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Why We Need to Know About Our Patients’ History of Trauma
This case is a little out of the ordinary, but we would love to find out how readers would handle it.
Diana is a 51-year-old woman with a history of depression, obesity, hypertension, type 2 diabetes, and coronary artery disease. She has come in for a routine visit for her chronic illnesses. She seems very distant and has a flat affect during the initial interview. When you ask about any recent stressful events, she begins crying and explains that her daughter was just deported, leaving behind a child and boyfriend.
Their country of origin suffers from chronic instability and violence. Diana’s father was murdered there, and Diana was the victim of sexual assault. “I escaped when I was 18, and I tried to never look back. Until now.” Diana is very worried about her daughter’s return to that country. “I don’t want her to have to endure what I have endured.”
You spend some time discussing the patient’s mental health burden and identify a counselor and online resources that might help. You wonder if Diana’s adverse childhood experiences (ACEs) might have contributed to some of her physical illnesses.
ACEs and Adult Health
One of the most pronounced and straightforward links is that between ACEs and depression. In the Southern Community Cohort Study of more than 38,200 US adults, the highest odds ratio between ACEs and chronic disease was for depression. Persons who reported more than three ACEs had about a twofold increase in the risk for depression compared with persons without ACEs. There was a monotonic increase in the risk for depression and other chronic illnesses as the burden of ACEs increased.
In another study from the United Kingdom, each additional ACE was associated with a significant 11% increase in the risk for incident diabetes during adulthood. Researchers found that both depression symptoms and cardiometabolic dysfunction mediated the effects of ACEs in promoting higher rates of diabetes.
Depression and diabetes are significant risk factors for coronary artery disease, so it is not surprising that ACEs are also associated with a higher risk for coronary events. A review by Godoy and colleagues described how ACEs promote neuroendocrine, autonomic, and inflammatory dysfunction, which in turn leads to higher rates of traditional cardiovascular risk factors such as diabetes and obesity. Ultimately, the presence of four or more ACEs is associated with more than a twofold higher risk for cardiovascular disease compared with no ACEs.
Many of the pathologic processes that promote cardiovascular disease also increase the risk for dementia. Could the reach of ACEs span decades to promote a higher risk for dementia among older adults? A study by Yuan and colleagues of 7222 Chinese adults suggests that the answer is yes. This study divided the cohort into persons with a history of no ACEs, household dysfunction during childhood, or mistreatment during childhood. Child mistreatment was associated with higher rates of diabetes, depression, and cardiovascular disease, as well as an odds ratio of 1.37 (95% CI, 1.12 to 1.68) for cognitive impairment.
The magnitude of the effects ACEs can have on well-being is reinforced by epidemiologic data surrounding ACEs. According to the US Centers for Disease Control and Prevention (CDC), 64% of US adults report at least one ACE and 17% experienced at least four ACEs. Risk factors for ACEs include being female, American Indian or Alaska Native, or unemployed.
How do we reduce the impact of ACEs? Prevention is key. The CDC estimates that nearly 2 million cases of adult heart disease and more than 20 million cases of adult depression could be avoided if ACEs were eliminated.
But what is the best means to pragmatically reduce ACEs in our current practice models? How do we discover a history of ACEs in patients, and what are the best practices in managing persons with a positive history? We will cover these critical subjects in a future article, but for now, please provide your own comments and pearls regarding the prevention and management of ACEs.
Dr. Vega, health sciences clinical professor, family medicine, University of California, Irvine, disclosed ties with GlaxoSmithKline and Johnson and Johnson. Ms. Hurtado, MD candidate, University of California, Irvine School of Medicine, has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This case is a little out of the ordinary, but we would love to find out how readers would handle it.
Diana is a 51-year-old woman with a history of depression, obesity, hypertension, type 2 diabetes, and coronary artery disease. She has come in for a routine visit for her chronic illnesses. She seems very distant and has a flat affect during the initial interview. When you ask about any recent stressful events, she begins crying and explains that her daughter was just deported, leaving behind a child and boyfriend.
Their country of origin suffers from chronic instability and violence. Diana’s father was murdered there, and Diana was the victim of sexual assault. “I escaped when I was 18, and I tried to never look back. Until now.” Diana is very worried about her daughter’s return to that country. “I don’t want her to have to endure what I have endured.”
You spend some time discussing the patient’s mental health burden and identify a counselor and online resources that might help. You wonder if Diana’s adverse childhood experiences (ACEs) might have contributed to some of her physical illnesses.
ACEs and Adult Health
One of the most pronounced and straightforward links is that between ACEs and depression. In the Southern Community Cohort Study of more than 38,200 US adults, the highest odds ratio between ACEs and chronic disease was for depression. Persons who reported more than three ACEs had about a twofold increase in the risk for depression compared with persons without ACEs. There was a monotonic increase in the risk for depression and other chronic illnesses as the burden of ACEs increased.
In another study from the United Kingdom, each additional ACE was associated with a significant 11% increase in the risk for incident diabetes during adulthood. Researchers found that both depression symptoms and cardiometabolic dysfunction mediated the effects of ACEs in promoting higher rates of diabetes.
