.
“I can see it in my office. People who didn’t necessarily complain about anxiety and depression before or who had been stable for many years are decompensating now,” Dr. De Faria said in an interview.
Although other parts of the interview may have been controversial, said Dr. De Faria, Markle’s disclosure has opened up a much-needed discussion.
“I’m all for people talking about mental health, and I commend [Markle] for sharing her struggle and putting it out there,” she added.
In a perfect world, she noted, there would be universal suicide screening by all medical professionals.
However, Dr. De Faria, associate clinical professor of psychiatry, University of Florida, Gainesville, acknowledged that from a resource standpoint this is not a pragmatic solution.
Primary care physicians are often the frontline defense for suicide prevention, noted Mona Masood, DO, a Philadelphia-area psychiatrist and founder and chief organizer of the Physician Support Line, a free mental health hotline exclusively for doctors staffed by volunteer psychiatrists.
“I believe our general practitioner colleagues, our family medicine colleagues are the ones who are going to be seeing the majority of mental health concerns or illnesses because of the stigma that is often there from seeing a psychiatrist,” Dr. Masood said in an interview.
Dr. De Faria noted that the Patient Health Questionnaire-2 (PHQ-2) for mental health offers a simple screen that includes two key questions. It asks: Over the last 2 weeks, how often have you been bothered by the following problems?
- Little interest or pleasure in doing things.
- Feeling down, depressed, or hopeless.
However, both Dr. De Faria and Dr. Masood emphasized that individualized follow-up questions and follow-up care are equally important.
Unlike Dr. De Faria, who prefers universal screening but understands the challenges of implementing it, Dr. Masood favors targeted screening.
“For physicians, the whole point of what we do is to save lives. To talk to somebody about the complete opposite and to ask, ‘Are you planning on ending your life?’ is very jarring. But for the patient, that may be their only outlet. A primary care provider may be the only professional that they talk to about their mental health,” said Dr. Masood.
Patients can easily say “no” to suicidal ideation questions from a general screen, but targeted, probing questions let patients know that they’re being heard and seen beyond their physical examination, she added.
She also suggested that clinicians ask open-ended questions of those patients who are struggling.
Dr. Masood noted that having a plan in place before screening a patient is especially key.
“I’d argue that one of the subconscious reasons why so many doctors do not ask the question [about suicidality] is because if you ask it, you have to be ready for the answer and to know what you’d do,” she said.
All primary care physicians should have “mental health professionals as resources in your back pocket” in order to have a referral ready to give to patients in need, she said.
“Outside of your clinic time, have a rapport with your local psychiatrist or therapist and know where to send someone who is suicidal,” Dr. Masood said. “Know what is in your local area so you’ll already know how to implement your plan.”
Dr. Masood also recommended:
- Informing staff about protocols for patients with suicidal thoughts who need to go to the hospital for evaluation.
- Creating a safe space in the clinic/office, such as an unused exam room, where patients can wait for next steps.
- Having staff inform a patient’s emergency contact about the situation.
- Trying for a “warm handoff,” where the emergency contact takes the patient to the nearest crisis center and having staff call ahead to let them know to expect the patient.
- If the patient has no emergency contact, following your state’s involuntary crisis response protocol, which involves calling 911 for emergency services.
In addition, the APA’s suicide prevention page includes a long list of helpful resources for patients, families, and physicians.
A version of this article first appeared on Medscape.com.
Let’s apply the lessons from the AIDS crisis to the COVID-19 pandemic
In 2020, COVID-19 disrupted our medical system, and life in general. In the 1980s, the AIDS epidemic devastated communities and overwhelmed hospitals. There were lessons learned from the AIDS epidemic that can be applied to the current situation.
Patients with HIV-spectrum illness faced stigmatization and societal indifference, including rejection by family members, increased rates of suicide, fears of sexual and/or intrauterine transmission, substance abuse issues, and alterations of body image for those with wasting syndromes and disfiguring Kaposi lesions. AIDS prevention strategies such as the provision of condoms and needle exchange programs were controversial, and many caregivers exposed to contaminated fluids had to endure months of antiretroviral treatment.
Similar to the AIDS epidemic, the COVID-19 pandemic has had significant psychological implications for patients and caregivers. Patients with COVID-19 infections also face feelings of guilt over potentially exposing a family member to the virus; devastating socioeconomic issues; restrictive hospital visitation policies for family members; disease news oversaturation; and feelings of hopelessness. People with AIDS in the 1980s faced the possibility of dying alone, and there was initial skepticism about medications to treat HIV—just as some individuals are now uneasy about recently introduced coronavirus vaccines.
The similarities of both diseases allow us some foresight on how to deal with current COVID-19 issues. Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers, creating advocacy and support groups for when a patient’s family is unavailable, instilling public confidence in treatment options, maintaining staff morale, addressing substance abuse (due to COVID-related stress), and depoliticizing prevention strategies. Addressing these issues is especially critical for minority populations.
As respected medical care leaders, we can provide and draw extra attention to the needs of patients’ family members and health care personnel during this COVID-19 pandemic. Hopefully, the distribution of vaccines will shorten some of our communal and professional distress.
Robert Frierson, MD
Steven Lippmann, MD
Louisville, KY
In 2020, COVID-19 disrupted our medical system, and life in general. In the 1980s, the AIDS epidemic devastated communities and overwhelmed hospitals. There were lessons learned from the AIDS epidemic that can be applied to the current situation.
Patients with HIV-spectrum illness faced stigmatization and societal indifference, including rejection by family members, increased rates of suicide, fears of sexual and/or intrauterine transmission, substance abuse issues, and alterations of body image for those with wasting syndromes and disfiguring Kaposi lesions. AIDS prevention strategies such as the provision of condoms and needle exchange programs were controversial, and many caregivers exposed to contaminated fluids had to endure months of antiretroviral treatment.
Similar to the AIDS epidemic, the COVID-19 pandemic has had significant psychological implications for patients and caregivers. Patients with COVID-19 infections also face feelings of guilt over potentially exposing a family member to the virus; devastating socioeconomic issues; restrictive hospital visitation policies for family members; disease news oversaturation; and feelings of hopelessness. People with AIDS in the 1980s faced the possibility of dying alone, and there was initial skepticism about medications to treat HIV—just as some individuals are now uneasy about recently introduced coronavirus vaccines.
The similarities of both diseases allow us some foresight on how to deal with current COVID-19 issues. Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers, creating advocacy and support groups for when a patient’s family is unavailable, instilling public confidence in treatment options, maintaining staff morale, addressing substance abuse (due to COVID-related stress), and depoliticizing prevention strategies. Addressing these issues is especially critical for minority populations.
As respected medical care leaders, we can provide and draw extra attention to the needs of patients’ family members and health care personnel during this COVID-19 pandemic. Hopefully, the distribution of vaccines will shorten some of our communal and professional distress.
Robert Frierson, MD
Steven Lippmann, MD
Louisville, KY
In 2020, COVID-19 disrupted our medical system, and life in general. In the 1980s, the AIDS epidemic devastated communities and overwhelmed hospitals. There were lessons learned from the AIDS epidemic that can be applied to the current situation.
Patients with HIV-spectrum illness faced stigmatization and societal indifference, including rejection by family members, increased rates of suicide, fears of sexual and/or intrauterine transmission, substance abuse issues, and alterations of body image for those with wasting syndromes and disfiguring Kaposi lesions. AIDS prevention strategies such as the provision of condoms and needle exchange programs were controversial, and many caregivers exposed to contaminated fluids had to endure months of antiretroviral treatment.
Similar to the AIDS epidemic, the COVID-19 pandemic has had significant psychological implications for patients and caregivers. Patients with COVID-19 infections also face feelings of guilt over potentially exposing a family member to the virus; devastating socioeconomic issues; restrictive hospital visitation policies for family members; disease news oversaturation; and feelings of hopelessness. People with AIDS in the 1980s faced the possibility of dying alone, and there was initial skepticism about medications to treat HIV—just as some individuals are now uneasy about recently introduced coronavirus vaccines.
The similarities of both diseases allow us some foresight on how to deal with current COVID-19 issues. Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers, creating advocacy and support groups for when a patient’s family is unavailable, instilling public confidence in treatment options, maintaining staff morale, addressing substance abuse (due to COVID-related stress), and depoliticizing prevention strategies. Addressing these issues is especially critical for minority populations.
As respected medical care leaders, we can provide and draw extra attention to the needs of patients’ family members and health care personnel during this COVID-19 pandemic. Hopefully, the distribution of vaccines will shorten some of our communal and professional distress.
Robert Frierson, MD
Steven Lippmann, MD
Louisville, KY
Meghan Markle disclosures can be used to raise awareness, reduce stigma
Suicidal thoughts require compassion and action
When I sat down to watch Oprah Winfrey’s interview with Meghan Markle on Sunday night, I didn’t know what to expect. As a psychiatrist dedicated to reducing the loss of life through suicide, I homed in on the aspect of the interview in which she discussed the depth of her suffering.
Meghan Markle is one of many celebrities to speak about their experience with suicidal crisis. Those disclosures provide opportunities to increase the public’s understanding of mental health and to deepen compassion for what others may be going through. They challenge our culturally normed assumptions: false beliefs – such as the idea that beauty, wealth, and success protect people from mental health struggles. We would do well to trust that the dichotomy between external appearances and internal experiences is always at play, and we never know what someone is going through. Human beings are both enormously resilient and vulnerable.
Suicide, while complex, is a health issue. Therefore, it is important that we all do our part in approaching mental health and suicide risk in a similar manner to other health issues.
We all have a dynamic and continuous interplay going on between life circumstances and our internal biological, genetic, and psychological makeup. The more honest and the more we learn about our own vulnerabilities and strengths, the more proactive we can be in protecting and optimizing our mental health. All individuals should be able to receive support and access to care to have their mental health needs addressed.
It’s important to note that distress leads many people to instinctually withdraw, just at a time when receiving support is even more important. In addition, cultures that traditionally emphasize self-sufficiency or stoicism may unintentionally create additional barriers to reaching out for help. Therefore, many people who experience suicidal thoughts do not disclose them to anyone. If someone does mention they are struggling, you can thank them for opening up and let them know you want to support them, and that you are there to help them find the help they need.
This is what we should tell our patients: If someone you know is struggling and might be thinking about suicide, assume you are the only one who will reach out. Having an honest conversation with the person will let them know that you care. Take the person seriously and speak up if you’re concerned about them. Ask directly if they are thinking about suicide. Help the person by connecting them with a mental health professional. If you aren’t sure if their safety is imminently at risk, connect with crisis resources and services immediately. Realize that most people who are suicidal are ambivalent about taking their life and really just want relief to their pain: Part of them wants to live and part of them wants to die. by helping them secure firearms, medications, and any other potentially lethal means.
Suicidal thoughts cut across all demographic groups, occupations, and socioeconomic strata. By understanding that life presents intense challenges for all of us and that suicidal thoughts are an indication of suffering warranting professional evaluation and intervention, we can approach the next person who discloses suicidal thoughts with compassion and action. To learn more, go to afsp.org.
Dr. Moutier is chief medical officer of the American Foundation for Suicide Prevention. She reported no disclosures.
Suicidal thoughts require compassion and action
Suicidal thoughts require compassion and action
When I sat down to watch Oprah Winfrey’s interview with Meghan Markle on Sunday night, I didn’t know what to expect. As a psychiatrist dedicated to reducing the loss of life through suicide, I homed in on the aspect of the interview in which she discussed the depth of her suffering.
Meghan Markle is one of many celebrities to speak about their experience with suicidal crisis. Those disclosures provide opportunities to increase the public’s understanding of mental health and to deepen compassion for what others may be going through. They challenge our culturally normed assumptions: false beliefs – such as the idea that beauty, wealth, and success protect people from mental health struggles. We would do well to trust that the dichotomy between external appearances and internal experiences is always at play, and we never know what someone is going through. Human beings are both enormously resilient and vulnerable.
Suicide, while complex, is a health issue. Therefore, it is important that we all do our part in approaching mental health and suicide risk in a similar manner to other health issues.
We all have a dynamic and continuous interplay going on between life circumstances and our internal biological, genetic, and psychological makeup. The more honest and the more we learn about our own vulnerabilities and strengths, the more proactive we can be in protecting and optimizing our mental health. All individuals should be able to receive support and access to care to have their mental health needs addressed.
It’s important to note that distress leads many people to instinctually withdraw, just at a time when receiving support is even more important. In addition, cultures that traditionally emphasize self-sufficiency or stoicism may unintentionally create additional barriers to reaching out for help. Therefore, many people who experience suicidal thoughts do not disclose them to anyone. If someone does mention they are struggling, you can thank them for opening up and let them know you want to support them, and that you are there to help them find the help they need.
This is what we should tell our patients: If someone you know is struggling and might be thinking about suicide, assume you are the only one who will reach out. Having an honest conversation with the person will let them know that you care. Take the person seriously and speak up if you’re concerned about them. Ask directly if they are thinking about suicide. Help the person by connecting them with a mental health professional. If you aren’t sure if their safety is imminently at risk, connect with crisis resources and services immediately. Realize that most people who are suicidal are ambivalent about taking their life and really just want relief to their pain: Part of them wants to live and part of them wants to die. by helping them secure firearms, medications, and any other potentially lethal means.
Suicidal thoughts cut across all demographic groups, occupations, and socioeconomic strata. By understanding that life presents intense challenges for all of us and that suicidal thoughts are an indication of suffering warranting professional evaluation and intervention, we can approach the next person who discloses suicidal thoughts with compassion and action. To learn more, go to afsp.org.
Dr. Moutier is chief medical officer of the American Foundation for Suicide Prevention. She reported no disclosures.
When I sat down to watch Oprah Winfrey’s interview with Meghan Markle on Sunday night, I didn’t know what to expect. As a psychiatrist dedicated to reducing the loss of life through suicide, I homed in on the aspect of the interview in which she discussed the depth of her suffering.
Meghan Markle is one of many celebrities to speak about their experience with suicidal crisis. Those disclosures provide opportunities to increase the public’s understanding of mental health and to deepen compassion for what others may be going through. They challenge our culturally normed assumptions: false beliefs – such as the idea that beauty, wealth, and success protect people from mental health struggles. We would do well to trust that the dichotomy between external appearances and internal experiences is always at play, and we never know what someone is going through. Human beings are both enormously resilient and vulnerable.
Suicide, while complex, is a health issue. Therefore, it is important that we all do our part in approaching mental health and suicide risk in a similar manner to other health issues.
