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Human sitters in the COVID era
Data collection needed for care of suicidal hospitalized patients
I am writing this commentary to bring to readers’ attention a medical and ethical complexity related to human sitters for presumably suicidal, COVID-19–positive hospitalized patients.
To shape and bundle the ethics issues addressed here into a single question, I offer the following: Should policies and practices requiring that patients in presumed need of a sitter because of assessed suicidality change when the patient is COVID-19–positive? Although the analysis might be similar when a sitter is monitoring a Patient Under Investigation (PUI), here I focus only on COVID-19–positive patients. Similarly, there are other reasons for sitters, of course, such as to prevent elopement, or, if a patient is in restraints, to prevent the patient from pulling out lines or tubes. Again, discussion of some of these ethical complications is beyond the scope of this piece. Just considering the matter of potential suicidality and sitters is complex enough. And so, to start, I sought out existing sources for guidance.
In looking for such sources, I first turned to the Centers for Medicare and Medicaid Services before COVID-19. CMS has required that there be a sitter for a patient who is suicidal and that the sitter remain in the room so that the sitter can intervene expeditiously if the patient tries to hurt himself or herself. There has been no change in this guidance since the COVID-19 pandemic in the United States. To the best of my knowledge, there is no substantive guidance for protecting sitters from contagion other than PPE. Given this, it begs the question:
In my hospital, I already have begun discussing the potential risks of harm and potential benefits to our suicidal patients of having a sitter directly outside the patient’s room. I also have considered whether to have one sitter watching several room cameras at once, commonly referred to as “telehealth strategies.”
To be sure, sitting for hours in the room of a COVID-19–positive patient is onerous. The sitter is required to be in full PPE (N-95 mask, gown, and gloves), which is hot and uncomfortable. Current practice is resource intensive in other ways. It requires changing out the sitter every 2 hours, which uses substantial amounts of PPE and multiple sitters.
Regardless, however, there are really no data upon which to base any sound ethics judgment about what should or should not be tried. We just have no information on how to attempt to balance potential risks and prospects for the benefit of whom and when. And, given that good clinical ethics always begin with the facts, I write this piece to see whether readers have thought about these issues before – and whether any of clinicians have started collecting the valuable data needed to begin making sound ethical judgments about how to care for our presumably suicidal COVID-19–positive patients and the sitters who watch over them.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].
This column is an outcome of a discussion that occurred during Psych/Ethics rounds on June 5, and does not represent any official statements of Medstar Washington Hospital Center or any entity of the MedStar Corp. Dr. Ritchie would like to thank Evan G. DeRenzo, PhD, of the John J. Lynch Center for Ethics, for her thoughtful review of a previous draft of this commentary.
Data collection needed for care of suicidal hospitalized patients
Data collection needed for care of suicidal hospitalized patients
I am writing this commentary to bring to readers’ attention a medical and ethical complexity related to human sitters for presumably suicidal, COVID-19–positive hospitalized patients.
To shape and bundle the ethics issues addressed here into a single question, I offer the following: Should policies and practices requiring that patients in presumed need of a sitter because of assessed suicidality change when the patient is COVID-19–positive? Although the analysis might be similar when a sitter is monitoring a Patient Under Investigation (PUI), here I focus only on COVID-19–positive patients. Similarly, there are other reasons for sitters, of course, such as to prevent elopement, or, if a patient is in restraints, to prevent the patient from pulling out lines or tubes. Again, discussion of some of these ethical complications is beyond the scope of this piece. Just considering the matter of potential suicidality and sitters is complex enough. And so, to start, I sought out existing sources for guidance.
In looking for such sources, I first turned to the Centers for Medicare and Medicaid Services before COVID-19. CMS has required that there be a sitter for a patient who is suicidal and that the sitter remain in the room so that the sitter can intervene expeditiously if the patient tries to hurt himself or herself. There has been no change in this guidance since the COVID-19 pandemic in the United States. To the best of my knowledge, there is no substantive guidance for protecting sitters from contagion other than PPE. Given this, it begs the question:
In my hospital, I already have begun discussing the potential risks of harm and potential benefits to our suicidal patients of having a sitter directly outside the patient’s room. I also have considered whether to have one sitter watching several room cameras at once, commonly referred to as “telehealth strategies.”
To be sure, sitting for hours in the room of a COVID-19–positive patient is onerous. The sitter is required to be in full PPE (N-95 mask, gown, and gloves), which is hot and uncomfortable. Current practice is resource intensive in other ways. It requires changing out the sitter every 2 hours, which uses substantial amounts of PPE and multiple sitters.
Regardless, however, there are really no data upon which to base any sound ethics judgment about what should or should not be tried. We just have no information on how to attempt to balance potential risks and prospects for the benefit of whom and when. And, given that good clinical ethics always begin with the facts, I write this piece to see whether readers have thought about these issues before – and whether any of clinicians have started collecting the valuable data needed to begin making sound ethical judgments about how to care for our presumably suicidal COVID-19–positive patients and the sitters who watch over them.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].
This column is an outcome of a discussion that occurred during Psych/Ethics rounds on June 5, and does not represent any official statements of Medstar Washington Hospital Center or any entity of the MedStar Corp. Dr. Ritchie would like to thank Evan G. DeRenzo, PhD, of the John J. Lynch Center for Ethics, for her thoughtful review of a previous draft of this commentary.
I am writing this commentary to bring to readers’ attention a medical and ethical complexity related to human sitters for presumably suicidal, COVID-19–positive hospitalized patients.
To shape and bundle the ethics issues addressed here into a single question, I offer the following: Should policies and practices requiring that patients in presumed need of a sitter because of assessed suicidality change when the patient is COVID-19–positive? Although the analysis might be similar when a sitter is monitoring a Patient Under Investigation (PUI), here I focus only on COVID-19–positive patients. Similarly, there are other reasons for sitters, of course, such as to prevent elopement, or, if a patient is in restraints, to prevent the patient from pulling out lines or tubes. Again, discussion of some of these ethical complications is beyond the scope of this piece. Just considering the matter of potential suicidality and sitters is complex enough. And so, to start, I sought out existing sources for guidance.
In looking for such sources, I first turned to the Centers for Medicare and Medicaid Services before COVID-19. CMS has required that there be a sitter for a patient who is suicidal and that the sitter remain in the room so that the sitter can intervene expeditiously if the patient tries to hurt himself or herself. There has been no change in this guidance since the COVID-19 pandemic in the United States. To the best of my knowledge, there is no substantive guidance for protecting sitters from contagion other than PPE. Given this, it begs the question:
In my hospital, I already have begun discussing the potential risks of harm and potential benefits to our suicidal patients of having a sitter directly outside the patient’s room. I also have considered whether to have one sitter watching several room cameras at once, commonly referred to as “telehealth strategies.”
To be sure, sitting for hours in the room of a COVID-19–positive patient is onerous. The sitter is required to be in full PPE (N-95 mask, gown, and gloves), which is hot and uncomfortable. Current practice is resource intensive in other ways. It requires changing out the sitter every 2 hours, which uses substantial amounts of PPE and multiple sitters.
Regardless, however, there are really no data upon which to base any sound ethics judgment about what should or should not be tried. We just have no information on how to attempt to balance potential risks and prospects for the benefit of whom and when. And, given that good clinical ethics always begin with the facts, I write this piece to see whether readers have thought about these issues before – and whether any of clinicians have started collecting the valuable data needed to begin making sound ethical judgments about how to care for our presumably suicidal COVID-19–positive patients and the sitters who watch over them.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].
This column is an outcome of a discussion that occurred during Psych/Ethics rounds on June 5, and does not represent any official statements of Medstar Washington Hospital Center or any entity of the MedStar Corp. Dr. Ritchie would like to thank Evan G. DeRenzo, PhD, of the John J. Lynch Center for Ethics, for her thoughtful review of a previous draft of this commentary.
NIMH strategic plan returns balance to research priorities
Digital health, suicide prevention, innovation addressed
The National Institute of Mental Health’s 2020 Strategic Plan outlines priorities in basic science research and clinical trials for psychiatry over the next 5 years, emphasizing where advances are needed in suicide prevention, digital health technology, early diagnosis in psychosis, and much more.
Experts’ reaction to the strategic plan is mixed. Some applaud the NIMH for addressing many essential research priorities and for returning a balance to the focus on basic/translational research and clinical advances. Others would have liked to see a different emphasis on some components of the plan.
Focusing on diversity
A greater weight on research in diverse populations and a renewed focus on studies across the lifespan – including developmental origins of psychiatric illness – are among the novel aspects of the plan.
“The enhanced attention to recruiting diverse subjects and focusing on diversity in our research is new and very welcome,” Jonathan E. Alpert, MD, PhD, chair of the American Psychiatric Association’s Council on Research, said in an interview.
Addressing the entire lifespan is likewise important, added Dr. Alpert, who holds the Dorothy and Marty Silverman Chair of Psychiatry at the Albert Einstein College of Medicine in New York. “Many of the conditions we treat – whether they are mood disorders or even dementia– might have developmental origins that would be best studied early in life.”
Furthermore, the plan promotes more interdisciplinary collaboration. For example, there are new cross-cutting research themes, including prevention, environmental influences, global health, and more. These are areas where psychiatry needs strengthening, said Stevan M. Weine, MD, director of Global Medicine at the University of Illinois at Chicago, in an interview.
In the era of COVID-19, which will involve ongoing diseases and disasters such as those tied to climate changes and disparities, there will be a need to conduct research and train researchers who are more open to new research questions, said Dr. Weine, also director of the Center for Global Health and professor of psychiatry at the university. It also will be important to partner with researchers from multiple disciplines, he added.
The plan also recognizes novel applications of digital technology. In addition, the plan outlines the promise of “harnessing the power of data,” such as machine learning, to help identify suicide risk factors based on large data, for example. However, Igor Galynker, MD, PhD, predicted that this technology will likely identify factors that “we see again and again,” such as depression, other forms of mental illness, and previous attempt history.
“Machine learning is useful but should not be emphasized” even if it is “technologically sexy and almost seductive,” Dr. Galynker, director of the Suicide Research & Prevention Laboratory at the Icahn School of Medicine at Mount Sinai in New York, said in an interview.
Addressing suicide
The strategic plan places a renewed emphasis on suicide prevention. The report cites a “troubling rise in the national suicide rate.” The authors suggested expanding initial success with brief screening tools in emergency departments to other clinical settings. Furthermore, the report highlights evidence that pairing such screening with low-cost follow-up interventions, such as telephone calls, can reduce the number of suicide attempts the following year.
Widespread screening could help identify people at risk, but it relies on the honesty of self-reporting, Dr. Galynker said, adding that about 75% of people who end their own lives never disclose their plan to anyone. Furthermore, suicide intent can be very short-lived – a crisis lasting as little as 15 minutes for some – reducing the likelihood that routine screening will flag a person in crisis.
“What is missing is an individual approach,” Dr. Galynker said while also endorsing the systemic approach to suicide prevention in the plan. “One thing in the strategic plan I may not agree with is the emphasis on administrative prediction measures ... based on drop-down menus and risk factors, and not on patient stories.” Risk factors are useful for long-term or lifetime risk, but they are not going to predict who will switch to acute suicidal state in the next several days or hours.”
Instead, Dr. Galynker suggested screening people for suicide crisis syndrome, which is “a very defined, characteristic, reproducible, and importantly, treatable,” state.
Covering basic neuroscience
Suicide prevention is just one of seven challenges and opportunities highlighted in the strategic plan. The authors also address research priorities for early treatment of psychosis and for research into mental health equity, HIV/AIDS research, genetics, and neural circuits.
“My overall impression is it’s very positive,” said Dr. Alpert, who is also professor and chair of the psychiatry and behavioral sciences department at Albert Einstein. “It really spans basic and translational neuroscience all the way to health services research and health disparities research. And I think, for many of us, we welcome that. It feels very relevant to the broad span of meaningful psychiatric research.”
Dr. Weine agreed. The strategic plan is “very helpful,” he said. “It is comprehensive, broad, and multidisciplinary.”
Promoting four overall goals
The plan seeks to promote the four following goals:
- Define the brain mechanisms underlying complex behaviors.
- Examine mental illness trajectories across the lifespan.
- Strive for prevention and cures.
- Strengthen the public health effects of National Institutes of Health–supported research.
The first goal is “an effort to try to make sense of the underlying biology, and that has to be your foundation point,” Ken Duckworth, MD, chief medical officer at the National Alliance on Mental Illness in Arlington, Va., said in an interview. “The reason we don’t have a lot of new drug discovery is because the fundamentals of biology still need understanding. It’s a long-term goal, so it’s hard,” he added. “Everyone living with someone in their life with an illness wants better ideas now.”
The third goal is likewise challenging, Dr. Duckworth said. “That is optimistic and ... aspirational, but very important and valuable.”
Developing innovative models
Regarding the public health goal, Dr. Duckworth cited one of the objectives, to “Develop innovative service delivery models to dramatically improve the outcomes of mental health services received in diverse communities and populations.” Dr. Duckworth explained, “Trying to solve for the problem in the context of an inadequate workforce that is insufficiently diverse – it just gets to something that I’m not sure would have been a priority in the past.
“That speaks to the awakening we’re having as a society. To address some of these historic and systemic injustices and how research can play into that is really important,” Dr. Duckworth added.
Overall, he saluted the plan and its goals. Dr. Duckworth added, “We gave some feedback that we wanted more emphasis on co-occurring disorders, such as research into people with mental health and addiction [issues] and on premature mortality. I think they took some of that feedback.”
Facing ‘significant challenges’
Dr. Weine added. “It sets a path for scientific advances that are responsive to these problems.”
“The future is bright. Looking forward to the next 5 years and beyond, the new NIMH Strategic Plan for Research aims to build on these advances,” Joshua A. Gordon, MD, PhD, NIMH director, noted in his Director’s Messages blog.
“Nonetheless, we face significant challenges,” he adds. “Studies of the origins of mental illnesses suggest that a combination of causes – genetic, environmental, social, and psychological – act on the brain through a complex web of interactions, resulting in a set of heterogeneous and overlapping illnesses.”
“My hope is that the actual funding of research over the coming years reflects the comprehensive, broad, and multidisciplinary characteristics of this strategic plan,” Dr. Weine said.
The NIMH plans to its post progress for each goal on an ongoing basis on the Strategic Plan website.
Dr. Alpert, Dr. Galynker, Dr. Weine, and Dr. Duckworth had no relevant disclosures.
Digital health, suicide prevention, innovation addressed
Digital health, suicide prevention, innovation addressed
The National Institute of Mental Health’s 2020 Strategic Plan outlines priorities in basic science research and clinical trials for psychiatry over the next 5 years, emphasizing where advances are needed in suicide prevention, digital health technology, early diagnosis in psychosis, and much more.
Experts’ reaction to the strategic plan is mixed. Some applaud the NIMH for addressing many essential research priorities and for returning a balance to the focus on basic/translational research and clinical advances. Others would have liked to see a different emphasis on some components of the plan.
Focusing on diversity
A greater weight on research in diverse populations and a renewed focus on studies across the lifespan – including developmental origins of psychiatric illness – are among the novel aspects of the plan.
“The enhanced attention to recruiting diverse subjects and focusing on diversity in our research is new and very welcome,” Jonathan E. Alpert, MD, PhD, chair of the American Psychiatric Association’s Council on Research, said in an interview.
Addressing the entire lifespan is likewise important, added Dr. Alpert, who holds the Dorothy and Marty Silverman Chair of Psychiatry at the Albert Einstein College of Medicine in New York. “Many of the conditions we treat – whether they are mood disorders or even dementia– might have developmental origins that would be best studied early in life.”
Furthermore, the plan promotes more interdisciplinary collaboration. For example, there are new cross-cutting research themes, including prevention, environmental influences, global health, and more. These are areas where psychiatry needs strengthening, said Stevan M. Weine, MD, director of Global Medicine at the University of Illinois at Chicago, in an interview.
In the era of COVID-19, which will involve ongoing diseases and disasters such as those tied to climate changes and disparities, there will be a need to conduct research and train researchers who are more open to new research questions, said Dr. Weine, also director of the Center for Global Health and professor of psychiatry at the university. It also will be important to partner with researchers from multiple disciplines, he added.
The plan also recognizes novel applications of digital technology. In addition, the plan outlines the promise of “harnessing the power of data,” such as machine learning, to help identify suicide risk factors based on large data, for example. However, Igor Galynker, MD, PhD, predicted that this technology will likely identify factors that “we see again and again,” such as depression, other forms of mental illness, and previous attempt history.
“Machine learning is useful but should not be emphasized” even if it is “technologically sexy and almost seductive,” Dr. Galynker, director of the Suicide Research & Prevention Laboratory at the Icahn School of Medicine at Mount Sinai in New York, said in an interview.
Addressing suicide
The strategic plan places a renewed emphasis on suicide prevention. The report cites a “troubling rise in the national suicide rate.” The authors suggested expanding initial success with brief screening tools in emergency departments to other clinical settings. Furthermore, the report highlights evidence that pairing such screening with low-cost follow-up interventions, such as telephone calls, can reduce the number of suicide attempts the following year.
Widespread screening could help identify people at risk, but it relies on the honesty of self-reporting, Dr. Galynker said, adding that about 75% of people who end their own lives never disclose their plan to anyone. Furthermore, suicide intent can be very short-lived – a crisis lasting as little as 15 minutes for some – reducing the likelihood that routine screening will flag a person in crisis.
“What is missing is an individual approach,” Dr. Galynker said while also endorsing the systemic approach to suicide prevention in the plan. “One thing in the strategic plan I may not agree with is the emphasis on administrative prediction measures ... based on drop-down menus and risk factors, and not on patient stories.” Risk factors are useful for long-term or lifetime risk, but they are not going to predict who will switch to acute suicidal state in the next several days or hours.”
Instead, Dr. Galynker suggested screening people for suicide crisis syndrome, which is “a very defined, characteristic, reproducible, and importantly, treatable,” state.
Covering basic neuroscience
Suicide prevention is just one of seven challenges and opportunities highlighted in the strategic plan. The authors also address research priorities for early treatment of psychosis and for research into mental health equity, HIV/AIDS research, genetics, and neural circuits.
“My overall impression is it’s very positive,” said Dr. Alpert, who is also professor and chair of the psychiatry and behavioral sciences department at Albert Einstein. “It really spans basic and translational neuroscience all the way to health services research and health disparities research. And I think, for many of us, we welcome that. It feels very relevant to the broad span of meaningful psychiatric research.”
Dr. Weine agreed. The strategic plan is “very helpful,” he said. “It is comprehensive, broad, and multidisciplinary.”