Depression and diabetes are significant risk factors for coronary artery disease, so it is not surprising that ACEs are also associated with a higher risk for coronary events. A review by Godoy and colleagues described how ACEs promote neuroendocrine, autonomic, and inflammatory dysfunction, which in turn leads to higher rates of traditional cardiovascular risk factors such as diabetes and obesity. Ultimately, the presence of four or more ACEs is associated with more than a twofold higher risk for cardiovascular disease compared with no ACEs.
Many of the pathologic processes that promote cardiovascular disease also increase the risk for dementia. Could the reach of ACEs span decades to promote a higher risk for dementia among older adults? A study by Yuan and colleagues of 7222 Chinese adults suggests that the answer is yes. This study divided the cohort into persons with a history of no ACEs, household dysfunction during childhood, or mistreatment during childhood. Child mistreatment was associated with higher rates of diabetes, depression, and cardiovascular disease, as well as an odds ratio of 1.37 (95% CI, 1.12 to 1.68) for cognitive impairment.
The magnitude of the effects ACEs can have on well-being is reinforced by epidemiologic data surrounding ACEs. According to the US Centers for Disease Control and Prevention (CDC), 64% of US adults report at least one ACE and 17% experienced at least four ACEs. Risk factors for ACEs include being female, American Indian or Alaska Native, or unemployed.
How do we reduce the impact of ACEs? Prevention is key. The CDC estimates that nearly 2 million cases of adult heart disease and more than 20 million cases of adult depression could be avoided if ACEs were eliminated.
But what is the best means to pragmatically reduce ACEs in our current practice models? How do we discover a history of ACEs in patients, and what are the best practices in managing persons with a positive history? We will cover these critical subjects in a future article, but for now, please provide your own comments and pearls regarding the prevention and management of ACEs.
Dr. Vega, health sciences clinical professor, family medicine, University of California, Irvine, disclosed ties with GlaxoSmithKline and Johnson and Johnson. Ms. Hurtado, MD candidate, University of California, Irvine School of Medicine, has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This case is a little out of the ordinary, but we would love to find out how readers would handle it.
Diana is a 51-year-old woman with a history of depression, obesity, hypertension, type 2 diabetes, and coronary artery disease. She has come in for a routine visit for her chronic illnesses. She seems very distant and has a flat affect during the initial interview. When you ask about any recent stressful events, she begins crying and explains that her daughter was just deported, leaving behind a child and boyfriend.
Their country of origin suffers from chronic instability and violence. Diana’s father was murdered there, and Diana was the victim of sexual assault. “I escaped when I was 18, and I tried to never look back. Until now.” Diana is very worried about her daughter’s return to that country. “I don’t want her to have to endure what I have endured.”
You spend some time discussing the patient’s mental health burden and identify a counselor and online resources that might help. You wonder if Diana’s adverse childhood experiences (ACEs) might have contributed to some of her physical illnesses.
ACEs and Adult Health
One of the most pronounced and straightforward links is that between ACEs and depression. In the Southern Community Cohort Study of more than 38,200 US adults, the highest odds ratio between ACEs and chronic disease was for depression. Persons who reported more than three ACEs had about a twofold increase in the risk for depression compared with persons without ACEs. There was a monotonic increase in the risk for depression and other chronic illnesses as the burden of ACEs increased.
In another study from the United Kingdom, each additional ACE was associated with a significant 11% increase in the risk for incident diabetes during adulthood. Researchers found that both depression symptoms and cardiometabolic dysfunction mediated the effects of ACEs in promoting higher rates of diabetes.
Depression and diabetes are significant risk factors for coronary artery disease, so it is not surprising that ACEs are also associated with a higher risk for coronary events. A review by Godoy and colleagues described how ACEs promote neuroendocrine, autonomic, and inflammatory dysfunction, which in turn leads to higher rates of traditional cardiovascular risk factors such as diabetes and obesity. Ultimately, the presence of four or more ACEs is associated with more than a twofold higher risk for cardiovascular disease compared with no ACEs.
Many of the pathologic processes that promote cardiovascular disease also increase the risk for dementia. Could the reach of ACEs span decades to promote a higher risk for dementia among older adults? A study by Yuan and colleagues of 7222 Chinese adults suggests that the answer is yes. This study divided the cohort into persons with a history of no ACEs, household dysfunction during childhood, or mistreatment during childhood. Child mistreatment was associated with higher rates of diabetes, depression, and cardiovascular disease, as well as an odds ratio of 1.37 (95% CI, 1.12 to 1.68) for cognitive impairment.
The magnitude of the effects ACEs can have on well-being is reinforced by epidemiologic data surrounding ACEs. According to the US Centers for Disease Control and Prevention (CDC), 64% of US adults report at least one ACE and 17% experienced at least four ACEs. Risk factors for ACEs include being female, American Indian or Alaska Native, or unemployed.