We all have a dynamic and continuous interplay going on between life circumstances and our internal biological, genetic, and psychological makeup. The more honest and the more we learn about our own vulnerabilities and strengths, the more proactive we can be in protecting and optimizing our mental health. All individuals should be able to receive support and access to care to have their mental health needs addressed.
It’s important to note that distress leads many people to instinctually withdraw, just at a time when receiving support is even more important. In addition, cultures that traditionally emphasize self-sufficiency or stoicism may unintentionally create additional barriers to reaching out for help. Therefore, many people who experience suicidal thoughts do not disclose them to anyone. If someone does mention they are struggling, you can thank them for opening up and let them know you want to support them, and that you are there to help them find the help they need.
This is what we should tell our patients: If someone you know is struggling and might be thinking about suicide, assume you are the only one who will reach out. Having an honest conversation with the person will let them know that you care. Take the person seriously and speak up if you’re concerned about them. Ask directly if they are thinking about suicide. Help the person by connecting them with a mental health professional. If you aren’t sure if their safety is imminently at risk, connect with crisis resources and services immediately. Realize that most people who are suicidal are ambivalent about taking their life and really just want relief to their pain: Part of them wants to live and part of them wants to die. by helping them secure firearms, medications, and any other potentially lethal means.
Suicidal thoughts cut across all demographic groups, occupations, and socioeconomic strata. By understanding that life presents intense challenges for all of us and that suicidal thoughts are an indication of suffering warranting professional evaluation and intervention, we can approach the next person who discloses suicidal thoughts with compassion and action. To learn more, go to afsp.org.
Dr. Moutier is chief medical officer of the American Foundation for Suicide Prevention. She reported no disclosures.
Helping parents deal with children’s transition to in-person school
This spring may bring an unusual transition for families: a return to in-person school after nearly a year in a virtual classroom. This will undoubtedly come as a welcome relief to many parents worried about their children’s education and development and struggling with running school from home. But it is important for parents to remember that transitions, even happy ones, are difficult. You can help parents to anticipate what may be challenging about this transition for their children so that they are all prepared and can diminish struggles and support their children’s mastery.
Be curious about their children’s thoughts and feelings
Parents should adopt a truly curious and open-minded approach with their children. Remind parents that, while they are experts on their own children, they should not assume they know what their children are thinking or feeling about the return to school. Some children, especially ones struggling with learning problems or difficulty with peers, will have grown very comfortable being at home with parents or siblings. Some children, especially pre- and early teens, may have changed substantially in the year and might feel uncertain about returning to a prior team or group of friends. Some children may feel concerned about leaving a pet at home alone. Some children may be going to a new school and be anxious about facing such a big transition without the usual planning and supports. Those on a college track may be worried they are “behind” academically or in college preparation.
Parents can show up when and where their children are most likely to talk, perhaps bath time or bedtime for younger children or in the car together with their adolescents. They can ask: “Have you been thinking about what it might be like to go back to school? Have your friends been chatting about it?” They might be curious together about what might have changed in a year. What might be really great about being back in a classroom? What might they miss about home school? And what might be new? Are you worried about the work, any of your friends, or not being home? If children can begin to anticipate both the good and the difficult, they will be better equipped to face and manage the challenges and appreciate the delights.
Children in elementary school are built to master new situations but are also prone to anxiety about new expectations and demands. Parents can be calmly curious about what their thoughts, feelings, and questions are and look for answers together. Often all they need is to see parents being calm in the face of uncertainty, bearing the strong feelings that may come, and preserving curiosity and compassion. Adolescents may be grieving the things they have missed, or they may have concerns about relationships and practical matters such as the implications for applying to college. Parents can offer compassion and validation and help them to devise their own strategies to face the practical challenges they are concerned about.
Be mindful of their children’s vulnerabilities
While most children will find the transition back to school easier than they may anticipate, there will be some for whom the transition will be very challenging. Children who have been bullied at school may have found themselves able to concentrate and learn free of the fear and stress of a classmate’s taunts or stares. Children with learning disabilities or ADHD have probably struggled with online school, but they have also likely established strategies and supports during the year that have enabled them to get enough individualized help to get their work done. These children are vulnerable to falling behind and getting discouraged when these supports are lost, and possibly not replaced with new ones in the chaos of transition. Parents should reassure their children that they will work with the school to make sure that they can succeed in the classroom as they did at home.
Children with an inhibited or shy temperament might have found that it was easier to focus and listen in the comfortable setting of home than in a busy, stimulating classroom. Children who suffer from anxiety disorders that may make separating from parents or managing the performance and social demands of school extra difficult will find the return to school especially challenging. Some younger children may have experienced the emergence of an anxiety disorder during the past year, and the return to school may mark the challenge that brings heretofore quiet symptoms into full relief.
These children have all enjoyed being able to avoid the discomfort of certain anxiety-provoking situations, and they may be particularly stressed by anticipating a return to school. Younger children may begin to have stomach aches and other physical complaints as the return to school gets close, older children may seem more withdrawn or irritable or begin discussing ways to continue school from home. Parents should help their children try to identify and describe their worries. For anxious children, having a chance to practice may be very helpful. Visiting their school, especially if it is a new school, or having a planned hangout with a friend (with appropriate precautions) is the kind of exposure that can lessen anticipatory anxiety. If this is not enough, parents should not hesitate to bring in other caring, supportive adults, such as school counselors or therapists that may be essential to helping their children face and manage what may be intense anxiety.
Consider routines to support their transition
Just as parents begin to return their children to an earlier bedtime toward the end of summer, it will be helpful to consider how changing certain routines will support their children now. If children will need to get up earlier to be ready for a bus or a team practice, they should start moving bedtime and wake-up time earlier gradually. Uniforms or backpacks that have not been seen for a year should be dug out. Children who are planning a return to a sport may benefit from gradually increasing their exercise or starting training now. This will have the added benefit of improving sleep and energy and fortifying children for the challenges of change. Parents might consider reaching out to other parents in the same class as their children and having a virtual conversation to share their thoughts.
If their family has developed some new “COVID routines” that they have come to enjoy, they should find a way to preserve them. Perhaps they are having dinner together more often or have established a family game night or Netflix night. Help parents consider how to avoid falling back into overscheduling their children and themselves. If they created a time to Zoom with distant or vulnerable loved ones, they might decide to continue this. School may determine some of their routines, but they should also prioritize their family connections and well-being in deciding how to schedule their days.
Find opportunity for mastery and meaning
As parents are listening, validating, and planning with their children, they might use this time to reflect on valuable lessons. They might point out the value of patience: Adjusting to change takes time and happens in fits and starts. It has been 12 months since many of the pandemic changes started and it will take more than a few days to adjust as schools reopen. They might point out how proud they are of what their children have been able to learn, build, or do during this year, what they admire about them. It may be a time to consider what their family may have lost and gained during the past year, what they are eager to leave behind, and what they might like to keep. And it is also a chance for parents to observe that change is an inevitable part of life (especially when growing up). It is always challenging, and often brings loss and sadness. But if we pay attention, there are also the green shoots of what is new and possible.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.
This spring may bring an unusual transition for families: a return to in-person school after nearly a year in a virtual classroom. This will undoubtedly come as a welcome relief to many parents worried about their children’s education and development and struggling with running school from home. But it is important for parents to remember that transitions, even happy ones, are difficult. You can help parents to anticipate what may be challenging about this transition for their children so that they are all prepared and can diminish struggles and support their children’s mastery.
Be curious about their children’s thoughts and feelings
Parents should adopt a truly curious and open-minded approach with their children. Remind parents that, while they are experts on their own children, they should not assume they know what their children are thinking or feeling about the return to school. Some children, especially ones struggling with learning problems or difficulty with peers, will have grown very comfortable being at home with parents or siblings. Some children, especially pre- and early teens, may have changed substantially in the year and might feel uncertain about returning to a prior team or group of friends. Some children may feel concerned about leaving a pet at home alone. Some children may be going to a new school and be anxious about facing such a big transition without the usual planning and supports. Those on a college track may be worried they are “behind” academically or in college preparation.
Parents can show up when and where their children are most likely to talk, perhaps bath time or bedtime for younger children or in the car together with their adolescents. They can ask: “Have you been thinking about what it might be like to go back to school? Have your friends been chatting about it?” They might be curious together about what might have changed in a year. What might be really great about being back in a classroom? What might they miss about home school? And what might be new? Are you worried about the work, any of your friends, or not being home? If children can begin to anticipate both the good and the difficult, they will be better equipped to face and manage the challenges and appreciate the delights.
Children in elementary school are built to master new situations but are also prone to anxiety about new expectations and demands. Parents can be calmly curious about what their thoughts, feelings, and questions are and look for answers together. Often all they need is to see parents being calm in the face of uncertainty, bearing the strong feelings that may come, and preserving curiosity and compassion. Adolescents may be grieving the things they have missed, or they may have concerns about relationships and practical matters such as the implications for applying to college. Parents can offer compassion and validation and help them to devise their own strategies to face the practical challenges they are concerned about.
Be mindful of their children’s vulnerabilities
While most children will find the transition back to school easier than they may anticipate, there will be some for whom the transition will be very challenging. Children who have been bullied at school may have found themselves able to concentrate and learn free of the fear and stress of a classmate’s taunts or stares. Children with learning disabilities or ADHD have probably struggled with online school, but they have also likely established strategies and supports during the year that have enabled them to get enough individualized help to get their work done. These children are vulnerable to falling behind and getting discouraged when these supports are lost, and possibly not replaced with new ones in the chaos of transition. Parents should reassure their children that they will work with the school to make sure that they can succeed in the classroom as they did at home.
Children with an inhibited or shy temperament might have found that it was easier to focus and listen in the comfortable setting of home than in a busy, stimulating classroom. Children who suffer from anxiety disorders that may make separating from parents or managing the performance and social demands of school extra difficult will find the return to school especially challenging. Some younger children may have experienced the emergence of an anxiety disorder during the past year, and the return to school may mark the challenge that brings heretofore quiet symptoms into full relief.
These children have all enjoyed being able to avoid the discomfort of certain anxiety-provoking situations, and they may be particularly stressed by anticipating a return to school. Younger children may begin to have stomach aches and other physical complaints as the return to school gets close, older children may seem more withdrawn or irritable or begin discussing ways to continue school from home. Parents should help their children try to identify and describe their worries. For anxious children, having a chance to practice may be very helpful. Visiting their school, especially if it is a new school, or having a planned hangout with a friend (with appropriate precautions) is the kind of exposure that can lessen anticipatory anxiety. If this is not enough, parents should not hesitate to bring in other caring, supportive adults, such as school counselors or therapists that may be essential to helping their children face and manage what may be intense anxiety.
Consider routines to support their transition
Just as parents begin to return their children to an earlier bedtime toward the end of summer, it will be helpful to consider how changing certain routines will support their children now. If children will need to get up earlier to be ready for a bus or a team practice, they should start moving bedtime and wake-up time earlier gradually. Uniforms or backpacks that have not been seen for a year should be dug out. Children who are planning a return to a sport may benefit from gradually increasing their exercise or starting training now. This will have the added benefit of improving sleep and energy and fortifying children for the challenges of change. Parents might consider reaching out to other parents in the same class as their children and having a virtual conversation to share their thoughts.
If their family has developed some new “COVID routines” that they have come to enjoy, they should find a way to preserve them. Perhaps they are having dinner together more often or have established a family game night or Netflix night. Help parents consider how to avoid falling back into overscheduling their children and themselves. If they created a time to Zoom with distant or vulnerable loved ones, they might decide to continue this. School may determine some of their routines, but they should also prioritize their family connections and well-being in deciding how to schedule their days.
Find opportunity for mastery and meaning
As parents are listening, validating, and planning with their children, they might use this time to reflect on valuable lessons. They might point out the value of patience: Adjusting to change takes time and happens in fits and starts. It has been 12 months since many of the pandemic changes started and it will take more than a few days to adjust as schools reopen. They might point out how proud they are of what their children have been able to learn, build, or do during this year, what they admire about them. It may be a time to consider what their family may have lost and gained during the past year, what they are eager to leave behind, and what they might like to keep. And it is also a chance for parents to observe that change is an inevitable part of life (especially when growing up). It is always challenging, and often brings loss and sadness. But if we pay attention, there are also the green shoots of what is new and possible.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.
This spring may bring an unusual transition for families: a return to in-person school after nearly a year in a virtual classroom. This will undoubtedly come as a welcome relief to many parents worried about their children’s education and development and struggling with running school from home. But it is important for parents to remember that transitions, even happy ones, are difficult. You can help parents to anticipate what may be challenging about this transition for their children so that they are all prepared and can diminish struggles and support their children’s mastery.
Be curious about their children’s thoughts and feelings
Parents should adopt a truly curious and open-minded approach with their children. Remind parents that, while they are experts on their own children, they should not assume they know what their children are thinking or feeling about the return to school. Some children, especially ones struggling with learning problems or difficulty with peers, will have grown very comfortable being at home with parents or siblings. Some children, especially pre- and early teens, may have changed substantially in the year and might feel uncertain about returning to a prior team or group of friends. Some children may feel concerned about leaving a pet at home alone. Some children may be going to a new school and be anxious about facing such a big transition without the usual planning and supports. Those on a college track may be worried they are “behind” academically or in college preparation.
Parents can show up when and where their children are most likely to talk, perhaps bath time or bedtime for younger children or in the car together with their adolescents. They can ask: “Have you been thinking about what it might be like to go back to school? Have your friends been chatting about it?” They might be curious together about what might have changed in a year. What might be really great about being back in a classroom? What might they miss about home school? And what might be new? Are you worried about the work, any of your friends, or not being home? If children can begin to anticipate both the good and the difficult, they will be better equipped to face and manage the challenges and appreciate the delights.
Children in elementary school are built to master new situations but are also prone to anxiety about new expectations and demands. Parents can be calmly curious about what their thoughts, feelings, and questions are and look for answers together. Often all they need is to see parents being calm in the face of uncertainty, bearing the strong feelings that may come, and preserving curiosity and compassion. Adolescents may be grieving the things they have missed, or they may have concerns about relationships and practical matters such as the implications for applying to college. Parents can offer compassion and validation and help them to devise their own strategies to face the practical challenges they are concerned about.
Be mindful of their children’s vulnerabilities
While most children will find the transition back to school easier than they may anticipate, there will be some for whom the transition will be very challenging. Children who have been bullied at school may have found themselves able to concentrate and learn free of the fear and stress of a classmate’s taunts or stares. Children with learning disabilities or ADHD have probably struggled with online school, but they have also likely established strategies and supports during the year that have enabled them to get enough individualized help to get their work done. These children are vulnerable to falling behind and getting discouraged when these supports are lost, and possibly not replaced with new ones in the chaos of transition. Parents should reassure their children that they will work with the school to make sure that they can succeed in the classroom as they did at home.