Promoting four overall goals
The plan seeks to promote the four following goals:
- Define the brain mechanisms underlying complex behaviors.
- Examine mental illness trajectories across the lifespan.
- Strive for prevention and cures.
- Strengthen the public health effects of National Institutes of Health–supported research.
The first goal is “an effort to try to make sense of the underlying biology, and that has to be your foundation point,” Ken Duckworth, MD, chief medical officer at the National Alliance on Mental Illness in Arlington, Va., said in an interview. “The reason we don’t have a lot of new drug discovery is because the fundamentals of biology still need understanding. It’s a long-term goal, so it’s hard,” he added. “Everyone living with someone in their life with an illness wants better ideas now.”
The third goal is likewise challenging, Dr. Duckworth said. “That is optimistic and ... aspirational, but very important and valuable.”
Developing innovative models
Regarding the public health goal, Dr. Duckworth cited one of the objectives, to “Develop innovative service delivery models to dramatically improve the outcomes of mental health services received in diverse communities and populations.” Dr. Duckworth explained, “Trying to solve for the problem in the context of an inadequate workforce that is insufficiently diverse – it just gets to something that I’m not sure would have been a priority in the past.
“That speaks to the awakening we’re having as a society. To address some of these historic and systemic injustices and how research can play into that is really important,” Dr. Duckworth added.
Overall, he saluted the plan and its goals. Dr. Duckworth added, “We gave some feedback that we wanted more emphasis on co-occurring disorders, such as research into people with mental health and addiction [issues] and on premature mortality. I think they took some of that feedback.”
Facing ‘significant challenges’
Dr. Weine added. “It sets a path for scientific advances that are responsive to these problems.”
“The future is bright. Looking forward to the next 5 years and beyond, the new NIMH Strategic Plan for Research aims to build on these advances,” Joshua A. Gordon, MD, PhD, NIMH director, noted in his Director’s Messages blog.
“Nonetheless, we face significant challenges,” he adds. “Studies of the origins of mental illnesses suggest that a combination of causes – genetic, environmental, social, and psychological – act on the brain through a complex web of interactions, resulting in a set of heterogeneous and overlapping illnesses.”
“My hope is that the actual funding of research over the coming years reflects the comprehensive, broad, and multidisciplinary characteristics of this strategic plan,” Dr. Weine said.
The NIMH plans to its post progress for each goal on an ongoing basis on the Strategic Plan website.
Dr. Alpert, Dr. Galynker, Dr. Weine, and Dr. Duckworth had no relevant disclosures.
The National Institute of Mental Health’s 2020 Strategic Plan outlines priorities in basic science research and clinical trials for psychiatry over the next 5 years, emphasizing where advances are needed in suicide prevention, digital health technology, early diagnosis in psychosis, and much more.
Experts’ reaction to the strategic plan is mixed. Some applaud the NIMH for addressing many essential research priorities and for returning a balance to the focus on basic/translational research and clinical advances. Others would have liked to see a different emphasis on some components of the plan.
Focusing on diversity
A greater weight on research in diverse populations and a renewed focus on studies across the lifespan – including developmental origins of psychiatric illness – are among the novel aspects of the plan.
“The enhanced attention to recruiting diverse subjects and focusing on diversity in our research is new and very welcome,” Jonathan E. Alpert, MD, PhD, chair of the American Psychiatric Association’s Council on Research, said in an interview.
Addressing the entire lifespan is likewise important, added Dr. Alpert, who holds the Dorothy and Marty Silverman Chair of Psychiatry at the Albert Einstein College of Medicine in New York. “Many of the conditions we treat – whether they are mood disorders or even dementia– might have developmental origins that would be best studied early in life.”
Furthermore, the plan promotes more interdisciplinary collaboration. For example, there are new cross-cutting research themes, including prevention, environmental influences, global health, and more. These are areas where psychiatry needs strengthening, said Stevan M. Weine, MD, director of Global Medicine at the University of Illinois at Chicago, in an interview.
In the era of COVID-19, which will involve ongoing diseases and disasters such as those tied to climate changes and disparities, there will be a need to conduct research and train researchers who are more open to new research questions, said Dr. Weine, also director of the Center for Global Health and professor of psychiatry at the university. It also will be important to partner with researchers from multiple disciplines, he added.
The plan also recognizes novel applications of digital technology. In addition, the plan outlines the promise of “harnessing the power of data,” such as machine learning, to help identify suicide risk factors based on large data, for example. However, Igor Galynker, MD, PhD, predicted that this technology will likely identify factors that “we see again and again,” such as depression, other forms of mental illness, and previous attempt history.
“Machine learning is useful but should not be emphasized” even if it is “technologically sexy and almost seductive,” Dr. Galynker, director of the Suicide Research & Prevention Laboratory at the Icahn School of Medicine at Mount Sinai in New York, said in an interview.
Addressing suicide
The strategic plan places a renewed emphasis on suicide prevention. The report cites a “troubling rise in the national suicide rate.” The authors suggested expanding initial success with brief screening tools in emergency departments to other clinical settings. Furthermore, the report highlights evidence that pairing such screening with low-cost follow-up interventions, such as telephone calls, can reduce the number of suicide attempts the following year.
Widespread screening could help identify people at risk, but it relies on the honesty of self-reporting, Dr. Galynker said, adding that about 75% of people who end their own lives never disclose their plan to anyone. Furthermore, suicide intent can be very short-lived – a crisis lasting as little as 15 minutes for some – reducing the likelihood that routine screening will flag a person in crisis.
“What is missing is an individual approach,” Dr. Galynker said while also endorsing the systemic approach to suicide prevention in the plan. “One thing in the strategic plan I may not agree with is the emphasis on administrative prediction measures ... based on drop-down menus and risk factors, and not on patient stories.” Risk factors are useful for long-term or lifetime risk, but they are not going to predict who will switch to acute suicidal state in the next several days or hours.”
Instead, Dr. Galynker suggested screening people for suicide crisis syndrome, which is “a very defined, characteristic, reproducible, and importantly, treatable,” state.
Covering basic neuroscience
Suicide prevention is just one of seven challenges and opportunities highlighted in the strategic plan. The authors also address research priorities for early treatment of psychosis and for research into mental health equity, HIV/AIDS research, genetics, and neural circuits.
“My overall impression is it’s very positive,” said Dr. Alpert, who is also professor and chair of the psychiatry and behavioral sciences department at Albert Einstein. “It really spans basic and translational neuroscience all the way to health services research and health disparities research. And I think, for many of us, we welcome that. It feels very relevant to the broad span of meaningful psychiatric research.”
Dr. Weine agreed. The strategic plan is “very helpful,” he said. “It is comprehensive, broad, and multidisciplinary.”
Promoting four overall goals
The plan seeks to promote the four following goals:
- Define the brain mechanisms underlying complex behaviors.
- Examine mental illness trajectories across the lifespan.
- Strive for prevention and cures.
- Strengthen the public health effects of National Institutes of Health–supported research.
The first goal is “an effort to try to make sense of the underlying biology, and that has to be your foundation point,” Ken Duckworth, MD, chief medical officer at the National Alliance on Mental Illness in Arlington, Va., said in an interview. “The reason we don’t have a lot of new drug discovery is because the fundamentals of biology still need understanding. It’s a long-term goal, so it’s hard,” he added. “Everyone living with someone in their life with an illness wants better ideas now.”
The third goal is likewise challenging, Dr. Duckworth said. “That is optimistic and ... aspirational, but very important and valuable.”
Developing innovative models
Regarding the public health goal, Dr. Duckworth cited one of the objectives, to “Develop innovative service delivery models to dramatically improve the outcomes of mental health services received in diverse communities and populations.” Dr. Duckworth explained, “Trying to solve for the problem in the context of an inadequate workforce that is insufficiently diverse – it just gets to something that I’m not sure would have been a priority in the past.
“That speaks to the awakening we’re having as a society. To address some of these historic and systemic injustices and how research can play into that is really important,” Dr. Duckworth added.
Overall, he saluted the plan and its goals. Dr. Duckworth added, “We gave some feedback that we wanted more emphasis on co-occurring disorders, such as research into people with mental health and addiction [issues] and on premature mortality. I think they took some of that feedback.”
Facing ‘significant challenges’
Dr. Weine added. “It sets a path for scientific advances that are responsive to these problems.”
“The future is bright. Looking forward to the next 5 years and beyond, the new NIMH Strategic Plan for Research aims to build on these advances,” Joshua A. Gordon, MD, PhD, NIMH director, noted in his Director’s Messages blog.
“Nonetheless, we face significant challenges,” he adds. “Studies of the origins of mental illnesses suggest that a combination of causes – genetic, environmental, social, and psychological – act on the brain through a complex web of interactions, resulting in a set of heterogeneous and overlapping illnesses.”
“My hope is that the actual funding of research over the coming years reflects the comprehensive, broad, and multidisciplinary characteristics of this strategic plan,” Dr. Weine said.
The NIMH plans to its post progress for each goal on an ongoing basis on the Strategic Plan website.
Dr. Alpert, Dr. Galynker, Dr. Weine, and Dr. Duckworth had no relevant disclosures.
Depression linked to neuro dysfunction, brain lesions in MS
Depression is associated with decreased neurologic function and new brain lesions in patients with multiple sclerosis (MS), new research suggests.
In an observational study of more than 2500 patients with relapsing-remitting MS (RRMS), participants with self-reported depression were more likely to have worse scores on neuroperformance measures, such as processing speed tests, than their peers without depression.
At baseline, the group with depression also had greater odds of having at least one new contrast-enhancing lesion on MRI.
“Our results suggest that depression is not merely a reactive symptom but indicates increased risk of future MS disease activity,” the investigators note.
Lead author Jenny Feng, MD, clinical associate at the Mellen Center for MS Treatment and Research at Cleveland Clinic, added that depression should be routinely screened for in all patients with MS, something done routinely at her center.
“Every single patient that comes through the door with newly diagnosed MS, we refer to neuropsychology to screen for depression; and if there is depression, then we actively manage it because it does have an effect” on patients, she told Medscape Medical News.
“Depression isn’t just a neuropsychiatric disease,” Feng added. As shown in their study, “it may have effects on MS, especially with regards to performance in neurological function testing.”
The research is presented on AAN.com as part of the American Academy of Neurology 2020 Science Highlights. Because of the COVID-19 pandemic, the AAN had to cancel its 2020 annual meeting.
Associations Have Been “Unclear”
Although inflammatory, psychosocial, and neurodegenerative factors “have been hypothesized as etiologies” for why depression is commonly found in patients with MS,
For the current study, they assessed data from the Partners Advancing Technology and Health Solutions (MS-PATHS) database, an ongoing collaborative network of seven MS centers in the United States and three in Europe.
MS disease history and MRI data were examined, as well as 12-month scores on neuroperformance tests measuring processing speed (Symbol Digit Modalities Test), walking speed (Timed 25-Foot Walk), and manual dexterity (Nine-Hole Peg Test).
Patient-reported outcomes (PROs), as measured with the Quality of Life in Neurological Disorders (Neuro-QoL) and patient-determined disease steps, were also assessed. Depression was defined as a depression T score at baseline greater than “the 50th percentile” on the Neuro-QoL.
In the patient sample, 1333 of the participants with RRMS were classified as “not depressed” (73.7% women; mean age, 45.6 years; disease duration, 13.7 years) while 1172 were “depressed” (78.4% women; mean age, 45.9 years; disease duration, 14.3 years).
“To balance for baseline variances in the observational cohort between group with depression and group without depression, propensity score analysis was used to adjust for potential confounding factors,” the investigators report.
Worse Performance
After adjustment for baseline covariates, results showed that the depressed patients performed worse on the walking speed test (0.48; 95% confidence interval, 0.038-0.918) and processing speed test (–1.899; 95% CI, –3.548 to –0.250).
The depressed group also had increased odds at baseline of having new contrast-enhancing lesions (odds ratio, 5.89; 95% CI, 2.236-15.517). This demonstrated an “association of depression and neuroinflammatory activity” in the central nervous system, the investigators note.
At 12 months, processing speed continued to be worse in the depressed group (–1.68; 95% CI, –3.254 to –0.105).
There were trends, albeit insignificant, for decreased walking speed scores at 12 months and for decreased manual dexterity scores at both baseline and at 12 months for the participants who were depressed.
Interestingly, there were “no significant differences in PROs at month 12, despite worsening neuroperformance,” the investigators report.
“This means that patients themselves may not even realize that they were getting worse,” Feng said.
Underpowered Study?
Further results showed nonsignificant trends for increased T2 lesion volume and white matter fraction and decreased brain volume, gray matter fraction, and cortical gray matter volume at baseline and at 12 months in the depressed group.
The researchers note that study limitations include the unavailability of information on treatment compliance for depression or date of depression onset.
Feng added that because this was an observational study, other missing data included depression status for some patients at year 1 and some MRI metrics.
“So this may have been underpowered to detect some of the results. The power may have been inadequate to detect all changes,” she said.
The investigators write that future research should assess larger sample sizes with longer follow-ups and should use more advanced MRI measures, such as diffusion tensor imaging or functional MRI.
In addition, they will continue examining data from MS-PATHS. “With the newest data cut, we have new patients that we can analyze. So perhaps that can provide sufficient power to detect [more MRI] changes,” Feng said.
Unusual, Intriguing Findings
Commenting on the study for Medscape Medical News, Mark Freedman, MD, professor of neurology at the University of Ottawa and director of the Multiple Sclerosis Research Clinic at the Ottawa Hospital Research Institute, noted that he wasn’t terribly surprised” by the overall findings.
“We’ve known for years that patients who are depressed don’t do as well on our performance methods,” said Freedman, who was not involved with the research.
However, the current investigators “took a huge number of patients in this multicenter study and started using some of the statistical methods we’ve seen in the use of real-world evidence,” he noted.
“So you’re looking at some outcome measures and you have to ask yourself, ‘Why would it influence that?’ and ‘Did it happen by chance or not?’ And you ask why it is that depressed people might actually have more lesions on their MRI, which is something that is unusual,” Freedman said.
“When you start to look at this, even when you’re trying to standardize things for the differences that we know of, there are some stuff that comes out as intriguing. In general, I think those depressed patients did worse on several outcome measures that one would say, ‘That’s somewhat surprising.’ That’s why this group was very careful to not conclude absolutely that depression drives this disease. But it was consistently trending in the direction that it looks like there was more inflammatory activity in these people,” he said.
He echoed the investigators’ note that drug adherence and which depression treatment was used wasn’t controlled for; and he added that depression in the study was not based on receiving a diagnosis of clinical depression but on self-report.
Still, the patients classified as depressed “did worse. They didn’t walk as fast, which was interesting; and we know that cognitive performance is often damped because of poor concentration. But how do you get worse MRIs? This study is raising a question and [the researchers] conclude that it may be that depression might be an independent factor” for that outcome, Freedman said.
“It might be that you could get more out of a particular [MS] medicine if you pay attention to depression; and if that’s the investigators’ conclusion, and I think it is, then I certainly agree with it.”
Freedman noted that, instead of a blanket recommendation that all patients with MS should be screened for depression, he thinks clinicians, especially those at smaller centers, should focus on what’s best for treating all aspects of an individual patient.
“Don’t try to manage them if you’re not going to manage the entire picture. Looking at depression and mood and other things is very important. And if you have the capacity for an official screening, I think it’s wonderful; but not everybody does,” he said.
Feng and Freedman have disclosed no relevant financial relationships. Freedman is currently a member of the Medscape Neurology Advisory Board.
This article appeared on Medscape.com.
Depression is associated with decreased neurologic function and new brain lesions in patients with multiple sclerosis (MS), new research suggests.
In an observational study of more than 2500 patients with relapsing-remitting MS (RRMS), participants with self-reported depression were more likely to have worse scores on neuroperformance measures, such as processing speed tests, than their peers without depression.
At baseline, the group with depression also had greater odds of having at least one new contrast-enhancing lesion on MRI.
“Our results suggest that depression is not merely a reactive symptom but indicates increased risk of future MS disease activity,” the investigators note.
Lead author Jenny Feng, MD, clinical associate at the Mellen Center for MS Treatment and Research at Cleveland Clinic, added that depression should be routinely screened for in all patients with MS, something done routinely at her center.
“Every single patient that comes through the door with newly diagnosed MS, we refer to neuropsychology to screen for depression; and if there is depression, then we actively manage it because it does have an effect” on patients, she told Medscape Medical News.
“Depression isn’t just a neuropsychiatric disease,” Feng added. As shown in their study, “it may have effects on MS, especially with regards to performance in neurological function testing.”
The research is presented on AAN.com as part of the American Academy of Neurology 2020 Science Highlights. Because of the COVID-19 pandemic, the AAN had to cancel its 2020 annual meeting.
Associations Have Been “Unclear”
Although inflammatory, psychosocial, and neurodegenerative factors “have been hypothesized as etiologies” for why depression is commonly found in patients with MS,
For the current study, they assessed data from the Partners Advancing Technology and Health Solutions (MS-PATHS) database, an ongoing collaborative network of seven MS centers in the United States and three in Europe.
MS disease history and MRI data were examined, as well as 12-month scores on neuroperformance tests measuring processing speed (Symbol Digit Modalities Test), walking speed (Timed 25-Foot Walk), and manual dexterity (Nine-Hole Peg Test).
Patient-reported outcomes (PROs), as measured with the Quality of Life in Neurological Disorders (Neuro-QoL) and patient-determined disease steps, were also assessed. Depression was defined as a depression T score at baseline greater than “the 50th percentile” on the Neuro-QoL.
In the patient sample, 1333 of the participants with RRMS were classified as “not depressed” (73.7% women; mean age, 45.6 years; disease duration, 13.7 years) while 1172 were “depressed” (78.4% women; mean age, 45.9 years; disease duration, 14.3 years).
“To balance for baseline variances in the observational cohort between group with depression and group without depression, propensity score analysis was used to adjust for potential confounding factors,” the investigators report.
Worse Performance
After adjustment for baseline covariates, results showed that the depressed patients performed worse on the walking speed test (0.48; 95% confidence interval, 0.038-0.918) and processing speed test (–1.899; 95% CI, –3.548 to –0.250).
The depressed group also had increased odds at baseline of having new contrast-enhancing lesions (odds ratio, 5.89; 95% CI, 2.236-15.517). This demonstrated an “association of depression and neuroinflammatory activity” in the central nervous system, the investigators note.
At 12 months, processing speed continued to be worse in the depressed group (–1.68; 95% CI, –3.254 to –0.105).
There were trends, albeit insignificant, for decreased walking speed scores at 12 months and for decreased manual dexterity scores at both baseline and at 12 months for the participants who were depressed.
