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Children with increased suicide risk are falling through the cracks
Children in the welfare system who died by suicide were twice as likely to receive mental health services within the 6 months before their death, according to a recent study published in Pediatrics.
“Health care settings that provide more robust mental health screening and suicide risk assessment are needed for youth with child welfare system involvement,” study author Donna Ruch, PhD, a research scientist at the Nationwide Children’s Hospital, said in an interview.
Researchers noted that integrating suicide prevention strategies in primary care and providing access to effective health services for this vulnerable group could be beneficial.
At-risk kids are falling through the cracks
Suicide is the second leading cause of death in children, adolescents, and young adults between the ages of 15 and 24 years old. Children in the welfare system are four times more likely to have attempted suicide; however, research on suicide rates in this population is minimal.
“Kids in the child welfare system are so understudied and yet at such a high risk for suicide,” said Lisa Horowitz, PhD, clinical psychologist at the National Institutes of Health, who was not involved in the study. “A lot of kids pass through the health care system undetected.”
In an attempt to understand and prevent suicide in this group, Dr. Ruch and her team examined health service utilization patterns of children in the welfare system who committed suicide, compared with those in the system who did not die by suicide.
Researchers collected data on 120 deceased youth between the ages of 5 and 21 years old who had an open case in Ohio’s Statewide Automated Child Welfare Information System between 2010 and 2017. For the purpose of the study, open cases were defined as investigated child maltreatment where the family received services or the child was removed from the home.
Researchers matched each child who died by suicide with 10 controls – children in the welfare system who did not commit suicide – based on sex, race, and ethnicity.
The findings revealed that 59.2% of suicide decedents had a diagnosed mental health condition, compared with 31.3% of the control group. Researchers also found that the suicide decedent group was more likely to have multiple mental health diagnoses, with a quarter of them having at least three diagnosed conditions.
Children who died by suicide were also more likely to have a history of self-harm and to have been placed in foster or kinship care.
“Existing research also suggests that known risk factors for youth suicide are more common in youth involved with the child welfare system. This includes mental health conditions, developmental delays, problematic family-related issues, and trauma,” said Dr. Ruch. “All of these factors may be compounded for youth who are removed from their homes.”
Dr. Ruch said it is likely that children who are removed from their homes and placed in foster care may not have consistent access to necessary health services, such as therapy, which may place them at an increased risk for suicidal behavior.
Robust prevention strategies needed
Researchers also found that 90% of children who died by suicide had a health care visit within 6 months of their deaths, compared with 69.4% of controls; 48% of those visits occurred 1 month before they died.
The frequency of health care services used by suicide decedents suggests that prevention strategies for children in the welfare system should be embedded in routine medical and mental health care.
“If we as mental health counselors allow these kids to pass through the health care system, it’s really further neglect,” said Dr. Horowitz, who wrote an accompanying commentary. “And these children already deal with abuse and neglect – we don’t need to further neglect them.”
Dr. Horowitz said health care providers could go over coping strategies and discuss how children deal with hard times and make sure they have access to suicide prevention resources, such as the suicide hotline.
Additionally, better coordination with health care systems and the child welfare system is necessary to make sure there are follow-ups and screenings for suicide and other mental health conditions.
It’s not one size fits all: There may be tailored suicide prevention strategies that work better,” Dr. Horowitz explained.
Dr. Ruch and her team also believe suicide prevention strategies such as the Zero Suicide approach – an initiative that aims to embed suicide prevention health and behavioral health care systems – as well as interventions focused on family preservation to reduce the chance of a child being removed from their home could also benefit children in the welfare system.
Dr. Ruch, the other authors of the study, and Dr. Horowitz disclosed no relevant financial conflicts,
Children in the welfare system who died by suicide were twice as likely to receive mental health services within the 6 months before their death, according to a recent study published in Pediatrics.
“Health care settings that provide more robust mental health screening and suicide risk assessment are needed for youth with child welfare system involvement,” study author Donna Ruch, PhD, a research scientist at the Nationwide Children’s Hospital, said in an interview.
Researchers noted that integrating suicide prevention strategies in primary care and providing access to effective health services for this vulnerable group could be beneficial.
At-risk kids are falling through the cracks
Suicide is the second leading cause of death in children, adolescents, and young adults between the ages of 15 and 24 years old. Children in the welfare system are four times more likely to have attempted suicide; however, research on suicide rates in this population is minimal.
“Kids in the child welfare system are so understudied and yet at such a high risk for suicide,” said Lisa Horowitz, PhD, clinical psychologist at the National Institutes of Health, who was not involved in the study. “A lot of kids pass through the health care system undetected.”
In an attempt to understand and prevent suicide in this group, Dr. Ruch and her team examined health service utilization patterns of children in the welfare system who committed suicide, compared with those in the system who did not die by suicide.
Researchers collected data on 120 deceased youth between the ages of 5 and 21 years old who had an open case in Ohio’s Statewide Automated Child Welfare Information System between 2010 and 2017. For the purpose of the study, open cases were defined as investigated child maltreatment where the family received services or the child was removed from the home.
Researchers matched each child who died by suicide with 10 controls – children in the welfare system who did not commit suicide – based on sex, race, and ethnicity.
The findings revealed that 59.2% of suicide decedents had a diagnosed mental health condition, compared with 31.3% of the control group. Researchers also found that the suicide decedent group was more likely to have multiple mental health diagnoses, with a quarter of them having at least three diagnosed conditions.
Children who died by suicide were also more likely to have a history of self-harm and to have been placed in foster or kinship care.
“Existing research also suggests that known risk factors for youth suicide are more common in youth involved with the child welfare system. This includes mental health conditions, developmental delays, problematic family-related issues, and trauma,” said Dr. Ruch. “All of these factors may be compounded for youth who are removed from their homes.”
Dr. Ruch said it is likely that children who are removed from their homes and placed in foster care may not have consistent access to necessary health services, such as therapy, which may place them at an increased risk for suicidal behavior.
Robust prevention strategies needed
Researchers also found that 90% of children who died by suicide had a health care visit within 6 months of their deaths, compared with 69.4% of controls; 48% of those visits occurred 1 month before they died.
The frequency of health care services used by suicide decedents suggests that prevention strategies for children in the welfare system should be embedded in routine medical and mental health care.
“If we as mental health counselors allow these kids to pass through the health care system, it’s really further neglect,” said Dr. Horowitz, who wrote an accompanying commentary. “And these children already deal with abuse and neglect – we don’t need to further neglect them.”
Dr. Horowitz said health care providers could go over coping strategies and discuss how children deal with hard times and make sure they have access to suicide prevention resources, such as the suicide hotline.
Additionally, better coordination with health care systems and the child welfare system is necessary to make sure there are follow-ups and screenings for suicide and other mental health conditions.
It’s not one size fits all: There may be tailored suicide prevention strategies that work better,” Dr. Horowitz explained.
Dr. Ruch and her team also believe suicide prevention strategies such as the Zero Suicide approach – an initiative that aims to embed suicide prevention health and behavioral health care systems – as well as interventions focused on family preservation to reduce the chance of a child being removed from their home could also benefit children in the welfare system.
Dr. Ruch, the other authors of the study, and Dr. Horowitz disclosed no relevant financial conflicts,
Children in the welfare system who died by suicide were twice as likely to receive mental health services within the 6 months before their death, according to a recent study published in Pediatrics.