Children with an inhibited or shy temperament might have found that it was easier to focus and listen in the comfortable setting of home than in a busy, stimulating classroom. Children who suffer from anxiety disorders that may make separating from parents or managing the performance and social demands of school extra difficult will find the return to school especially challenging. Some younger children may have experienced the emergence of an anxiety disorder during the past year, and the return to school may mark the challenge that brings heretofore quiet symptoms into full relief.
These children have all enjoyed being able to avoid the discomfort of certain anxiety-provoking situations, and they may be particularly stressed by anticipating a return to school. Younger children may begin to have stomach aches and other physical complaints as the return to school gets close, older children may seem more withdrawn or irritable or begin discussing ways to continue school from home. Parents should help their children try to identify and describe their worries. For anxious children, having a chance to practice may be very helpful. Visiting their school, especially if it is a new school, or having a planned hangout with a friend (with appropriate precautions) is the kind of exposure that can lessen anticipatory anxiety. If this is not enough, parents should not hesitate to bring in other caring, supportive adults, such as school counselors or therapists that may be essential to helping their children face and manage what may be intense anxiety.
Consider routines to support their transition
Just as parents begin to return their children to an earlier bedtime toward the end of summer, it will be helpful to consider how changing certain routines will support their children now. If children will need to get up earlier to be ready for a bus or a team practice, they should start moving bedtime and wake-up time earlier gradually. Uniforms or backpacks that have not been seen for a year should be dug out. Children who are planning a return to a sport may benefit from gradually increasing their exercise or starting training now. This will have the added benefit of improving sleep and energy and fortifying children for the challenges of change. Parents might consider reaching out to other parents in the same class as their children and having a virtual conversation to share their thoughts.
If their family has developed some new “COVID routines” that they have come to enjoy, they should find a way to preserve them. Perhaps they are having dinner together more often or have established a family game night or Netflix night. Help parents consider how to avoid falling back into overscheduling their children and themselves. If they created a time to Zoom with distant or vulnerable loved ones, they might decide to continue this. School may determine some of their routines, but they should also prioritize their family connections and well-being in deciding how to schedule their days.
Find opportunity for mastery and meaning
As parents are listening, validating, and planning with their children, they might use this time to reflect on valuable lessons. They might point out the value of patience: Adjusting to change takes time and happens in fits and starts. It has been 12 months since many of the pandemic changes started and it will take more than a few days to adjust as schools reopen. They might point out how proud they are of what their children have been able to learn, build, or do during this year, what they admire about them. It may be a time to consider what their family may have lost and gained during the past year, what they are eager to leave behind, and what they might like to keep. And it is also a chance for parents to observe that change is an inevitable part of life (especially when growing up). It is always challenging, and often brings loss and sadness. But if we pay attention, there are also the green shoots of what is new and possible.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.
Smartphone ‘addiction’ tied to poor sleep in young adults
Smartphone “addiction” may explain poor sleep quality in a significant proportion of young adults, new research suggests.
Investigators found that almost 40% of adults aged 18-30 years who self-reported excessive smartphone use also reported poor sleep.
“Our study provides further support to the growing body of evidence that smartphone addiction has a deleterious impact on sleep,” wrote the researchers.
The study was published online March 2 in Frontiers of Psychiatry.
Not a clinical diagnosis
Smartphone addiction is not formally recognized as a clinical diagnosis, but it’s an “active” area of research, lead investigator Ben Carter, PhD, King’s College London, noted in the report.
In a cross-sectional survey, 1,043 college students (aged 18-30 years, 73% women) completed the 10-question validated Smartphone Addiction Scale Short Version (SAS-SV) and the adapted Pittsburgh Sleep Quality Score Index.
On the SAS-SV, 406 students (38.9%) reported “addiction” to their smartphones. This estimated prevalence is consistent with other reported studies in young adult populations globally, which is in the range of 30%-45%, the researchers noted.
Overall, 61.6% of participants surveyed reported poor sleep; among those who reported smartphone addiction, 68.7% had poor sleep quality, vs. 57.1% of those who did not report smartphone addiction.
In multivariable analysis that adjusted for a variety of relevant factors, among those for whom there was evidence of smartphone addiction, the odds of poor sleep were increased by 41% (adjusted odds ratio [aOR] = 1.41; 95% confidence interval, 1.06-1.87, P = .018).
The findings also suggest that a greater amount of time spent using the phone and greater use late at night can raise the risk for smartphone addiction.
“Should smartphone addiction become firmly established as a focus of clinical concern, those using their phones after midnight or using their phones for four or more hours per day are likely to be at high risk, and should guide administration of the SAS-SV,” the researchers wrote.
Caveats, cautions, and concerns
Reached for comment, Paul Weigle, MD, psychiatrist with Hartford HealthCare and Hartford (Conn.) Hospital, and member of the American Academy of Child and Adolescent Psychiatry, said the finding of a relationship between addictive smartphone usage and poor sleep quality is not surprising.
“Great increases in adolescent screen media habits in recent decades have seen a concurrent increase in rates of insomnia among this population,” he said in an interview.
Dr. Weigle also noted that young people who use the phone excessively often do so in bed, “which decreases sleep onset by disrupting conditioning (the tendency for our bodies to relate bed with sleep) and by increasing physiological arousal, which makes it more difficult to fall asleep. The blue light from smartphones used at night disrupts our body’s natural circadian rhythms, confusing our brains regarding whether it is night or day, and further worsens sleep.”
Dr. Weigle said in an interview that some of his patients come to him seeking sleep medications, although the best treatment is to perform a “smartphone-ectomy” every evening.
Teenage patients will “beg, borrow, or steal” to be allowed to keep their phones by the bed with the promise not to use them overnight. Three-quarters of the time, when the parents are able to charge the phone in another room, “the sleep problem resolves,” Dr. Weigle said.
One caveat, he said, is that it’s “somewhat unclear whether this is best classified as an addiction or simply a seriously problematic habit. Either way, this type of habit causes a great deal of distress and dysfunction in the lives of those it affects, so it is important to understand,” he said.
In a statement, Bob Patton, PhD, lecturer in clinical psychology, University of Surrey, Guildford, England, noted that this is a cross-sectional study “and as such cannot lead to any firm conclusions about phone usage as the cause of reduced sleep quality.
“It does, however, provide some compelling evidence,” Dr. Patton said, “that the nature of smartphone usage and its related consequences are important considerations in addressing the emerging phenomenon of ‘smartphone addiction.’ ”
Also weighing in, Andrew Przybylski, PhD, director of research, Oxford (England) Internet Institute, University of Oxford, said by any global health body and is not a psychiatric disorder.
“The study is a correlational analysis of a sample of participants recruited on university campuses and therefore only reflects the experiences of those who had the purpose of the study explained to them. It can say nothing about behaviors in the general population,” Dr. Przybylski said in a statement.
“Readers should be cautious of making any firm conclusions about the impact of smartphone use in the general population, or the idea that they’re addictive in any objective sense, on the basis of this work,” he added. The study had no specific funding. Dr. Carter, Dr. Weigle, Dr. Patton, and Dr. Przybylski have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Smartphone “addiction” may explain poor sleep quality in a significant proportion of young adults, new research suggests.
Investigators found that almost 40% of adults aged 18-30 years who self-reported excessive smartphone use also reported poor sleep.
“Our study provides further support to the growing body of evidence that smartphone addiction has a deleterious impact on sleep,” wrote the researchers.
The study was published online March 2 in Frontiers of Psychiatry.
Not a clinical diagnosis
Smartphone addiction is not formally recognized as a clinical diagnosis, but it’s an “active” area of research, lead investigator Ben Carter, PhD, King’s College London, noted in the report.
In a cross-sectional survey, 1,043 college students (aged 18-30 years, 73% women) completed the 10-question validated Smartphone Addiction Scale Short Version (SAS-SV) and the adapted Pittsburgh Sleep Quality Score Index.
On the SAS-SV, 406 students (38.9%) reported “addiction” to their smartphones. This estimated prevalence is consistent with other reported studies in young adult populations globally, which is in the range of 30%-45%, the researchers noted.
Overall, 61.6% of participants surveyed reported poor sleep; among those who reported smartphone addiction, 68.7% had poor sleep quality, vs. 57.1% of those who did not report smartphone addiction.
In multivariable analysis that adjusted for a variety of relevant factors, among those for whom there was evidence of smartphone addiction, the odds of poor sleep were increased by 41% (adjusted odds ratio [aOR] = 1.41; 95% confidence interval, 1.06-1.87, P = .018).
The findings also suggest that a greater amount of time spent using the phone and greater use late at night can raise the risk for smartphone addiction.
“Should smartphone addiction become firmly established as a focus of clinical concern, those using their phones after midnight or using their phones for four or more hours per day are likely to be at high risk, and should guide administration of the SAS-SV,” the researchers wrote.
Caveats, cautions, and concerns
Reached for comment, Paul Weigle, MD, psychiatrist with Hartford HealthCare and Hartford (Conn.) Hospital, and member of the American Academy of Child and Adolescent Psychiatry, said the finding of a relationship between addictive smartphone usage and poor sleep quality is not surprising.
“Great increases in adolescent screen media habits in recent decades have seen a concurrent increase in rates of insomnia among this population,” he said in an interview.
Dr. Weigle also noted that young people who use the phone excessively often do so in bed, “which decreases sleep onset by disrupting conditioning (the tendency for our bodies to relate bed with sleep) and by increasing physiological arousal, which makes it more difficult to fall asleep. The blue light from smartphones used at night disrupts our body’s natural circadian rhythms, confusing our brains regarding whether it is night or day, and further worsens sleep.”
Dr. Weigle said in an interview that some of his patients come to him seeking sleep medications, although the best treatment is to perform a “smartphone-ectomy” every evening.
Teenage patients will “beg, borrow, or steal” to be allowed to keep their phones by the bed with the promise not to use them overnight. Three-quarters of the time, when the parents are able to charge the phone in another room, “the sleep problem resolves,” Dr. Weigle said.
One caveat, he said, is that it’s “somewhat unclear whether this is best classified as an addiction or simply a seriously problematic habit. Either way, this type of habit causes a great deal of distress and dysfunction in the lives of those it affects, so it is important to understand,” he said.
In a statement, Bob Patton, PhD, lecturer in clinical psychology, University of Surrey, Guildford, England, noted that this is a cross-sectional study “and as such cannot lead to any firm conclusions about phone usage as the cause of reduced sleep quality.
“It does, however, provide some compelling evidence,” Dr. Patton said, “that the nature of smartphone usage and its related consequences are important considerations in addressing the emerging phenomenon of ‘smartphone addiction.’ ”
Also weighing in, Andrew Przybylski, PhD, director of research, Oxford (England) Internet Institute, University of Oxford, said by any global health body and is not a psychiatric disorder.
“The study is a correlational analysis of a sample of participants recruited on university campuses and therefore only reflects the experiences of those who had the purpose of the study explained to them. It can say nothing about behaviors in the general population,” Dr. Przybylski said in a statement.
“Readers should be cautious of making any firm conclusions about the impact of smartphone use in the general population, or the idea that they’re addictive in any objective sense, on the basis of this work,” he added. The study had no specific funding. Dr. Carter, Dr. Weigle, Dr. Patton, and Dr. Przybylski have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Smartphone “addiction” may explain poor sleep quality in a significant proportion of young adults, new research suggests.
Investigators found that almost 40% of adults aged 18-30 years who self-reported excessive smartphone use also reported poor sleep.
“Our study provides further support to the growing body of evidence that smartphone addiction has a deleterious impact on sleep,” wrote the researchers.
The study was published online March 2 in Frontiers of Psychiatry.
Not a clinical diagnosis
Smartphone addiction is not formally recognized as a clinical diagnosis, but it’s an “active” area of research, lead investigator Ben Carter, PhD, King’s College London, noted in the report.
In a cross-sectional survey, 1,043 college students (aged 18-30 years, 73% women) completed the 10-question validated Smartphone Addiction Scale Short Version (SAS-SV) and the adapted Pittsburgh Sleep Quality Score Index.
On the SAS-SV, 406 students (38.9%) reported “addiction” to their smartphones. This estimated prevalence is consistent with other reported studies in young adult populations globally, which is in the range of 30%-45%, the researchers noted.
Overall, 61.6% of participants surveyed reported poor sleep; among those who reported smartphone addiction, 68.7% had poor sleep quality, vs. 57.1% of those who did not report smartphone addiction.
In multivariable analysis that adjusted for a variety of relevant factors, among those for whom there was evidence of smartphone addiction, the odds of poor sleep were increased by 41% (adjusted odds ratio [aOR] = 1.41; 95% confidence interval, 1.06-1.87, P = .018).
The findings also suggest that a greater amount of time spent using the phone and greater use late at night can raise the risk for smartphone addiction.
“Should smartphone addiction become firmly established as a focus of clinical concern, those using their phones after midnight or using their phones for four or more hours per day are likely to be at high risk, and should guide administration of the SAS-SV,” the researchers wrote.
Caveats, cautions, and concerns
Reached for comment, Paul Weigle, MD, psychiatrist with Hartford HealthCare and Hartford (Conn.) Hospital, and member of the American Academy of Child and Adolescent Psychiatry, said the finding of a relationship between addictive smartphone usage and poor sleep quality is not surprising.
“Great increases in adolescent screen media habits in recent decades have seen a concurrent increase in rates of insomnia among this population,” he said in an interview.
Dr. Weigle also noted that young people who use the phone excessively often do so in bed, “which decreases sleep onset by disrupting conditioning (the tendency for our bodies to relate bed with sleep) and by increasing physiological arousal, which makes it more difficult to fall asleep. The blue light from smartphones used at night disrupts our body’s natural circadian rhythms, confusing our brains regarding whether it is night or day, and further worsens sleep.”
Dr. Weigle said in an interview that some of his patients come to him seeking sleep medications, although the best treatment is to perform a “smartphone-ectomy” every evening.
Teenage patients will “beg, borrow, or steal” to be allowed to keep their phones by the bed with the promise not to use them overnight. Three-quarters of the time, when the parents are able to charge the phone in another room, “the sleep problem resolves,” Dr. Weigle said.
One caveat, he said, is that it’s “somewhat unclear whether this is best classified as an addiction or simply a seriously problematic habit. Either way, this type of habit causes a great deal of distress and dysfunction in the lives of those it affects, so it is important to understand,” he said.