Interestingly, there were “no significant differences in PROs at month 12, despite worsening neuroperformance,” the investigators report.
“This means that patients themselves may not even realize that they were getting worse,” Feng said.
Underpowered Study?
Further results showed nonsignificant trends for increased T2 lesion volume and white matter fraction and decreased brain volume, gray matter fraction, and cortical gray matter volume at baseline and at 12 months in the depressed group.
The researchers note that study limitations include the unavailability of information on treatment compliance for depression or date of depression onset.
Feng added that because this was an observational study, other missing data included depression status for some patients at year 1 and some MRI metrics.
“So this may have been underpowered to detect some of the results. The power may have been inadequate to detect all changes,” she said.
The investigators write that future research should assess larger sample sizes with longer follow-ups and should use more advanced MRI measures, such as diffusion tensor imaging or functional MRI.
In addition, they will continue examining data from MS-PATHS. “With the newest data cut, we have new patients that we can analyze. So perhaps that can provide sufficient power to detect [more MRI] changes,” Feng said.
Unusual, Intriguing Findings
Commenting on the study for Medscape Medical News, Mark Freedman, MD, professor of neurology at the University of Ottawa and director of the Multiple Sclerosis Research Clinic at the Ottawa Hospital Research Institute, noted that he wasn’t terribly surprised” by the overall findings.
“We’ve known for years that patients who are depressed don’t do as well on our performance methods,” said Freedman, who was not involved with the research.
However, the current investigators “took a huge number of patients in this multicenter study and started using some of the statistical methods we’ve seen in the use of real-world evidence,” he noted.
“So you’re looking at some outcome measures and you have to ask yourself, ‘Why would it influence that?’ and ‘Did it happen by chance or not?’ And you ask why it is that depressed people might actually have more lesions on their MRI, which is something that is unusual,” Freedman said.
“When you start to look at this, even when you’re trying to standardize things for the differences that we know of, there are some stuff that comes out as intriguing. In general, I think those depressed patients did worse on several outcome measures that one would say, ‘That’s somewhat surprising.’ That’s why this group was very careful to not conclude absolutely that depression drives this disease. But it was consistently trending in the direction that it looks like there was more inflammatory activity in these people,” he said.
He echoed the investigators’ note that drug adherence and which depression treatment was used wasn’t controlled for; and he added that depression in the study was not based on receiving a diagnosis of clinical depression but on self-report.
Still, the patients classified as depressed “did worse. They didn’t walk as fast, which was interesting; and we know that cognitive performance is often damped because of poor concentration. But how do you get worse MRIs? This study is raising a question and [the researchers] conclude that it may be that depression might be an independent factor” for that outcome, Freedman said.
“It might be that you could get more out of a particular [MS] medicine if you pay attention to depression; and if that’s the investigators’ conclusion, and I think it is, then I certainly agree with it.”
Freedman noted that, instead of a blanket recommendation that all patients with MS should be screened for depression, he thinks clinicians, especially those at smaller centers, should focus on what’s best for treating all aspects of an individual patient.
“Don’t try to manage them if you’re not going to manage the entire picture. Looking at depression and mood and other things is very important. And if you have the capacity for an official screening, I think it’s wonderful; but not everybody does,” he said.
Feng and Freedman have disclosed no relevant financial relationships. Freedman is currently a member of the Medscape Neurology Advisory Board.
This article appeared on Medscape.com.
Depression is associated with decreased neurologic function and new brain lesions in patients with multiple sclerosis (MS), new research suggests.
In an observational study of more than 2500 patients with relapsing-remitting MS (RRMS), participants with self-reported depression were more likely to have worse scores on neuroperformance measures, such as processing speed tests, than their peers without depression.
At baseline, the group with depression also had greater odds of having at least one new contrast-enhancing lesion on MRI.
“Our results suggest that depression is not merely a reactive symptom but indicates increased risk of future MS disease activity,” the investigators note.
Lead author Jenny Feng, MD, clinical associate at the Mellen Center for MS Treatment and Research at Cleveland Clinic, added that depression should be routinely screened for in all patients with MS, something done routinely at her center.
“Every single patient that comes through the door with newly diagnosed MS, we refer to neuropsychology to screen for depression; and if there is depression, then we actively manage it because it does have an effect” on patients, she told Medscape Medical News.
“Depression isn’t just a neuropsychiatric disease,” Feng added. As shown in their study, “it may have effects on MS, especially with regards to performance in neurological function testing.”
The research is presented on AAN.com as part of the American Academy of Neurology 2020 Science Highlights. Because of the COVID-19 pandemic, the AAN had to cancel its 2020 annual meeting.
Associations Have Been “Unclear”
Although inflammatory, psychosocial, and neurodegenerative factors “have been hypothesized as etiologies” for why depression is commonly found in patients with MS,
For the current study, they assessed data from the Partners Advancing Technology and Health Solutions (MS-PATHS) database, an ongoing collaborative network of seven MS centers in the United States and three in Europe.
MS disease history and MRI data were examined, as well as 12-month scores on neuroperformance tests measuring processing speed (Symbol Digit Modalities Test), walking speed (Timed 25-Foot Walk), and manual dexterity (Nine-Hole Peg Test).
Patient-reported outcomes (PROs), as measured with the Quality of Life in Neurological Disorders (Neuro-QoL) and patient-determined disease steps, were also assessed. Depression was defined as a depression T score at baseline greater than “the 50th percentile” on the Neuro-QoL.
In the patient sample, 1333 of the participants with RRMS were classified as “not depressed” (73.7% women; mean age, 45.6 years; disease duration, 13.7 years) while 1172 were “depressed” (78.4% women; mean age, 45.9 years; disease duration, 14.3 years).
“To balance for baseline variances in the observational cohort between group with depression and group without depression, propensity score analysis was used to adjust for potential confounding factors,” the investigators report.
Worse Performance
After adjustment for baseline covariates, results showed that the depressed patients performed worse on the walking speed test (0.48; 95% confidence interval, 0.038-0.918) and processing speed test (–1.899; 95% CI, –3.548 to –0.250).
The depressed group also had increased odds at baseline of having new contrast-enhancing lesions (odds ratio, 5.89; 95% CI, 2.236-15.517). This demonstrated an “association of depression and neuroinflammatory activity” in the central nervous system, the investigators note.
At 12 months, processing speed continued to be worse in the depressed group (–1.68; 95% CI, –3.254 to –0.105).
There were trends, albeit insignificant, for decreased walking speed scores at 12 months and for decreased manual dexterity scores at both baseline and at 12 months for the participants who were depressed.
Interestingly, there were “no significant differences in PROs at month 12, despite worsening neuroperformance,” the investigators report.
“This means that patients themselves may not even realize that they were getting worse,” Feng said.
Underpowered Study?
Further results showed nonsignificant trends for increased T2 lesion volume and white matter fraction and decreased brain volume, gray matter fraction, and cortical gray matter volume at baseline and at 12 months in the depressed group.
The researchers note that study limitations include the unavailability of information on treatment compliance for depression or date of depression onset.
Feng added that because this was an observational study, other missing data included depression status for some patients at year 1 and some MRI metrics.
“So this may have been underpowered to detect some of the results. The power may have been inadequate to detect all changes,” she said.
The investigators write that future research should assess larger sample sizes with longer follow-ups and should use more advanced MRI measures, such as diffusion tensor imaging or functional MRI.
In addition, they will continue examining data from MS-PATHS. “With the newest data cut, we have new patients that we can analyze. So perhaps that can provide sufficient power to detect [more MRI] changes,” Feng said.
Unusual, Intriguing Findings
Commenting on the study for Medscape Medical News, Mark Freedman, MD, professor of neurology at the University of Ottawa and director of the Multiple Sclerosis Research Clinic at the Ottawa Hospital Research Institute, noted that he wasn’t terribly surprised” by the overall findings.
“We’ve known for years that patients who are depressed don’t do as well on our performance methods,” said Freedman, who was not involved with the research.
However, the current investigators “took a huge number of patients in this multicenter study and started using some of the statistical methods we’ve seen in the use of real-world evidence,” he noted.
“So you’re looking at some outcome measures and you have to ask yourself, ‘Why would it influence that?’ and ‘Did it happen by chance or not?’ And you ask why it is that depressed people might actually have more lesions on their MRI, which is something that is unusual,” Freedman said.
“When you start to look at this, even when you’re trying to standardize things for the differences that we know of, there are some stuff that comes out as intriguing. In general, I think those depressed patients did worse on several outcome measures that one would say, ‘That’s somewhat surprising.’ That’s why this group was very careful to not conclude absolutely that depression drives this disease. But it was consistently trending in the direction that it looks like there was more inflammatory activity in these people,” he said.
He echoed the investigators’ note that drug adherence and which depression treatment was used wasn’t controlled for; and he added that depression in the study was not based on receiving a diagnosis of clinical depression but on self-report.
Still, the patients classified as depressed “did worse. They didn’t walk as fast, which was interesting; and we know that cognitive performance is often damped because of poor concentration. But how do you get worse MRIs? This study is raising a question and [the researchers] conclude that it may be that depression might be an independent factor” for that outcome, Freedman said.
“It might be that you could get more out of a particular [MS] medicine if you pay attention to depression; and if that’s the investigators’ conclusion, and I think it is, then I certainly agree with it.”
Freedman noted that, instead of a blanket recommendation that all patients with MS should be screened for depression, he thinks clinicians, especially those at smaller centers, should focus on what’s best for treating all aspects of an individual patient.
“Don’t try to manage them if you’re not going to manage the entire picture. Looking at depression and mood and other things is very important. And if you have the capacity for an official screening, I think it’s wonderful; but not everybody does,” he said.
Feng and Freedman have disclosed no relevant financial relationships. Freedman is currently a member of the Medscape Neurology Advisory Board.
This article appeared on Medscape.com.
Suicide attempts more common, more lethal, new U.S. data show
From 2006 to 2015, suicide attempts in the United States became more common and more lethal in certain subgroups of the population, new data from the Centers for Disease Control and Prevention show.
Investigators found the incidence of suicidal acts increased in females, adolescents, and older adults aged 65-74 years, whereas suicidal acts became more lethal in both sexes and in those between the ages of 20 and 64 years.
“Effective suicide prevention efforts must be informed by an understanding of whether increased suicide rates are associated with more suicidal acts, greater lethality of suicidal acts, or a combination of both,” wrote Jing Wang, MD, MPH, and colleagues at the CDC’s National Center for Injury Prevention and Control.
The study was published online April 22 in JAMA Psychiatry.
Prior U.S. studies show a greater incidence of suicide attempts among some adult subgroups and young people, as well as changing patterns in suicide methods over time.
Between 2000 and 2010, for example, the rate of suicide by suffocation jumped 52% compared with a 19% increase in suicide by poisoning and a 3% increase in firearm-related suicides.
However, until now, there’s been no research examining the trends in both incidence and lethality of suicidal acts.
Medically treated nonfatal suicide attempts were identified via the Nationwide Inpatient Sample and Nationwide Emergency Department Sample databases, and suicide deaths were identified via the National Vital Statistics System.
The incidence rate of total suicidal acts rose 10% during the study period (annual percentage change [APC] 0.8%; 95% confidence interval [CI], 0.3%-1.3%). The case fatality rate (CFR) increased 13% (APC, 2.3%; 95% CI, 1.3%-3.3%).
In subgroup analyses, the incidence rate of suicidal acts increased 1.1% (95% CI, 0.6%-1.6%) per year for women but held stable for men. The CFR increased for women and men, with APCs of 5% (95% CI, 3.1%-6.9%) since 2010 for women and 1.6% (95% CI, 0.6%-2.5%) since 2009 for men.
The data show an increase in incidence rate of suicidal acts among adults aged 65-74 years throughout the study period, and among adolescents from 2011 to 2015. The CFR increased since 2009 among those aged 20-44 years (APC, 3.7%; 95% CI, 2.5%-5.0%) and since 2012 for individuals 45-64 years (APC, 2.7%; 95% CI, 0%-5.4%).
Among males and females aged 20-64 years, suicidal acts involving guns and suffocation (methods of greater lethality) increased, but suicidal acts by poisoning (a method of lesser lethality) decreased or flattened, “which may explain the observed increases in lethality,” the CDC researchers said.
“Adolescents and older adults aged 65-74 years experienced general increases in suicide attempts by all means, including poisoning, which was associated with stable or declining lethality for these subgroups,” they reported.
Dr. Wang and colleagues said their findings on population-level epidemiologic patterns may help with efforts to develop comprehensive suicide prevention strategies.
In particular, they said, reducing access to lethal means of suicide among those at risk, “which include not only firearms but also medications and other potentially dangerous household products, may be a helpful approach for reducing suicide rates.
“Ultimately, upstream prevention approaches, including teaching coping and problem-solving skills early in life, promoting connectedness, and developing and implementing policies that strengthen economic supports, may mitigate the risk of suicidal behavior for all age groups,” they concluded.
The study had no specific funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
From 2006 to 2015, suicide attempts in the United States became more common and more lethal in certain subgroups of the population, new data from the Centers for Disease Control and Prevention show.
Investigators found the incidence of suicidal acts increased in females, adolescents, and older adults aged 65-74 years, whereas suicidal acts became more lethal in both sexes and in those between the ages of 20 and 64 years.
“Effective suicide prevention efforts must be informed by an understanding of whether increased suicide rates are associated with more suicidal acts, greater lethality of suicidal acts, or a combination of both,” wrote Jing Wang, MD, MPH, and colleagues at the CDC’s National Center for Injury Prevention and Control.
The study was published online April 22 in JAMA Psychiatry.
Prior U.S. studies show a greater incidence of suicide attempts among some adult subgroups and young people, as well as changing patterns in suicide methods over time.
Between 2000 and 2010, for example, the rate of suicide by suffocation jumped 52% compared with a 19% increase in suicide by poisoning and a 3% increase in firearm-related suicides.
However, until now, there’s been no research examining the trends in both incidence and lethality of suicidal acts.
Medically treated nonfatal suicide attempts were identified via the Nationwide Inpatient Sample and Nationwide Emergency Department Sample databases, and suicide deaths were identified via the National Vital Statistics System.
The incidence rate of total suicidal acts rose 10% during the study period (annual percentage change [APC] 0.8%; 95% confidence interval [CI], 0.3%-1.3%). The case fatality rate (CFR) increased 13% (APC, 2.3%; 95% CI, 1.3%-3.3%).
In subgroup analyses, the incidence rate of suicidal acts increased 1.1% (95% CI, 0.6%-1.6%) per year for women but held stable for men. The CFR increased for women and men, with APCs of 5% (95% CI, 3.1%-6.9%) since 2010 for women and 1.6% (95% CI, 0.6%-2.5%) since 2009 for men.
The data show an increase in incidence rate of suicidal acts among adults aged 65-74 years throughout the study period, and among adolescents from 2011 to 2015. The CFR increased since 2009 among those aged 20-44 years (APC, 3.7%; 95% CI, 2.5%-5.0%) and since 2012 for individuals 45-64 years (APC, 2.7%; 95% CI, 0%-5.4%).
Among males and females aged 20-64 years, suicidal acts involving guns and suffocation (methods of greater lethality) increased, but suicidal acts by poisoning (a method of lesser lethality) decreased or flattened, “which may explain the observed increases in lethality,” the CDC researchers said.
“Adolescents and older adults aged 65-74 years experienced general increases in suicide attempts by all means, including poisoning, which was associated with stable or declining lethality for these subgroups,” they reported.
Dr. Wang and colleagues said their findings on population-level epidemiologic patterns may help with efforts to develop comprehensive suicide prevention strategies.
In particular, they said, reducing access to lethal means of suicide among those at risk, “which include not only firearms but also medications and other potentially dangerous household products, may be a helpful approach for reducing suicide rates.
“Ultimately, upstream prevention approaches, including teaching coping and problem-solving skills early in life, promoting connectedness, and developing and implementing policies that strengthen economic supports, may mitigate the risk of suicidal behavior for all age groups,” they concluded.
The study had no specific funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
From 2006 to 2015, suicide attempts in the United States became more common and more lethal in certain subgroups of the population, new data from the Centers for Disease Control and Prevention show.
Investigators found the incidence of suicidal acts increased in females, adolescents, and older adults aged 65-74 years, whereas suicidal acts became more lethal in both sexes and in those between the ages of 20 and 64 years.
“Effective suicide prevention efforts must be informed by an understanding of whether increased suicide rates are associated with more suicidal acts, greater lethality of suicidal acts, or a combination of both,” wrote Jing Wang, MD, MPH, and colleagues at the CDC’s National Center for Injury Prevention and Control.
The study was published online April 22 in JAMA Psychiatry.
Prior U.S. studies show a greater incidence of suicide attempts among some adult subgroups and young people, as well as changing patterns in suicide methods over time.
Between 2000 and 2010, for example, the rate of suicide by suffocation jumped 52% compared with a 19% increase in suicide by poisoning and a 3% increase in firearm-related suicides.
However, until now, there’s been no research examining the trends in both incidence and lethality of suicidal acts.
Medically treated nonfatal suicide attempts were identified via the Nationwide Inpatient Sample and Nationwide Emergency Department Sample databases, and suicide deaths were identified via the National Vital Statistics System.
The incidence rate of total suicidal acts rose 10% during the study period (annual percentage change [APC] 0.8%; 95% confidence interval [CI], 0.3%-1.3%). The case fatality rate (CFR) increased 13% (APC, 2.3%; 95% CI, 1.3%-3.3%).
In subgroup analyses, the incidence rate of suicidal acts increased 1.1% (95% CI, 0.6%-1.6%) per year for women but held stable for men. The CFR increased for women and men, with APCs of 5% (95% CI, 3.1%-6.9%) since 2010 for women and 1.6% (95% CI, 0.6%-2.5%) since 2009 for men.
The data show an increase in incidence rate of suicidal acts among adults aged 65-74 years throughout the study period, and among adolescents from 2011 to 2015. The CFR increased since 2009 among those aged 20-44 years (APC, 3.7%; 95% CI, 2.5%-5.0%) and since 2012 for individuals 45-64 years (APC, 2.7%; 95% CI, 0%-5.4%).
Among males and females aged 20-64 years, suicidal acts involving guns and suffocation (methods of greater lethality) increased, but suicidal acts by poisoning (a method of lesser lethality) decreased or flattened, “which may explain the observed increases in lethality,” the CDC researchers said.
“Adolescents and older adults aged 65-74 years experienced general increases in suicide attempts by all means, including poisoning, which was associated with stable or declining lethality for these subgroups,” they reported.