How do we reduce the impact of ACEs? Prevention is key. The CDC estimates that nearly 2 million cases of adult heart disease and more than 20 million cases of adult depression could be avoided if ACEs were eliminated.
But what is the best means to pragmatically reduce ACEs in our current practice models? How do we discover a history of ACEs in patients, and what are the best practices in managing persons with a positive history? We will cover these critical subjects in a future article, but for now, please provide your own comments and pearls regarding the prevention and management of ACEs.
Dr. Vega, health sciences clinical professor, family medicine, University of California, Irvine, disclosed ties with GlaxoSmithKline and Johnson and Johnson. Ms. Hurtado, MD candidate, University of California, Irvine School of Medicine, has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Single Session Mindfulness Intervention Linked to Reduced Depression
TOPLINE:
One session of a telehealth intervention combining mindfulness and compassion significantly lowered self-perceived stress and symptoms of depression and anxiety compared with a waitlist control group, results of a new trial showed.
METHODOLOGY:
- The randomized clinical trial (RCT) included 91 participants aged 18-70 years recruited from the community and the University of Texas at Austin and followed from 2020 to 2021.
- To be included in the trial, participants had to be sheltering at home during the pandemic and endorse loneliness as one of the top issues affecting them.
- Participants were randomized to one of three groups that received single-session online interventions. These included mindfulness-only (MO), mindfulness and compassion (MC), and a waitlist control (WL) group.
- During the compassion component, participants were instructed to focus on a person, place, object, or spiritual figure that evoked feelings of warmth, love, and kindness in them. The primary outcome was self-reported loneliness and secondary outcomes were self-reported stress, depression, and anxiety.
TAKEAWAY:
- At 1-week follow-up, the MC group led to reductions in perceived stress (b = −3.75), anxiety (b = −3.79), and depression (b = −3.01) but not loneliness compared with control individuals.
- Compared with the MO group alone, the MC group had no meaningful differences in perceived depression (b = −1.08) or anxiety (b = −1.50), and the same was true at the 2-week follow-up.
- Researchers speculated that the lack of difference between outcomes in the two mindfulness groups probably meant that the MC group may have only been effective in reducing self-perceived symptoms of stress, anxiety, and depression compared with the control group.
IN PRACTICE:
“This brief single session mindfulness intervention offers an approach that can be easily adopted in a range of contexts. It is important for future research to evaluate this approach with larger samples and to examine whether changes in symptoms are maintained over longer periods of time,” the researchers wrote.
SOURCE:
Mikael Rubin, PhD, of Palo Alto University in Palo Alto, California, led the study, which was published online in PLOS ONE.
LIMITATIONS:
The study was limited by its small sample size and short follow-up period.
DISCLOSURES:
There was no funding listed for the study nor were there any reported disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
One session of a telehealth intervention combining mindfulness and compassion significantly lowered self-perceived stress and symptoms of depression and anxiety compared with a waitlist control group, results of a new trial showed.
METHODOLOGY:
- The randomized clinical trial (RCT) included 91 participants aged 18-70 years recruited from the community and the University of Texas at Austin and followed from 2020 to 2021.
- To be included in the trial, participants had to be sheltering at home during the pandemic and endorse loneliness as one of the top issues affecting them.
- Participants were randomized to one of three groups that received single-session online interventions. These included mindfulness-only (MO), mindfulness and compassion (MC), and a waitlist control (WL) group.
- During the compassion component, participants were instructed to focus on a person, place, object, or spiritual figure that evoked feelings of warmth, love, and kindness in them. The primary outcome was self-reported loneliness and secondary outcomes were self-reported stress, depression, and anxiety.
TAKEAWAY:
- At 1-week follow-up, the MC group led to reductions in perceived stress (b = −3.75), anxiety (b = −3.79), and depression (b = −3.01) but not loneliness compared with control individuals.
- Compared with the MO group alone, the MC group had no meaningful differences in perceived depression (b = −1.08) or anxiety (b = −1.50), and the same was true at the 2-week follow-up.
- Researchers speculated that the lack of difference between outcomes in the two mindfulness groups probably meant that the MC group may have only been effective in reducing self-perceived symptoms of stress, anxiety, and depression compared with the control group.
IN PRACTICE:
“This brief single session mindfulness intervention offers an approach that can be easily adopted in a range of contexts. It is important for future research to evaluate this approach with larger samples and to examine whether changes in symptoms are maintained over longer periods of time,” the researchers wrote.
SOURCE:
Mikael Rubin, PhD, of Palo Alto University in Palo Alto, California, led the study, which was published online in PLOS ONE.
LIMITATIONS:
The study was limited by its small sample size and short follow-up period.
DISCLOSURES:
There was no funding listed for the study nor were there any reported disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
One session of a telehealth intervention combining mindfulness and compassion significantly lowered self-perceived stress and symptoms of depression and anxiety compared with a waitlist control group, results of a new trial showed.
METHODOLOGY:
- The randomized clinical trial (RCT) included 91 participants aged 18-70 years recruited from the community and the University of Texas at Austin and followed from 2020 to 2021.