In a statement, Bob Patton, PhD, lecturer in clinical psychology, University of Surrey, Guildford, England, noted that this is a cross-sectional study “and as such cannot lead to any firm conclusions about phone usage as the cause of reduced sleep quality.
“It does, however, provide some compelling evidence,” Dr. Patton said, “that the nature of smartphone usage and its related consequences are important considerations in addressing the emerging phenomenon of ‘smartphone addiction.’ ”
Also weighing in, Andrew Przybylski, PhD, director of research, Oxford (England) Internet Institute, University of Oxford, said by any global health body and is not a psychiatric disorder.
“The study is a correlational analysis of a sample of participants recruited on university campuses and therefore only reflects the experiences of those who had the purpose of the study explained to them. It can say nothing about behaviors in the general population,” Dr. Przybylski said in a statement.
“Readers should be cautious of making any firm conclusions about the impact of smartphone use in the general population, or the idea that they’re addictive in any objective sense, on the basis of this work,” he added. The study had no specific funding. Dr. Carter, Dr. Weigle, Dr. Patton, and Dr. Przybylski have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
‘Stunning’ report shows eating disorders are vastly underestimated
A “stunning” new analysis of global data on eating disorders show that they are far more prevalent and disabling than previously reported.
Investigators found the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 underestimated the prevalence of eating disorders by nearly 42 million cases, meaning these disorders are four times more common than previously reported.
“Our work highlights that eating disorders are far more prevalent and disabling than previously quantified,” lead author Damian F. Santomauro, PhD, University of Queensland and Center for Mental Health Research, Brisbane, Australia, said in an interview.
The study was published online March 3 in The Lancet Psychiatry.
Policy implications
The GBD Study 2019 reports the prevalence and burden of anorexia nervosa and bulimia nervosa under the umbrella of “eating disorders.”
However, binge-eating disorder (BED) and other specified feeding or eating disorder (OSFED) are more common, the investigators noted.
By excluding BED and OSFED, 41.9 million cases of eating disorders were not represented in the study.
The researchers calculate that the GBD 2019 overlooked 17.3 million people with BED and 24.6 million people with OSFED.
, bringing the total eating disorder DALYs to 6.6 million in 2019, they reported.
“When disorders are left out of the GBD, there is a risk that policymakers and service planners will interpret that these diseases are not prevalent or disabling and therefore not important to address,” said Dr. Santomauro.
“Our results show that the formal inclusion of binge-eating disorder and OSFED in GBD is both feasible and important and will lead to better representation of eating disorder burden globally.
“In turn, this will enhance recognition of the burden experienced by people living with these disorders and hopefully motivate increased investment in research, prevention, and treatment in future,” he added.
Landmark article, clarion call for action
In an accompanying commentary, Jennifer J. Thomas, PhD, and Kendra R. Becker, PhD, with the Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, said that this “stunning” analysis highlights that eating disorders are four times more common than previously thought.
This “landmark” analysis also demonstrates that BED and OSFED are especially common with increasing age. It highlights the burden of eating disorders in men, “shattering the inaccurate but entrenched stereotype that eating disorders affect only thin, young, White women,” Dr. Thomas and Dr. Becker pointed out.
This article, they wrote, is a “clarion call” for BED and OSFED to be included in future versions of the GBD Study.
Going a step further, Dr. Thomas and Dr. Becker said the GBD Study should also include estimates of the prevalence of avoidant/restrictive food intake disorder, rumination disorder, and pica and that the investigators should obtain direct measures of the disability associated with all feeding and eating disorders included in the DSM-5.
“If they do, the reported global burden will be even greater, underscoring the clear need for increased funding to study, prevent, and treat these debilitating illnesses,” they concluded.
The study was funded by Queensland Health, the Australian National Health and Medical Research Council, and the Bill & Melinda Gates Foundation. The authors have disclosed no relevant financial relationships. Disclosures for the editorialists are listed with the original article.
A version of this article first appeared on Medscape.com.
A “stunning” new analysis of global data on eating disorders show that they are far more prevalent and disabling than previously reported.
Investigators found the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 underestimated the prevalence of eating disorders by nearly 42 million cases, meaning these disorders are four times more common than previously reported.
“Our work highlights that eating disorders are far more prevalent and disabling than previously quantified,” lead author Damian F. Santomauro, PhD, University of Queensland and Center for Mental Health Research, Brisbane, Australia, said in an interview.
The study was published online March 3 in The Lancet Psychiatry.
Policy implications
The GBD Study 2019 reports the prevalence and burden of anorexia nervosa and bulimia nervosa under the umbrella of “eating disorders.”
However, binge-eating disorder (BED) and other specified feeding or eating disorder (OSFED) are more common, the investigators noted.
By excluding BED and OSFED, 41.9 million cases of eating disorders were not represented in the study.
The researchers calculate that the GBD 2019 overlooked 17.3 million people with BED and 24.6 million people with OSFED.
, bringing the total eating disorder DALYs to 6.6 million in 2019, they reported.
“When disorders are left out of the GBD, there is a risk that policymakers and service planners will interpret that these diseases are not prevalent or disabling and therefore not important to address,” said Dr. Santomauro.
“Our results show that the formal inclusion of binge-eating disorder and OSFED in GBD is both feasible and important and will lead to better representation of eating disorder burden globally.
“In turn, this will enhance recognition of the burden experienced by people living with these disorders and hopefully motivate increased investment in research, prevention, and treatment in future,” he added.
Landmark article, clarion call for action
In an accompanying commentary, Jennifer J. Thomas, PhD, and Kendra R. Becker, PhD, with the Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, said that this “stunning” analysis highlights that eating disorders are four times more common than previously thought.
This “landmark” analysis also demonstrates that BED and OSFED are especially common with increasing age. It highlights the burden of eating disorders in men, “shattering the inaccurate but entrenched stereotype that eating disorders affect only thin, young, White women,” Dr. Thomas and Dr. Becker pointed out.
This article, they wrote, is a “clarion call” for BED and OSFED to be included in future versions of the GBD Study.
Going a step further, Dr. Thomas and Dr. Becker said the GBD Study should also include estimates of the prevalence of avoidant/restrictive food intake disorder, rumination disorder, and pica and that the investigators should obtain direct measures of the disability associated with all feeding and eating disorders included in the DSM-5.
“If they do, the reported global burden will be even greater, underscoring the clear need for increased funding to study, prevent, and treat these debilitating illnesses,” they concluded.
The study was funded by Queensland Health, the Australian National Health and Medical Research Council, and the Bill & Melinda Gates Foundation. The authors have disclosed no relevant financial relationships. Disclosures for the editorialists are listed with the original article.
A version of this article first appeared on Medscape.com.
A “stunning” new analysis of global data on eating disorders show that they are far more prevalent and disabling than previously reported.
Investigators found the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 underestimated the prevalence of eating disorders by nearly 42 million cases, meaning these disorders are four times more common than previously reported.
“Our work highlights that eating disorders are far more prevalent and disabling than previously quantified,” lead author Damian F. Santomauro, PhD, University of Queensland and Center for Mental Health Research, Brisbane, Australia, said in an interview.
The study was published online March 3 in The Lancet Psychiatry.
Policy implications
The GBD Study 2019 reports the prevalence and burden of anorexia nervosa and bulimia nervosa under the umbrella of “eating disorders.”
However, binge-eating disorder (BED) and other specified feeding or eating disorder (OSFED) are more common, the investigators noted.
By excluding BED and OSFED, 41.9 million cases of eating disorders were not represented in the study.
The researchers calculate that the GBD 2019 overlooked 17.3 million people with BED and 24.6 million people with OSFED.
, bringing the total eating disorder DALYs to 6.6 million in 2019, they reported.
“When disorders are left out of the GBD, there is a risk that policymakers and service planners will interpret that these diseases are not prevalent or disabling and therefore not important to address,” said Dr. Santomauro.
“Our results show that the formal inclusion of binge-eating disorder and OSFED in GBD is both feasible and important and will lead to better representation of eating disorder burden globally.
“In turn, this will enhance recognition of the burden experienced by people living with these disorders and hopefully motivate increased investment in research, prevention, and treatment in future,” he added.
Landmark article, clarion call for action
In an accompanying commentary, Jennifer J. Thomas, PhD, and Kendra R. Becker, PhD, with the Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, said that this “stunning” analysis highlights that eating disorders are four times more common than previously thought.
This “landmark” analysis also demonstrates that BED and OSFED are especially common with increasing age. It highlights the burden of eating disorders in men, “shattering the inaccurate but entrenched stereotype that eating disorders affect only thin, young, White women,” Dr. Thomas and Dr. Becker pointed out.
This article, they wrote, is a “clarion call” for BED and OSFED to be included in future versions of the GBD Study.
Going a step further, Dr. Thomas and Dr. Becker said the GBD Study should also include estimates of the prevalence of avoidant/restrictive food intake disorder, rumination disorder, and pica and that the investigators should obtain direct measures of the disability associated with all feeding and eating disorders included in the DSM-5.
“If they do, the reported global burden will be even greater, underscoring the clear need for increased funding to study, prevent, and treat these debilitating illnesses,” they concluded.
The study was funded by Queensland Health, the Australian National Health and Medical Research Council, and the Bill & Melinda Gates Foundation. The authors have disclosed no relevant financial relationships. Disclosures for the editorialists are listed with the original article.
A version of this article first appeared on Medscape.com.
Benefits of bremelanotide to women with HSDD questioned in analysis paper
Dr. Spielmans, professor of psychology at Metropolitan State University in Saint Paul, Minn., examined data from the FDA application for bremelanotide, clinicaltrials.gov entries for two phase 3 trials of the drug, and a 2019 article published in Obstetrics & Gynecology that described results from the 24-week trials.
In Dr. Speilman’s analysis, which was published online March 7 in the Journal of Sex Research, he notes that 42.1% of trial participants who received bremelanotide did not complete the trial, compared with 20.48% of participants who received placebo.
Of those who completed the study, 87.22% who received placebo wanted to continue treatment in an open-label extension, compared with 69.97% who received bremelanotide, he wrote.
Women “should be aware of the small degree of bremelanotide’s efficacy, that the protocol-specified outcomes of bremelanotide are mostly unknown, and that participants would rather take a placebo than bremelanotide,” Dr. Spielmans said.
Anita H. Clayton, MD, an author of the Obstetrics & Gynecology paper addressed in Dr. Spielmans’ analysis, says the Journal of Sex Research article does not provide new information and is a disservice to women because it questions accurate scientific data.
Measuring outcomes in HSDD is an evolving field, Dr. Clayton, a psychiatrist at the University of Virginia in Charlottesville, said in an interview. Initial FDA guidance relied on satisfying sexual events as an outcome measure, but this measure was derived from erectile dysfunction studies and is not necessarily adequate for assessing HSDD, she said. The FDA and drug developers agreed to use the desire subscale of the Female Sexual Function Index (FSFI-D) as a coprimary outcome measure instead, she noted.
Dr. Spielmans’ critique of Obstetrics & Gynecology paper
The article published in Obstetrics & Gynecology reporting bremelanotide trial results was noteworthy, although the various issues involved can be seen in reports about other drug trials, Dr. Spielmans said in an interview.
“It is well-established that journal articles reporting clinical trial data overstate benefits and understate harms,” he continued. In this case, “the very incomplete data reporting, reliance on many post-hoc measures of questionable validity, hiding the concerning number of dropouts due to adverse events, and putting a positive spin on efficacy and tolerability is both remarkable and highly problematic,” Dr. Spielmans said.
Dr. Clayton’s reaction
Data about dropout rates due to adverse events have been reported and presented at national meetings, she said in an interview. In addition, a questionnaire found that bremelanotide was superior to placebo in terms of patients feeling that the treatment had provided clinically meaningful benefit, Dr. Clayton said.
The available information enables patients to make informed treatment decisions, Dr. Clayton continued. “There is really this sexist attitude of women needing protection from their own decisions,” she said.
Diagnosing and treating HSDD
Eight of 11 efficacy outcomes in the clinicaltrials.gov study protocols for bremelanotide were not reported in the Obstetrics & Gynecology article in a way that was consistent with the protocols, Dr. Spielmans said. Changing a coprimary outcome to the key secondary outcome “occurred over a year after the trials had begun,” and the authors of the journal article “did not mention that this change occurred,” Dr. Spielmans wrote.
For the coprimary outcome measures of mean change on FSFI-D and Female Sexual Distress Scale–Desire/Arousal/Orgasm #13, “bremelanotide offers modest benefits over placebo,” Dr. Spielmans reported.
In addition to outlining his concerns about transparency in the reporting of trial data and raising questions about the outcome measures used in the Obstetrics & Gynecology article, Dr. Spielmans wrote that the diagnosis of HSDD is problematic.
“The lack of specifying symptom duration, questionable validity for the lack of sexual fantasies as a diagnostic criterion, difficulty in disentangling individual sexual problems from relational problems, and the failure to consider cultural influence (including the pressure on women to satisfy the sexual desires of their male partners) in the experience of sexuality all render HSDD as a problematic entity,” Dr. Spielmans wrote.
The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders replaced HSDD and female sexual arousal disorder with the combined condition female sexual interest/arousal disorder. HSDD is in the 11th edition of the International Classification of Diseases and can be applied to men or women, Dr. Spielmans said.
FDA acknowledged HSDD as an unmet medical need
Dr. Clayton pointed out that HSDD was described decades ago and the FDA acknowledged it as an unmet medical need, and she expressed dissatisfaction with the fact the hypoactive sexual desire disorder appears with quotation marks around it in the title of Dr. Spielmans’ article. This way of presenting HSDD indicates that “the author has no concept of sexual health or sexual dysfunction,” Dr. Clayton said. “Basically this is sort of a dramatic tool, I think, to act like this is not a real disorder,” she added.
Carl Spana, PhD, CEO and president of Palatin Technologies, the developer of bremelanotide, defined the article in the Journal of Sex Research as a “retrospective meta-analysis, and not a re-analysis of the data.
“As a meta-analysis, it is open to various interpretations and reflects the author’s interpretations, which appear to have clear biases,” Dr. Spana said in an interview. “We believe several of this author’s interpretations are contrary to the FDA’s positive assessment that led to Vyleesi’s approval as a safe and effective treatment for women suffering from hypoactive sexual desire disorder.”
The author is unaware of the validation that was conducted at the direction of the FDA to establish clinically meaningful cutoffs for patient-reported outcomes and to establish metrics that define clinical benefit, Dr. Spana said
“Vyleesi was approved by the FDA after a thorough analysis of data from two well-controlled phase 3 clinical studies and multiple clinical and preclinical safety studies,” he said. “The analyses in the New Drug Application were prespecified and conducted according to a statistical analysis plan that the sponsor and FDA agreed to prior to database lock.”