Dr. Wang and colleagues said their findings on population-level epidemiologic patterns may help with efforts to develop comprehensive suicide prevention strategies.
In particular, they said, reducing access to lethal means of suicide among those at risk, “which include not only firearms but also medications and other potentially dangerous household products, may be a helpful approach for reducing suicide rates.
“Ultimately, upstream prevention approaches, including teaching coping and problem-solving skills early in life, promoting connectedness, and developing and implementing policies that strengthen economic supports, may mitigate the risk of suicidal behavior for all age groups,” they concluded.
The study had no specific funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Reproductive psychiatry during the COVID-19 pandemic
When last I wrote this column, I was preparing for travel to professional meetings in the spring, planning a presentation for an upcoming grand rounds, and readying to host a scientific advisory board meeting as part of a large scientific project we conduct in Center for Women’s Mental Health. We were also awaiting the relocation of several junior faculty and research staff to Boston this spring and summer as we build our team.
It is now obvious that the COVID-19 pandemic is not a passing squall, but rather a persistent gale that has placed our collective sails in the water. It has not capsized the boat, however, thanks in part to the actions of courageous frontline caregivers and first responders who have mobilized in the wake of this recent public health crisis. From doctors, nurses, and hospital staff to grocery store clerks, home health aides, and neighbors checking in on the elderly – to name just a few – a whole crew of members across society have helped buoy our collective ship. Resilience also is required by all of us who are managing the array of feelings brought about by the day-in, day-out challenges of living life with restricted movement and freedom to engage in pre-COVID-19 activities we took for granted. What seemed like a temporary workaround is now becoming the “new normal” for an unknown amount of time looking forward.
For over 3 decades, my colleagues and I have worked with women who suffer from serious psychiatric disorders and whose treatment has required psychiatric medications such as antidepressants, mood stabilizers, and anxiolytics. The challenge of our work with women who are pregnant or planning pregnancy has been the configuration of the safest ways to navigate treatment on an individual basis for these women across pregnancy and post partum, with continual assessments of how to minimize the risk to fetus from in utero exposure to medications that have been instrumental in the treatment of psychiatric disorders on one hand versus the risks of untreated psychiatric disorder on the other. This work has been the essence of the clinical mission and the cornerstone of the research conducted at the Center for Women’s Mental Health since its inception.
While I have worked shoulder to shoulder with obstetricians for years, my respect for these colleagues during these past weeks has only grown as they have instituted the swiftest protocols to mitigate risk associated with COVID-19 for our pregnant patients, some of whom have tested positive for COVID-19, all in an effort to keep both mother, fetus, and newborn as safe as possible.
For those of us providing mental health services to pregnant women during this time, certain clinical situations have arisen in the context of the COVID-19 pandemic which require particular attention and discussion.
Planned pregnancy and contraception during the COVID-19 pandemic
Half of the pregnancies in this country are unplanned. Now more than ever, it is critical that decisions about moving forward with a plan to conceive be deliberate. These considerations range from the existential to the most concrete. For example, during these last weeks, we have consulted on cases where couples on the cusp of attempts to conceive face concerns about COVID-19, hence making more complicated their timeline with respect to actual plans to get pregnant. These are complicated decisions, particularly for women who may be slightly older and at the reproductive age where delaying pregnancy may have an adverse effect on fertility.
A concrete example of how the pandemic has affected fertility is evident as we encounter situations where women may defer starting a prescription oral contraceptive or lapse in its use because they have had difficulty coordinating visits with health care providers and may fear picking up prescriptions from pharmacies. We also have seen that procedures such as IUD placements have been deferred or canceled, or that some patients decline trips to the hospital or clinic to receive this type of service. These new barriers to access of contraception may require more planning at this time so that decisions about family planning are by design and not default during a time as complicated as the current public health crisis.
Telemedicine: telepsychiatry and obstetrics virtual visits
While wide-scale use of telemedicine platforms was not the standard day-to-day practice in either obstetrics or psychiatry prior to the pandemic, telepsychiatry has come up to speed within a short number of weeks. At our institution, 85% of outpatient visits are being conducted remotely, with in-person visits being reserved for only urgent or emergent visits. Our inpatient psychiatry service remains a setting where psychiatric patients, regardless of their COVID-19 status, can receive necessary care.
The use of telemedicine and specifically telepsychiatry is critical to mitigate the likelihood of exposure to SARS-CoV-2. On our reproductive psychiatry service, it has actually been an opportunity to engage with patients for comprehensive initial consults about reproductive safety of psychiatric medications currently being taken, or for ongoing consultation and direct patient care during follow-up visits during pregnancy to see that patients are sustaining emotional well-being or have changes for treatment implemented if they are not well. An increased frequency of visits allows us more opportunity to capture any signs of early clinical worsening of symptoms that might have been missed previously using the more traditional in-person setting.
Telepsychiatry and “virtual visits” have allowed us to do real-time, nimble modifications of treatment regimens with both pharmacologic and nonpharmacologic interventions to keep women well and to keep them out of the hospital for psychiatric care as often as possible. It also has facilitated a closer collaboration with our colleagues in obstetrics. In a way, the team of providers, including psychiatrists, obstetrical providers, social workers, and therapists can more easily communicate virtually than has sometimes been the case previously, when day-to-day use of telemedicine and virtual team meetings was less common.
Recognition and treatment of anxiety in perinatal patients
Even pregnant women without preexisting anxiety disorders may have heightened anxiety during usual times, and women and their partners cope with this typically in numerous ways including participation in peer-support opportunities, wellness and self-care activities, leveraging support from care providers, and engaging with family. But the previously “typical pregnancy experience” has shifted in the context of COVID-19. Specifically, added concerns of pregnant women about becoming infected, of potential separation from family if they do become ill, or of separation from partners or support systems during labor and delivery (an issue that has been largely resolved in many hospitals), as well as the possibility that a neonate might become ill with exposure to the coronavirus are obviously understandable and real. Such contingencies are unsettling, even for the most settled of our patients. Labor and delivery plans, and plans for outside help from family or others with the baby and older children in the postpartum period, have been upended for many patients.
These are anxious times. The number of nonpharmacologic virtual interventions available to mitigate anxiety are filling email inboxes daily. Curating these options can be a challenge, although several resources are worth noting, such as our department’s page on mental health resources.
During these past weeks, we have seen growing numbers of women for whom the normative anxiety of pregnancy is increasing to the point of causing distress to the level of functional impairment. Many patients for the first time meet criteria for frank anxiety disorders. These patients deserve prompt evaluation by mental health professionals and treatment with evidence-based therapies for anxiety disorders whether nonpharmacologic or pharmacologic so as to mitigate the risk of untreated anxiety on maternal and fetal well-being and also to limit risk for postpartum depression and postpartum anxiety disorders.
Miscarriage and infertility
A 36-year-old patient came to see me in clinic in late January following a miscarriage. She had a history of a previous miscarriage a year before and had an episode of major depression to follow for which she received treatment with an antidepressant and cognitive-behavioral therapy; she also attended a perinatal loss support group. She saw me in early March, anxious to try to conceive but extremely concerned about the risks associated with becoming pregnant at this point in time. Following a lengthy discussion with me and her obstetrician, the patient decided to wait until “the curve flattened” in Boston in terms of new cases of COVID-19, and then start trying to conceive. The case of another patient with a very similar history was presented at our rounds a few weeks ago; she also elected to defer attempts to conceive until life is more settled.
Perhaps one of the most dramatic examples of the impact of COVID-19 on fertility has been for those women with plans to pursue treatment with one of the assisted reproductive technologies. They have been told that professional societies have made recommendations regarding use of assisted reproductive technologies that are not entirely consistent across the country, but where in many places such interventions have been suspended during the COVID-19 pandemic. For many women near the end of their reproductive years, delays in trying to conceive either with or without the aid of fertility treatments may indelibly shape their plans to have children.
Sustaining emotional well-being across pregnancy
Because most psychiatric disorders are chronic in course, it is often the situation where women are treated to wellness for serious psychiatric disorders, with the goal of maintaining wellness across pregnancy and the post partum. One of the most critical takeaway points from 30 years of working with psychiatrically ill pregnant women is the maxim that keeping women well during pregnancy is simply imperative. Maternal psychiatric well-being during pregnancy is a strong predictor of obstetrical and neonatal outcomes, postpartum mental health, and longer-term neurobehavioral outcomes in children. Critically, in the context of the pandemic, keeping women out of psychiatric crises mitigates the necessity of visits to urgent clinical settings such as EDs and psychiatric inpatient units, which can increase the likelihood of exposure to the coronavirus.
Preservation of sleep
Disruption in sleep (duration and quality) can be seen in well over half of women during pregnancy with and without psychiatric disorders, and our experience has been that this has been exacerbated for many women during the COVID-19 crisis. Yet there are very rich data showing that sleep deprivation or sleep dysregulation in women, for example, who suffer from bipolar disorder or major depression can be a strong trigger for psychiatric relapse of underlying illness during pregnancy and the postpartum period.
During a time when normal rhythms of day-to-day life have been shifted – if not frankly disrupted – by swift transitions to remote work, cancellation of school and associated school activities across the country, complaints of insomnia and non-restorative sleep have been exceedingly common. Relevant to all but particularly for pregnant women with histories of psychiatric disorder, attention to sleep hygiene, moderation of caffeine use (if any), and use of any number of biobehavioral interventions to enhance relaxation and modulate stress may be of great value.
Cognitive-behavioral therapy for insomnia (CBT-I) has been demonstrated to be effective in pregnant women. Fortunately, there are user-friendly options on digital platforms that can be used during the pandemic that may play an important role in sustaining emotional well-being for pregnant women who have frank symptoms of insomnia.
Maintenance of ongoing antidepressant treatment during pregnancy among women with histories of mood disorder
Over a decade ago, my colleagues and I wrote about the comparison of outcomes for women with histories of recurrent major depression, demonstrating the value of maintenance treatment with antidepressants, compared with discontinuation of these medications during pregnancy (JAMA. 2006 Feb 1;295[5]:499-507). Recently, I was asked if maintenance antidepressant use in women with histories of recurrent depression was still our clinical recommendation. Over the last decade, we have noted that nearly half of women treated with antidepressants, regardless of illness severity, will discontinue their use of these medications prior to or early on in pregnancy given concerns about potential unknown effects of fetal exposure to medications, even medications for which there are robust data supporting reproductive safety regarding risk of congenital malformations. Routine discontinuation of antidepressants prior to or during pregnancy continues, despite the fact that we showed nearly 70% of those women with past histories of depression on maintenance antidepressant treatment relapsed shortly after discontinuing medication.
While we do not dictate the decisions women make about antidepressant use before, during, or after pregnancy, women with the same severity of illness will frequently make different decisions (a good thing) but we are now having very frank discussions about the particular need during a pandemic to avoid the relapse of serious psychiatric disorders. We typically endorse maintenance medication use with all but a very few number of psychotropic medications for which benefit may not outweigh risk to the fetus. However, for women who have decided nonetheless to discontinue antidepressants or other psychotropics during pregnancy despite the known risk of relapse, we strongly advise that they initiate treatment with evidence-based nonpharmacologic intervention such as CBT or mindfulness-based cognitive therapy (MBCT).
As in other areas of medicine, the pandemic is prompting we professionals in psychiatry, and specifically in perinatal psychiatry, to use all of our tools to keep pregnant and postpartum women well. The availability of digital tools to deliver MBCT and CBT has made the use of such interventions particularly viable at a time of social distancing. That being said, for patients with highly recurrent affective disorder with histories of previous recurrence when they stop their antidepressants, we are more strongly recommending serious consideration of maintenance medication treatment.
Virtual rounds in reproductive psychiatry and women’s mental health
The use of virtual platforms to connect with both patients and colleagues also has provided new opportunities for interaction with the reproductive psychiatry community as a whole. Peer teaching and peer support has been a critical part of our mission, and we decided 1 month ago to establish Virtual Rounds at the Center for Women’s Mental Health. This is a free digital platform, held on a weekly basis with our colleagues from across the country, where we discuss cases that come up in our own clinical rounds and also questions that get put forth by our colleagues in the area of reproductive psychiatry as they manage patients during the pandemic.
Changes in the postpartum experience
The last decade has brought a growing appreciation of postpartum depression and the need to screen and treat postpartum psychiatric disorders, such as postpartum mood and anxiety disorders. Yet in the era of this pandemic, the postpartum experience is itself is changing. Changes in carefully configured plans for the postpartum period – from family coming and going to mobilizing extra support at home and to now having new moms having to manage families and their other children at home – has been an enormous stressor for many women. Plans to have more elderly parents visit during the acute postpartum period, and the increased concerns about people traveling to and from a home where there is a newborn and the need to quarantine, has made the transition to motherhood much more complicated for all postpartum women, let alone for those postpartum women who have histories of psychiatric disorder.
There is a risk of social isolation for postpartum women even under normal circumstances, and this is profoundly more likely during this pandemic. We are actively working with our postpartum patients and optimizing treatment, brainstorming options in terms of using both virtual and real-time support to the extent that it is safe in order to keep women healthy during such a stressful and critical time.
I am heartened by the efforts on the part of organizations such as Postpartum Support International to make available virtually their resources with respect to community-based support and education for women who feel increasingly isolated during the postpartum period, a time where connectedness is so critical.
Summarily, these have been challenging times, but also times of opportunity. The COVID-19 pandemic has prompted us to get even more creative as we configure ways to optimize the emotional well-being of our patients who are planning to get pregnant, who are pregnant, or who are post partum.
The current time, while challenging in so many ways and a time of great pain, loss, and grief for far too many, has also provided an opportunity to work even more collaboratively with our colleagues, coming up with new paradigms of treatments as we weather this historic challenge.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email him at [email protected].
When last I wrote this column, I was preparing for travel to professional meetings in the spring, planning a presentation for an upcoming grand rounds, and readying to host a scientific advisory board meeting as part of a large scientific project we conduct in Center for Women’s Mental Health. We were also awaiting the relocation of several junior faculty and research staff to Boston this spring and summer as we build our team.
It is now obvious that the COVID-19 pandemic is not a passing squall, but rather a persistent gale that has placed our collective sails in the water. It has not capsized the boat, however, thanks in part to the actions of courageous frontline caregivers and first responders who have mobilized in the wake of this recent public health crisis. From doctors, nurses, and hospital staff to grocery store clerks, home health aides, and neighbors checking in on the elderly – to name just a few – a whole crew of members across society have helped buoy our collective ship. Resilience also is required by all of us who are managing the array of feelings brought about by the day-in, day-out challenges of living life with restricted movement and freedom to engage in pre-COVID-19 activities we took for granted. What seemed like a temporary workaround is now becoming the “new normal” for an unknown amount of time looking forward.
For over 3 decades, my colleagues and I have worked with women who suffer from serious psychiatric disorders and whose treatment has required psychiatric medications such as antidepressants, mood stabilizers, and anxiolytics. The challenge of our work with women who are pregnant or planning pregnancy has been the configuration of the safest ways to navigate treatment on an individual basis for these women across pregnancy and post partum, with continual assessments of how to minimize the risk to fetus from in utero exposure to medications that have been instrumental in the treatment of psychiatric disorders on one hand versus the risks of untreated psychiatric disorder on the other. This work has been the essence of the clinical mission and the cornerstone of the research conducted at the Center for Women’s Mental Health since its inception.
While I have worked shoulder to shoulder with obstetricians for years, my respect for these colleagues during these past weeks has only grown as they have instituted the swiftest protocols to mitigate risk associated with COVID-19 for our pregnant patients, some of whom have tested positive for COVID-19, all in an effort to keep both mother, fetus, and newborn as safe as possible.
For those of us providing mental health services to pregnant women during this time, certain clinical situations have arisen in the context of the COVID-19 pandemic which require particular attention and discussion.
Planned pregnancy and contraception during the COVID-19 pandemic
Half of the pregnancies in this country are unplanned. Now more than ever, it is critical that decisions about moving forward with a plan to conceive be deliberate. These considerations range from the existential to the most concrete. For example, during these last weeks, we have consulted on cases where couples on the cusp of attempts to conceive face concerns about COVID-19, hence making more complicated their timeline with respect to actual plans to get pregnant. These are complicated decisions, particularly for women who may be slightly older and at the reproductive age where delaying pregnancy may have an adverse effect on fertility.
A concrete example of how the pandemic has affected fertility is evident as we encounter situations where women may defer starting a prescription oral contraceptive or lapse in its use because they have had difficulty coordinating visits with health care providers and may fear picking up prescriptions from pharmacies. We also have seen that procedures such as IUD placements have been deferred or canceled, or that some patients decline trips to the hospital or clinic to receive this type of service. These new barriers to access of contraception may require more planning at this time so that decisions about family planning are by design and not default during a time as complicated as the current public health crisis.
Telemedicine: telepsychiatry and obstetrics virtual visits
While wide-scale use of telemedicine platforms was not the standard day-to-day practice in either obstetrics or psychiatry prior to the pandemic, telepsychiatry has come up to speed within a short number of weeks. At our institution, 85% of outpatient visits are being conducted remotely, with in-person visits being reserved for only urgent or emergent visits. Our inpatient psychiatry service remains a setting where psychiatric patients, regardless of their COVID-19 status, can receive necessary care.
The use of telemedicine and specifically telepsychiatry is critical to mitigate the likelihood of exposure to SARS-CoV-2. On our reproductive psychiatry service, it has actually been an opportunity to engage with patients for comprehensive initial consults about reproductive safety of psychiatric medications currently being taken, or for ongoing consultation and direct patient care during follow-up visits during pregnancy to see that patients are sustaining emotional well-being or have changes for treatment implemented if they are not well. An increased frequency of visits allows us more opportunity to capture any signs of early clinical worsening of symptoms that might have been missed previously using the more traditional in-person setting.
Telepsychiatry and “virtual visits” have allowed us to do real-time, nimble modifications of treatment regimens with both pharmacologic and nonpharmacologic interventions to keep women well and to keep them out of the hospital for psychiatric care as often as possible. It also has facilitated a closer collaboration with our colleagues in obstetrics. In a way, the team of providers, including psychiatrists, obstetrical providers, social workers, and therapists can more easily communicate virtually than has sometimes been the case previously, when day-to-day use of telemedicine and virtual team meetings was less common.
Recognition and treatment of anxiety in perinatal patients
Even pregnant women without preexisting anxiety disorders may have heightened anxiety during usual times, and women and their partners cope with this typically in numerous ways including participation in peer-support opportunities, wellness and self-care activities, leveraging support from care providers, and engaging with family. But the previously “typical pregnancy experience” has shifted in the context of COVID-19. Specifically, added concerns of pregnant women about becoming infected, of potential separation from family if they do become ill, or of separation from partners or support systems during labor and delivery (an issue that has been largely resolved in many hospitals), as well as the possibility that a neonate might become ill with exposure to the coronavirus are obviously understandable and real. Such contingencies are unsettling, even for the most settled of our patients. Labor and delivery plans, and plans for outside help from family or others with the baby and older children in the postpartum period, have been upended for many patients.