“Health care settings that provide more robust mental health screening and suicide risk assessment are needed for youth with child welfare system involvement,” study author Donna Ruch, PhD, a research scientist at the Nationwide Children’s Hospital, said in an interview.
Researchers noted that integrating suicide prevention strategies in primary care and providing access to effective health services for this vulnerable group could be beneficial.
At-risk kids are falling through the cracks
Suicide is the second leading cause of death in children, adolescents, and young adults between the ages of 15 and 24 years old. Children in the welfare system are four times more likely to have attempted suicide; however, research on suicide rates in this population is minimal.
“Kids in the child welfare system are so understudied and yet at such a high risk for suicide,” said Lisa Horowitz, PhD, clinical psychologist at the National Institutes of Health, who was not involved in the study. “A lot of kids pass through the health care system undetected.”
In an attempt to understand and prevent suicide in this group, Dr. Ruch and her team examined health service utilization patterns of children in the welfare system who committed suicide, compared with those in the system who did not die by suicide.
Researchers collected data on 120 deceased youth between the ages of 5 and 21 years old who had an open case in Ohio’s Statewide Automated Child Welfare Information System between 2010 and 2017. For the purpose of the study, open cases were defined as investigated child maltreatment where the family received services or the child was removed from the home.
Researchers matched each child who died by suicide with 10 controls – children in the welfare system who did not commit suicide – based on sex, race, and ethnicity.
The findings revealed that 59.2% of suicide decedents had a diagnosed mental health condition, compared with 31.3% of the control group. Researchers also found that the suicide decedent group was more likely to have multiple mental health diagnoses, with a quarter of them having at least three diagnosed conditions.
Children who died by suicide were also more likely to have a history of self-harm and to have been placed in foster or kinship care.
“Existing research also suggests that known risk factors for youth suicide are more common in youth involved with the child welfare system. This includes mental health conditions, developmental delays, problematic family-related issues, and trauma,” said Dr. Ruch. “All of these factors may be compounded for youth who are removed from their homes.”
Dr. Ruch said it is likely that children who are removed from their homes and placed in foster care may not have consistent access to necessary health services, such as therapy, which may place them at an increased risk for suicidal behavior.
Robust prevention strategies needed
Researchers also found that 90% of children who died by suicide had a health care visit within 6 months of their deaths, compared with 69.4% of controls; 48% of those visits occurred 1 month before they died.
The frequency of health care services used by suicide decedents suggests that prevention strategies for children in the welfare system should be embedded in routine medical and mental health care.
“If we as mental health counselors allow these kids to pass through the health care system, it’s really further neglect,” said Dr. Horowitz, who wrote an accompanying commentary. “And these children already deal with abuse and neglect – we don’t need to further neglect them.”
Dr. Horowitz said health care providers could go over coping strategies and discuss how children deal with hard times and make sure they have access to suicide prevention resources, such as the suicide hotline.
Additionally, better coordination with health care systems and the child welfare system is necessary to make sure there are follow-ups and screenings for suicide and other mental health conditions.
It’s not one size fits all: There may be tailored suicide prevention strategies that work better,” Dr. Horowitz explained.
Dr. Ruch and her team also believe suicide prevention strategies such as the Zero Suicide approach – an initiative that aims to embed suicide prevention health and behavioral health care systems – as well as interventions focused on family preservation to reduce the chance of a child being removed from their home could also benefit children in the welfare system.
Dr. Ruch, the other authors of the study, and Dr. Horowitz disclosed no relevant financial conflicts,
Addressing mental health for transgender patients during the pandemic
Obstetrician/gynecologists are often first-line providers in addressing mental health concerns for our patients. Routine screening for intimate partner violence, obtaining a history of sexual assault, and assessing patients for postpartum depression are among the many tools that we use to ascertain the psychological well-being of cisgender women. As transgender patients continue to seek care from ob.gyns., it is vital that we not only screen transgender patients for depression and intimate partner violence, but also assess factors relating to social support.
Mental health disorders disproportionately affect the transgender population. A large online survey showed that 41% of transgender patients had experienced suicidality, with rates among transgender youth even higher.1 While the rates of sexual violence are higher among LGBTQ patients compared with cisgender counterparts, the rate of sexual assault is as high as 47% in the transgender population.2,3 Additional surveys and studies have demonstrated that more than 70% of transgender individuals report discrimination in school (K-12), 27% have lost their jobs because of their gender identity; and 30% have experienced homelessness at some point.3 Tragically, these rates are further affected by race and ethnicity with American Indian (65%), multiracial (59%), Middle Eastern (58%), and Black (53%) respondents in the survey stating they were assaulted at some point.3
In a prepandemic world, mental health for transgender patients was influenced by several factors, such as stigmatization, health care disparities, limited access to health care, prolonged exposure to discrimination, lack of a supportive environment, and history of trauma or violence. During the pandemic, these factors have been magnified. Furthermore, many of the supportive services such as group meetings at LGBTQ centers, networking events/conferences, LGBTQ pride events, and social gatherings at bars or restaurants have been postponed, reduced to accommodate social distancing measures, or moved to virtual platforms.
While the pandemic has led to increased unemployment rates, concerns over housing and rent payments, and limiting one’s social circle in the general population, these rates are increased among LGBTQ adults. Data are limited on how significantly the pandemic has affected LGBTQ adults, but an analysis conducted by the Kaiser Family Foundation found that 56% of LGBTQ adults reported that they or someone they know lost a job, compared with 44% of non-LGBTQ adults.4 In addition, 75% of LGBTQ adults report that the pandemic has negatively affected their mental health, compared with 49% of the non-LGBTQ population.4 To my dismay, I’ve seen these statistics reflected in my own patient population.
Given this knowledge, it is even more crucial that obstetrician/gynecologists screen for depression, substance use, and intimate partner violence, in addition to assessing the patient’s social determinants for overall well-being. These often include determining a patient’s living situation, employment status, familial support, and social support. In my practice, if concerns are raised in any of these areas, we have a streamlined referral system connecting patients to a variety of therapists, psychologists, and/or social workers, with close follow-up on either a weekly or monthly basis depending on the particular issue the patient is facing. While many patients may be hesitant to go to in-office appointments or where transportation poses a barrier, telemedicine visits are useful adjuncts to assess patient’s overall well-being.
While the pandemic has been extraordinarily difficult for us all, it is important for us to be even stronger advocates for communities that have experienced further challenges as a result of this global tragedy.
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.
References
1. Karasic D. Mental health care for the adult transgender patient. In: Ferrando CA, ed. Comprehensive Care of the Transgender Patient. Philadelphia, PA: Elsevier; 2020:8-11.
2. Black MC et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011.
3. James SE et al. The Report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality; 2016.
4. Dawson L et al. The impact of the COVID-19 pandemic on LGBT people. KFF COVID-19 Vaccine Monitor. Kaiser Family Foundation. March 11, 2021.
Obstetrician/gynecologists are often first-line providers in addressing mental health concerns for our patients. Routine screening for intimate partner violence, obtaining a history of sexual assault, and assessing patients for postpartum depression are among the many tools that we use to ascertain the psychological well-being of cisgender women. As transgender patients continue to seek care from ob.gyns., it is vital that we not only screen transgender patients for depression and intimate partner violence, but also assess factors relating to social support.