- To be included in the trial, participants had to be sheltering at home during the pandemic and endorse loneliness as one of the top issues affecting them.
- Participants were randomized to one of three groups that received single-session online interventions. These included mindfulness-only (MO), mindfulness and compassion (MC), and a waitlist control (WL) group.
- During the compassion component, participants were instructed to focus on a person, place, object, or spiritual figure that evoked feelings of warmth, love, and kindness in them. The primary outcome was self-reported loneliness and secondary outcomes were self-reported stress, depression, and anxiety.
TAKEAWAY:
- At 1-week follow-up, the MC group led to reductions in perceived stress (b = −3.75), anxiety (b = −3.79), and depression (b = −3.01) but not loneliness compared with control individuals.
- Compared with the MO group alone, the MC group had no meaningful differences in perceived depression (b = −1.08) or anxiety (b = −1.50), and the same was true at the 2-week follow-up.
- Researchers speculated that the lack of difference between outcomes in the two mindfulness groups probably meant that the MC group may have only been effective in reducing self-perceived symptoms of stress, anxiety, and depression compared with the control group.
IN PRACTICE:
“This brief single session mindfulness intervention offers an approach that can be easily adopted in a range of contexts. It is important for future research to evaluate this approach with larger samples and to examine whether changes in symptoms are maintained over longer periods of time,” the researchers wrote.
SOURCE:
Mikael Rubin, PhD, of Palo Alto University in Palo Alto, California, led the study, which was published online in PLOS ONE.
LIMITATIONS:
The study was limited by its small sample size and short follow-up period.
DISCLOSURES:
There was no funding listed for the study nor were there any reported disclosures.
A version of this article appeared on Medscape.com.
Perinatal Mood and Anxiety Disorder Increasing Rapidly
The number of women with perinatal mood and anxiety disorder (PMAD) has spiked sharply in the United States. A new study explores trends by state and time period.
Between 2008 and 2020, in a national cohort of 750,004 commercially insured women with a live birth, nearly 1 in 5 (144,037 [19.2%]) were diagnosed with PMAD, according to a paper published in Health Affairs. PMAD diagnoses among privately insured women increased by 93.3% over those years, wrote lead author Kara Zivin, PhD, of the University of Michigan, Veterans Affairs Ann Arbor Healthcare System, and colleagues.
PMAD describes a spectrum of emotional complications with mild to severe symptoms that can affect women while pregnant and through the first year after giving birth.
The total number of perinatal women decreased from a high of 64,842 in 2008 to a low of 52,479 in 2020, a 19.1% decrease, but over the same time, women with diagnosed PMAD increased 56.4% from 9,520 in 2008 to 14,890 in 2020. Prevalence of PMAD doubled from 1,468 per 10,000 deliveries to 2,837 per 10,000 deliveries in 2020, according to the analysis.
Differences by State
Increases differed substantially by state. Though average annual changes across all states reached 109 additional PMAD diagnoses per 10,000 deliveries, Iowa had the greatest increase with an additional 163 PMAD diagnoses per 10,000 deliveries annually. New Mexico had the smallest annual growth, at an additional 49 per 10,000 deliveries.
The increases were accompanied by maternal health improvement efforts. The Affordable Care Act (ACA) required insurance companies to cover maternity and preventive services, which likely increased PMAD screening and detection, the researchers noted.
“Diagnosis of PMAD is rising due to increased awareness and in all likelihood, decrease in stigma, but availability of providers is so challenging,” said Lee S. Cohen, MD, who was not part of the study. Dr. Cohen is director of the Ammon-Pinizzotto Center for Women’s Mental Health and Perinatal and Reproductive Psychiatry at Massachusetts General Hospital in Boston. “The navigation to providers by women who are suffering is beyond challenging,” he said.
The authors reported that all states except Vermont saw increasing rates of PMAD diagnoses post-ACA vs. pre-ACA. The researchers also found that relative to the period from 2008 to 2014, psychotherapy rates continued rising from 2015 to 2020 and suicidality (suicidal ideation or self-harm diagnoses) rates declined.
States’ Suicidality Rates Vary Widely
“Overall, access to psychotherapy may have stemmed suicidality despite increasing PMAD diagnoses. But although more PMAD diagnoses may have led to increased psychotherapy, therapy access depends on provider availability, which varies by geographic region and insurance coverage network,” the authors wrote.
Suicidality rates differed greatly by state. Louisiana’s annual rate of increase was greatest, at 22 per 10,000 while Maryland had the greatest negative annual rate of change, at −15 per 10,000 deliveries, the authors explained.
“Observed trends in PMAD diagnoses among privately insured people during 2008-2020 and in associated suicidality and psychotherapy use suggest an increasingly rapid worsening of US maternal mental health,” the authors wrote.
The authors noted that this study did not include those on public insurance, a group that may experience disproportionate maternal morbidity and mortality burden, and urged that future studies include them.