These are anxious times. The number of nonpharmacologic virtual interventions available to mitigate anxiety are filling email inboxes daily. Curating these options can be a challenge, although several resources are worth noting, such as our department’s page on mental health resources.
During these past weeks, we have seen growing numbers of women for whom the normative anxiety of pregnancy is increasing to the point of causing distress to the level of functional impairment. Many patients for the first time meet criteria for frank anxiety disorders. These patients deserve prompt evaluation by mental health professionals and treatment with evidence-based therapies for anxiety disorders whether nonpharmacologic or pharmacologic so as to mitigate the risk of untreated anxiety on maternal and fetal well-being and also to limit risk for postpartum depression and postpartum anxiety disorders.
Miscarriage and infertility
A 36-year-old patient came to see me in clinic in late January following a miscarriage. She had a history of a previous miscarriage a year before and had an episode of major depression to follow for which she received treatment with an antidepressant and cognitive-behavioral therapy; she also attended a perinatal loss support group. She saw me in early March, anxious to try to conceive but extremely concerned about the risks associated with becoming pregnant at this point in time. Following a lengthy discussion with me and her obstetrician, the patient decided to wait until “the curve flattened” in Boston in terms of new cases of COVID-19, and then start trying to conceive. The case of another patient with a very similar history was presented at our rounds a few weeks ago; she also elected to defer attempts to conceive until life is more settled.
Perhaps one of the most dramatic examples of the impact of COVID-19 on fertility has been for those women with plans to pursue treatment with one of the assisted reproductive technologies. They have been told that professional societies have made recommendations regarding use of assisted reproductive technologies that are not entirely consistent across the country, but where in many places such interventions have been suspended during the COVID-19 pandemic. For many women near the end of their reproductive years, delays in trying to conceive either with or without the aid of fertility treatments may indelibly shape their plans to have children.
Sustaining emotional well-being across pregnancy
Because most psychiatric disorders are chronic in course, it is often the situation where women are treated to wellness for serious psychiatric disorders, with the goal of maintaining wellness across pregnancy and the post partum. One of the most critical takeaway points from 30 years of working with psychiatrically ill pregnant women is the maxim that keeping women well during pregnancy is simply imperative. Maternal psychiatric well-being during pregnancy is a strong predictor of obstetrical and neonatal outcomes, postpartum mental health, and longer-term neurobehavioral outcomes in children. Critically, in the context of the pandemic, keeping women out of psychiatric crises mitigates the necessity of visits to urgent clinical settings such as EDs and psychiatric inpatient units, which can increase the likelihood of exposure to the coronavirus.
Preservation of sleep
Disruption in sleep (duration and quality) can be seen in well over half of women during pregnancy with and without psychiatric disorders, and our experience has been that this has been exacerbated for many women during the COVID-19 crisis. Yet there are very rich data showing that sleep deprivation or sleep dysregulation in women, for example, who suffer from bipolar disorder or major depression can be a strong trigger for psychiatric relapse of underlying illness during pregnancy and the postpartum period.
During a time when normal rhythms of day-to-day life have been shifted – if not frankly disrupted – by swift transitions to remote work, cancellation of school and associated school activities across the country, complaints of insomnia and non-restorative sleep have been exceedingly common. Relevant to all but particularly for pregnant women with histories of psychiatric disorder, attention to sleep hygiene, moderation of caffeine use (if any), and use of any number of biobehavioral interventions to enhance relaxation and modulate stress may be of great value.
Cognitive-behavioral therapy for insomnia (CBT-I) has been demonstrated to be effective in pregnant women. Fortunately, there are user-friendly options on digital platforms that can be used during the pandemic that may play an important role in sustaining emotional well-being for pregnant women who have frank symptoms of insomnia.
Maintenance of ongoing antidepressant treatment during pregnancy among women with histories of mood disorder
Over a decade ago, my colleagues and I wrote about the comparison of outcomes for women with histories of recurrent major depression, demonstrating the value of maintenance treatment with antidepressants, compared with discontinuation of these medications during pregnancy (JAMA. 2006 Feb 1;295[5]:499-507). Recently, I was asked if maintenance antidepressant use in women with histories of recurrent depression was still our clinical recommendation. Over the last decade, we have noted that nearly half of women treated with antidepressants, regardless of illness severity, will discontinue their use of these medications prior to or early on in pregnancy given concerns about potential unknown effects of fetal exposure to medications, even medications for which there are robust data supporting reproductive safety regarding risk of congenital malformations. Routine discontinuation of antidepressants prior to or during pregnancy continues, despite the fact that we showed nearly 70% of those women with past histories of depression on maintenance antidepressant treatment relapsed shortly after discontinuing medication.
While we do not dictate the decisions women make about antidepressant use before, during, or after pregnancy, women with the same severity of illness will frequently make different decisions (a good thing) but we are now having very frank discussions about the particular need during a pandemic to avoid the relapse of serious psychiatric disorders. We typically endorse maintenance medication use with all but a very few number of psychotropic medications for which benefit may not outweigh risk to the fetus. However, for women who have decided nonetheless to discontinue antidepressants or other psychotropics during pregnancy despite the known risk of relapse, we strongly advise that they initiate treatment with evidence-based nonpharmacologic intervention such as CBT or mindfulness-based cognitive therapy (MBCT).
As in other areas of medicine, the pandemic is prompting we professionals in psychiatry, and specifically in perinatal psychiatry, to use all of our tools to keep pregnant and postpartum women well. The availability of digital tools to deliver MBCT and CBT has made the use of such interventions particularly viable at a time of social distancing. That being said, for patients with highly recurrent affective disorder with histories of previous recurrence when they stop their antidepressants, we are more strongly recommending serious consideration of maintenance medication treatment.
Virtual rounds in reproductive psychiatry and women’s mental health
The use of virtual platforms to connect with both patients and colleagues also has provided new opportunities for interaction with the reproductive psychiatry community as a whole. Peer teaching and peer support has been a critical part of our mission, and we decided 1 month ago to establish Virtual Rounds at the Center for Women’s Mental Health. This is a free digital platform, held on a weekly basis with our colleagues from across the country, where we discuss cases that come up in our own clinical rounds and also questions that get put forth by our colleagues in the area of reproductive psychiatry as they manage patients during the pandemic.
Changes in the postpartum experience
The last decade has brought a growing appreciation of postpartum depression and the need to screen and treat postpartum psychiatric disorders, such as postpartum mood and anxiety disorders. Yet in the era of this pandemic, the postpartum experience is itself is changing. Changes in carefully configured plans for the postpartum period – from family coming and going to mobilizing extra support at home and to now having new moms having to manage families and their other children at home – has been an enormous stressor for many women. Plans to have more elderly parents visit during the acute postpartum period, and the increased concerns about people traveling to and from a home where there is a newborn and the need to quarantine, has made the transition to motherhood much more complicated for all postpartum women, let alone for those postpartum women who have histories of psychiatric disorder.
There is a risk of social isolation for postpartum women even under normal circumstances, and this is profoundly more likely during this pandemic. We are actively working with our postpartum patients and optimizing treatment, brainstorming options in terms of using both virtual and real-time support to the extent that it is safe in order to keep women healthy during such a stressful and critical time.
I am heartened by the efforts on the part of organizations such as Postpartum Support International to make available virtually their resources with respect to community-based support and education for women who feel increasingly isolated during the postpartum period, a time where connectedness is so critical.
Summarily, these have been challenging times, but also times of opportunity. The COVID-19 pandemic has prompted us to get even more creative as we configure ways to optimize the emotional well-being of our patients who are planning to get pregnant, who are pregnant, or who are post partum.
The current time, while challenging in so many ways and a time of great pain, loss, and grief for far too many, has also provided an opportunity to work even more collaboratively with our colleagues, coming up with new paradigms of treatments as we weather this historic challenge.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email him at [email protected].
When last I wrote this column, I was preparing for travel to professional meetings in the spring, planning a presentation for an upcoming grand rounds, and readying to host a scientific advisory board meeting as part of a large scientific project we conduct in Center for Women’s Mental Health. We were also awaiting the relocation of several junior faculty and research staff to Boston this spring and summer as we build our team.
It is now obvious that the COVID-19 pandemic is not a passing squall, but rather a persistent gale that has placed our collective sails in the water. It has not capsized the boat, however, thanks in part to the actions of courageous frontline caregivers and first responders who have mobilized in the wake of this recent public health crisis. From doctors, nurses, and hospital staff to grocery store clerks, home health aides, and neighbors checking in on the elderly – to name just a few – a whole crew of members across society have helped buoy our collective ship. Resilience also is required by all of us who are managing the array of feelings brought about by the day-in, day-out challenges of living life with restricted movement and freedom to engage in pre-COVID-19 activities we took for granted. What seemed like a temporary workaround is now becoming the “new normal” for an unknown amount of time looking forward.
For over 3 decades, my colleagues and I have worked with women who suffer from serious psychiatric disorders and whose treatment has required psychiatric medications such as antidepressants, mood stabilizers, and anxiolytics. The challenge of our work with women who are pregnant or planning pregnancy has been the configuration of the safest ways to navigate treatment on an individual basis for these women across pregnancy and post partum, with continual assessments of how to minimize the risk to fetus from in utero exposure to medications that have been instrumental in the treatment of psychiatric disorders on one hand versus the risks of untreated psychiatric disorder on the other. This work has been the essence of the clinical mission and the cornerstone of the research conducted at the Center for Women’s Mental Health since its inception.
While I have worked shoulder to shoulder with obstetricians for years, my respect for these colleagues during these past weeks has only grown as they have instituted the swiftest protocols to mitigate risk associated with COVID-19 for our pregnant patients, some of whom have tested positive for COVID-19, all in an effort to keep both mother, fetus, and newborn as safe as possible.
For those of us providing mental health services to pregnant women during this time, certain clinical situations have arisen in the context of the COVID-19 pandemic which require particular attention and discussion.
Planned pregnancy and contraception during the COVID-19 pandemic
Half of the pregnancies in this country are unplanned. Now more than ever, it is critical that decisions about moving forward with a plan to conceive be deliberate. These considerations range from the existential to the most concrete. For example, during these last weeks, we have consulted on cases where couples on the cusp of attempts to conceive face concerns about COVID-19, hence making more complicated their timeline with respect to actual plans to get pregnant. These are complicated decisions, particularly for women who may be slightly older and at the reproductive age where delaying pregnancy may have an adverse effect on fertility.
A concrete example of how the pandemic has affected fertility is evident as we encounter situations where women may defer starting a prescription oral contraceptive or lapse in its use because they have had difficulty coordinating visits with health care providers and may fear picking up prescriptions from pharmacies. We also have seen that procedures such as IUD placements have been deferred or canceled, or that some patients decline trips to the hospital or clinic to receive this type of service. These new barriers to access of contraception may require more planning at this time so that decisions about family planning are by design and not default during a time as complicated as the current public health crisis.
Telemedicine: telepsychiatry and obstetrics virtual visits
While wide-scale use of telemedicine platforms was not the standard day-to-day practice in either obstetrics or psychiatry prior to the pandemic, telepsychiatry has come up to speed within a short number of weeks. At our institution, 85% of outpatient visits are being conducted remotely, with in-person visits being reserved for only urgent or emergent visits. Our inpatient psychiatry service remains a setting where psychiatric patients, regardless of their COVID-19 status, can receive necessary care.
The use of telemedicine and specifically telepsychiatry is critical to mitigate the likelihood of exposure to SARS-CoV-2. On our reproductive psychiatry service, it has actually been an opportunity to engage with patients for comprehensive initial consults about reproductive safety of psychiatric medications currently being taken, or for ongoing consultation and direct patient care during follow-up visits during pregnancy to see that patients are sustaining emotional well-being or have changes for treatment implemented if they are not well. An increased frequency of visits allows us more opportunity to capture any signs of early clinical worsening of symptoms that might have been missed previously using the more traditional in-person setting.
Telepsychiatry and “virtual visits” have allowed us to do real-time, nimble modifications of treatment regimens with both pharmacologic and nonpharmacologic interventions to keep women well and to keep them out of the hospital for psychiatric care as often as possible. It also has facilitated a closer collaboration with our colleagues in obstetrics. In a way, the team of providers, including psychiatrists, obstetrical providers, social workers, and therapists can more easily communicate virtually than has sometimes been the case previously, when day-to-day use of telemedicine and virtual team meetings was less common.
Recognition and treatment of anxiety in perinatal patients
Even pregnant women without preexisting anxiety disorders may have heightened anxiety during usual times, and women and their partners cope with this typically in numerous ways including participation in peer-support opportunities, wellness and self-care activities, leveraging support from care providers, and engaging with family. But the previously “typical pregnancy experience” has shifted in the context of COVID-19. Specifically, added concerns of pregnant women about becoming infected, of potential separation from family if they do become ill, or of separation from partners or support systems during labor and delivery (an issue that has been largely resolved in many hospitals), as well as the possibility that a neonate might become ill with exposure to the coronavirus are obviously understandable and real. Such contingencies are unsettling, even for the most settled of our patients. Labor and delivery plans, and plans for outside help from family or others with the baby and older children in the postpartum period, have been upended for many patients.
These are anxious times. The number of nonpharmacologic virtual interventions available to mitigate anxiety are filling email inboxes daily. Curating these options can be a challenge, although several resources are worth noting, such as our department’s page on mental health resources.
During these past weeks, we have seen growing numbers of women for whom the normative anxiety of pregnancy is increasing to the point of causing distress to the level of functional impairment. Many patients for the first time meet criteria for frank anxiety disorders. These patients deserve prompt evaluation by mental health professionals and treatment with evidence-based therapies for anxiety disorders whether nonpharmacologic or pharmacologic so as to mitigate the risk of untreated anxiety on maternal and fetal well-being and also to limit risk for postpartum depression and postpartum anxiety disorders.
Miscarriage and infertility
A 36-year-old patient came to see me in clinic in late January following a miscarriage. She had a history of a previous miscarriage a year before and had an episode of major depression to follow for which she received treatment with an antidepressant and cognitive-behavioral therapy; she also attended a perinatal loss support group. She saw me in early March, anxious to try to conceive but extremely concerned about the risks associated with becoming pregnant at this point in time. Following a lengthy discussion with me and her obstetrician, the patient decided to wait until “the curve flattened” in Boston in terms of new cases of COVID-19, and then start trying to conceive. The case of another patient with a very similar history was presented at our rounds a few weeks ago; she also elected to defer attempts to conceive until life is more settled.
Perhaps one of the most dramatic examples of the impact of COVID-19 on fertility has been for those women with plans to pursue treatment with one of the assisted reproductive technologies. They have been told that professional societies have made recommendations regarding use of assisted reproductive technologies that are not entirely consistent across the country, but where in many places such interventions have been suspended during the COVID-19 pandemic. For many women near the end of their reproductive years, delays in trying to conceive either with or without the aid of fertility treatments may indelibly shape their plans to have children.
Sustaining emotional well-being across pregnancy
Because most psychiatric disorders are chronic in course, it is often the situation where women are treated to wellness for serious psychiatric disorders, with the goal of maintaining wellness across pregnancy and the post partum. One of the most critical takeaway points from 30 years of working with psychiatrically ill pregnant women is the maxim that keeping women well during pregnancy is simply imperative. Maternal psychiatric well-being during pregnancy is a strong predictor of obstetrical and neonatal outcomes, postpartum mental health, and longer-term neurobehavioral outcomes in children. Critically, in the context of the pandemic, keeping women out of psychiatric crises mitigates the necessity of visits to urgent clinical settings such as EDs and psychiatric inpatient units, which can increase the likelihood of exposure to the coronavirus.
Preservation of sleep
Disruption in sleep (duration and quality) can be seen in well over half of women during pregnancy with and without psychiatric disorders, and our experience has been that this has been exacerbated for many women during the COVID-19 crisis. Yet there are very rich data showing that sleep deprivation or sleep dysregulation in women, for example, who suffer from bipolar disorder or major depression can be a strong trigger for psychiatric relapse of underlying illness during pregnancy and the postpartum period.
During a time when normal rhythms of day-to-day life have been shifted – if not frankly disrupted – by swift transitions to remote work, cancellation of school and associated school activities across the country, complaints of insomnia and non-restorative sleep have been exceedingly common. Relevant to all but particularly for pregnant women with histories of psychiatric disorder, attention to sleep hygiene, moderation of caffeine use (if any), and use of any number of biobehavioral interventions to enhance relaxation and modulate stress may be of great value.
Cognitive-behavioral therapy for insomnia (CBT-I) has been demonstrated to be effective in pregnant women. Fortunately, there are user-friendly options on digital platforms that can be used during the pandemic that may play an important role in sustaining emotional well-being for pregnant women who have frank symptoms of insomnia.
Maintenance of ongoing antidepressant treatment during pregnancy among women with histories of mood disorder
Over a decade ago, my colleagues and I wrote about the comparison of outcomes for women with histories of recurrent major depression, demonstrating the value of maintenance treatment with antidepressants, compared with discontinuation of these medications during pregnancy (JAMA. 2006 Feb 1;295[5]:499-507). Recently, I was asked if maintenance antidepressant use in women with histories of recurrent depression was still our clinical recommendation. Over the last decade, we have noted that nearly half of women treated with antidepressants, regardless of illness severity, will discontinue their use of these medications prior to or early on in pregnancy given concerns about potential unknown effects of fetal exposure to medications, even medications for which there are robust data supporting reproductive safety regarding risk of congenital malformations. Routine discontinuation of antidepressants prior to or during pregnancy continues, despite the fact that we showed nearly 70% of those women with past histories of depression on maintenance antidepressant treatment relapsed shortly after discontinuing medication.
While we do not dictate the decisions women make about antidepressant use before, during, or after pregnancy, women with the same severity of illness will frequently make different decisions (a good thing) but we are now having very frank discussions about the particular need during a pandemic to avoid the relapse of serious psychiatric disorders. We typically endorse maintenance medication use with all but a very few number of psychotropic medications for which benefit may not outweigh risk to the fetus. However, for women who have decided nonetheless to discontinue antidepressants or other psychotropics during pregnancy despite the known risk of relapse, we strongly advise that they initiate treatment with evidence-based nonpharmacologic intervention such as CBT or mindfulness-based cognitive therapy (MBCT).