Mental health disorders disproportionately affect the transgender population. A large online survey showed that 41% of transgender patients had experienced suicidality, with rates among transgender youth even higher.1 While the rates of sexual violence are higher among LGBTQ patients compared with cisgender counterparts, the rate of sexual assault is as high as 47% in the transgender population.2,3 Additional surveys and studies have demonstrated that more than 70% of transgender individuals report discrimination in school (K-12), 27% have lost their jobs because of their gender identity; and 30% have experienced homelessness at some point.3 Tragically, these rates are further affected by race and ethnicity with American Indian (65%), multiracial (59%), Middle Eastern (58%), and Black (53%) respondents in the survey stating they were assaulted at some point.3
In a prepandemic world, mental health for transgender patients was influenced by several factors, such as stigmatization, health care disparities, limited access to health care, prolonged exposure to discrimination, lack of a supportive environment, and history of trauma or violence. During the pandemic, these factors have been magnified. Furthermore, many of the supportive services such as group meetings at LGBTQ centers, networking events/conferences, LGBTQ pride events, and social gatherings at bars or restaurants have been postponed, reduced to accommodate social distancing measures, or moved to virtual platforms.
While the pandemic has led to increased unemployment rates, concerns over housing and rent payments, and limiting one’s social circle in the general population, these rates are increased among LGBTQ adults. Data are limited on how significantly the pandemic has affected LGBTQ adults, but an analysis conducted by the Kaiser Family Foundation found that 56% of LGBTQ adults reported that they or someone they know lost a job, compared with 44% of non-LGBTQ adults.4 In addition, 75% of LGBTQ adults report that the pandemic has negatively affected their mental health, compared with 49% of the non-LGBTQ population.4 To my dismay, I’ve seen these statistics reflected in my own patient population.
Given this knowledge, it is even more crucial that obstetrician/gynecologists screen for depression, substance use, and intimate partner violence, in addition to assessing the patient’s social determinants for overall well-being. These often include determining a patient’s living situation, employment status, familial support, and social support. In my practice, if concerns are raised in any of these areas, we have a streamlined referral system connecting patients to a variety of therapists, psychologists, and/or social workers, with close follow-up on either a weekly or monthly basis depending on the particular issue the patient is facing. While many patients may be hesitant to go to in-office appointments or where transportation poses a barrier, telemedicine visits are useful adjuncts to assess patient’s overall well-being.
While the pandemic has been extraordinarily difficult for us all, it is important for us to be even stronger advocates for communities that have experienced further challenges as a result of this global tragedy.
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.
References
1. Karasic D. Mental health care for the adult transgender patient. In: Ferrando CA, ed. Comprehensive Care of the Transgender Patient. Philadelphia, PA: Elsevier; 2020:8-11.
2. Black MC et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011.
3. James SE et al. The Report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality; 2016.
4. Dawson L et al. The impact of the COVID-19 pandemic on LGBT people. KFF COVID-19 Vaccine Monitor. Kaiser Family Foundation. March 11, 2021.
Obstetrician/gynecologists are often first-line providers in addressing mental health concerns for our patients. Routine screening for intimate partner violence, obtaining a history of sexual assault, and assessing patients for postpartum depression are among the many tools that we use to ascertain the psychological well-being of cisgender women. As transgender patients continue to seek care from ob.gyns., it is vital that we not only screen transgender patients for depression and intimate partner violence, but also assess factors relating to social support.
Mental health disorders disproportionately affect the transgender population. A large online survey showed that 41% of transgender patients had experienced suicidality, with rates among transgender youth even higher.1 While the rates of sexual violence are higher among LGBTQ patients compared with cisgender counterparts, the rate of sexual assault is as high as 47% in the transgender population.2,3 Additional surveys and studies have demonstrated that more than 70% of transgender individuals report discrimination in school (K-12), 27% have lost their jobs because of their gender identity; and 30% have experienced homelessness at some point.3 Tragically, these rates are further affected by race and ethnicity with American Indian (65%), multiracial (59%), Middle Eastern (58%), and Black (53%) respondents in the survey stating they were assaulted at some point.3
In a prepandemic world, mental health for transgender patients was influenced by several factors, such as stigmatization, health care disparities, limited access to health care, prolonged exposure to discrimination, lack of a supportive environment, and history of trauma or violence. During the pandemic, these factors have been magnified. Furthermore, many of the supportive services such as group meetings at LGBTQ centers, networking events/conferences, LGBTQ pride events, and social gatherings at bars or restaurants have been postponed, reduced to accommodate social distancing measures, or moved to virtual platforms.
While the pandemic has led to increased unemployment rates, concerns over housing and rent payments, and limiting one’s social circle in the general population, these rates are increased among LGBTQ adults. Data are limited on how significantly the pandemic has affected LGBTQ adults, but an analysis conducted by the Kaiser Family Foundation found that 56% of LGBTQ adults reported that they or someone they know lost a job, compared with 44% of non-LGBTQ adults.4 In addition, 75% of LGBTQ adults report that the pandemic has negatively affected their mental health, compared with 49% of the non-LGBTQ population.4 To my dismay, I’ve seen these statistics reflected in my own patient population.
Given this knowledge, it is even more crucial that obstetrician/gynecologists screen for depression, substance use, and intimate partner violence, in addition to assessing the patient’s social determinants for overall well-being. These often include determining a patient’s living situation, employment status, familial support, and social support. In my practice, if concerns are raised in any of these areas, we have a streamlined referral system connecting patients to a variety of therapists, psychologists, and/or social workers, with close follow-up on either a weekly or monthly basis depending on the particular issue the patient is facing. While many patients may be hesitant to go to in-office appointments or where transportation poses a barrier, telemedicine visits are useful adjuncts to assess patient’s overall well-being.
While the pandemic has been extraordinarily difficult for us all, it is important for us to be even stronger advocates for communities that have experienced further challenges as a result of this global tragedy.
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.
References
1. Karasic D. Mental health care for the adult transgender patient. In: Ferrando CA, ed. Comprehensive Care of the Transgender Patient. Philadelphia, PA: Elsevier; 2020:8-11.
2. Black MC et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011.
3. James SE et al. The Report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality; 2016.
4. Dawson L et al. The impact of the COVID-19 pandemic on LGBT people. KFF COVID-19 Vaccine Monitor. Kaiser Family Foundation. March 11, 2021.
Let’s not criticize off-label prescribing
The public health crisis sparked by COVID-19 has engendered much debate in the realm where politics, journalism, law, and medicine meet.
Doctors have used the media to name other doctors as sources of harmful misinformation, in some cases going so far as to invoke medical practice board oversight as a potential intervention when doctors make public statements deemed too far out of bounds scientifically. Over the past year, some physicians have been harshly criticized for speaking about off-label prescribing, a widely accepted part of everyday medical practice.
The science and ethics of off-label prescribing have not changed; what has changed is the quality of dialogue around it. As psychiatrists, it does not fall within our scope of practice to offer definitive public opinions on the treatment of COVID-19, nor is that our purpose here. However, we can speak to a process that damages patients and doctors alike by undermining trust. All of this heat around bad medical information, in our opinion, amounts to using the methods of other fields to evaluate science and clinical practice. A remedy, then, to improve the quality of public medical intelligence would be to clarify the rules of scientific debate and to once again clearly state that off-label prescribing is part and parcel of the good practice of clinical medicine.
Physicians who work in the field of professional discipline have thought about the limits of propriety in making charges of impropriety. We (R.S.E. and R.S.K.) asked the American Psychiatric Association’s Ethics Committee to expand upon its existing commentary on innovative practice and making allegations of professional misconduct. We used the committee’s answers to our questions as the basis for the arguments we are making in this piece.