Strengths of Study
Kimberly McKee, PhD, MPH, assistant professor in the department of family medicine at University of Michigan in Ann Arbor, who was not part of this research, said this paper gives a broader look than prior work because it includes the year before and after birth, rather than delivery and hospitalization.
“It’s really important to look out at least 12 months postpartum,” she noted.
Another strength is that the study was able to look at use of services such as psychotherapy before and post ACA. She noted the increased use of psychotherapy and the decrease in suicidal ideation was an association, but said, “I think it’s reasonable to assume that there was a benefit.”
She noted that these data go through 2020 and the COVID-19 pandemic has even further stressed the healthcare system, which could affect these numbers.
Primary Care’s Role
“The opportunity for primary care to really be the medical home for reproductive-age women is key here,” Dr. McKee said, adding that primary care can provide the continuity if women go off and on insurance around pregnancy and make sure the women get follow-up care and referrals to specialty care.
Models that integrate behavioral health and primary care are particularly promising, she said. Inclusion of social workers at the point of care can also help meet needs regarding social determinants of health.
Telehealth is another avenue for expansion extending the reach for following perinatal women, she said. “Using every tool we have to reach individuals where they are can allow for more frequent check-ins, which is really important here.”
Dr. McKee said the paper highlights an important reality: Mental health is a leading cause and contributor to maternal mortality, which “is 100% preventable.” Yet, current literature continues to show increases.
“This is a fairly common problem that affects not just women, but the fetus, their children, their families,” she noted.
The authors and Dr. Cohen and Dr. McKee reported no relevant financial relationships.
The number of women with perinatal mood and anxiety disorder (PMAD) has spiked sharply in the United States. A new study explores trends by state and time period.
Between 2008 and 2020, in a national cohort of 750,004 commercially insured women with a live birth, nearly 1 in 5 (144,037 [19.2%]) were diagnosed with PMAD, according to a paper published in Health Affairs. PMAD diagnoses among privately insured women increased by 93.3% over those years, wrote lead author Kara Zivin, PhD, of the University of Michigan, Veterans Affairs Ann Arbor Healthcare System, and colleagues.
PMAD describes a spectrum of emotional complications with mild to severe symptoms that can affect women while pregnant and through the first year after giving birth.
The total number of perinatal women decreased from a high of 64,842 in 2008 to a low of 52,479 in 2020, a 19.1% decrease, but over the same time, women with diagnosed PMAD increased 56.4% from 9,520 in 2008 to 14,890 in 2020. Prevalence of PMAD doubled from 1,468 per 10,000 deliveries to 2,837 per 10,000 deliveries in 2020, according to the analysis.
Differences by State
Increases differed substantially by state. Though average annual changes across all states reached 109 additional PMAD diagnoses per 10,000 deliveries, Iowa had the greatest increase with an additional 163 PMAD diagnoses per 10,000 deliveries annually. New Mexico had the smallest annual growth, at an additional 49 per 10,000 deliveries.
The increases were accompanied by maternal health improvement efforts. The Affordable Care Act (ACA) required insurance companies to cover maternity and preventive services, which likely increased PMAD screening and detection, the researchers noted.
“Diagnosis of PMAD is rising due to increased awareness and in all likelihood, decrease in stigma, but availability of providers is so challenging,” said Lee S. Cohen, MD, who was not part of the study. Dr. Cohen is director of the Ammon-Pinizzotto Center for Women’s Mental Health and Perinatal and Reproductive Psychiatry at Massachusetts General Hospital in Boston. “The navigation to providers by women who are suffering is beyond challenging,” he said.
The authors reported that all states except Vermont saw increasing rates of PMAD diagnoses post-ACA vs. pre-ACA. The researchers also found that relative to the period from 2008 to 2014, psychotherapy rates continued rising from 2015 to 2020 and suicidality (suicidal ideation or self-harm diagnoses) rates declined.
States’ Suicidality Rates Vary Widely
“Overall, access to psychotherapy may have stemmed suicidality despite increasing PMAD diagnoses. But although more PMAD diagnoses may have led to increased psychotherapy, therapy access depends on provider availability, which varies by geographic region and insurance coverage network,” the authors wrote.
Suicidality rates differed greatly by state. Louisiana’s annual rate of increase was greatest, at 22 per 10,000 while Maryland had the greatest negative annual rate of change, at −15 per 10,000 deliveries, the authors explained.
“Observed trends in PMAD diagnoses among privately insured people during 2008-2020 and in associated suicidality and psychotherapy use suggest an increasingly rapid worsening of US maternal mental health,” the authors wrote.
The authors noted that this study did not include those on public insurance, a group that may experience disproportionate maternal morbidity and mortality burden, and urged that future studies include them.
Strengths of Study
Kimberly McKee, PhD, MPH, assistant professor in the department of family medicine at University of Michigan in Ann Arbor, who was not part of this research, said this paper gives a broader look than prior work because it includes the year before and after birth, rather than delivery and hospitalization.
“It’s really important to look out at least 12 months postpartum,” she noted.