As in other areas of medicine, the pandemic is prompting we professionals in psychiatry, and specifically in perinatal psychiatry, to use all of our tools to keep pregnant and postpartum women well. The availability of digital tools to deliver MBCT and CBT has made the use of such interventions particularly viable at a time of social distancing. That being said, for patients with highly recurrent affective disorder with histories of previous recurrence when they stop their antidepressants, we are more strongly recommending serious consideration of maintenance medication treatment.
Virtual rounds in reproductive psychiatry and women’s mental health
The use of virtual platforms to connect with both patients and colleagues also has provided new opportunities for interaction with the reproductive psychiatry community as a whole. Peer teaching and peer support has been a critical part of our mission, and we decided 1 month ago to establish Virtual Rounds at the Center for Women’s Mental Health. This is a free digital platform, held on a weekly basis with our colleagues from across the country, where we discuss cases that come up in our own clinical rounds and also questions that get put forth by our colleagues in the area of reproductive psychiatry as they manage patients during the pandemic.
Changes in the postpartum experience
The last decade has brought a growing appreciation of postpartum depression and the need to screen and treat postpartum psychiatric disorders, such as postpartum mood and anxiety disorders. Yet in the era of this pandemic, the postpartum experience is itself is changing. Changes in carefully configured plans for the postpartum period – from family coming and going to mobilizing extra support at home and to now having new moms having to manage families and their other children at home – has been an enormous stressor for many women. Plans to have more elderly parents visit during the acute postpartum period, and the increased concerns about people traveling to and from a home where there is a newborn and the need to quarantine, has made the transition to motherhood much more complicated for all postpartum women, let alone for those postpartum women who have histories of psychiatric disorder.
There is a risk of social isolation for postpartum women even under normal circumstances, and this is profoundly more likely during this pandemic. We are actively working with our postpartum patients and optimizing treatment, brainstorming options in terms of using both virtual and real-time support to the extent that it is safe in order to keep women healthy during such a stressful and critical time.
I am heartened by the efforts on the part of organizations such as Postpartum Support International to make available virtually their resources with respect to community-based support and education for women who feel increasingly isolated during the postpartum period, a time where connectedness is so critical.
Summarily, these have been challenging times, but also times of opportunity. The COVID-19 pandemic has prompted us to get even more creative as we configure ways to optimize the emotional well-being of our patients who are planning to get pregnant, who are pregnant, or who are post partum.
The current time, while challenging in so many ways and a time of great pain, loss, and grief for far too many, has also provided an opportunity to work even more collaboratively with our colleagues, coming up with new paradigms of treatments as we weather this historic challenge.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email him at [email protected].
COVID-19: Loss and grief without an expiration date
We are all experiencing collective loss and grief because of COVID-19, but that doesn’t mean that we are experiencing the same loss or grieving the same way.
Losses can be unique to individuals, such as the death of a loved one or divorce from a spouse. They can also be more universal, such as the tragedy of Sept. 11, 2001. However, both of these types of losses are generally associated with a distinct event that has a known beginning and endpoint. What makes the losses related to the coronavirus so different is that there is not a known expiration date. This lack of certainty about when the losses caused by the pandemic will end makes it difficult to process and mourn appropriately.
The multitude of potential losses includes, of course, the death of thousands of people. Many of us have personally lost loved ones or know people who have had loss because of COVID-19-related illnesses. There have also been numerous illnesses caused by delayed medical care tied to fears of going to a hospital during the pandemic. Unfortunately, there is an anticipatory loss because of the invariable diseases that will be diagnosed because of the halt of routine and preventive medical care during this current restricted phase of social distancing.
There are also losses that are not related to health. These more intangible losses may include the loss of employment and stable income; loss of our children’s completion of their academic year; loss of socialization; loss of travel and visits to friends and family; loss of normal childbirth where a pregnant mother is accompanied by her partner; loss of visiting sick relatives and newborns; loss of dating, weddings, graduations, and milestone birthday celebrations; loss of visits to nursing homes of your loved ones; loss of the needed services and support to help with your young child’s disabilities; and loss of intimacy, connection and touch.
Such losses may seem inconsequential, compared with the death of an acquaintance or loved one. But we do not know the back story behind these other losses. For example, could a family member who is unable to meet the newest addition to the family have a terminal disease and his or her own expiration date? Could the lack of dating exacerbate a new divorcée’s feeling of loneliness and despair?
When we know the details associated with the individual’s loss due to COVID-19, we can understand and better empathize. Continued collective loss without an expiration date will lead to collective grief without an endpoint.
Stages of grief
The five distinct stages of grief experienced after a loss were initially developed by psychiatrist Elisabeth Kübler-Ross, in her 1969 book “On Death and Dying” and again explored in her book “On Grief and Grieving” in 2005. The stages of grief are denial, anger, bargaining, depression, and acceptance.
The grief process is unique to each individual and not necessarily a predictable process, with some moving through the stages at a slower pace while others can get stuck in one or more of the stages. This non-linear pattern of grief is evident in our grief response to the COVID-19 pandemic.
Some of us had experiences of denial back in early March, when initial thoughts crept up, such as “this can’t be as bad as what the medical officials are proposing” and “how is this any different from the flu?” Denial is used as a protective defense against feeling an abundance of emotions all at once, while allowing us time to adjust to the new situation.
Most of us have also had experiences with anger directed at our leaders for not adequately preparing us and intense rage at health care administrators for lack of proper protective gear for our first-line health care workers.
Bargaining tactics were noticeable with common thoughts such as “if we stay home and risk the demise of our economy, we will have the chance to protect our most vulnerable populations and therefore save lives.” Unfortunately, many of us have also experienced thoughts of despair and depression. Feelings of hopelessness and helplessness set in with many parents, who, overnight, were given dual roles as a parent and teacher. Many parents are attempting to simultaneously juggle a full-time workload.
Some of us already have begun to move to the last stage of grief, which is acceptance. Although most of us will experience all five of the stages of grief, we are not necessarily in the same stage at the same time. This can lead to contentious conversations among colleagues, friends, and family members. We might not necessarily be in the same mourning stage as our spouse, child, mother, father, sister, brother, aunt, uncle, cousins, or friend. The differences in how we mourn can result in your spouse remaining in the denial phase of grief and refusing to wear a mask to the grocery store. At the same time, you may have already entered the bargaining phase and are willing to forgo the niceties of grocery shopping to protect and promote the common good.
With loss inevitably comes change
This difference in these stages of loss can affect how we all return to a new sense of routine when we begin to reopen our communities.
Unfortunately, we will not have defined guidelines or cookbook steps and rules to abide by. The one thing we will have is our ability to accept each other’s differences, especially when it comes to grief.
Remember, we all will grieve in our way, and this isn’t a race to the finish line. What we do know is that none of us are coming out of this unscathed. This global loss will forever change us. Our new standard will take time for acclimation, but we will get there. With loss inevitably comes change, and this experience will allow us to redefine who we are and what we choose to prioritize and focus on post pandemic. There will be a post-pandemic period, whether it is 6 months, 1 year, or 2 years from now; we will eventually start to shake hands again, even hug and kiss hello. What we need to make sure of is that we don’t forget this time. Whatever meaning you find, and change for the better, will hopefully transcend to your post-pandemic life.
Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.
We are all experiencing collective loss and grief because of COVID-19, but that doesn’t mean that we are experiencing the same loss or grieving the same way.
Losses can be unique to individuals, such as the death of a loved one or divorce from a spouse. They can also be more universal, such as the tragedy of Sept. 11, 2001. However, both of these types of losses are generally associated with a distinct event that has a known beginning and endpoint. What makes the losses related to the coronavirus so different is that there is not a known expiration date. This lack of certainty about when the losses caused by the pandemic will end makes it difficult to process and mourn appropriately.
The multitude of potential losses includes, of course, the death of thousands of people. Many of us have personally lost loved ones or know people who have had loss because of COVID-19-related illnesses. There have also been numerous illnesses caused by delayed medical care tied to fears of going to a hospital during the pandemic. Unfortunately, there is an anticipatory loss because of the invariable diseases that will be diagnosed because of the halt of routine and preventive medical care during this current restricted phase of social distancing.
There are also losses that are not related to health. These more intangible losses may include the loss of employment and stable income; loss of our children’s completion of their academic year; loss of socialization; loss of travel and visits to friends and family; loss of normal childbirth where a pregnant mother is accompanied by her partner; loss of visiting sick relatives and newborns; loss of dating, weddings, graduations, and milestone birthday celebrations; loss of visits to nursing homes of your loved ones; loss of the needed services and support to help with your young child’s disabilities; and loss of intimacy, connection and touch.
Such losses may seem inconsequential, compared with the death of an acquaintance or loved one. But we do not know the back story behind these other losses. For example, could a family member who is unable to meet the newest addition to the family have a terminal disease and his or her own expiration date? Could the lack of dating exacerbate a new divorcée’s feeling of loneliness and despair?
When we know the details associated with the individual’s loss due to COVID-19, we can understand and better empathize. Continued collective loss without an expiration date will lead to collective grief without an endpoint.
Stages of grief
The five distinct stages of grief experienced after a loss were initially developed by psychiatrist Elisabeth Kübler-Ross, in her 1969 book “On Death and Dying” and again explored in her book “On Grief and Grieving” in 2005. The stages of grief are denial, anger, bargaining, depression, and acceptance.
The grief process is unique to each individual and not necessarily a predictable process, with some moving through the stages at a slower pace while others can get stuck in one or more of the stages. This non-linear pattern of grief is evident in our grief response to the COVID-19 pandemic.
Some of us had experiences of denial back in early March, when initial thoughts crept up, such as “this can’t be as bad as what the medical officials are proposing” and “how is this any different from the flu?” Denial is used as a protective defense against feeling an abundance of emotions all at once, while allowing us time to adjust to the new situation.
Most of us have also had experiences with anger directed at our leaders for not adequately preparing us and intense rage at health care administrators for lack of proper protective gear for our first-line health care workers.
Bargaining tactics were noticeable with common thoughts such as “if we stay home and risk the demise of our economy, we will have the chance to protect our most vulnerable populations and therefore save lives.” Unfortunately, many of us have also experienced thoughts of despair and depression. Feelings of hopelessness and helplessness set in with many parents, who, overnight, were given dual roles as a parent and teacher. Many parents are attempting to simultaneously juggle a full-time workload.
Some of us already have begun to move to the last stage of grief, which is acceptance. Although most of us will experience all five of the stages of grief, we are not necessarily in the same stage at the same time. This can lead to contentious conversations among colleagues, friends, and family members. We might not necessarily be in the same mourning stage as our spouse, child, mother, father, sister, brother, aunt, uncle, cousins, or friend. The differences in how we mourn can result in your spouse remaining in the denial phase of grief and refusing to wear a mask to the grocery store. At the same time, you may have already entered the bargaining phase and are willing to forgo the niceties of grocery shopping to protect and promote the common good.
With loss inevitably comes change
This difference in these stages of loss can affect how we all return to a new sense of routine when we begin to reopen our communities.
Unfortunately, we will not have defined guidelines or cookbook steps and rules to abide by. The one thing we will have is our ability to accept each other’s differences, especially when it comes to grief.
Remember, we all will grieve in our way, and this isn’t a race to the finish line. What we do know is that none of us are coming out of this unscathed. This global loss will forever change us. Our new standard will take time for acclimation, but we will get there. With loss inevitably comes change, and this experience will allow us to redefine who we are and what we choose to prioritize and focus on post pandemic. There will be a post-pandemic period, whether it is 6 months, 1 year, or 2 years from now; we will eventually start to shake hands again, even hug and kiss hello. What we need to make sure of is that we don’t forget this time. Whatever meaning you find, and change for the better, will hopefully transcend to your post-pandemic life.
Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.
We are all experiencing collective loss and grief because of COVID-19, but that doesn’t mean that we are experiencing the same loss or grieving the same way.
Losses can be unique to individuals, such as the death of a loved one or divorce from a spouse. They can also be more universal, such as the tragedy of Sept. 11, 2001. However, both of these types of losses are generally associated with a distinct event that has a known beginning and endpoint. What makes the losses related to the coronavirus so different is that there is not a known expiration date. This lack of certainty about when the losses caused by the pandemic will end makes it difficult to process and mourn appropriately.
The multitude of potential losses includes, of course, the death of thousands of people. Many of us have personally lost loved ones or know people who have had loss because of COVID-19-related illnesses. There have also been numerous illnesses caused by delayed medical care tied to fears of going to a hospital during the pandemic. Unfortunately, there is an anticipatory loss because of the invariable diseases that will be diagnosed because of the halt of routine and preventive medical care during this current restricted phase of social distancing.
There are also losses that are not related to health. These more intangible losses may include the loss of employment and stable income; loss of our children’s completion of their academic year; loss of socialization; loss of travel and visits to friends and family; loss of normal childbirth where a pregnant mother is accompanied by her partner; loss of visiting sick relatives and newborns; loss of dating, weddings, graduations, and milestone birthday celebrations; loss of visits to nursing homes of your loved ones; loss of the needed services and support to help with your young child’s disabilities; and loss of intimacy, connection and touch.
Such losses may seem inconsequential, compared with the death of an acquaintance or loved one. But we do not know the back story behind these other losses. For example, could a family member who is unable to meet the newest addition to the family have a terminal disease and his or her own expiration date? Could the lack of dating exacerbate a new divorcée’s feeling of loneliness and despair?
When we know the details associated with the individual’s loss due to COVID-19, we can understand and better empathize. Continued collective loss without an expiration date will lead to collective grief without an endpoint.
Stages of grief
The five distinct stages of grief experienced after a loss were initially developed by psychiatrist Elisabeth Kübler-Ross, in her 1969 book “On Death and Dying” and again explored in her book “On Grief and Grieving” in 2005. The stages of grief are denial, anger, bargaining, depression, and acceptance.
The grief process is unique to each individual and not necessarily a predictable process, with some moving through the stages at a slower pace while others can get stuck in one or more of the stages. This non-linear pattern of grief is evident in our grief response to the COVID-19 pandemic.
Some of us had experiences of denial back in early March, when initial thoughts crept up, such as “this can’t be as bad as what the medical officials are proposing” and “how is this any different from the flu?” Denial is used as a protective defense against feeling an abundance of emotions all at once, while allowing us time to adjust to the new situation.
Most of us have also had experiences with anger directed at our leaders for not adequately preparing us and intense rage at health care administrators for lack of proper protective gear for our first-line health care workers.
Bargaining tactics were noticeable with common thoughts such as “if we stay home and risk the demise of our economy, we will have the chance to protect our most vulnerable populations and therefore save lives.” Unfortunately, many of us have also experienced thoughts of despair and depression. Feelings of hopelessness and helplessness set in with many parents, who, overnight, were given dual roles as a parent and teacher. Many parents are attempting to simultaneously juggle a full-time workload.
Some of us already have begun to move to the last stage of grief, which is acceptance. Although most of us will experience all five of the stages of grief, we are not necessarily in the same stage at the same time. This can lead to contentious conversations among colleagues, friends, and family members. We might not necessarily be in the same mourning stage as our spouse, child, mother, father, sister, brother, aunt, uncle, cousins, or friend. The differences in how we mourn can result in your spouse remaining in the denial phase of grief and refusing to wear a mask to the grocery store. At the same time, you may have already entered the bargaining phase and are willing to forgo the niceties of grocery shopping to protect and promote the common good.
With loss inevitably comes change
This difference in these stages of loss can affect how we all return to a new sense of routine when we begin to reopen our communities.
Unfortunately, we will not have defined guidelines or cookbook steps and rules to abide by. The one thing we will have is our ability to accept each other’s differences, especially when it comes to grief.
Remember, we all will grieve in our way, and this isn’t a race to the finish line. What we do know is that none of us are coming out of this unscathed. This global loss will forever change us. Our new standard will take time for acclimation, but we will get there. With loss inevitably comes change, and this experience will allow us to redefine who we are and what we choose to prioritize and focus on post pandemic. There will be a post-pandemic period, whether it is 6 months, 1 year, or 2 years from now; we will eventually start to shake hands again, even hug and kiss hello. What we need to make sure of is that we don’t forget this time. Whatever meaning you find, and change for the better, will hopefully transcend to your post-pandemic life.
Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.
Hormone therapy boosts body image in transgender youth
based on data from 148 individuals.
“Understanding the impact of gender-affirming hormone therapy on the mental health of transgender youth is critical given the health disparities documented in this population,” wrote Laura E. Kuper, PhD, of Children’s Health Systems of Texas, Dallas, and colleagues.
In a study published in Pediatrics, the researchers reviewed data from 148 youth aged 9-18 years who underwent gender-affirming hormone therapy in a multidisciplinary program. The average age of the patients was 15 years; 25 were receiving puberty suppression hormones only, 93 were receiving just feminizing or masculinizing hormones, and 30 were receiving both treatments.
At baseline and at approximately 1 year follow-up, all patients completed the Body Image Scale, Quick Inventory of Depressive Symptoms, and Screen for Child Anxiety Related Emotional Disorders. In addition, clinicians collected information on patients’ suicidal ideation, suicide attempts, and nonsuicidal self-injury.
Overall, the average scores on the Body Image Scale on body dissatisfaction decreased from 70 to 52, and average scores on the Quick Inventory of Depressive Symptoms decreased from 9 to 7; both were statistically significant (P less than .001), as were changes from baseline on the anxiety subscale of the Screen for Child Anxiety Related Emotional Disorders, which decreased from 32 to 29 (P less than .01). No change occurred in the average overall clinician-reported depressive symptoms.
During the follow-up period, the rates of suicidal ideation, suicide attempts, and nonsuicidal self-injury were 38%, 5%, and 17%, respectively. Of patients who reported these experiences, the lifetime histories of suicidal ideation, suicide attempts, and nonsuicidal self-injury were 81%, 15%, and 52%, respectively.
The findings were limited by several factors including some missing data and the relatively small sample size, the researchers noted.
Nonetheless, the results suggest “that youth receiving gender-affirming hormone therapy experience meaningful short-term improvements in body dissatisfaction, and no participants discontinued feminizing or masculinizing hormone therapy.” These results support the use of such therapy, Dr. Kuper and associates wrote.
The study is important because of the need for evidence that hormones actually improve patient outcomes, said Shauna M. Lawlis, MD, of the University of Oklahoma Medical Center, Oklahoma City.
“Especially given the rash of legislation across the country aimed at blocking care for transgender youth, it is helpful to show that these treatments really do decrease patients’ anxiety and depressive symptoms,” she said in an interview. “In addition, previous research has been focused on those who have undergone puberty suppression followed by gender-affirming hormone therapy, but many patients are too far along in puberty for puberty suppression to be effective and providers often go straight to gender-affirming hormones in those cases.”