Dr. Spielmans disclosed holdings in Vanguard Healthcare, a mutual fund that invests in pharmaceutical firms. Dr. Clayton has received financial support from Palatin and AMAG Pharmaceuticals, the companies that developed bremelanotide, in previous years.
Dr. Spielmans, professor of psychology at Metropolitan State University in Saint Paul, Minn., examined data from the FDA application for bremelanotide, clinicaltrials.gov entries for two phase 3 trials of the drug, and a 2019 article published in Obstetrics & Gynecology that described results from the 24-week trials.
In Dr. Speilman’s analysis, which was published online March 7 in the Journal of Sex Research, he notes that 42.1% of trial participants who received bremelanotide did not complete the trial, compared with 20.48% of participants who received placebo.
Of those who completed the study, 87.22% who received placebo wanted to continue treatment in an open-label extension, compared with 69.97% who received bremelanotide, he wrote.
Women “should be aware of the small degree of bremelanotide’s efficacy, that the protocol-specified outcomes of bremelanotide are mostly unknown, and that participants would rather take a placebo than bremelanotide,” Dr. Spielmans said.
Anita H. Clayton, MD, an author of the Obstetrics & Gynecology paper addressed in Dr. Spielmans’ analysis, says the Journal of Sex Research article does not provide new information and is a disservice to women because it questions accurate scientific data.
Measuring outcomes in HSDD is an evolving field, Dr. Clayton, a psychiatrist at the University of Virginia in Charlottesville, said in an interview. Initial FDA guidance relied on satisfying sexual events as an outcome measure, but this measure was derived from erectile dysfunction studies and is not necessarily adequate for assessing HSDD, she said. The FDA and drug developers agreed to use the desire subscale of the Female Sexual Function Index (FSFI-D) as a coprimary outcome measure instead, she noted.
Dr. Spielmans’ critique of Obstetrics & Gynecology paper
The article published in Obstetrics & Gynecology reporting bremelanotide trial results was noteworthy, although the various issues involved can be seen in reports about other drug trials, Dr. Spielmans said in an interview.
“It is well-established that journal articles reporting clinical trial data overstate benefits and understate harms,” he continued. In this case, “the very incomplete data reporting, reliance on many post-hoc measures of questionable validity, hiding the concerning number of dropouts due to adverse events, and putting a positive spin on efficacy and tolerability is both remarkable and highly problematic,” Dr. Spielmans said.
Dr. Clayton’s reaction
Data about dropout rates due to adverse events have been reported and presented at national meetings, she said in an interview. In addition, a questionnaire found that bremelanotide was superior to placebo in terms of patients feeling that the treatment had provided clinically meaningful benefit, Dr. Clayton said.
The available information enables patients to make informed treatment decisions, Dr. Clayton continued. “There is really this sexist attitude of women needing protection from their own decisions,” she said.
Diagnosing and treating HSDD
Eight of 11 efficacy outcomes in the clinicaltrials.gov study protocols for bremelanotide were not reported in the Obstetrics & Gynecology article in a way that was consistent with the protocols, Dr. Spielmans said. Changing a coprimary outcome to the key secondary outcome “occurred over a year after the trials had begun,” and the authors of the journal article “did not mention that this change occurred,” Dr. Spielmans wrote.
For the coprimary outcome measures of mean change on FSFI-D and Female Sexual Distress Scale–Desire/Arousal/Orgasm #13, “bremelanotide offers modest benefits over placebo,” Dr. Spielmans reported.
In addition to outlining his concerns about transparency in the reporting of trial data and raising questions about the outcome measures used in the Obstetrics & Gynecology article, Dr. Spielmans wrote that the diagnosis of HSDD is problematic.
“The lack of specifying symptom duration, questionable validity for the lack of sexual fantasies as a diagnostic criterion, difficulty in disentangling individual sexual problems from relational problems, and the failure to consider cultural influence (including the pressure on women to satisfy the sexual desires of their male partners) in the experience of sexuality all render HSDD as a problematic entity,” Dr. Spielmans wrote.
The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders replaced HSDD and female sexual arousal disorder with the combined condition female sexual interest/arousal disorder. HSDD is in the 11th edition of the International Classification of Diseases and can be applied to men or women, Dr. Spielmans said.
FDA acknowledged HSDD as an unmet medical need
Dr. Clayton pointed out that HSDD was described decades ago and the FDA acknowledged it as an unmet medical need, and she expressed dissatisfaction with the fact the hypoactive sexual desire disorder appears with quotation marks around it in the title of Dr. Spielmans’ article. This way of presenting HSDD indicates that “the author has no concept of sexual health or sexual dysfunction,” Dr. Clayton said. “Basically this is sort of a dramatic tool, I think, to act like this is not a real disorder,” she added.
Carl Spana, PhD, CEO and president of Palatin Technologies, the developer of bremelanotide, defined the article in the Journal of Sex Research as a “retrospective meta-analysis, and not a re-analysis of the data.
“As a meta-analysis, it is open to various interpretations and reflects the author’s interpretations, which appear to have clear biases,” Dr. Spana said in an interview. “We believe several of this author’s interpretations are contrary to the FDA’s positive assessment that led to Vyleesi’s approval as a safe and effective treatment for women suffering from hypoactive sexual desire disorder.”
The author is unaware of the validation that was conducted at the direction of the FDA to establish clinically meaningful cutoffs for patient-reported outcomes and to establish metrics that define clinical benefit, Dr. Spana said
“Vyleesi was approved by the FDA after a thorough analysis of data from two well-controlled phase 3 clinical studies and multiple clinical and preclinical safety studies,” he said. “The analyses in the New Drug Application were prespecified and conducted according to a statistical analysis plan that the sponsor and FDA agreed to prior to database lock.”
Dr. Spielmans disclosed holdings in Vanguard Healthcare, a mutual fund that invests in pharmaceutical firms. Dr. Clayton has received financial support from Palatin and AMAG Pharmaceuticals, the companies that developed bremelanotide, in previous years.
Dr. Spielmans, professor of psychology at Metropolitan State University in Saint Paul, Minn., examined data from the FDA application for bremelanotide, clinicaltrials.gov entries for two phase 3 trials of the drug, and a 2019 article published in Obstetrics & Gynecology that described results from the 24-week trials.
In Dr. Speilman’s analysis, which was published online March 7 in the Journal of Sex Research, he notes that 42.1% of trial participants who received bremelanotide did not complete the trial, compared with 20.48% of participants who received placebo.
Of those who completed the study, 87.22% who received placebo wanted to continue treatment in an open-label extension, compared with 69.97% who received bremelanotide, he wrote.
Women “should be aware of the small degree of bremelanotide’s efficacy, that the protocol-specified outcomes of bremelanotide are mostly unknown, and that participants would rather take a placebo than bremelanotide,” Dr. Spielmans said.
Anita H. Clayton, MD, an author of the Obstetrics & Gynecology paper addressed in Dr. Spielmans’ analysis, says the Journal of Sex Research article does not provide new information and is a disservice to women because it questions accurate scientific data.
Measuring outcomes in HSDD is an evolving field, Dr. Clayton, a psychiatrist at the University of Virginia in Charlottesville, said in an interview. Initial FDA guidance relied on satisfying sexual events as an outcome measure, but this measure was derived from erectile dysfunction studies and is not necessarily adequate for assessing HSDD, she said. The FDA and drug developers agreed to use the desire subscale of the Female Sexual Function Index (FSFI-D) as a coprimary outcome measure instead, she noted.
Dr. Spielmans’ critique of Obstetrics & Gynecology paper
The article published in Obstetrics & Gynecology reporting bremelanotide trial results was noteworthy, although the various issues involved can be seen in reports about other drug trials, Dr. Spielmans said in an interview.
“It is well-established that journal articles reporting clinical trial data overstate benefits and understate harms,” he continued. In this case, “the very incomplete data reporting, reliance on many post-hoc measures of questionable validity, hiding the concerning number of dropouts due to adverse events, and putting a positive spin on efficacy and tolerability is both remarkable and highly problematic,” Dr. Spielmans said.
Dr. Clayton’s reaction
Data about dropout rates due to adverse events have been reported and presented at national meetings, she said in an interview. In addition, a questionnaire found that bremelanotide was superior to placebo in terms of patients feeling that the treatment had provided clinically meaningful benefit, Dr. Clayton said.
The available information enables patients to make informed treatment decisions, Dr. Clayton continued. “There is really this sexist attitude of women needing protection from their own decisions,” she said.
Diagnosing and treating HSDD
Eight of 11 efficacy outcomes in the clinicaltrials.gov study protocols for bremelanotide were not reported in the Obstetrics & Gynecology article in a way that was consistent with the protocols, Dr. Spielmans said. Changing a coprimary outcome to the key secondary outcome “occurred over a year after the trials had begun,” and the authors of the journal article “did not mention that this change occurred,” Dr. Spielmans wrote.
For the coprimary outcome measures of mean change on FSFI-D and Female Sexual Distress Scale–Desire/Arousal/Orgasm #13, “bremelanotide offers modest benefits over placebo,” Dr. Spielmans reported.
In addition to outlining his concerns about transparency in the reporting of trial data and raising questions about the outcome measures used in the Obstetrics & Gynecology article, Dr. Spielmans wrote that the diagnosis of HSDD is problematic.
“The lack of specifying symptom duration, questionable validity for the lack of sexual fantasies as a diagnostic criterion, difficulty in disentangling individual sexual problems from relational problems, and the failure to consider cultural influence (including the pressure on women to satisfy the sexual desires of their male partners) in the experience of sexuality all render HSDD as a problematic entity,” Dr. Spielmans wrote.
The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders replaced HSDD and female sexual arousal disorder with the combined condition female sexual interest/arousal disorder. HSDD is in the 11th edition of the International Classification of Diseases and can be applied to men or women, Dr. Spielmans said.
FDA acknowledged HSDD as an unmet medical need
Dr. Clayton pointed out that HSDD was described decades ago and the FDA acknowledged it as an unmet medical need, and she expressed dissatisfaction with the fact the hypoactive sexual desire disorder appears with quotation marks around it in the title of Dr. Spielmans’ article. This way of presenting HSDD indicates that “the author has no concept of sexual health or sexual dysfunction,” Dr. Clayton said. “Basically this is sort of a dramatic tool, I think, to act like this is not a real disorder,” she added.
Carl Spana, PhD, CEO and president of Palatin Technologies, the developer of bremelanotide, defined the article in the Journal of Sex Research as a “retrospective meta-analysis, and not a re-analysis of the data.
“As a meta-analysis, it is open to various interpretations and reflects the author’s interpretations, which appear to have clear biases,” Dr. Spana said in an interview. “We believe several of this author’s interpretations are contrary to the FDA’s positive assessment that led to Vyleesi’s approval as a safe and effective treatment for women suffering from hypoactive sexual desire disorder.”
The author is unaware of the validation that was conducted at the direction of the FDA to establish clinically meaningful cutoffs for patient-reported outcomes and to establish metrics that define clinical benefit, Dr. Spana said
“Vyleesi was approved by the FDA after a thorough analysis of data from two well-controlled phase 3 clinical studies and multiple clinical and preclinical safety studies,” he said. “The analyses in the New Drug Application were prespecified and conducted according to a statistical analysis plan that the sponsor and FDA agreed to prior to database lock.”
Dr. Spielmans disclosed holdings in Vanguard Healthcare, a mutual fund that invests in pharmaceutical firms. Dr. Clayton has received financial support from Palatin and AMAG Pharmaceuticals, the companies that developed bremelanotide, in previous years.
FROM THE JOURNAL OF SEX RESEARCH
Novel therapeutic target for depression identified
An antiseizure medication appears to reduce anhedonia in patients with depression via a novel mechanism that may offer a new therapeutic target for the disorder, new research suggests.
Results of a small, randomized trial show those who received ezogabine (Potiga) experienced a significant reduction in key measures of depression and anhedonia versus placebo.
Participants in the treatment group also showed a trend toward increased response to reward anticipation on functional MRI (fMRI), compared with those treated with placebo, although the effect did not reach statistical significance.
“Our study was the first randomized, placebo-controlled trial to show that a drug affecting this kind of ion channel in the brain can improve depression and anhedonia in patients,” senior investigator James Murrough, MD, PhD, associate professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai, New York, said in a press release.
“Targeting this channel represents a completely different mechanism of action than any currently available antidepressant treatment,” said Dr. Murrough, who is also director of the Depression and Anxiety Center for Discovery and Treatment at Mount Sinai.
The study was published online March 3 in the American Journal of Psychiatry.
Need for a novel target
“One of the main issues in treating depression is that many of our current antidepressants have similar mechanisms of action,” Dr. Murrough said in an interview. “Once a patient hasn’t responded to currently available agents, it’s hard think of new medications to fill that need.”
This need for a novel target motivated Dr. Murrough and associates to research the KCNQ2/3 potassium channel, which has not been previously studied as a therapeutic target for depression.
The KCNQ2/3 channel controls brain cell excitability and function by controlling the flow of the electrical charge across the cell membrane in the form of potassium ions, Dr. Murrough explained.
Previous research using a chronic social defeat model of depression in mice showed changes in the KCNQ2/3 channel. “This was key to determining whether a mouse showed depressive behavior in the context of stress, or whether the mice were resistant or resilient to stress,” he said.
Mice resistant to stress showed increased markers in brain regions associated with reward, while the less resilient mice showed excessive excitability and dysfunction. Dysfunction in the brain’s reward system leads to anhedonia, a “core feature” of depressive disorders.
This inspired Dr. Murrough’s group to identify ezogabine, a drug that acts on this channel.
“ for addressing depressive symptoms,” Dr. Murrough said
Nonsignificant trend
The researchers studied 45 adults diagnosed with depression who exhibited significant anhedonia and at least moderate illness severity.
Participants were randomly assigned to receive either ezogabine (n = 21, mean age 44 years at enrollment, 28.3% male) or placebo (n = 24, mean age 39 years at enrollment, 50% male). At baseline and following treatment, participants completed the incentive flanker test under fMRI conditions to model brain activity during anticipation of a reward. In addition, clinical measures of depression and anhedonia were assessed at weekly visits.
The study groups did not differ significantly in performance accuracy during the fMRI task at baseline or following treatment. The table below summarizes the percentage of errors in each group, with standard deviation.
Participants in the ezogabine group showed a numerical increase in ventral striatum activation in response to reward anticipation, compared with participants in the placebo group, but this trend was not considered significant.