Another strength is that the study was able to look at use of services such as psychotherapy before and post ACA. She noted the increased use of psychotherapy and the decrease in suicidal ideation was an association, but said, “I think it’s reasonable to assume that there was a benefit.”
She noted that these data go through 2020 and the COVID-19 pandemic has even further stressed the healthcare system, which could affect these numbers.
Primary Care’s Role
“The opportunity for primary care to really be the medical home for reproductive-age women is key here,” Dr. McKee said, adding that primary care can provide the continuity if women go off and on insurance around pregnancy and make sure the women get follow-up care and referrals to specialty care.
Models that integrate behavioral health and primary care are particularly promising, she said. Inclusion of social workers at the point of care can also help meet needs regarding social determinants of health.
Telehealth is another avenue for expansion extending the reach for following perinatal women, she said. “Using every tool we have to reach individuals where they are can allow for more frequent check-ins, which is really important here.”
Dr. McKee said the paper highlights an important reality: Mental health is a leading cause and contributor to maternal mortality, which “is 100% preventable.” Yet, current literature continues to show increases.
“This is a fairly common problem that affects not just women, but the fetus, their children, their families,” she noted.
The authors and Dr. Cohen and Dr. McKee reported no relevant financial relationships.
The number of women with perinatal mood and anxiety disorder (PMAD) has spiked sharply in the United States. A new study explores trends by state and time period.
Between 2008 and 2020, in a national cohort of 750,004 commercially insured women with a live birth, nearly 1 in 5 (144,037 [19.2%]) were diagnosed with PMAD, according to a paper published in Health Affairs. PMAD diagnoses among privately insured women increased by 93.3% over those years, wrote lead author Kara Zivin, PhD, of the University of Michigan, Veterans Affairs Ann Arbor Healthcare System, and colleagues.
PMAD describes a spectrum of emotional complications with mild to severe symptoms that can affect women while pregnant and through the first year after giving birth.
The total number of perinatal women decreased from a high of 64,842 in 2008 to a low of 52,479 in 2020, a 19.1% decrease, but over the same time, women with diagnosed PMAD increased 56.4% from 9,520 in 2008 to 14,890 in 2020. Prevalence of PMAD doubled from 1,468 per 10,000 deliveries to 2,837 per 10,000 deliveries in 2020, according to the analysis.
Differences by State
Increases differed substantially by state. Though average annual changes across all states reached 109 additional PMAD diagnoses per 10,000 deliveries, Iowa had the greatest increase with an additional 163 PMAD diagnoses per 10,000 deliveries annually. New Mexico had the smallest annual growth, at an additional 49 per 10,000 deliveries.
The increases were accompanied by maternal health improvement efforts. The Affordable Care Act (ACA) required insurance companies to cover maternity and preventive services, which likely increased PMAD screening and detection, the researchers noted.
“Diagnosis of PMAD is rising due to increased awareness and in all likelihood, decrease in stigma, but availability of providers is so challenging,” said Lee S. Cohen, MD, who was not part of the study. Dr. Cohen is director of the Ammon-Pinizzotto Center for Women’s Mental Health and Perinatal and Reproductive Psychiatry at Massachusetts General Hospital in Boston. “The navigation to providers by women who are suffering is beyond challenging,” he said.
The authors reported that all states except Vermont saw increasing rates of PMAD diagnoses post-ACA vs. pre-ACA. The researchers also found that relative to the period from 2008 to 2014, psychotherapy rates continued rising from 2015 to 2020 and suicidality (suicidal ideation or self-harm diagnoses) rates declined.
States’ Suicidality Rates Vary Widely
“Overall, access to psychotherapy may have stemmed suicidality despite increasing PMAD diagnoses. But although more PMAD diagnoses may have led to increased psychotherapy, therapy access depends on provider availability, which varies by geographic region and insurance coverage network,” the authors wrote.
Suicidality rates differed greatly by state. Louisiana’s annual rate of increase was greatest, at 22 per 10,000 while Maryland had the greatest negative annual rate of change, at −15 per 10,000 deliveries, the authors explained.
“Observed trends in PMAD diagnoses among privately insured people during 2008-2020 and in associated suicidality and psychotherapy use suggest an increasingly rapid worsening of US maternal mental health,” the authors wrote.
The authors noted that this study did not include those on public insurance, a group that may experience disproportionate maternal morbidity and mortality burden, and urged that future studies include them.
Strengths of Study
Kimberly McKee, PhD, MPH, assistant professor in the department of family medicine at University of Michigan in Ann Arbor, who was not part of this research, said this paper gives a broader look than prior work because it includes the year before and after birth, rather than delivery and hospitalization.
“It’s really important to look out at least 12 months postpartum,” she noted.
Another strength is that the study was able to look at use of services such as psychotherapy before and post ACA. She noted the increased use of psychotherapy and the decrease in suicidal ideation was an association, but said, “I think it’s reasonable to assume that there was a benefit.”
She noted that these data go through 2020 and the COVID-19 pandemic has even further stressed the healthcare system, which could affect these numbers.