Dr. Lawlis said she was not at all surprised by the study findings. “In my own practice, I have seen patients improve greatly on gender-affirming hormones with overall improvement in anxiety and depression. As a patient’s outward appearance more closely matches their gender identity, they feel more comfortable in their own bodies and their interactions with the world around them, thus improving these symptoms.”
Dr. Lawlis added that the message for pediatricians who treat transgender youth is simple: Gender-affirming hormones improve patient outcomes. “They are essential for the mental health of this vulnerable population.”
She noted that long-term follow-up studies would be useful. “There is still a lot of concern about regret and detransitioning among health care providers and the general population – showing that patients maintain satisfaction in the long-term would be helpful.
“In addition, long-term studies about other health outcomes (cardiovascular disease, cancer risk, etc.) would also be helpful,” said Dr. Lawlis, who was asked to comment on this study, with which she had no involvement.
The study was supported in part by Children’s Health. The researchers had no financial conflicts to disclose. Dr. Lawlis had no relevant financial disclosures.
SOURCE: Kuper LE et al. Pediatrics. 2020 Mar 27. doi: 10.1542/peds.2019-3006.
based on data from 148 individuals.
“Understanding the impact of gender-affirming hormone therapy on the mental health of transgender youth is critical given the health disparities documented in this population,” wrote Laura E. Kuper, PhD, of Children’s Health Systems of Texas, Dallas, and colleagues.
In a study published in Pediatrics, the researchers reviewed data from 148 youth aged 9-18 years who underwent gender-affirming hormone therapy in a multidisciplinary program. The average age of the patients was 15 years; 25 were receiving puberty suppression hormones only, 93 were receiving just feminizing or masculinizing hormones, and 30 were receiving both treatments.
At baseline and at approximately 1 year follow-up, all patients completed the Body Image Scale, Quick Inventory of Depressive Symptoms, and Screen for Child Anxiety Related Emotional Disorders. In addition, clinicians collected information on patients’ suicidal ideation, suicide attempts, and nonsuicidal self-injury.
Overall, the average scores on the Body Image Scale on body dissatisfaction decreased from 70 to 52, and average scores on the Quick Inventory of Depressive Symptoms decreased from 9 to 7; both were statistically significant (P less than .001), as were changes from baseline on the anxiety subscale of the Screen for Child Anxiety Related Emotional Disorders, which decreased from 32 to 29 (P less than .01). No change occurred in the average overall clinician-reported depressive symptoms.
During the follow-up period, the rates of suicidal ideation, suicide attempts, and nonsuicidal self-injury were 38%, 5%, and 17%, respectively. Of patients who reported these experiences, the lifetime histories of suicidal ideation, suicide attempts, and nonsuicidal self-injury were 81%, 15%, and 52%, respectively.
The findings were limited by several factors including some missing data and the relatively small sample size, the researchers noted.
Nonetheless, the results suggest “that youth receiving gender-affirming hormone therapy experience meaningful short-term improvements in body dissatisfaction, and no participants discontinued feminizing or masculinizing hormone therapy.” These results support the use of such therapy, Dr. Kuper and associates wrote.
The study is important because of the need for evidence that hormones actually improve patient outcomes, said Shauna M. Lawlis, MD, of the University of Oklahoma Medical Center, Oklahoma City.
“Especially given the rash of legislation across the country aimed at blocking care for transgender youth, it is helpful to show that these treatments really do decrease patients’ anxiety and depressive symptoms,” she said in an interview. “In addition, previous research has been focused on those who have undergone puberty suppression followed by gender-affirming hormone therapy, but many patients are too far along in puberty for puberty suppression to be effective and providers often go straight to gender-affirming hormones in those cases.”
Dr. Lawlis said she was not at all surprised by the study findings. “In my own practice, I have seen patients improve greatly on gender-affirming hormones with overall improvement in anxiety and depression. As a patient’s outward appearance more closely matches their gender identity, they feel more comfortable in their own bodies and their interactions with the world around them, thus improving these symptoms.”
Dr. Lawlis added that the message for pediatricians who treat transgender youth is simple: Gender-affirming hormones improve patient outcomes. “They are essential for the mental health of this vulnerable population.”
She noted that long-term follow-up studies would be useful. “There is still a lot of concern about regret and detransitioning among health care providers and the general population – showing that patients maintain satisfaction in the long-term would be helpful.
“In addition, long-term studies about other health outcomes (cardiovascular disease, cancer risk, etc.) would also be helpful,” said Dr. Lawlis, who was asked to comment on this study, with which she had no involvement.
The study was supported in part by Children’s Health. The researchers had no financial conflicts to disclose. Dr. Lawlis had no relevant financial disclosures.
SOURCE: Kuper LE et al. Pediatrics. 2020 Mar 27. doi: 10.1542/peds.2019-3006.
based on data from 148 individuals.
“Understanding the impact of gender-affirming hormone therapy on the mental health of transgender youth is critical given the health disparities documented in this population,” wrote Laura E. Kuper, PhD, of Children’s Health Systems of Texas, Dallas, and colleagues.
In a study published in Pediatrics, the researchers reviewed data from 148 youth aged 9-18 years who underwent gender-affirming hormone therapy in a multidisciplinary program. The average age of the patients was 15 years; 25 were receiving puberty suppression hormones only, 93 were receiving just feminizing or masculinizing hormones, and 30 were receiving both treatments.
At baseline and at approximately 1 year follow-up, all patients completed the Body Image Scale, Quick Inventory of Depressive Symptoms, and Screen for Child Anxiety Related Emotional Disorders. In addition, clinicians collected information on patients’ suicidal ideation, suicide attempts, and nonsuicidal self-injury.
Overall, the average scores on the Body Image Scale on body dissatisfaction decreased from 70 to 52, and average scores on the Quick Inventory of Depressive Symptoms decreased from 9 to 7; both were statistically significant (P less than .001), as were changes from baseline on the anxiety subscale of the Screen for Child Anxiety Related Emotional Disorders, which decreased from 32 to 29 (P less than .01). No change occurred in the average overall clinician-reported depressive symptoms.
During the follow-up period, the rates of suicidal ideation, suicide attempts, and nonsuicidal self-injury were 38%, 5%, and 17%, respectively. Of patients who reported these experiences, the lifetime histories of suicidal ideation, suicide attempts, and nonsuicidal self-injury were 81%, 15%, and 52%, respectively.
The findings were limited by several factors including some missing data and the relatively small sample size, the researchers noted.
Nonetheless, the results suggest “that youth receiving gender-affirming hormone therapy experience meaningful short-term improvements in body dissatisfaction, and no participants discontinued feminizing or masculinizing hormone therapy.” These results support the use of such therapy, Dr. Kuper and associates wrote.
The study is important because of the need for evidence that hormones actually improve patient outcomes, said Shauna M. Lawlis, MD, of the University of Oklahoma Medical Center, Oklahoma City.
“Especially given the rash of legislation across the country aimed at blocking care for transgender youth, it is helpful to show that these treatments really do decrease patients’ anxiety and depressive symptoms,” she said in an interview. “In addition, previous research has been focused on those who have undergone puberty suppression followed by gender-affirming hormone therapy, but many patients are too far along in puberty for puberty suppression to be effective and providers often go straight to gender-affirming hormones in those cases.”
Dr. Lawlis said she was not at all surprised by the study findings. “In my own practice, I have seen patients improve greatly on gender-affirming hormones with overall improvement in anxiety and depression. As a patient’s outward appearance more closely matches their gender identity, they feel more comfortable in their own bodies and their interactions with the world around them, thus improving these symptoms.”
Dr. Lawlis added that the message for pediatricians who treat transgender youth is simple: Gender-affirming hormones improve patient outcomes. “They are essential for the mental health of this vulnerable population.”
She noted that long-term follow-up studies would be useful. “There is still a lot of concern about regret and detransitioning among health care providers and the general population – showing that patients maintain satisfaction in the long-term would be helpful.
“In addition, long-term studies about other health outcomes (cardiovascular disease, cancer risk, etc.) would also be helpful,” said Dr. Lawlis, who was asked to comment on this study, with which she had no involvement.
The study was supported in part by Children’s Health. The researchers had no financial conflicts to disclose. Dr. Lawlis had no relevant financial disclosures.
SOURCE: Kuper LE et al. Pediatrics. 2020 Mar 27. doi: 10.1542/peds.2019-3006.
FROM PEDIATRICS
Expert: Eliminating HCV ‘sounds ambitious, but I think it’s possible’
LAS VEGAS – Between 2010 and 2017, the proportion of newly diagnosed cases of acute hepatitis C virus infection rose threefold, driven largely by the concomitant opioid epidemic.
That makes efforts to screen, diagnose, and cure high-risk populations more important than ever, Stevan A. Gonzalez, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
About 70% of HCV cases are related to injection drug use,” said Dr. Gonzalez, medical director of liver transplantation at the Baylor Simmons Transplant Institute at the Baylor Scott & White All Saints Medical Center in Fort Worth, Tex. “This is affecting whites as much as blacks and Hispanics, females as much as males, and in nonurban areas as much as in urban areas.”
Data from the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration indicate that during 2004-2014, the number of acute HCV cases among those aged 18-29 years increased 400%, and the use of injection opioids rose 600%.
At the same time, the number of HCV cases among those aged 30-39 years increased 325%, and the use of injection opioids rose 83%.
“We’re starting to see a pattern overlapping between HCV exposure and opioid injection,” Dr. Gonzalez said. Other high-risk populations include homeless and incarcerated individuals.
More than 70 million people worldwide have chronic HCV infection, Dr. Gonzalez noted, with possibly as many as 5 million cases in the United States. It remains the nation’s most common blood-borne infection.
Chronic disease develops in up to 85% of people who are exposed, infection is asymptomatic, and HCV remains one of the leading indications for liver transplantation and causes of liver cancer.
From a geographic standpoint, the prevalence of HCV in young adults is eclipsing that of Baby Boomers in several states in the Appalachian region and in Northeast, which have long been trouble spots for opioid use disorder (Gastroenterol. 2018 May;154[6]:1850-1).
Surprising exposure risk
The primary risk of transmission is through contaminated blood and the exposure through needles.
“It really doesn’t matter whether it’s a needle that has a small amount of dead space where a little bit of blood can remain or needles that have a larger amount of blood,” Dr. Gonzalez said.
“I’ve had patients who come to me and say, ‘I can’t believe I have HCV. It’s impossible. I always use my own needles. They’re always brand new; I’ve never shared with anybody,’” he continued.
“This is where education and awareness is so critical, because it’s not just the needles,” Dr. Gonzalez explained. “HCV can survive on inanimate objects. For example, on a tabletop surface or a water container, HCV can remain viable up to 3 weeks. In a syringe, 2 months. For that reason, HCV can also be transmitted through crack pipes and nasal drug use, where the prevalence can be up to 35%.”
The duration of a person’s HCV infection drives the transmission.
“That’s important to think about, because people who have chronic hepatitis C are infectious until they’re treated,” Dr. Gonzalez said. “If they don’t know that they have hepatitis C, they continue to transmit the virus to others.”
One study found that half of people living with HCV are unaware of their infection (PLoS One. 2014 Jul 2;9[7]:e101554). According to Dr. Gonzalez, forthcoming guidelines from the U.S. Preventive Services Task Force are expected to recommend a one-time screening for HCV infection in all adults aged 18-79 years, a Grade B recommendation. “That’s a big deal,” he said. (The draft recommendations are available here.)
HCV infection disproportionately affects individuals in correctional institutions. In fact, an estimated one in three inmates in the United States has chronic HCV.
“This is sort of a forgotten population with a lot of substance use and mental illness,” Dr. Gonzalez said. “Injection drug use in that setting is the most common risk factor: It’s about 60% in terms of the risk of transmission within correctional settings. HCV-associated liver disease has now surpassed HIV as a cause of death within correctional settings.”
Weighing treatment options
The most common oral regimens for chronic HCV include sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir. They achieve cure in 93%-100% of cases.
“HCV can be cured; it can be eradicated from the body long term,” Dr. Gonzalez said. “The choice of regimen, treatment duration, and use of ribavirin depends on the presence/absence of cirrhosis, prior treatment experience, and the genotype.”
All six forms of the HCV genotype can be treated with oral medication, he added, and methadone, bupropion, and naloxone are safe to use during therapy.
Reinfection following HCV treatment occurs infrequently. Dr. Gonzalez cited a randomized, controlled trial presented as an abstract at the 2018 annual meeting of the American Association for the Study of Liver Diseases. That study’s researchers found that – among 199 patients on opioid-replacement therapy who were receiving direct-acting antiviral therapy, in whom greater than 50% were actively using drugs – the rate of reinfection at 3 years was 1.8 reinfections/100 person-years.
“That’s lower than people expect,” Dr. Gonzalez said.
How to boost screening
Electronic health record systems can be used as an important tool to increase HCV screening in health care settings.
In 2017, researchers published an analysis of three randomized trials carried out at three separate primary care settings to improve screening for HCV: repeated mailings, an EHR best practice alert (BPA), and patient solicitation (Hepatology 2017 Jan;65[1]:44-53). They evaluated HCV antibody testing, diagnosis, and costs for each of the interventions, compared with standard-of-care testing.
The investigators found that the BPA intervention had the lowest incremental cost per completed test – $24 with fixed start-up costs, including technical design and development of the BPA system; $3 without fixed start-up costs. The BPA intervention also had the lowest incremental cost per new case identified.
Other efforts to expand access to screening and treatment are underway.
In 2019, Louisiana health officials negotiated a one-time fee for unlimited access for 5 years to sofosbuvir/velpatasvir (Epclusa) to treat the estimated 30,000 patients on Louisiana Medicaid and in that state’s department of corrections who have HCV.
“The goal is 90% cure; the burden is on the state health department to screen, diagnose, and dispense medication,” Dr. Gonzalez said.
Also in 2019, the state of Washington used an open bidding process to negotiate access to glecaprevir/pibrentasvir (Mavyret) for the state’s Medicaid population who have HCV.
“Those states are setting the pace,” Dr. Gonzalez said. “They are showing examples of how we can start implementing a process to treat these vulnerable populations.”
Meanwhile, the World Health Organization set a goal of eliminating viral hepatitis as a major public health threat by 2030.
“That sounds ambitious, but I think it’s possible,” Dr. Gonzalez said. “It’s important to address these high-risk populations: the incarcerated, people who use drugs, and the homeless, because those are the groups that have a high prevalence of HCV – mainly through injection drug use.
“If we don’t address that population, and we only target the general population, we’re going to have a continual source of transmission,” Dr. Gonzalez warned. “In that case, we would never be able to achieve elimination.”
Dr. Gonzalez disclosed that he is a member of the speakers bureau for AbbVie and Salix.
LAS VEGAS – Between 2010 and 2017, the proportion of newly diagnosed cases of acute hepatitis C virus infection rose threefold, driven largely by the concomitant opioid epidemic.
That makes efforts to screen, diagnose, and cure high-risk populations more important than ever, Stevan A. Gonzalez, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
About 70% of HCV cases are related to injection drug use,” said Dr. Gonzalez, medical director of liver transplantation at the Baylor Simmons Transplant Institute at the Baylor Scott & White All Saints Medical Center in Fort Worth, Tex. “This is affecting whites as much as blacks and Hispanics, females as much as males, and in nonurban areas as much as in urban areas.”
Data from the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration indicate that during 2004-2014, the number of acute HCV cases among those aged 18-29 years increased 400%, and the use of injection opioids rose 600%.
At the same time, the number of HCV cases among those aged 30-39 years increased 325%, and the use of injection opioids rose 83%.
“We’re starting to see a pattern overlapping between HCV exposure and opioid injection,” Dr. Gonzalez said. Other high-risk populations include homeless and incarcerated individuals.
More than 70 million people worldwide have chronic HCV infection, Dr. Gonzalez noted, with possibly as many as 5 million cases in the United States. It remains the nation’s most common blood-borne infection.
Chronic disease develops in up to 85% of people who are exposed, infection is asymptomatic, and HCV remains one of the leading indications for liver transplantation and causes of liver cancer.
From a geographic standpoint, the prevalence of HCV in young adults is eclipsing that of Baby Boomers in several states in the Appalachian region and in Northeast, which have long been trouble spots for opioid use disorder (Gastroenterol. 2018 May;154[6]:1850-1).
Surprising exposure risk
The primary risk of transmission is through contaminated blood and the exposure through needles.
“It really doesn’t matter whether it’s a needle that has a small amount of dead space where a little bit of blood can remain or needles that have a larger amount of blood,” Dr. Gonzalez said.
“I’ve had patients who come to me and say, ‘I can’t believe I have HCV. It’s impossible. I always use my own needles. They’re always brand new; I’ve never shared with anybody,’” he continued.
“This is where education and awareness is so critical, because it’s not just the needles,” Dr. Gonzalez explained. “HCV can survive on inanimate objects. For example, on a tabletop surface or a water container, HCV can remain viable up to 3 weeks. In a syringe, 2 months. For that reason, HCV can also be transmitted through crack pipes and nasal drug use, where the prevalence can be up to 35%.”
The duration of a person’s HCV infection drives the transmission.
“That’s important to think about, because people who have chronic hepatitis C are infectious until they’re treated,” Dr. Gonzalez said. “If they don’t know that they have hepatitis C, they continue to transmit the virus to others.”
One study found that half of people living with HCV are unaware of their infection (PLoS One. 2014 Jul 2;9[7]:e101554). According to Dr. Gonzalez, forthcoming guidelines from the U.S. Preventive Services Task Force are expected to recommend a one-time screening for HCV infection in all adults aged 18-79 years, a Grade B recommendation. “That’s a big deal,” he said. (The draft recommendations are available here.)
HCV infection disproportionately affects individuals in correctional institutions. In fact, an estimated one in three inmates in the United States has chronic HCV.
“This is sort of a forgotten population with a lot of substance use and mental illness,” Dr. Gonzalez said. “Injection drug use in that setting is the most common risk factor: It’s about 60% in terms of the risk of transmission within correctional settings. HCV-associated liver disease has now surpassed HIV as a cause of death within correctional settings.”
Weighing treatment options
The most common oral regimens for chronic HCV include sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir. They achieve cure in 93%-100% of cases.
“HCV can be cured; it can be eradicated from the body long term,” Dr. Gonzalez said. “The choice of regimen, treatment duration, and use of ribavirin depends on the presence/absence of cirrhosis, prior treatment experience, and the genotype.”
All six forms of the HCV genotype can be treated with oral medication, he added, and methadone, bupropion, and naloxone are safe to use during therapy.