The APA’s Ethics Committee uses clear-cut benchmarks to define innovative medical care: “The standards of care ... evolve with evidence from research and observations of practice. Among the expected supports for innovative practice are scientific testing, peer-reviewed publication, replication, and broad or widespread acceptance within a relevant scientific or professional community.” When it comes to off-label prescribing for any medical condition, it is easy enough to ascertain whether clinical reports have appeared in peer-reviewed journals.
Two of the biggest blockbusters in psychiatry, chlorpromazine and lithium, began as drugs used for other conditions almost since the inception of our field. In other words, the use of these drugs for mental illness began, in today’s jargon, as off-label. We practitioners of psychiatry live in the land of off-label prescribing and have always comfortably done so. In fact, almost all of medicine does. The key in today’s world of best-practice medicine is obtaining a truly informed consent.
For COVID-19, our incredible psychotropic molecules may once again be doing some trail-blazing off-label work. Late last year, Eric J. Lenze, MD, professor of psychiatry and director of the Healthy Mind Lab at Washington University in St. Louis, reported in a preliminary study of adult outpatients with symptomatic COVID-19 that those treated with fluvoxamine “had a lower likelihood of clinical deterioration over 15 days,” compared with those on placebo (JAMA. 2020;324[22]:2292-300). We were heartened to see Dr. Lenze discuss his work on a recent “60 Minutes” segment. David Seftel, MD, MBA, a clinician who administered fluvoxamine as early treatment for a COVID-19 outbreak that occurred in a community of racetrack employees and their families in the San Francisco Bay Area, also was featured. Rather than waiting for the results of large clinical trials, Dr. Lenze and Dr. Seftel proceeded, based on reports published in peer-reviewed journals, to treat patients whose lives were at risk.
If we find ourselves strongly disagreeing about the science of off-label prescribing, the proper response is to critique methodologies, not the character or competence of colleagues. The APA Ethics Committee discourages use of the media as a forum for making allegations of incompetent or unethical practice: “Judgments regarding violations of established norms of ethical or professional conduct should be made not by individuals but by bodies authorized to take evidence and make informed decisions.”
At least one state legislature is taking action to protect patients’ access to the doctors they trust. In Arizona, SB 1416 passed in the Senate and is now working its way through the House. This bill would prohibit medical boards from disciplining doctors for speaking out about or prescribing off-label drugs when a reasonable basis for use exists.
Psychological research on the “backfire effect” suggests that heavy-handed campaigns to enforce medical consensus will only harden minds in ways that neither advance science nor improve the quality of clinical decision-making.
Medical disciplinary boards and the news media were neither designed nor are they equipped to adjudicate scientific debates. Science is never settled: Hypothesis and theory are always open to testing and revision as new evidence emerges. There is a place in medicine for formal disciplinary processes, as well-delineated by professional bodies such as the APA Ethics Committee. Another important part of protecting the public is to support an environment of scientific inquiry in which diversity of opinion is welcomed. As physicians, we translate science into excellent clinical care every day in our practices, and we advance science by sharing what we learn through friendly collegial communication and collaboration.
Dr. Emmons is part-time clinical associate professor in the department of psychiatry at the University of Vermont, Burlington, and is a past chair of the Ethics Committee for the Vermont District Branch of the American Psychiatric Association. He is in private practice in Moretown, Vt., and disclosed no relevant financial relationships. Dr. Kohanski is in private practice in Dayton, N.J., and is a diplomate of the American Board of Psychiatry & Neurology. She also is the host and author of Clinical Correlation, a series of the Psychcast. Dr. Kohanski disclosed no relevant financial relationships.
The public health crisis sparked by COVID-19 has engendered much debate in the realm where politics, journalism, law, and medicine meet.
Doctors have used the media to name other doctors as sources of harmful misinformation, in some cases going so far as to invoke medical practice board oversight as a potential intervention when doctors make public statements deemed too far out of bounds scientifically. Over the past year, some physicians have been harshly criticized for speaking about off-label prescribing, a widely accepted part of everyday medical practice.
The science and ethics of off-label prescribing have not changed; what has changed is the quality of dialogue around it. As psychiatrists, it does not fall within our scope of practice to offer definitive public opinions on the treatment of COVID-19, nor is that our purpose here. However, we can speak to a process that damages patients and doctors alike by undermining trust. All of this heat around bad medical information, in our opinion, amounts to using the methods of other fields to evaluate science and clinical practice. A remedy, then, to improve the quality of public medical intelligence would be to clarify the rules of scientific debate and to once again clearly state that off-label prescribing is part and parcel of the good practice of clinical medicine.
Physicians who work in the field of professional discipline have thought about the limits of propriety in making charges of impropriety. We (R.S.E. and R.S.K.) asked the American Psychiatric Association’s Ethics Committee to expand upon its existing commentary on innovative practice and making allegations of professional misconduct. We used the committee’s answers to our questions as the basis for the arguments we are making in this piece.
The APA’s Ethics Committee uses clear-cut benchmarks to define innovative medical care: “The standards of care ... evolve with evidence from research and observations of practice. Among the expected supports for innovative practice are scientific testing, peer-reviewed publication, replication, and broad or widespread acceptance within a relevant scientific or professional community.” When it comes to off-label prescribing for any medical condition, it is easy enough to ascertain whether clinical reports have appeared in peer-reviewed journals.
Two of the biggest blockbusters in psychiatry, chlorpromazine and lithium, began as drugs used for other conditions almost since the inception of our field. In other words, the use of these drugs for mental illness began, in today’s jargon, as off-label. We practitioners of psychiatry live in the land of off-label prescribing and have always comfortably done so. In fact, almost all of medicine does. The key in today’s world of best-practice medicine is obtaining a truly informed consent.
For COVID-19, our incredible psychotropic molecules may once again be doing some trail-blazing off-label work. Late last year, Eric J. Lenze, MD, professor of psychiatry and director of the Healthy Mind Lab at Washington University in St. Louis, reported in a preliminary study of adult outpatients with symptomatic COVID-19 that those treated with fluvoxamine “had a lower likelihood of clinical deterioration over 15 days,” compared with those on placebo (JAMA. 2020;324[22]:2292-300). We were heartened to see Dr. Lenze discuss his work on a recent “60 Minutes” segment. David Seftel, MD, MBA, a clinician who administered fluvoxamine as early treatment for a COVID-19 outbreak that occurred in a community of racetrack employees and their families in the San Francisco Bay Area, also was featured. Rather than waiting for the results of large clinical trials, Dr. Lenze and Dr. Seftel proceeded, based on reports published in peer-reviewed journals, to treat patients whose lives were at risk.
If we find ourselves strongly disagreeing about the science of off-label prescribing, the proper response is to critique methodologies, not the character or competence of colleagues. The APA Ethics Committee discourages use of the media as a forum for making allegations of incompetent or unethical practice: “Judgments regarding violations of established norms of ethical or professional conduct should be made not by individuals but by bodies authorized to take evidence and make informed decisions.”
At least one state legislature is taking action to protect patients’ access to the doctors they trust. In Arizona, SB 1416 passed in the Senate and is now working its way through the House. This bill would prohibit medical boards from disciplining doctors for speaking out about or prescribing off-label drugs when a reasonable basis for use exists.