Heterogeneous condition
In contrast, there were notable improvements from baseline to the final outcome visit in clinical measures of depression and anhedonia in the ezogabine group, compared with the placebo group. Mean (SD) differences in depression scores, based on the MADRS (Montgomery-Åsberg Depression Rating Scale) from baseline to endpoint as follows: mean difference, –7.9 (3.0); effect size, 0.76; response rate, 61.9% (ezogabine) and 37.5% (placebo); remission rate: 38.1% (ezogabine) and 20.8% (placebo)
Compared with placebo, there were also large improvements in hedonic capacity, as measured by the Snaith-Hamilton Pleasure Scale and the anticipatory subscale of the Temporal Experience of Pleasure Scale (t, –4.1; df, 212; P < .001 and t, 3.4; df, 213; P < .001, respectively).
Compared with placebo, ezogabine was associated with “significant benefit” in global illness severity and improvement (Clinical Global Impression–Severity: t, –2.2; df, 214; P = .026 and CGI-Improvement: t, –2.9; d, 214; P = .004, respectively).
Ezogabine was well tolerated. Dizziness and headache were the most common adverse events.
Depression is a “heterogeneous condition” with a single diagnosis encompassing a “large, multifaceted” array of symptoms, Dr. Murrough noted. A growing body of research is focusing on specific components as potential treatment targets. “Our study looked specifically at patients with a diagnosis of depression but high scores on the anhedonia scale and we found that boosting the function of the KCNQ2/3 channel may have a beneficial antidepressant effect by improving anhedonia.”
Potential gain
In a comment, Alan Schatzberg, MD, professor in the department of psychiatry and behavioral sciences at Stanford (Calif.) University, said that “anytime there’s a new treatment with a new mechanism of action for a given condition, there’s a potential gain for the field.”
Dr. Schatzberg, who was not involved with the study, said that ezogabine, with its “potentially new mechanism of action, seems to have an effect and reasonable safety and could be important for patients who may not respond to traditional medications. It might also be important for all sorts of patients, depending on findings of later trials.”
Dr. Murrough said that ezogabine in still in “early stages” of research. “We hope that future studies will look at other agents that would also affect this channel,” he added.
This research was supported by the National Institute of Mental Health. Additional funding was provided by the Friedman Brain Institute at the Icahn School of Medicine at Mount Sinai and the Ehrenkranz Laboratory for Human Resilience, a component of the Depression and Anxiety Center for Discovery and Treatment at the Icahn School of Medicine at Mount Sinai. Dr. Murrough is an inventor of a pending patent application for the use of ezogabine and other KCNQ channel openers to treat depression and related disorders. Dr. Schatzberg disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An antiseizure medication appears to reduce anhedonia in patients with depression via a novel mechanism that may offer a new therapeutic target for the disorder, new research suggests.
Results of a small, randomized trial show those who received ezogabine (Potiga) experienced a significant reduction in key measures of depression and anhedonia versus placebo.
Participants in the treatment group also showed a trend toward increased response to reward anticipation on functional MRI (fMRI), compared with those treated with placebo, although the effect did not reach statistical significance.
“Our study was the first randomized, placebo-controlled trial to show that a drug affecting this kind of ion channel in the brain can improve depression and anhedonia in patients,” senior investigator James Murrough, MD, PhD, associate professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai, New York, said in a press release.
“Targeting this channel represents a completely different mechanism of action than any currently available antidepressant treatment,” said Dr. Murrough, who is also director of the Depression and Anxiety Center for Discovery and Treatment at Mount Sinai.
The study was published online March 3 in the American Journal of Psychiatry.
Need for a novel target
“One of the main issues in treating depression is that many of our current antidepressants have similar mechanisms of action,” Dr. Murrough said in an interview. “Once a patient hasn’t responded to currently available agents, it’s hard think of new medications to fill that need.”
This need for a novel target motivated Dr. Murrough and associates to research the KCNQ2/3 potassium channel, which has not been previously studied as a therapeutic target for depression.
The KCNQ2/3 channel controls brain cell excitability and function by controlling the flow of the electrical charge across the cell membrane in the form of potassium ions, Dr. Murrough explained.
Previous research using a chronic social defeat model of depression in mice showed changes in the KCNQ2/3 channel. “This was key to determining whether a mouse showed depressive behavior in the context of stress, or whether the mice were resistant or resilient to stress,” he said.
Mice resistant to stress showed increased markers in brain regions associated with reward, while the less resilient mice showed excessive excitability and dysfunction. Dysfunction in the brain’s reward system leads to anhedonia, a “core feature” of depressive disorders.
This inspired Dr. Murrough’s group to identify ezogabine, a drug that acts on this channel.
“ for addressing depressive symptoms,” Dr. Murrough said
Nonsignificant trend
The researchers studied 45 adults diagnosed with depression who exhibited significant anhedonia and at least moderate illness severity.
Participants were randomly assigned to receive either ezogabine (n = 21, mean age 44 years at enrollment, 28.3% male) or placebo (n = 24, mean age 39 years at enrollment, 50% male). At baseline and following treatment, participants completed the incentive flanker test under fMRI conditions to model brain activity during anticipation of a reward. In addition, clinical measures of depression and anhedonia were assessed at weekly visits.
The study groups did not differ significantly in performance accuracy during the fMRI task at baseline or following treatment. The table below summarizes the percentage of errors in each group, with standard deviation.
Participants in the ezogabine group showed a numerical increase in ventral striatum activation in response to reward anticipation, compared with participants in the placebo group, but this trend was not considered significant.
Heterogeneous condition
In contrast, there were notable improvements from baseline to the final outcome visit in clinical measures of depression and anhedonia in the ezogabine group, compared with the placebo group. Mean (SD) differences in depression scores, based on the MADRS (Montgomery-Åsberg Depression Rating Scale) from baseline to endpoint as follows: mean difference, –7.9 (3.0); effect size, 0.76; response rate, 61.9% (ezogabine) and 37.5% (placebo); remission rate: 38.1% (ezogabine) and 20.8% (placebo)
Compared with placebo, there were also large improvements in hedonic capacity, as measured by the Snaith-Hamilton Pleasure Scale and the anticipatory subscale of the Temporal Experience of Pleasure Scale (t, –4.1; df, 212; P < .001 and t, 3.4; df, 213; P < .001, respectively).
Compared with placebo, ezogabine was associated with “significant benefit” in global illness severity and improvement (Clinical Global Impression–Severity: t, –2.2; df, 214; P = .026 and CGI-Improvement: t, –2.9; d, 214; P = .004, respectively).
Ezogabine was well tolerated. Dizziness and headache were the most common adverse events.
Depression is a “heterogeneous condition” with a single diagnosis encompassing a “large, multifaceted” array of symptoms, Dr. Murrough noted. A growing body of research is focusing on specific components as potential treatment targets. “Our study looked specifically at patients with a diagnosis of depression but high scores on the anhedonia scale and we found that boosting the function of the KCNQ2/3 channel may have a beneficial antidepressant effect by improving anhedonia.”
Potential gain
In a comment, Alan Schatzberg, MD, professor in the department of psychiatry and behavioral sciences at Stanford (Calif.) University, said that “anytime there’s a new treatment with a new mechanism of action for a given condition, there’s a potential gain for the field.”
Dr. Schatzberg, who was not involved with the study, said that ezogabine, with its “potentially new mechanism of action, seems to have an effect and reasonable safety and could be important for patients who may not respond to traditional medications. It might also be important for all sorts of patients, depending on findings of later trials.”
Dr. Murrough said that ezogabine in still in “early stages” of research. “We hope that future studies will look at other agents that would also affect this channel,” he added.
This research was supported by the National Institute of Mental Health. Additional funding was provided by the Friedman Brain Institute at the Icahn School of Medicine at Mount Sinai and the Ehrenkranz Laboratory for Human Resilience, a component of the Depression and Anxiety Center for Discovery and Treatment at the Icahn School of Medicine at Mount Sinai. Dr. Murrough is an inventor of a pending patent application for the use of ezogabine and other KCNQ channel openers to treat depression and related disorders. Dr. Schatzberg disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An antiseizure medication appears to reduce anhedonia in patients with depression via a novel mechanism that may offer a new therapeutic target for the disorder, new research suggests.
Results of a small, randomized trial show those who received ezogabine (Potiga) experienced a significant reduction in key measures of depression and anhedonia versus placebo.
Participants in the treatment group also showed a trend toward increased response to reward anticipation on functional MRI (fMRI), compared with those treated with placebo, although the effect did not reach statistical significance.
“Our study was the first randomized, placebo-controlled trial to show that a drug affecting this kind of ion channel in the brain can improve depression and anhedonia in patients,” senior investigator James Murrough, MD, PhD, associate professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai, New York, said in a press release.
“Targeting this channel represents a completely different mechanism of action than any currently available antidepressant treatment,” said Dr. Murrough, who is also director of the Depression and Anxiety Center for Discovery and Treatment at Mount Sinai.
The study was published online March 3 in the American Journal of Psychiatry.
Need for a novel target
“One of the main issues in treating depression is that many of our current antidepressants have similar mechanisms of action,” Dr. Murrough said in an interview. “Once a patient hasn’t responded to currently available agents, it’s hard think of new medications to fill that need.”
This need for a novel target motivated Dr. Murrough and associates to research the KCNQ2/3 potassium channel, which has not been previously studied as a therapeutic target for depression.
The KCNQ2/3 channel controls brain cell excitability and function by controlling the flow of the electrical charge across the cell membrane in the form of potassium ions, Dr. Murrough explained.
Previous research using a chronic social defeat model of depression in mice showed changes in the KCNQ2/3 channel. “This was key to determining whether a mouse showed depressive behavior in the context of stress, or whether the mice were resistant or resilient to stress,” he said.
Mice resistant to stress showed increased markers in brain regions associated with reward, while the less resilient mice showed excessive excitability and dysfunction. Dysfunction in the brain’s reward system leads to anhedonia, a “core feature” of depressive disorders.
This inspired Dr. Murrough’s group to identify ezogabine, a drug that acts on this channel.
“ for addressing depressive symptoms,” Dr. Murrough said
Nonsignificant trend
The researchers studied 45 adults diagnosed with depression who exhibited significant anhedonia and at least moderate illness severity.
Participants were randomly assigned to receive either ezogabine (n = 21, mean age 44 years at enrollment, 28.3% male) or placebo (n = 24, mean age 39 years at enrollment, 50% male). At baseline and following treatment, participants completed the incentive flanker test under fMRI conditions to model brain activity during anticipation of a reward. In addition, clinical measures of depression and anhedonia were assessed at weekly visits.
The study groups did not differ significantly in performance accuracy during the fMRI task at baseline or following treatment. The table below summarizes the percentage of errors in each group, with standard deviation.
Participants in the ezogabine group showed a numerical increase in ventral striatum activation in response to reward anticipation, compared with participants in the placebo group, but this trend was not considered significant.
Heterogeneous condition
In contrast, there were notable improvements from baseline to the final outcome visit in clinical measures of depression and anhedonia in the ezogabine group, compared with the placebo group. Mean (SD) differences in depression scores, based on the MADRS (Montgomery-Åsberg Depression Rating Scale) from baseline to endpoint as follows: mean difference, –7.9 (3.0); effect size, 0.76; response rate, 61.9% (ezogabine) and 37.5% (placebo); remission rate: 38.1% (ezogabine) and 20.8% (placebo)
Compared with placebo, there were also large improvements in hedonic capacity, as measured by the Snaith-Hamilton Pleasure Scale and the anticipatory subscale of the Temporal Experience of Pleasure Scale (t, –4.1; df, 212; P < .001 and t, 3.4; df, 213; P < .001, respectively).
Compared with placebo, ezogabine was associated with “significant benefit” in global illness severity and improvement (Clinical Global Impression–Severity: t, –2.2; df, 214; P = .026 and CGI-Improvement: t, –2.9; d, 214; P = .004, respectively).
Ezogabine was well tolerated. Dizziness and headache were the most common adverse events.
Depression is a “heterogeneous condition” with a single diagnosis encompassing a “large, multifaceted” array of symptoms, Dr. Murrough noted. A growing body of research is focusing on specific components as potential treatment targets. “Our study looked specifically at patients with a diagnosis of depression but high scores on the anhedonia scale and we found that boosting the function of the KCNQ2/3 channel may have a beneficial antidepressant effect by improving anhedonia.”
Potential gain
In a comment, Alan Schatzberg, MD, professor in the department of psychiatry and behavioral sciences at Stanford (Calif.) University, said that “anytime there’s a new treatment with a new mechanism of action for a given condition, there’s a potential gain for the field.”
Dr. Schatzberg, who was not involved with the study, said that ezogabine, with its “potentially new mechanism of action, seems to have an effect and reasonable safety and could be important for patients who may not respond to traditional medications. It might also be important for all sorts of patients, depending on findings of later trials.”
Dr. Murrough said that ezogabine in still in “early stages” of research. “We hope that future studies will look at other agents that would also affect this channel,” he added.
This research was supported by the National Institute of Mental Health. Additional funding was provided by the Friedman Brain Institute at the Icahn School of Medicine at Mount Sinai and the Ehrenkranz Laboratory for Human Resilience, a component of the Depression and Anxiety Center for Discovery and Treatment at the Icahn School of Medicine at Mount Sinai. Dr. Murrough is an inventor of a pending patent application for the use of ezogabine and other KCNQ channel openers to treat depression and related disorders. Dr. Schatzberg disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA okays novel dual-action stimulant med for ADHD
The Food and Drug Administration has approved a new, once-daily oral stimulant medication for treatment of ADHD in people aged 6 years and older.
Azstarys (KemPharm) combines extended-release serdexmethylphenidate (SDX), KemPharm’s prodrug of dexmethylphenidate (d-MPH), coformulated with immediate-release d-MPH.
Following absorption in the gastrointestinal tract, SDX is converted to d-MPH, which is gradually released throughout the day, providing symptom control both rapidly with the d-MPH and for an extended duration with SDX.
The dual action of Azstarys addresses an unmet need for a medication that has early onset of action and long duration of therapy, with steady ADHD symptom control in one capsule, Corium, the company that will lead U.S. commercialization of the drug, stated in a news release.
“The data documenting the efficacy and safety of this new dual-action medicine, the first ever to use the novel prodrug serdexmethylphenidate together with dexmethylphenidate, is welcome news for clinicians and families to consider when choosing an appropriate ADHD therapy for children,” Ann Childress, MD, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas, who led the phase 3 trial of the drug, said in the release.