Primary Care’s Role
“The opportunity for primary care to really be the medical home for reproductive-age women is key here,” Dr. McKee said, adding that primary care can provide the continuity if women go off and on insurance around pregnancy and make sure the women get follow-up care and referrals to specialty care.
Models that integrate behavioral health and primary care are particularly promising, she said. Inclusion of social workers at the point of care can also help meet needs regarding social determinants of health.
Telehealth is another avenue for expansion extending the reach for following perinatal women, she said. “Using every tool we have to reach individuals where they are can allow for more frequent check-ins, which is really important here.”
Dr. McKee said the paper highlights an important reality: Mental health is a leading cause and contributor to maternal mortality, which “is 100% preventable.” Yet, current literature continues to show increases.
“This is a fairly common problem that affects not just women, but the fetus, their children, their families,” she noted.
The authors and Dr. Cohen and Dr. McKee reported no relevant financial relationships.
FROM HEALTH AFFAIRS
Remote CBT as Effective as In-Person Therapy for Mental Illness
Remote cognitive behavioral therapy (CBT) is just as effective as in-person CBT for a range of mental health and somatic disorders, a new review of more than 50 randomized clinical trials (RCTs) showed.
The RCTs included more than 5000 patients receiving CBT for conditions such as mood, anxiety, and body dysmorphic disorders, as well as chronic pain, insomnia, and alcohol use disorder.
“The World Health Organization has designated CBT as essential healthcare, but access remains an important barrier for many people in Canada. Our findings suggest that therapist-guided, remotely delivered CBT can be used to facilitate greater access to evidence-based care,” lead investigator Jason Busse, PhD, McMaster University, Hamilton, Ontario, Canada, said in a press release.
The findings were published online on March 18 in CMAJ.
Access Problematic
In Canada, CBT may be provided within existing government-funded healthcare services and by private providers such as registered psychotherapists, social worker, and psychologists who require out-of-pocket expenses.
Access to evidence-based mental healthcare such as CBT can be challenging in a country as geographically large, and as sparsely populated, as Canada. To increase access, some of the provinces have funded Internet-based CBT, but the efficacy of in-person vs remote CBT remains uncertain.
The investigators searched the medical literature for RCTs that enrolled adult patients randomized to receive either therapist-guided remote or in-person CBT.
The study included 52 RCTs with 5463 participants with a mean age of 43 years, and 3354 (61%) were female.
A total of 17 studies focused on the treatment of anxiety and related disorders, 14 on depression and mood disorders, seven on insomnia, six on chronic pain or fatigue syndromes, five on body image or eating disorders, three on tinnitus, and one on alcohol use disorder.
CBT was provided on an individual and group basis. Treatment duration ranged from 5 to 21 sessions, with the median follow-up of 180 days.
Investigators found little to no difference in effectiveness between in-person and therapist-guided remote CBT on primary outcomes (standardized mean difference [SMD], −0.02; 95% CI, −0.11 to 0.07).
Analysis using end scores also showed little to no difference in efficacy between in-person and remote CBT (SMD, −0.01; 95% CI, −0.11 to 0.08).
Policy Implications
The authors noted that remote CBT can potentially expand access to care as it is more convenient for patients and potentially more cost-effective.
“Our finding that remote CBT is an effective alternative to in-person delivery has potential policy implications,” they wrote.
The researchers recommended Canadian provinces and territories increase funding to boost access to therapist-guided remote CBT, thereby expanding access to evidence-based care.
Study limitations included the fact that most of the eligible RCTs reviewed in the analysis were conducted in high-income countries with middle-aged patients and followed them for a median 180 days, so generalizability of the findings to older patients living in lower-income patients or for longer follow-up periods was uncertain.
The study was partially funded by the Canadian Institutes of Health Research. Disclosures were noted in the original article.
A version of this article appeared on Medscape.com .
Remote cognitive behavioral therapy (CBT) is just as effective as in-person CBT for a range of mental health and somatic disorders, a new review of more than 50 randomized clinical trials (RCTs) showed.
The RCTs included more than 5000 patients receiving CBT for conditions such as mood, anxiety, and body dysmorphic disorders, as well as chronic pain, insomnia, and alcohol use disorder.
“The World Health Organization has designated CBT as essential healthcare, but access remains an important barrier for many people in Canada. Our findings suggest that therapist-guided, remotely delivered CBT can be used to facilitate greater access to evidence-based care,” lead investigator Jason Busse, PhD, McMaster University, Hamilton, Ontario, Canada, said in a press release.
The findings were published online on March 18 in CMAJ.
Access Problematic
In Canada, CBT may be provided within existing government-funded healthcare services and by private providers such as registered psychotherapists, social worker, and psychologists who require out-of-pocket expenses.
Access to evidence-based mental healthcare such as CBT can be challenging in a country as geographically large, and as sparsely populated, as Canada. To increase access, some of the provinces have funded Internet-based CBT, but the efficacy of in-person vs remote CBT remains uncertain.
The investigators searched the medical literature for RCTs that enrolled adult patients randomized to receive either therapist-guided remote or in-person CBT.