Psychological research on the “backfire effect” suggests that heavy-handed campaigns to enforce medical consensus will only harden minds in ways that neither advance science nor improve the quality of clinical decision-making.
Medical disciplinary boards and the news media were neither designed nor are they equipped to adjudicate scientific debates. Science is never settled: Hypothesis and theory are always open to testing and revision as new evidence emerges. There is a place in medicine for formal disciplinary processes, as well-delineated by professional bodies such as the APA Ethics Committee. Another important part of protecting the public is to support an environment of scientific inquiry in which diversity of opinion is welcomed. As physicians, we translate science into excellent clinical care every day in our practices, and we advance science by sharing what we learn through friendly collegial communication and collaboration.
Dr. Emmons is part-time clinical associate professor in the department of psychiatry at the University of Vermont, Burlington, and is a past chair of the Ethics Committee for the Vermont District Branch of the American Psychiatric Association. He is in private practice in Moretown, Vt., and disclosed no relevant financial relationships. Dr. Kohanski is in private practice in Dayton, N.J., and is a diplomate of the American Board of Psychiatry & Neurology. She also is the host and author of Clinical Correlation, a series of the Psychcast. Dr. Kohanski disclosed no relevant financial relationships.
The public health crisis sparked by COVID-19 has engendered much debate in the realm where politics, journalism, law, and medicine meet.
Doctors have used the media to name other doctors as sources of harmful misinformation, in some cases going so far as to invoke medical practice board oversight as a potential intervention when doctors make public statements deemed too far out of bounds scientifically. Over the past year, some physicians have been harshly criticized for speaking about off-label prescribing, a widely accepted part of everyday medical practice.
The science and ethics of off-label prescribing have not changed; what has changed is the quality of dialogue around it. As psychiatrists, it does not fall within our scope of practice to offer definitive public opinions on the treatment of COVID-19, nor is that our purpose here. However, we can speak to a process that damages patients and doctors alike by undermining trust. All of this heat around bad medical information, in our opinion, amounts to using the methods of other fields to evaluate science and clinical practice. A remedy, then, to improve the quality of public medical intelligence would be to clarify the rules of scientific debate and to once again clearly state that off-label prescribing is part and parcel of the good practice of clinical medicine.
Physicians who work in the field of professional discipline have thought about the limits of propriety in making charges of impropriety. We (R.S.E. and R.S.K.) asked the American Psychiatric Association’s Ethics Committee to expand upon its existing commentary on innovative practice and making allegations of professional misconduct. We used the committee’s answers to our questions as the basis for the arguments we are making in this piece.
The APA’s Ethics Committee uses clear-cut benchmarks to define innovative medical care: “The standards of care ... evolve with evidence from research and observations of practice. Among the expected supports for innovative practice are scientific testing, peer-reviewed publication, replication, and broad or widespread acceptance within a relevant scientific or professional community.” When it comes to off-label prescribing for any medical condition, it is easy enough to ascertain whether clinical reports have appeared in peer-reviewed journals.
Two of the biggest blockbusters in psychiatry, chlorpromazine and lithium, began as drugs used for other conditions almost since the inception of our field. In other words, the use of these drugs for mental illness began, in today’s jargon, as off-label. We practitioners of psychiatry live in the land of off-label prescribing and have always comfortably done so. In fact, almost all of medicine does. The key in today’s world of best-practice medicine is obtaining a truly informed consent.
For COVID-19, our incredible psychotropic molecules may once again be doing some trail-blazing off-label work. Late last year, Eric J. Lenze, MD, professor of psychiatry and director of the Healthy Mind Lab at Washington University in St. Louis, reported in a preliminary study of adult outpatients with symptomatic COVID-19 that those treated with fluvoxamine “had a lower likelihood of clinical deterioration over 15 days,” compared with those on placebo (JAMA. 2020;324[22]:2292-300). We were heartened to see Dr. Lenze discuss his work on a recent “60 Minutes” segment. David Seftel, MD, MBA, a clinician who administered fluvoxamine as early treatment for a COVID-19 outbreak that occurred in a community of racetrack employees and their families in the San Francisco Bay Area, also was featured. Rather than waiting for the results of large clinical trials, Dr. Lenze and Dr. Seftel proceeded, based on reports published in peer-reviewed journals, to treat patients whose lives were at risk.
If we find ourselves strongly disagreeing about the science of off-label prescribing, the proper response is to critique methodologies, not the character or competence of colleagues. The APA Ethics Committee discourages use of the media as a forum for making allegations of incompetent or unethical practice: “Judgments regarding violations of established norms of ethical or professional conduct should be made not by individuals but by bodies authorized to take evidence and make informed decisions.”
At least one state legislature is taking action to protect patients’ access to the doctors they trust. In Arizona, SB 1416 passed in the Senate and is now working its way through the House. This bill would prohibit medical boards from disciplining doctors for speaking out about or prescribing off-label drugs when a reasonable basis for use exists.
Psychological research on the “backfire effect” suggests that heavy-handed campaigns to enforce medical consensus will only harden minds in ways that neither advance science nor improve the quality of clinical decision-making.
Medical disciplinary boards and the news media were neither designed nor are they equipped to adjudicate scientific debates. Science is never settled: Hypothesis and theory are always open to testing and revision as new evidence emerges. There is a place in medicine for formal disciplinary processes, as well-delineated by professional bodies such as the APA Ethics Committee. Another important part of protecting the public is to support an environment of scientific inquiry in which diversity of opinion is welcomed. As physicians, we translate science into excellent clinical care every day in our practices, and we advance science by sharing what we learn through friendly collegial communication and collaboration.
Dr. Emmons is part-time clinical associate professor in the department of psychiatry at the University of Vermont, Burlington, and is a past chair of the Ethics Committee for the Vermont District Branch of the American Psychiatric Association. He is in private practice in Moretown, Vt., and disclosed no relevant financial relationships. Dr. Kohanski is in private practice in Dayton, N.J., and is a diplomate of the American Board of Psychiatry & Neurology. She also is the host and author of Clinical Correlation, a series of the Psychcast. Dr. Kohanski disclosed no relevant financial relationships.
Fauci worries about possible post–COVID-19 ‘mental health pandemic’
Anthony Fauci, MD, says he’s concerned about how Americans will react once the coronavirus pandemic is brought under control, CBS News reports.
Noting that an American Psychological Association survey showed people reporting high stress levels because of the pandemic, CBS’s Norah O’Donnell asked if Dr. Fauci was concerned about a possible “mental health pandemic.”
“Very much so,” Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases and a top White House coronavirus adviser, replied.
“That’s the reason why I want to get the virological aspect of this pandemic behind us as quickly as we possibly can because the long-term ravages of this are so multifaceted,” Dr. Fauci said.
, he said.
“And then the other things: Not only the mental health effects, but many people have put off routine types of medical examinations that they normally would have done,” Dr. Fauci said.
“I hope we don’t see an increase in some preventable situations that would not have happened if people had the normal access to medical care, which clearly was interrupted by the shutdown associated with COVID-19,” he added.
The American Psychological Association released the survey results March 11 in what many people consider the 1-year anniversary of the start of the coronavirus pandemic.
“The prolonged stress experienced by adults, especially the high levels of stress reported by Americans directly linked to the pandemic, is seriously affecting mental and physical health, including changes to weight, sleep and alcohol use,” the APA said in a news release.