The study included 150 children aged 6-12 years with ADHD. Compared with placebo, treatment with Azstarys led to significant improvement in ADHD symptoms, as measured by the primary endpoint, the change from baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale–Combined scores averaged over 13 hours.
Adverse events seen more often with Azstarys than placebo were headache (5.4% vs. 1.3%), upper abdominal pain (4.1% vs. 1.3%), insomnia (2.7% vs. 1.3%) and pharyngitis (2.7% vs. 0%). No serious adverse events were reported.
The FDA has recommended a schedule II controlled substance classification for Azstarys and the Drug Enforcement Administration will decide on scheduling within 90 days.
Pending the DEA’s action, the launch of Azstarys is anticipated this summer. Azstarys will be available in three once-daily dosage strengths of SDX/d-MPH: 26.1/5.2 mg, 39.2/7.8 mg, and 52.3/10.4 mg.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved a new, once-daily oral stimulant medication for treatment of ADHD in people aged 6 years and older.
Azstarys (KemPharm) combines extended-release serdexmethylphenidate (SDX), KemPharm’s prodrug of dexmethylphenidate (d-MPH), coformulated with immediate-release d-MPH.
Following absorption in the gastrointestinal tract, SDX is converted to d-MPH, which is gradually released throughout the day, providing symptom control both rapidly with the d-MPH and for an extended duration with SDX.
The dual action of Azstarys addresses an unmet need for a medication that has early onset of action and long duration of therapy, with steady ADHD symptom control in one capsule, Corium, the company that will lead U.S. commercialization of the drug, stated in a news release.
“The data documenting the efficacy and safety of this new dual-action medicine, the first ever to use the novel prodrug serdexmethylphenidate together with dexmethylphenidate, is welcome news for clinicians and families to consider when choosing an appropriate ADHD therapy for children,” Ann Childress, MD, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas, who led the phase 3 trial of the drug, said in the release.
The study included 150 children aged 6-12 years with ADHD. Compared with placebo, treatment with Azstarys led to significant improvement in ADHD symptoms, as measured by the primary endpoint, the change from baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale–Combined scores averaged over 13 hours.
Adverse events seen more often with Azstarys than placebo were headache (5.4% vs. 1.3%), upper abdominal pain (4.1% vs. 1.3%), insomnia (2.7% vs. 1.3%) and pharyngitis (2.7% vs. 0%). No serious adverse events were reported.
The FDA has recommended a schedule II controlled substance classification for Azstarys and the Drug Enforcement Administration will decide on scheduling within 90 days.
Pending the DEA’s action, the launch of Azstarys is anticipated this summer. Azstarys will be available in three once-daily dosage strengths of SDX/d-MPH: 26.1/5.2 mg, 39.2/7.8 mg, and 52.3/10.4 mg.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved a new, once-daily oral stimulant medication for treatment of ADHD in people aged 6 years and older.
Azstarys (KemPharm) combines extended-release serdexmethylphenidate (SDX), KemPharm’s prodrug of dexmethylphenidate (d-MPH), coformulated with immediate-release d-MPH.
Following absorption in the gastrointestinal tract, SDX is converted to d-MPH, which is gradually released throughout the day, providing symptom control both rapidly with the d-MPH and for an extended duration with SDX.
The dual action of Azstarys addresses an unmet need for a medication that has early onset of action and long duration of therapy, with steady ADHD symptom control in one capsule, Corium, the company that will lead U.S. commercialization of the drug, stated in a news release.
“The data documenting the efficacy and safety of this new dual-action medicine, the first ever to use the novel prodrug serdexmethylphenidate together with dexmethylphenidate, is welcome news for clinicians and families to consider when choosing an appropriate ADHD therapy for children,” Ann Childress, MD, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas, who led the phase 3 trial of the drug, said in the release.
The study included 150 children aged 6-12 years with ADHD. Compared with placebo, treatment with Azstarys led to significant improvement in ADHD symptoms, as measured by the primary endpoint, the change from baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale–Combined scores averaged over 13 hours.
Adverse events seen more often with Azstarys than placebo were headache (5.4% vs. 1.3%), upper abdominal pain (4.1% vs. 1.3%), insomnia (2.7% vs. 1.3%) and pharyngitis (2.7% vs. 0%). No serious adverse events were reported.
The FDA has recommended a schedule II controlled substance classification for Azstarys and the Drug Enforcement Administration will decide on scheduling within 90 days.
Pending the DEA’s action, the launch of Azstarys is anticipated this summer. Azstarys will be available in three once-daily dosage strengths of SDX/d-MPH: 26.1/5.2 mg, 39.2/7.8 mg, and 52.3/10.4 mg.
A version of this article first appeared on Medscape.com.
How to make resident mental health care stigma free
Sarah Sofka, MD, FACP, noticed a pattern. As program director for the internal medicine (IM) residency at West Virginia University, Morgantown, she was informed when residents were sent to counseling because they were affected by burnout, depression, or anxiety. When trainees returned from these visits, many told her the same thing: They wished they had sought help sooner.
IM residents and their families had access to free counseling at WVU, but few used the resource, says Dr. Sofka. “So, we thought, let’s just schedule all of our residents for a therapy visit so they can go and see what it’s like,” she said. “This will hopefully decrease the stigma for seeking mental health care. If everybody’s going, it’s not a big deal.”
In July 2015, Dr. Sofka and her colleagues launched a universal well-being assessment program for the IM residents at WVU. The program leaders automatically scheduled first- and second-year residents for a visit to the faculty staff assistance program counselors. The visits were not mandatory, and residents could choose not to go; but if they did go, they received the entire day of their visit off from work.
Five and a half years after launching their program, Dr. Sofka and her colleagues conducted one of the first studies of the efficacy of an opt-out approach for resident mental wellness. They found that , suggesting that residents were seeking help proactively after having to at least consider it.
Opt-out counseling is a recent concept in residency programs – one that’s attracting interest from training programs across the country. Brown University, Providence, R.I.; the University of Colorado at Denver, Aurora; University of Pennsylvania, Philadelphia; and the University of California, San Francisco have at least one residency program that uses the approach.
Lisa Meeks, PhD, an assistant professor of family medicine at Michigan Medicine, in Ann Arbor, and other experts also believe opt-out counseling could decrease stigma and help normalize seeking care for mental health problems in the medical community while lowering the barriers for trainees who need help.
No time, no access, plenty of stigma
Burnout and mental health are known to be major concerns for health care workers, especially trainees. College graduates starting medical education have lower rates of burnout and depression, compared with demographically matched peers; however, once they’ve started training, medical students, residents, and fellows are more likely to be burned out and exhibit symptoms of depression. The ongoing COVID-19 pandemic is further fraying the well-being of overworked and traumatized health care professionals, and experts predict a mental health crisis will follow the viral crisis.
The Accreditation Council for Graduate Medical Education recently mandated that programs offer wellness services to trainees. Yet this doesn’t mean they are always used; well-known barriers stand between residents, medical students, and physicians and their receiving effective mental health treatment.
Two of the most obvious are access and time, given the grueling and often inflexible schedules of most trainees, says Jessica Gold, MD, a psychiatrist at Washington University, St. Louis, who specializes in treating medical professionals. Dr. Gold also points out that, to be done correctly, these programs require institutional support and investment – resources that aren’t always adequate.
“A lack of transparency and clear messaging around what is available, who provides the services, and how to access these services can be a major barrier,” says Erene Stergiopoulos, MD, a second-year psychiatry resident at the University of Toronto. In addition, there can be considerable lag between when a resident realizes they need help and when they manage to find a provider and schedule an appointment, says Dr. Meeks.
Even when these logistical barriers are overcome, trainees and physicians have to contend with the persistent stigma associated with mental health treatment in the culture of medicine, says Dr. Gold. A recent survey by the American College of Emergency Physicians found that 73% of surveyed physicians feel there is stigma in their workplace about seeking mental health treatment. Many state medical licensing boards still require physicians to disclose mental health treatment, which discourages many trainees and providers from seeking proactive care, says Mary Moffit, PhD, associate professor of psychiatry and director of the resident and faculty wellness program at Oregon Health & Science University, Portland.
How the opt-out approach works
“The idea is by making it opt-out, you really normalize it,” says Maneesh Batra, MD, MPH, associate director of the University of Washington, Seattle, Children’s Hospital residency program. Similar approaches have proven effective at shaping human behavior in other health care settings, including boosting testing rates for HIV and increasing immunization rates for childhood vaccines, Dr. Batra says.
In general, opt-out programs acknowledge that people are busy and won’t take that extra step or click that extra button if they don’t have to, says Oana Tomescu, MD, PhD, associate professor of clinical medicine and pediatrics at the University of Pennsylvania, Philadelphia.
In 2018, Dr. Sofka and her colleagues at WVU conducted a survey that showed that a majority of residents thought favorably of their opt-out program and said they would return to counseling for follow-up care. In their most recent study, published in the Journal of Graduate Medical Education in 2021, Dr. Sofka and her colleagues found that residents did just that – only 8 of 239 opted out of universally scheduled visits. Resident-initiated visits increased significantly from zero during the 2014-2015 academic year to 23 in 2018-2019. Between those periods, program-mandated visits decreased significantly from 12 to 3.
The initiative has succeeded in creating a culture of openness and caring at WVU, says 2nd-year internal medicine resident Nistha Modi, MD. “It sets the tone for the program – we talk about mental health openly,” says Dr. Modi.
Crucially, the counselors work out of a different building than the hospital where Dr. Modi and her fellow residents work and use a separate electronic medical record system to protect resident privacy. This is hugely important for medical trainees, note Dr. Tomescu, Dr. Gold, and many other experts. The therapists understand residency and medical education, and there is no limit to the number of visits a resident or fellow can make with the program counselors, says Dr. Modi.
Opt-out programs offer a counterbalance to many negative tendencies in residency, says Dr. Meeks. “We’ve normalized so many things that are not healthy and productive. ... We need to counterbalance that with normalizing help seeking. And it’s really difficult to normalize something that’s not part of a system.”
Costs, concerns, and systematic support
Providing unlimited, free counseling for trainees can be very beneficial, but it requires adequate funding and personnel resources. Offering unlimited access means that an institution has to follow through in making this degree of care available while also ensuring that the system doesn’t get overwhelmed or is unable to accommodate very sick individuals, says Dr. Gold.
Another concern that experts like Dr. Batra, Dr. Moffit, and Dr. Gold share is that residents who go to their scheduled appointments may not completely buy into the experience because it wasn’t their idea in the first place. Participation alone doesn’t necessarily indicate full acceptance. Program personnel don’t intend for these appointments to be thought of as mandatory, yet residents may still experience them that way. Several leading resident well-being programs instead emphasize outreach to trainees, institutional support, and accessible mental health resources that are – and feel – entirely voluntary.
“If I tell someone that they have to do something, it’s very different than if they arrive at that conclusion for themselves,” says Dr. Batra. “That’s how life works.”
When it comes to cost, a recent study published in Academic Medicine provides encouraging data. At the University of Colorado, an opt-out pilot program for IM and pediatrics interns during the 2017-2018 academic year cost just $940 total, equal to $11.75 per intern. As in West Virginia, the program in Colorado covered the cost of the visit, interns were provided a half day off (whether they attended their appointment or not), and the visits and surveys were entirely optional and confidential. During the 1-year pilot program, 29% of 80 interns attended the scheduled appointment, 56% opted out in advance, and 15% didn’t show up. The majority of interns who were surveyed (85%), however, thought the program should continue and that it had a positive effect on their wellness even if they didn’t attend their appointment.
In West Virginia, program costs are higher. The program has $20,000 in annual funding to cover the opt-out program and unlimited counseling visits for residents and fellows. With that funding, Dr. Sofka and her colleagues were also able to expand the program slightly last year to schedule all the critical care faculty for counseling visits. Cost is a barrier to expanding these services to the entire institution, which Dr. Sofka says she hopes to do one day.
Research in this area is still preliminary. The WVU and Colorado studies provide some of the first evidence in support of an opt-out approach. Eventually, it would be beneficial for multicenter studies and longitudinal research to track the effects of such programs over time, say Dr. Sofka and Ajay Major, MD, MBA, one of the study’s coauthors and a hematology/oncology fellow at the University of Chicago.
Whether a program goes with an opt-out approach or not, the systematic supports – protecting resident privacy, providing flexible scheduling, and more – are crucial.
As Dr. Tomescu notes, wellness shouldn’t be just something trainees have to do. “The key with really working on burnout at a huge level is for all programs and schools to recognize that it’s a shared responsibility.”
“I felt very fortunate that I was able to get some help throughout residency,” says Dr. Modi. “About how to be a better daughter. How to be content with things I have in life. How to be happy, and grateful. With the kind of job we have, I think we sometimes forget to be grateful.”
A version of this article first appeared on Medscape.com.
Sarah Sofka, MD, FACP, noticed a pattern. As program director for the internal medicine (IM) residency at West Virginia University, Morgantown, she was informed when residents were sent to counseling because they were affected by burnout, depression, or anxiety. When trainees returned from these visits, many told her the same thing: They wished they had sought help sooner.
IM residents and their families had access to free counseling at WVU, but few used the resource, says Dr. Sofka. “So, we thought, let’s just schedule all of our residents for a therapy visit so they can go and see what it’s like,” she said. “This will hopefully decrease the stigma for seeking mental health care. If everybody’s going, it’s not a big deal.”
In July 2015, Dr. Sofka and her colleagues launched a universal well-being assessment program for the IM residents at WVU. The program leaders automatically scheduled first- and second-year residents for a visit to the faculty staff assistance program counselors. The visits were not mandatory, and residents could choose not to go; but if they did go, they received the entire day of their visit off from work.
Five and a half years after launching their program, Dr. Sofka and her colleagues conducted one of the first studies of the efficacy of an opt-out approach for resident mental wellness. They found that , suggesting that residents were seeking help proactively after having to at least consider it.
Opt-out counseling is a recent concept in residency programs – one that’s attracting interest from training programs across the country. Brown University, Providence, R.I.; the University of Colorado at Denver, Aurora; University of Pennsylvania, Philadelphia; and the University of California, San Francisco have at least one residency program that uses the approach.
Lisa Meeks, PhD, an assistant professor of family medicine at Michigan Medicine, in Ann Arbor, and other experts also believe opt-out counseling could decrease stigma and help normalize seeking care for mental health problems in the medical community while lowering the barriers for trainees who need help.