Reinfection following HCV treatment occurs infrequently. Dr. Gonzalez cited a randomized, controlled trial presented as an abstract at the 2018 annual meeting of the American Association for the Study of Liver Diseases. That study’s researchers found that – among 199 patients on opioid-replacement therapy who were receiving direct-acting antiviral therapy, in whom greater than 50% were actively using drugs – the rate of reinfection at 3 years was 1.8 reinfections/100 person-years.
“That’s lower than people expect,” Dr. Gonzalez said.
How to boost screening
Electronic health record systems can be used as an important tool to increase HCV screening in health care settings.
In 2017, researchers published an analysis of three randomized trials carried out at three separate primary care settings to improve screening for HCV: repeated mailings, an EHR best practice alert (BPA), and patient solicitation (Hepatology 2017 Jan;65[1]:44-53). They evaluated HCV antibody testing, diagnosis, and costs for each of the interventions, compared with standard-of-care testing.
The investigators found that the BPA intervention had the lowest incremental cost per completed test – $24 with fixed start-up costs, including technical design and development of the BPA system; $3 without fixed start-up costs. The BPA intervention also had the lowest incremental cost per new case identified.
Other efforts to expand access to screening and treatment are underway.
In 2019, Louisiana health officials negotiated a one-time fee for unlimited access for 5 years to sofosbuvir/velpatasvir (Epclusa) to treat the estimated 30,000 patients on Louisiana Medicaid and in that state’s department of corrections who have HCV.
“The goal is 90% cure; the burden is on the state health department to screen, diagnose, and dispense medication,” Dr. Gonzalez said.
Also in 2019, the state of Washington used an open bidding process to negotiate access to glecaprevir/pibrentasvir (Mavyret) for the state’s Medicaid population who have HCV.
“Those states are setting the pace,” Dr. Gonzalez said. “They are showing examples of how we can start implementing a process to treat these vulnerable populations.”
Meanwhile, the World Health Organization set a goal of eliminating viral hepatitis as a major public health threat by 2030.
“That sounds ambitious, but I think it’s possible,” Dr. Gonzalez said. “It’s important to address these high-risk populations: the incarcerated, people who use drugs, and the homeless, because those are the groups that have a high prevalence of HCV – mainly through injection drug use.
“If we don’t address that population, and we only target the general population, we’re going to have a continual source of transmission,” Dr. Gonzalez warned. “In that case, we would never be able to achieve elimination.”
Dr. Gonzalez disclosed that he is a member of the speakers bureau for AbbVie and Salix.
LAS VEGAS – Between 2010 and 2017, the proportion of newly diagnosed cases of acute hepatitis C virus infection rose threefold, driven largely by the concomitant opioid epidemic.
That makes efforts to screen, diagnose, and cure high-risk populations more important than ever, Stevan A. Gonzalez, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
About 70% of HCV cases are related to injection drug use,” said Dr. Gonzalez, medical director of liver transplantation at the Baylor Simmons Transplant Institute at the Baylor Scott & White All Saints Medical Center in Fort Worth, Tex. “This is affecting whites as much as blacks and Hispanics, females as much as males, and in nonurban areas as much as in urban areas.”
Data from the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration indicate that during 2004-2014, the number of acute HCV cases among those aged 18-29 years increased 400%, and the use of injection opioids rose 600%.
At the same time, the number of HCV cases among those aged 30-39 years increased 325%, and the use of injection opioids rose 83%.
“We’re starting to see a pattern overlapping between HCV exposure and opioid injection,” Dr. Gonzalez said. Other high-risk populations include homeless and incarcerated individuals.
More than 70 million people worldwide have chronic HCV infection, Dr. Gonzalez noted, with possibly as many as 5 million cases in the United States. It remains the nation’s most common blood-borne infection.
Chronic disease develops in up to 85% of people who are exposed, infection is asymptomatic, and HCV remains one of the leading indications for liver transplantation and causes of liver cancer.
From a geographic standpoint, the prevalence of HCV in young adults is eclipsing that of Baby Boomers in several states in the Appalachian region and in Northeast, which have long been trouble spots for opioid use disorder (Gastroenterol. 2018 May;154[6]:1850-1).
Surprising exposure risk
The primary risk of transmission is through contaminated blood and the exposure through needles.
“It really doesn’t matter whether it’s a needle that has a small amount of dead space where a little bit of blood can remain or needles that have a larger amount of blood,” Dr. Gonzalez said.
“I’ve had patients who come to me and say, ‘I can’t believe I have HCV. It’s impossible. I always use my own needles. They’re always brand new; I’ve never shared with anybody,’” he continued.
“This is where education and awareness is so critical, because it’s not just the needles,” Dr. Gonzalez explained. “HCV can survive on inanimate objects. For example, on a tabletop surface or a water container, HCV can remain viable up to 3 weeks. In a syringe, 2 months. For that reason, HCV can also be transmitted through crack pipes and nasal drug use, where the prevalence can be up to 35%.”
The duration of a person’s HCV infection drives the transmission.
“That’s important to think about, because people who have chronic hepatitis C are infectious until they’re treated,” Dr. Gonzalez said. “If they don’t know that they have hepatitis C, they continue to transmit the virus to others.”
One study found that half of people living with HCV are unaware of their infection (PLoS One. 2014 Jul 2;9[7]:e101554). According to Dr. Gonzalez, forthcoming guidelines from the U.S. Preventive Services Task Force are expected to recommend a one-time screening for HCV infection in all adults aged 18-79 years, a Grade B recommendation. “That’s a big deal,” he said. (The draft recommendations are available here.)
HCV infection disproportionately affects individuals in correctional institutions. In fact, an estimated one in three inmates in the United States has chronic HCV.
“This is sort of a forgotten population with a lot of substance use and mental illness,” Dr. Gonzalez said. “Injection drug use in that setting is the most common risk factor: It’s about 60% in terms of the risk of transmission within correctional settings. HCV-associated liver disease has now surpassed HIV as a cause of death within correctional settings.”
Weighing treatment options
The most common oral regimens for chronic HCV include sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir. They achieve cure in 93%-100% of cases.
“HCV can be cured; it can be eradicated from the body long term,” Dr. Gonzalez said. “The choice of regimen, treatment duration, and use of ribavirin depends on the presence/absence of cirrhosis, prior treatment experience, and the genotype.”
All six forms of the HCV genotype can be treated with oral medication, he added, and methadone, bupropion, and naloxone are safe to use during therapy.
Reinfection following HCV treatment occurs infrequently. Dr. Gonzalez cited a randomized, controlled trial presented as an abstract at the 2018 annual meeting of the American Association for the Study of Liver Diseases. That study’s researchers found that – among 199 patients on opioid-replacement therapy who were receiving direct-acting antiviral therapy, in whom greater than 50% were actively using drugs – the rate of reinfection at 3 years was 1.8 reinfections/100 person-years.
“That’s lower than people expect,” Dr. Gonzalez said.
How to boost screening
Electronic health record systems can be used as an important tool to increase HCV screening in health care settings.
In 2017, researchers published an analysis of three randomized trials carried out at three separate primary care settings to improve screening for HCV: repeated mailings, an EHR best practice alert (BPA), and patient solicitation (Hepatology 2017 Jan;65[1]:44-53). They evaluated HCV antibody testing, diagnosis, and costs for each of the interventions, compared with standard-of-care testing.
The investigators found that the BPA intervention had the lowest incremental cost per completed test – $24 with fixed start-up costs, including technical design and development of the BPA system; $3 without fixed start-up costs. The BPA intervention also had the lowest incremental cost per new case identified.
Other efforts to expand access to screening and treatment are underway.
In 2019, Louisiana health officials negotiated a one-time fee for unlimited access for 5 years to sofosbuvir/velpatasvir (Epclusa) to treat the estimated 30,000 patients on Louisiana Medicaid and in that state’s department of corrections who have HCV.
“The goal is 90% cure; the burden is on the state health department to screen, diagnose, and dispense medication,” Dr. Gonzalez said.
Also in 2019, the state of Washington used an open bidding process to negotiate access to glecaprevir/pibrentasvir (Mavyret) for the state’s Medicaid population who have HCV.
“Those states are setting the pace,” Dr. Gonzalez said. “They are showing examples of how we can start implementing a process to treat these vulnerable populations.”
Meanwhile, the World Health Organization set a goal of eliminating viral hepatitis as a major public health threat by 2030.
“That sounds ambitious, but I think it’s possible,” Dr. Gonzalez said. “It’s important to address these high-risk populations: the incarcerated, people who use drugs, and the homeless, because those are the groups that have a high prevalence of HCV – mainly through injection drug use.
“If we don’t address that population, and we only target the general population, we’re going to have a continual source of transmission,” Dr. Gonzalez warned. “In that case, we would never be able to achieve elimination.”
Dr. Gonzalez disclosed that he is a member of the speakers bureau for AbbVie and Salix.
REPORTING FROM NPA 2020
Novel analysis links insomnia to first-onset major depressive disorder
a prospective study of 768 adults with a history of depression suggests.
Insomnia has been identified as a risk factor for depression, but the impact of lifetime depression history and the role of insomnia in major depressive disorder (MDD) remains unclear, wrote Tessa Blanken, MSc, of the Netherlands Institute for Neuroscience, Amsterdam, and colleagues. Studies of this relationship have been hampered by the difficulty of isolating the impact of insomnia as an independent predictor of MDD from depression and other disorders.
In a study published in Sleep, the researchers reviewed data from 768 adults aged 18-65 years who were participants in the Netherlands Study of Depression and Anxiety, a multicenter, longitudinal study that included four assessments over 6 years. The participants had no current or prior diagnosis of MDD. The average age of the participants was 41 years, and 63% were women.
The investigators used Network Outcome Analysis to study the link between insomnia and MDD. The investigators wrote, “Network modeling techniques provide a unique framework to study the interactions among symptoms and their role in the development and maintenance of psychiatric disorders. Using network analysis we can estimate the unique association between pairs of symptoms, while controlling for the state and associations of all other symptoms.”
Over 6-years’ follow-up, 141 participants (18%) were diagnosed with first-onset MDD. Overall, insomnia severity was a significant predictor of first-onset MDD (hazard ratio 1.11, 95% confidence interval). The analysis showed that the predictive effect of insomnia on first-onset MDD was driven solely by the item “Did you have trouble falling asleep” (hazard ratio, 1.33; 95% confidence interval, 1.12-1.57; observed range, 0-4). Those individuals who had trouble falling asleep 3-4 times or more than 4 times a week were 2.3 or 3.2 times, respectively, more likely to develop first-onset MDD. None of the other sleep complaints, such as nocturnal and early morning awakening, significantly increased the risk of first-onset MDD.
The study findings were limited by several factors including the full impact of short sleep duration and lack of chronotype assessment, the researchers noted. However, “the identification of ‘difficulty initiating sleep’ as a risk factor is particularly promising because a recent meta-analysis showed that cognitive behavioural therapy, the treatment of choice for insomnia, is highly effective,” the researchers wrote. The results suggest that treating problems in sleep initiation could contribute to preventing first-onset depression and reducing the overall burden of MDD, they concluded.
The study was supported by the European Research Council. The researchers had no financial conflicts to disclose.
SOURCE: Blanken TF et al. Sleep. 2019 Dec 2. doi: 10.1093/sleep/zsz288.
a prospective study of 768 adults with a history of depression suggests.
Insomnia has been identified as a risk factor for depression, but the impact of lifetime depression history and the role of insomnia in major depressive disorder (MDD) remains unclear, wrote Tessa Blanken, MSc, of the Netherlands Institute for Neuroscience, Amsterdam, and colleagues. Studies of this relationship have been hampered by the difficulty of isolating the impact of insomnia as an independent predictor of MDD from depression and other disorders.
In a study published in Sleep, the researchers reviewed data from 768 adults aged 18-65 years who were participants in the Netherlands Study of Depression and Anxiety, a multicenter, longitudinal study that included four assessments over 6 years. The participants had no current or prior diagnosis of MDD. The average age of the participants was 41 years, and 63% were women.
The investigators used Network Outcome Analysis to study the link between insomnia and MDD. The investigators wrote, “Network modeling techniques provide a unique framework to study the interactions among symptoms and their role in the development and maintenance of psychiatric disorders. Using network analysis we can estimate the unique association between pairs of symptoms, while controlling for the state and associations of all other symptoms.”
Over 6-years’ follow-up, 141 participants (18%) were diagnosed with first-onset MDD. Overall, insomnia severity was a significant predictor of first-onset MDD (hazard ratio 1.11, 95% confidence interval). The analysis showed that the predictive effect of insomnia on first-onset MDD was driven solely by the item “Did you have trouble falling asleep” (hazard ratio, 1.33; 95% confidence interval, 1.12-1.57; observed range, 0-4). Those individuals who had trouble falling asleep 3-4 times or more than 4 times a week were 2.3 or 3.2 times, respectively, more likely to develop first-onset MDD. None of the other sleep complaints, such as nocturnal and early morning awakening, significantly increased the risk of first-onset MDD.
The study findings were limited by several factors including the full impact of short sleep duration and lack of chronotype assessment, the researchers noted. However, “the identification of ‘difficulty initiating sleep’ as a risk factor is particularly promising because a recent meta-analysis showed that cognitive behavioural therapy, the treatment of choice for insomnia, is highly effective,” the researchers wrote. The results suggest that treating problems in sleep initiation could contribute to preventing first-onset depression and reducing the overall burden of MDD, they concluded.
The study was supported by the European Research Council. The researchers had no financial conflicts to disclose.
SOURCE: Blanken TF et al. Sleep. 2019 Dec 2. doi: 10.1093/sleep/zsz288.
a prospective study of 768 adults with a history of depression suggests.
Insomnia has been identified as a risk factor for depression, but the impact of lifetime depression history and the role of insomnia in major depressive disorder (MDD) remains unclear, wrote Tessa Blanken, MSc, of the Netherlands Institute for Neuroscience, Amsterdam, and colleagues. Studies of this relationship have been hampered by the difficulty of isolating the impact of insomnia as an independent predictor of MDD from depression and other disorders.
In a study published in Sleep, the researchers reviewed data from 768 adults aged 18-65 years who were participants in the Netherlands Study of Depression and Anxiety, a multicenter, longitudinal study that included four assessments over 6 years. The participants had no current or prior diagnosis of MDD. The average age of the participants was 41 years, and 63% were women.
The investigators used Network Outcome Analysis to study the link between insomnia and MDD. The investigators wrote, “Network modeling techniques provide a unique framework to study the interactions among symptoms and their role in the development and maintenance of psychiatric disorders. Using network analysis we can estimate the unique association between pairs of symptoms, while controlling for the state and associations of all other symptoms.”
Over 6-years’ follow-up, 141 participants (18%) were diagnosed with first-onset MDD. Overall, insomnia severity was a significant predictor of first-onset MDD (hazard ratio 1.11, 95% confidence interval). The analysis showed that the predictive effect of insomnia on first-onset MDD was driven solely by the item “Did you have trouble falling asleep” (hazard ratio, 1.33; 95% confidence interval, 1.12-1.57; observed range, 0-4). Those individuals who had trouble falling asleep 3-4 times or more than 4 times a week were 2.3 or 3.2 times, respectively, more likely to develop first-onset MDD. None of the other sleep complaints, such as nocturnal and early morning awakening, significantly increased the risk of first-onset MDD.
The study findings were limited by several factors including the full impact of short sleep duration and lack of chronotype assessment, the researchers noted. However, “the identification of ‘difficulty initiating sleep’ as a risk factor is particularly promising because a recent meta-analysis showed that cognitive behavioural therapy, the treatment of choice for insomnia, is highly effective,” the researchers wrote. The results suggest that treating problems in sleep initiation could contribute to preventing first-onset depression and reducing the overall burden of MDD, they concluded.
The study was supported by the European Research Council. The researchers had no financial conflicts to disclose.
SOURCE: Blanken TF et al. Sleep. 2019 Dec 2. doi: 10.1093/sleep/zsz288.
FROM SLEEP
FDA fast-tracks psilocybin for major depressive disorder
Psilocybin, a short-acting compound that is the psychoactive ingredient in “magic mushrooms,” has received a Breakthrough Therapy designation from the Food and Drug Administration for the treatment of adults with major depressive disorder.
The designation was given to the Usona Institute, a nonprofit medical research organization, and comes in the wake of Usona’s launch of a phase 2 clinical trial that will include about 80 participants at seven study sites across the United States, according to a press release. Two sites are currently recruiting patients, and the others are expected to begin recruiting in 2020.
Breakthrough Therapy designation as defined by the FDA means that, based on preliminary research, “the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.” In this case, Usona is working with the University of Wisconsin’s University Hospital in Madison, and other collaborators, according to a presentation by Malynn Utzinger, MD, director of integrative medicine and cofounder of the organization.
More information on the Usona Institute and Usona’s clinical trials is available at https://usonaclinicaltrials.org/.
Psilocybin, a short-acting compound that is the psychoactive ingredient in “magic mushrooms,” has received a Breakthrough Therapy designation from the Food and Drug Administration for the treatment of adults with major depressive disorder.
The designation was given to the Usona Institute, a nonprofit medical research organization, and comes in the wake of Usona’s launch of a phase 2 clinical trial that will include about 80 participants at seven study sites across the United States, according to a press release. Two sites are currently recruiting patients, and the others are expected to begin recruiting in 2020.
Breakthrough Therapy designation as defined by the FDA means that, based on preliminary research, “the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.” In this case, Usona is working with the University of Wisconsin’s University Hospital in Madison, and other collaborators, according to a presentation by Malynn Utzinger, MD, director of integrative medicine and cofounder of the organization.
More information on the Usona Institute and Usona’s clinical trials is available at https://usonaclinicaltrials.org/.
Psilocybin, a short-acting compound that is the psychoactive ingredient in “magic mushrooms,” has received a Breakthrough Therapy designation from the Food and Drug Administration for the treatment of adults with major depressive disorder.
The designation was given to the Usona Institute, a nonprofit medical research organization, and comes in the wake of Usona’s launch of a phase 2 clinical trial that will include about 80 participants at seven study sites across the United States, according to a press release. Two sites are currently recruiting patients, and the others are expected to begin recruiting in 2020.
Breakthrough Therapy designation as defined by the FDA means that, based on preliminary research, “the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.” In this case, Usona is working with the University of Wisconsin’s University Hospital in Madison, and other collaborators, according to a presentation by Malynn Utzinger, MD, director of integrative medicine and cofounder of the organization.
More information on the Usona Institute and Usona’s clinical trials is available at https://usonaclinicaltrials.org/.