Some of the key findings of the survey include:
- 61% of respondents reported experiencing undesired weight changes since the start of the pandemic.
- 67% said their sleep habits changed, with 35% saying they slept more and 31% less.
- 23% reported drinking more alcohol to cope with stress.
- 47% said they delayed or canceled health care services because of the pandemic.
- 48% said their stress levels had increased.
A version of this article first appeared on Medscape.com.
Anthony Fauci, MD, says he’s concerned about how Americans will react once the coronavirus pandemic is brought under control, CBS News reports.
Noting that an American Psychological Association survey showed people reporting high stress levels because of the pandemic, CBS’s Norah O’Donnell asked if Dr. Fauci was concerned about a possible “mental health pandemic.”
“Very much so,” Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases and a top White House coronavirus adviser, replied.
“That’s the reason why I want to get the virological aspect of this pandemic behind us as quickly as we possibly can because the long-term ravages of this are so multifaceted,” Dr. Fauci said.
, he said.
“And then the other things: Not only the mental health effects, but many people have put off routine types of medical examinations that they normally would have done,” Dr. Fauci said.
“I hope we don’t see an increase in some preventable situations that would not have happened if people had the normal access to medical care, which clearly was interrupted by the shutdown associated with COVID-19,” he added.
The American Psychological Association released the survey results March 11 in what many people consider the 1-year anniversary of the start of the coronavirus pandemic.
“The prolonged stress experienced by adults, especially the high levels of stress reported by Americans directly linked to the pandemic, is seriously affecting mental and physical health, including changes to weight, sleep and alcohol use,” the APA said in a news release.
Some of the key findings of the survey include:
- 61% of respondents reported experiencing undesired weight changes since the start of the pandemic.
- 67% said their sleep habits changed, with 35% saying they slept more and 31% less.
- 23% reported drinking more alcohol to cope with stress.
- 47% said they delayed or canceled health care services because of the pandemic.
- 48% said their stress levels had increased.
A version of this article first appeared on Medscape.com.
Anthony Fauci, MD, says he’s concerned about how Americans will react once the coronavirus pandemic is brought under control, CBS News reports.
Noting that an American Psychological Association survey showed people reporting high stress levels because of the pandemic, CBS’s Norah O’Donnell asked if Dr. Fauci was concerned about a possible “mental health pandemic.”
“Very much so,” Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases and a top White House coronavirus adviser, replied.
“That’s the reason why I want to get the virological aspect of this pandemic behind us as quickly as we possibly can because the long-term ravages of this are so multifaceted,” Dr. Fauci said.
, he said.
“And then the other things: Not only the mental health effects, but many people have put off routine types of medical examinations that they normally would have done,” Dr. Fauci said.
“I hope we don’t see an increase in some preventable situations that would not have happened if people had the normal access to medical care, which clearly was interrupted by the shutdown associated with COVID-19,” he added.
The American Psychological Association released the survey results March 11 in what many people consider the 1-year anniversary of the start of the coronavirus pandemic.
“The prolonged stress experienced by adults, especially the high levels of stress reported by Americans directly linked to the pandemic, is seriously affecting mental and physical health, including changes to weight, sleep and alcohol use,” the APA said in a news release.
Some of the key findings of the survey include:
- 61% of respondents reported experiencing undesired weight changes since the start of the pandemic.
- 67% said their sleep habits changed, with 35% saying they slept more and 31% less.
- 23% reported drinking more alcohol to cope with stress.
- 47% said they delayed or canceled health care services because of the pandemic.
- 48% said their stress levels had increased.
A version of this article first appeared on Medscape.com.
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.
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.
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.
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.
Fear, stigma can stymie the care of criminal justice-involved outpatients
One of the greatest challenges psychotherapists face when working with justice-involved outpatients is a lack of familiarity with the criminal legal system, according to Debra A. Pinals, MD.
“It’s certainly nothing we learned about in medical school or in our mental health training, per se,” said Dr. Pinals, director of the program in psychiatry, law, and ethics at the University of Michigan, Ann Arbor, during an annual psychopharmacology update held by the Nevada Psychiatric Association.
“Another challenge is a lack of comfort with some patient personality styles, particularly those with antisocial personality styles,” she said. “We may have countertransference issues that emerge in our work with this population. That can lead to concerns about our own safety, which may at times be reasonable but often because of stereotypes often becomes of mythical proportion. The population is a high-demand population with limited resources, usually tapping public mental health services. That becomes a challenge as well. And there can be burnout when the challenges of our patient population exceed our capacity.”
Despite such obstacles, Dr. Pinals described the outpatient treatment of individuals involved in the criminal justice system as exciting, interesting, and intellectually challenging. But she acknowledged the role that stigma and fear can play.
“Though there are some unique challenges, the benefits of working with criminal justice–involved persons with serious mental illness are often not discussed,” Dr. Pinals said. “There is a tendency to overvalue the risk they may present without really looking at the specific nuances that would be involved in conducting true risk assessments and understanding that not all of these patients will be as risky as we might believe due to stigma and fear.”
Separate from how patients with criminal histories may be perceived in clinical settings. There is much to learn about the role of mental illness in crime. In a 2014 study, researchers reviewed the records of criminal arrests in 143 people with mental illness and tried to discern whether the crime itself was completely independent or completely directly connected to the symptoms of mental illness the individual was experiencing. They found that 65% were completely independent of mental illness symptoms while 8% were directly related to mental illness symptoms.
“This means that as clinicians working with outpatients, we have to understand the whole person, and what might be going on in their lives that leads them down this criminal pathway,” said Dr. Pinals, who is also a clinical professor of psychiatry at the medical school.
According to the risk-need-responsivity (RNR) paradigm, eight criminogenic risk factors are associated with recurrent involvement in the criminal legal system (Crime & Delinquency. 2006;52:7-27). The big four include history of antisocial behavior, antisocial personality pattern, antisocial cognition, and antisocial attitudes. “These are the factors that certain cognitive-behavioral therapy approaches try to address, in an effort to reduce those antisocial cognitive tendencies,” Dr. Pinals said. The other four risk factors include family or marital discord, poor school and/or work performance, few leisure or recreation activities, and substance misuse.
“You’ll notice that mental illness is not listed,” she said. “ although it might be considered a responsivity factor within this RNR paradigm. This means it’s important to address it because it may help people better respond to criminal justice supervision and thereby have an indirect effect in reducing criminal recidivism. For example, if somebody has a social anxiety disorder or agoraphobia and therefore can’t make their probation appointment, probation won’t be able to help them adhere to the terms of their probation conditions. So, we do have to treat the illnesses underlying responsivity to how the criminal justice system operates.”
To optimally serve this population, Dr. Pinals recommends that psychotherapists become familiar with the Sequential Intercept Model, which was first published in 2006. “It takes the premise that individuals move through the criminal legal system in logical steps, and if we could identify those with mental health or substance use conditions and redirect them out of the criminal legal system and into treatment, we could reduce the overall penetration of those individuals from the criminal legal system,” she said. “We know that individuals with mental illness are overrepresented in the criminal legal system.”
By understanding what happens when a patient is arrested, mental health professionals can foster communication that could facilitate treatment for their patients.
“It’s important that we remember that these are people who are going through a challenging time,” Dr. Pinals said. “Maybe we don’t like what they did. Maybe we don’t like that they were accused of committing some kind of crime. However, it is important to realize that they are patients, and we want them to achieve the best outcome, whatever setting they’re in, that continuity of care and communication across systems might be beneficial. It might reduce their chance of returning to the criminal system and having other people victimized.”