No time, no access, plenty of stigma
Burnout and mental health are known to be major concerns for health care workers, especially trainees. College graduates starting medical education have lower rates of burnout and depression, compared with demographically matched peers; however, once they’ve started training, medical students, residents, and fellows are more likely to be burned out and exhibit symptoms of depression. The ongoing COVID-19 pandemic is further fraying the well-being of overworked and traumatized health care professionals, and experts predict a mental health crisis will follow the viral crisis.
The Accreditation Council for Graduate Medical Education recently mandated that programs offer wellness services to trainees. Yet this doesn’t mean they are always used; well-known barriers stand between residents, medical students, and physicians and their receiving effective mental health treatment.
Two of the most obvious are access and time, given the grueling and often inflexible schedules of most trainees, says Jessica Gold, MD, a psychiatrist at Washington University, St. Louis, who specializes in treating medical professionals. Dr. Gold also points out that, to be done correctly, these programs require institutional support and investment – resources that aren’t always adequate.
“A lack of transparency and clear messaging around what is available, who provides the services, and how to access these services can be a major barrier,” says Erene Stergiopoulos, MD, a second-year psychiatry resident at the University of Toronto. In addition, there can be considerable lag between when a resident realizes they need help and when they manage to find a provider and schedule an appointment, says Dr. Meeks.
Even when these logistical barriers are overcome, trainees and physicians have to contend with the persistent stigma associated with mental health treatment in the culture of medicine, says Dr. Gold. A recent survey by the American College of Emergency Physicians found that 73% of surveyed physicians feel there is stigma in their workplace about seeking mental health treatment. Many state medical licensing boards still require physicians to disclose mental health treatment, which discourages many trainees and providers from seeking proactive care, says Mary Moffit, PhD, associate professor of psychiatry and director of the resident and faculty wellness program at Oregon Health & Science University, Portland.
How the opt-out approach works
“The idea is by making it opt-out, you really normalize it,” says Maneesh Batra, MD, MPH, associate director of the University of Washington, Seattle, Children’s Hospital residency program. Similar approaches have proven effective at shaping human behavior in other health care settings, including boosting testing rates for HIV and increasing immunization rates for childhood vaccines, Dr. Batra says.
In general, opt-out programs acknowledge that people are busy and won’t take that extra step or click that extra button if they don’t have to, says Oana Tomescu, MD, PhD, associate professor of clinical medicine and pediatrics at the University of Pennsylvania, Philadelphia.
In 2018, Dr. Sofka and her colleagues at WVU conducted a survey that showed that a majority of residents thought favorably of their opt-out program and said they would return to counseling for follow-up care. In their most recent study, published in the Journal of Graduate Medical Education in 2021, Dr. Sofka and her colleagues found that residents did just that – only 8 of 239 opted out of universally scheduled visits. Resident-initiated visits increased significantly from zero during the 2014-2015 academic year to 23 in 2018-2019. Between those periods, program-mandated visits decreased significantly from 12 to 3.
The initiative has succeeded in creating a culture of openness and caring at WVU, says 2nd-year internal medicine resident Nistha Modi, MD. “It sets the tone for the program – we talk about mental health openly,” says Dr. Modi.
Crucially, the counselors work out of a different building than the hospital where Dr. Modi and her fellow residents work and use a separate electronic medical record system to protect resident privacy. This is hugely important for medical trainees, note Dr. Tomescu, Dr. Gold, and many other experts. The therapists understand residency and medical education, and there is no limit to the number of visits a resident or fellow can make with the program counselors, says Dr. Modi.
Opt-out programs offer a counterbalance to many negative tendencies in residency, says Dr. Meeks. “We’ve normalized so many things that are not healthy and productive. ... We need to counterbalance that with normalizing help seeking. And it’s really difficult to normalize something that’s not part of a system.”
Costs, concerns, and systematic support
Providing unlimited, free counseling for trainees can be very beneficial, but it requires adequate funding and personnel resources. Offering unlimited access means that an institution has to follow through in making this degree of care available while also ensuring that the system doesn’t get overwhelmed or is unable to accommodate very sick individuals, says Dr. Gold.
Another concern that experts like Dr. Batra, Dr. Moffit, and Dr. Gold share is that residents who go to their scheduled appointments may not completely buy into the experience because it wasn’t their idea in the first place. Participation alone doesn’t necessarily indicate full acceptance. Program personnel don’t intend for these appointments to be thought of as mandatory, yet residents may still experience them that way. Several leading resident well-being programs instead emphasize outreach to trainees, institutional support, and accessible mental health resources that are – and feel – entirely voluntary.
“If I tell someone that they have to do something, it’s very different than if they arrive at that conclusion for themselves,” says Dr. Batra. “That’s how life works.”
When it comes to cost, a recent study published in Academic Medicine provides encouraging data. At the University of Colorado, an opt-out pilot program for IM and pediatrics interns during the 2017-2018 academic year cost just $940 total, equal to $11.75 per intern. As in West Virginia, the program in Colorado covered the cost of the visit, interns were provided a half day off (whether they attended their appointment or not), and the visits and surveys were entirely optional and confidential. During the 1-year pilot program, 29% of 80 interns attended the scheduled appointment, 56% opted out in advance, and 15% didn’t show up. The majority of interns who were surveyed (85%), however, thought the program should continue and that it had a positive effect on their wellness even if they didn’t attend their appointment.
In West Virginia, program costs are higher. The program has $20,000 in annual funding to cover the opt-out program and unlimited counseling visits for residents and fellows. With that funding, Dr. Sofka and her colleagues were also able to expand the program slightly last year to schedule all the critical care faculty for counseling visits. Cost is a barrier to expanding these services to the entire institution, which Dr. Sofka says she hopes to do one day.
Research in this area is still preliminary. The WVU and Colorado studies provide some of the first evidence in support of an opt-out approach. Eventually, it would be beneficial for multicenter studies and longitudinal research to track the effects of such programs over time, say Dr. Sofka and Ajay Major, MD, MBA, one of the study’s coauthors and a hematology/oncology fellow at the University of Chicago.
Whether a program goes with an opt-out approach or not, the systematic supports – protecting resident privacy, providing flexible scheduling, and more – are crucial.
As Dr. Tomescu notes, wellness shouldn’t be just something trainees have to do. “The key with really working on burnout at a huge level is for all programs and schools to recognize that it’s a shared responsibility.”
“I felt very fortunate that I was able to get some help throughout residency,” says Dr. Modi. “About how to be a better daughter. How to be content with things I have in life. How to be happy, and grateful. With the kind of job we have, I think we sometimes forget to be grateful.”
A version of this article first appeared on Medscape.com.
Sarah Sofka, MD, FACP, noticed a pattern. As program director for the internal medicine (IM) residency at West Virginia University, Morgantown, she was informed when residents were sent to counseling because they were affected by burnout, depression, or anxiety. When trainees returned from these visits, many told her the same thing: They wished they had sought help sooner.
IM residents and their families had access to free counseling at WVU, but few used the resource, says Dr. Sofka. “So, we thought, let’s just schedule all of our residents for a therapy visit so they can go and see what it’s like,” she said. “This will hopefully decrease the stigma for seeking mental health care. If everybody’s going, it’s not a big deal.”
In July 2015, Dr. Sofka and her colleagues launched a universal well-being assessment program for the IM residents at WVU. The program leaders automatically scheduled first- and second-year residents for a visit to the faculty staff assistance program counselors. The visits were not mandatory, and residents could choose not to go; but if they did go, they received the entire day of their visit off from work.
Five and a half years after launching their program, Dr. Sofka and her colleagues conducted one of the first studies of the efficacy of an opt-out approach for resident mental wellness. They found that , suggesting that residents were seeking help proactively after having to at least consider it.
Opt-out counseling is a recent concept in residency programs – one that’s attracting interest from training programs across the country. Brown University, Providence, R.I.; the University of Colorado at Denver, Aurora; University of Pennsylvania, Philadelphia; and the University of California, San Francisco have at least one residency program that uses the approach.
Lisa Meeks, PhD, an assistant professor of family medicine at Michigan Medicine, in Ann Arbor, and other experts also believe opt-out counseling could decrease stigma and help normalize seeking care for mental health problems in the medical community while lowering the barriers for trainees who need help.
No time, no access, plenty of stigma
Burnout and mental health are known to be major concerns for health care workers, especially trainees. College graduates starting medical education have lower rates of burnout and depression, compared with demographically matched peers; however, once they’ve started training, medical students, residents, and fellows are more likely to be burned out and exhibit symptoms of depression. The ongoing COVID-19 pandemic is further fraying the well-being of overworked and traumatized health care professionals, and experts predict a mental health crisis will follow the viral crisis.
The Accreditation Council for Graduate Medical Education recently mandated that programs offer wellness services to trainees. Yet this doesn’t mean they are always used; well-known barriers stand between residents, medical students, and physicians and their receiving effective mental health treatment.
Two of the most obvious are access and time, given the grueling and often inflexible schedules of most trainees, says Jessica Gold, MD, a psychiatrist at Washington University, St. Louis, who specializes in treating medical professionals. Dr. Gold also points out that, to be done correctly, these programs require institutional support and investment – resources that aren’t always adequate.
“A lack of transparency and clear messaging around what is available, who provides the services, and how to access these services can be a major barrier,” says Erene Stergiopoulos, MD, a second-year psychiatry resident at the University of Toronto. In addition, there can be considerable lag between when a resident realizes they need help and when they manage to find a provider and schedule an appointment, says Dr. Meeks.
Even when these logistical barriers are overcome, trainees and physicians have to contend with the persistent stigma associated with mental health treatment in the culture of medicine, says Dr. Gold. A recent survey by the American College of Emergency Physicians found that 73% of surveyed physicians feel there is stigma in their workplace about seeking mental health treatment. Many state medical licensing boards still require physicians to disclose mental health treatment, which discourages many trainees and providers from seeking proactive care, says Mary Moffit, PhD, associate professor of psychiatry and director of the resident and faculty wellness program at Oregon Health & Science University, Portland.
How the opt-out approach works
“The idea is by making it opt-out, you really normalize it,” says Maneesh Batra, MD, MPH, associate director of the University of Washington, Seattle, Children’s Hospital residency program. Similar approaches have proven effective at shaping human behavior in other health care settings, including boosting testing rates for HIV and increasing immunization rates for childhood vaccines, Dr. Batra says.
In general, opt-out programs acknowledge that people are busy and won’t take that extra step or click that extra button if they don’t have to, says Oana Tomescu, MD, PhD, associate professor of clinical medicine and pediatrics at the University of Pennsylvania, Philadelphia.
In 2018, Dr. Sofka and her colleagues at WVU conducted a survey that showed that a majority of residents thought favorably of their opt-out program and said they would return to counseling for follow-up care. In their most recent study, published in the Journal of Graduate Medical Education in 2021, Dr. Sofka and her colleagues found that residents did just that – only 8 of 239 opted out of universally scheduled visits. Resident-initiated visits increased significantly from zero during the 2014-2015 academic year to 23 in 2018-2019. Between those periods, program-mandated visits decreased significantly from 12 to 3.
The initiative has succeeded in creating a culture of openness and caring at WVU, says 2nd-year internal medicine resident Nistha Modi, MD. “It sets the tone for the program – we talk about mental health openly,” says Dr. Modi.
Crucially, the counselors work out of a different building than the hospital where Dr. Modi and her fellow residents work and use a separate electronic medical record system to protect resident privacy. This is hugely important for medical trainees, note Dr. Tomescu, Dr. Gold, and many other experts. The therapists understand residency and medical education, and there is no limit to the number of visits a resident or fellow can make with the program counselors, says Dr. Modi.
Opt-out programs offer a counterbalance to many negative tendencies in residency, says Dr. Meeks. “We’ve normalized so many things that are not healthy and productive. ... We need to counterbalance that with normalizing help seeking. And it’s really difficult to normalize something that’s not part of a system.”
Costs, concerns, and systematic support
Providing unlimited, free counseling for trainees can be very beneficial, but it requires adequate funding and personnel resources. Offering unlimited access means that an institution has to follow through in making this degree of care available while also ensuring that the system doesn’t get overwhelmed or is unable to accommodate very sick individuals, says Dr. Gold.
Another concern that experts like Dr. Batra, Dr. Moffit, and Dr. Gold share is that residents who go to their scheduled appointments may not completely buy into the experience because it wasn’t their idea in the first place. Participation alone doesn’t necessarily indicate full acceptance. Program personnel don’t intend for these appointments to be thought of as mandatory, yet residents may still experience them that way. Several leading resident well-being programs instead emphasize outreach to trainees, institutional support, and accessible mental health resources that are – and feel – entirely voluntary.
“If I tell someone that they have to do something, it’s very different than if they arrive at that conclusion for themselves,” says Dr. Batra. “That’s how life works.”
When it comes to cost, a recent study published in Academic Medicine provides encouraging data. At the University of Colorado, an opt-out pilot program for IM and pediatrics interns during the 2017-2018 academic year cost just $940 total, equal to $11.75 per intern. As in West Virginia, the program in Colorado covered the cost of the visit, interns were provided a half day off (whether they attended their appointment or not), and the visits and surveys were entirely optional and confidential. During the 1-year pilot program, 29% of 80 interns attended the scheduled appointment, 56% opted out in advance, and 15% didn’t show up. The majority of interns who were surveyed (85%), however, thought the program should continue and that it had a positive effect on their wellness even if they didn’t attend their appointment.
In West Virginia, program costs are higher. The program has $20,000 in annual funding to cover the opt-out program and unlimited counseling visits for residents and fellows. With that funding, Dr. Sofka and her colleagues were also able to expand the program slightly last year to schedule all the critical care faculty for counseling visits. Cost is a barrier to expanding these services to the entire institution, which Dr. Sofka says she hopes to do one day.
Research in this area is still preliminary. The WVU and Colorado studies provide some of the first evidence in support of an opt-out approach. Eventually, it would be beneficial for multicenter studies and longitudinal research to track the effects of such programs over time, say Dr. Sofka and Ajay Major, MD, MBA, one of the study’s coauthors and a hematology/oncology fellow at the University of Chicago.
Whether a program goes with an opt-out approach or not, the systematic supports – protecting resident privacy, providing flexible scheduling, and more – are crucial.
As Dr. Tomescu notes, wellness shouldn’t be just something trainees have to do. “The key with really working on burnout at a huge level is for all programs and schools to recognize that it’s a shared responsibility.”
“I felt very fortunate that I was able to get some help throughout residency,” says Dr. Modi. “About how to be a better daughter. How to be content with things I have in life. How to be happy, and grateful. With the kind of job we have, I think we sometimes forget to be grateful.”
A version of this article first appeared on Medscape.com.