Mental health services vary across jails and prisons, she continued, but they are generally required to be commensurate with community standards.
“Of course, that’s often fraught with complexity and may not be available in particular jurisdictions” she said. Prisons, unlike local county jails, tend to have more levels of outpatient care, including inpatient, outpatient, and residential services. “Persons with mental illness can be moved in and out of these levels of care as needed,” Dr. Pinals said. “However, persons with mental illness can be at more risk for disciplinary infractions, especially if they’re not able to follow directions or if they’re psychotic or manic.”
Reentry creates certain risks to be mindful of, including social isolation, recurrent symptoms, problems acquiring medications and housing, suicide, violence, and a return to substance use. A reentry approach she recommended is the APIC model, which stands for Assess, Plan, Identify, and Coordinate. “That means individuals approaching release should be screened and assessed for their needs with a plan to meet the needs, identify critical periods and needed policies, and coordinate across systems,” Dr. Pinals said. “So, if you get a call as an outpatient provider from the reentry coordinator at a local jail trying to help you coordinate a patient’s reentry, that’s something to pay attention to.”
When first meeting with patients after a criminal justice experience, Dr. Pinals recommends asking them to discuss their arrest and criminal justice experience, and to address any emerging psychiatric or clinical issues, including trauma and adjustment associated with the arrests, incarceration, and legal processes. “The risks of rearrest are higher for those who have already touched the criminal justice system, so we want to help minimize that risk of rearrest,” she said.
Some clinics won’t allow patients with a criminal record to return, “which means you have to help potentially find alternative places for them to be seen,” she noted. “You may want to consult a specialist if you have doubts about your capacity to work with the patient. You also want to support staff who might have concerns about how to continue to treat this patient and you want to advocate for the patient’s needs and help them return to a stable treatment setting.”
Dr. Pinals concluded her presentation by underscoring the importance of delivering treatment services that are trauma informed. “There are high levels of trauma for those receiving care in psychiatric settings and among those who have spent time in jails and prisons,” she said. “We want to be sensitive to the fact that any of our patients who were involved in the criminal legal system might have a strong trauma history. Help instill a sense of safety and community, and hold hope for positive change.”
She reported consulting to jurisdictions and attorneys pertaining to behavioral health and justice, and forensic psychiatry. She reported having no relevant commercial financial disclosures.
One of the greatest challenges psychotherapists face when working with justice-involved outpatients is a lack of familiarity with the criminal legal system, according to Debra A. Pinals, MD.
“It’s certainly nothing we learned about in medical school or in our mental health training, per se,” said Dr. Pinals, director of the program in psychiatry, law, and ethics at the University of Michigan, Ann Arbor, during an annual psychopharmacology update held by the Nevada Psychiatric Association.
“Another challenge is a lack of comfort with some patient personality styles, particularly those with antisocial personality styles,” she said. “We may have countertransference issues that emerge in our work with this population. That can lead to concerns about our own safety, which may at times be reasonable but often because of stereotypes often becomes of mythical proportion. The population is a high-demand population with limited resources, usually tapping public mental health services. That becomes a challenge as well. And there can be burnout when the challenges of our patient population exceed our capacity.”
Despite such obstacles, Dr. Pinals described the outpatient treatment of individuals involved in the criminal justice system as exciting, interesting, and intellectually challenging. But she acknowledged the role that stigma and fear can play.
“Though there are some unique challenges, the benefits of working with criminal justice–involved persons with serious mental illness are often not discussed,” Dr. Pinals said. “There is a tendency to overvalue the risk they may present without really looking at the specific nuances that would be involved in conducting true risk assessments and understanding that not all of these patients will be as risky as we might believe due to stigma and fear.”
Separate from how patients with criminal histories may be perceived in clinical settings. There is much to learn about the role of mental illness in crime. In a 2014 study, researchers reviewed the records of criminal arrests in 143 people with mental illness and tried to discern whether the crime itself was completely independent or completely directly connected to the symptoms of mental illness the individual was experiencing. They found that 65% were completely independent of mental illness symptoms while 8% were directly related to mental illness symptoms.
“This means that as clinicians working with outpatients, we have to understand the whole person, and what might be going on in their lives that leads them down this criminal pathway,” said Dr. Pinals, who is also a clinical professor of psychiatry at the medical school.
According to the risk-need-responsivity (RNR) paradigm, eight criminogenic risk factors are associated with recurrent involvement in the criminal legal system (Crime & Delinquency. 2006;52:7-27). The big four include history of antisocial behavior, antisocial personality pattern, antisocial cognition, and antisocial attitudes. “These are the factors that certain cognitive-behavioral therapy approaches try to address, in an effort to reduce those antisocial cognitive tendencies,” Dr. Pinals said. The other four risk factors include family or marital discord, poor school and/or work performance, few leisure or recreation activities, and substance misuse.
“You’ll notice that mental illness is not listed,” she said. “ although it might be considered a responsivity factor within this RNR paradigm. This means it’s important to address it because it may help people better respond to criminal justice supervision and thereby have an indirect effect in reducing criminal recidivism. For example, if somebody has a social anxiety disorder or agoraphobia and therefore can’t make their probation appointment, probation won’t be able to help them adhere to the terms of their probation conditions. So, we do have to treat the illnesses underlying responsivity to how the criminal justice system operates.”
To optimally serve this population, Dr. Pinals recommends that psychotherapists become familiar with the Sequential Intercept Model, which was first published in 2006. “It takes the premise that individuals move through the criminal legal system in logical steps, and if we could identify those with mental health or substance use conditions and redirect them out of the criminal legal system and into treatment, we could reduce the overall penetration of those individuals from the criminal legal system,” she said. “We know that individuals with mental illness are overrepresented in the criminal legal system.”
By understanding what happens when a patient is arrested, mental health professionals can foster communication that could facilitate treatment for their patients.
“It’s important that we remember that these are people who are going through a challenging time,” Dr. Pinals said. “Maybe we don’t like what they did. Maybe we don’t like that they were accused of committing some kind of crime. However, it is important to realize that they are patients, and we want them to achieve the best outcome, whatever setting they’re in, that continuity of care and communication across systems might be beneficial. It might reduce their chance of returning to the criminal system and having other people victimized.”
Mental health services vary across jails and prisons, she continued, but they are generally required to be commensurate with community standards.
“Of course, that’s often fraught with complexity and may not be available in particular jurisdictions” she said. Prisons, unlike local county jails, tend to have more levels of outpatient care, including inpatient, outpatient, and residential services. “Persons with mental illness can be moved in and out of these levels of care as needed,” Dr. Pinals said. “However, persons with mental illness can be at more risk for disciplinary infractions, especially if they’re not able to follow directions or if they’re psychotic or manic.”
Reentry creates certain risks to be mindful of, including social isolation, recurrent symptoms, problems acquiring medications and housing, suicide, violence, and a return to substance use. A reentry approach she recommended is the APIC model, which stands for Assess, Plan, Identify, and Coordinate. “That means individuals approaching release should be screened and assessed for their needs with a plan to meet the needs, identify critical periods and needed policies, and coordinate across systems,” Dr. Pinals said. “So, if you get a call as an outpatient provider from the reentry coordinator at a local jail trying to help you coordinate a patient’s reentry, that’s something to pay attention to.”
When first meeting with patients after a criminal justice experience, Dr. Pinals recommends asking them to discuss their arrest and criminal justice experience, and to address any emerging psychiatric or clinical issues, including trauma and adjustment associated with the arrests, incarceration, and legal processes. “The risks of rearrest are higher for those who have already touched the criminal justice system, so we want to help minimize that risk of rearrest,” she said.
Some clinics won’t allow patients with a criminal record to return, “which means you have to help potentially find alternative places for them to be seen,” she noted. “You may want to consult a specialist if you have doubts about your capacity to work with the patient. You also want to support staff who might have concerns about how to continue to treat this patient and you want to advocate for the patient’s needs and help them return to a stable treatment setting.”
Dr. Pinals concluded her presentation by underscoring the importance of delivering treatment services that are trauma informed. “There are high levels of trauma for those receiving care in psychiatric settings and among those who have spent time in jails and prisons,” she said. “We want to be sensitive to the fact that any of our patients who were involved in the criminal legal system might have a strong trauma history. Help instill a sense of safety and community, and hold hope for positive change.”
She reported consulting to jurisdictions and attorneys pertaining to behavioral health and justice, and forensic psychiatry. She reported having no relevant commercial financial disclosures.
One of the greatest challenges psychotherapists face when working with justice-involved outpatients is a lack of familiarity with the criminal legal system, according to Debra A. Pinals, MD.
“It’s certainly nothing we learned about in medical school or in our mental health training, per se,” said Dr. Pinals, director of the program in psychiatry, law, and ethics at the University of Michigan, Ann Arbor, during an annual psychopharmacology update held by the Nevada Psychiatric Association.
“Another challenge is a lack of comfort with some patient personality styles, particularly those with antisocial personality styles,” she said. “We may have countertransference issues that emerge in our work with this population. That can lead to concerns about our own safety, which may at times be reasonable but often because of stereotypes often becomes of mythical proportion. The population is a high-demand population with limited resources, usually tapping public mental health services. That becomes a challenge as well. And there can be burnout when the challenges of our patient population exceed our capacity.”
Despite such obstacles, Dr. Pinals described the outpatient treatment of individuals involved in the criminal justice system as exciting, interesting, and intellectually challenging. But she acknowledged the role that stigma and fear can play.
“Though there are some unique challenges, the benefits of working with criminal justice–involved persons with serious mental illness are often not discussed,” Dr. Pinals said. “There is a tendency to overvalue the risk they may present without really looking at the specific nuances that would be involved in conducting true risk assessments and understanding that not all of these patients will be as risky as we might believe due to stigma and fear.”
Separate from how patients with criminal histories may be perceived in clinical settings. There is much to learn about the role of mental illness in crime. In a 2014 study, researchers reviewed the records of criminal arrests in 143 people with mental illness and tried to discern whether the crime itself was completely independent or completely directly connected to the symptoms of mental illness the individual was experiencing. They found that 65% were completely independent of mental illness symptoms while 8% were directly related to mental illness symptoms.
“This means that as clinicians working with outpatients, we have to understand the whole person, and what might be going on in their lives that leads them down this criminal pathway,” said Dr. Pinals, who is also a clinical professor of psychiatry at the medical school.
According to the risk-need-responsivity (RNR) paradigm, eight criminogenic risk factors are associated with recurrent involvement in the criminal legal system (Crime & Delinquency. 2006;52:7-27). The big four include history of antisocial behavior, antisocial personality pattern, antisocial cognition, and antisocial attitudes. “These are the factors that certain cognitive-behavioral therapy approaches try to address, in an effort to reduce those antisocial cognitive tendencies,” Dr. Pinals said. The other four risk factors include family or marital discord, poor school and/or work performance, few leisure or recreation activities, and substance misuse.
“You’ll notice that mental illness is not listed,” she said. “ although it might be considered a responsivity factor within this RNR paradigm. This means it’s important to address it because it may help people better respond to criminal justice supervision and thereby have an indirect effect in reducing criminal recidivism. For example, if somebody has a social anxiety disorder or agoraphobia and therefore can’t make their probation appointment, probation won’t be able to help them adhere to the terms of their probation conditions. So, we do have to treat the illnesses underlying responsivity to how the criminal justice system operates.”
To optimally serve this population, Dr. Pinals recommends that psychotherapists become familiar with the Sequential Intercept Model, which was first published in 2006. “It takes the premise that individuals move through the criminal legal system in logical steps, and if we could identify those with mental health or substance use conditions and redirect them out of the criminal legal system and into treatment, we could reduce the overall penetration of those individuals from the criminal legal system,” she said. “We know that individuals with mental illness are overrepresented in the criminal legal system.”
By understanding what happens when a patient is arrested, mental health professionals can foster communication that could facilitate treatment for their patients.
“It’s important that we remember that these are people who are going through a challenging time,” Dr. Pinals said. “Maybe we don’t like what they did. Maybe we don’t like that they were accused of committing some kind of crime. However, it is important to realize that they are patients, and we want them to achieve the best outcome, whatever setting they’re in, that continuity of care and communication across systems might be beneficial. It might reduce their chance of returning to the criminal system and having other people victimized.”
Mental health services vary across jails and prisons, she continued, but they are generally required to be commensurate with community standards.
“Of course, that’s often fraught with complexity and may not be available in particular jurisdictions” she said. Prisons, unlike local county jails, tend to have more levels of outpatient care, including inpatient, outpatient, and residential services. “Persons with mental illness can be moved in and out of these levels of care as needed,” Dr. Pinals said. “However, persons with mental illness can be at more risk for disciplinary infractions, especially if they’re not able to follow directions or if they’re psychotic or manic.”
Reentry creates certain risks to be mindful of, including social isolation, recurrent symptoms, problems acquiring medications and housing, suicide, violence, and a return to substance use. A reentry approach she recommended is the APIC model, which stands for Assess, Plan, Identify, and Coordinate. “That means individuals approaching release should be screened and assessed for their needs with a plan to meet the needs, identify critical periods and needed policies, and coordinate across systems,” Dr. Pinals said. “So, if you get a call as an outpatient provider from the reentry coordinator at a local jail trying to help you coordinate a patient’s reentry, that’s something to pay attention to.”
When first meeting with patients after a criminal justice experience, Dr. Pinals recommends asking them to discuss their arrest and criminal justice experience, and to address any emerging psychiatric or clinical issues, including trauma and adjustment associated with the arrests, incarceration, and legal processes. “The risks of rearrest are higher for those who have already touched the criminal justice system, so we want to help minimize that risk of rearrest,” she said.
Some clinics won’t allow patients with a criminal record to return, “which means you have to help potentially find alternative places for them to be seen,” she noted. “You may want to consult a specialist if you have doubts about your capacity to work with the patient. You also want to support staff who might have concerns about how to continue to treat this patient and you want to advocate for the patient’s needs and help them return to a stable treatment setting.”
Dr. Pinals concluded her presentation by underscoring the importance of delivering treatment services that are trauma informed. “There are high levels of trauma for those receiving care in psychiatric settings and among those who have spent time in jails and prisons,” she said. “We want to be sensitive to the fact that any of our patients who were involved in the criminal legal system might have a strong trauma history. Help instill a sense of safety and community, and hold hope for positive change.”
She reported consulting to jurisdictions and attorneys pertaining to behavioral health and justice, and forensic psychiatry. She reported having no relevant commercial financial disclosures.
FROM NPA 2021