The study included 52 RCTs with 5463 participants with a mean age of 43 years, and 3354 (61%) were female.
A total of 17 studies focused on the treatment of anxiety and related disorders, 14 on depression and mood disorders, seven on insomnia, six on chronic pain or fatigue syndromes, five on body image or eating disorders, three on tinnitus, and one on alcohol use disorder.
CBT was provided on an individual and group basis. Treatment duration ranged from 5 to 21 sessions, with the median follow-up of 180 days.
Investigators found little to no difference in effectiveness between in-person and therapist-guided remote CBT on primary outcomes (standardized mean difference [SMD], −0.02; 95% CI, −0.11 to 0.07).
Analysis using end scores also showed little to no difference in efficacy between in-person and remote CBT (SMD, −0.01; 95% CI, −0.11 to 0.08).
Policy Implications
The authors noted that remote CBT can potentially expand access to care as it is more convenient for patients and potentially more cost-effective.
“Our finding that remote CBT is an effective alternative to in-person delivery has potential policy implications,” they wrote.
The researchers recommended Canadian provinces and territories increase funding to boost access to therapist-guided remote CBT, thereby expanding access to evidence-based care.
Study limitations included the fact that most of the eligible RCTs reviewed in the analysis were conducted in high-income countries with middle-aged patients and followed them for a median 180 days, so generalizability of the findings to older patients living in lower-income patients or for longer follow-up periods was uncertain.
The study was partially funded by the Canadian Institutes of Health Research. Disclosures were noted in the original article.
A version of this article appeared on Medscape.com .
Remote cognitive behavioral therapy (CBT) is just as effective as in-person CBT for a range of mental health and somatic disorders, a new review of more than 50 randomized clinical trials (RCTs) showed.
The RCTs included more than 5000 patients receiving CBT for conditions such as mood, anxiety, and body dysmorphic disorders, as well as chronic pain, insomnia, and alcohol use disorder.
“The World Health Organization has designated CBT as essential healthcare, but access remains an important barrier for many people in Canada. Our findings suggest that therapist-guided, remotely delivered CBT can be used to facilitate greater access to evidence-based care,” lead investigator Jason Busse, PhD, McMaster University, Hamilton, Ontario, Canada, said in a press release.
The findings were published online on March 18 in CMAJ.
Access Problematic
In Canada, CBT may be provided within existing government-funded healthcare services and by private providers such as registered psychotherapists, social worker, and psychologists who require out-of-pocket expenses.
Access to evidence-based mental healthcare such as CBT can be challenging in a country as geographically large, and as sparsely populated, as Canada. To increase access, some of the provinces have funded Internet-based CBT, but the efficacy of in-person vs remote CBT remains uncertain.
The investigators searched the medical literature for RCTs that enrolled adult patients randomized to receive either therapist-guided remote or in-person CBT.
The study included 52 RCTs with 5463 participants with a mean age of 43 years, and 3354 (61%) were female.
A total of 17 studies focused on the treatment of anxiety and related disorders, 14 on depression and mood disorders, seven on insomnia, six on chronic pain or fatigue syndromes, five on body image or eating disorders, three on tinnitus, and one on alcohol use disorder.
CBT was provided on an individual and group basis. Treatment duration ranged from 5 to 21 sessions, with the median follow-up of 180 days.
Investigators found little to no difference in effectiveness between in-person and therapist-guided remote CBT on primary outcomes (standardized mean difference [SMD], −0.02; 95% CI, −0.11 to 0.07).
Analysis using end scores also showed little to no difference in efficacy between in-person and remote CBT (SMD, −0.01; 95% CI, −0.11 to 0.08).
Policy Implications
The authors noted that remote CBT can potentially expand access to care as it is more convenient for patients and potentially more cost-effective.
“Our finding that remote CBT is an effective alternative to in-person delivery has potential policy implications,” they wrote.
The researchers recommended Canadian provinces and territories increase funding to boost access to therapist-guided remote CBT, thereby expanding access to evidence-based care.
Study limitations included the fact that most of the eligible RCTs reviewed in the analysis were conducted in high-income countries with middle-aged patients and followed them for a median 180 days, so generalizability of the findings to older patients living in lower-income patients or for longer follow-up periods was uncertain.
The study was partially funded by the Canadian Institutes of Health Research. Disclosures were noted in the original article.
A version of this article appeared on Medscape.com .
Childhood Adversity Robustly Linked to Adult Mental Illness
Adverse childhood experiences (ACEs) are associated with a significantly increased risk for adult depressive, anxiety, and stress-related disorders, new data from a large registry study of twins showed.
Researchers found that each additional adverse event placed children at a 52% greater risk for a psychiatric disorder as an adult, with sexual abuse associated with the greatest risk.
The findings showed that the association held even after controlling for shared genetic and environmental factors.
The results suggested that “interventions targeting ACEs, including primary prevention and enhanced access to evidence-based trauma therapies to individuals who experienced ACEs, may be associated with reduced risk of future psychopathology,” the investigators, with first author Hilda Björk Daníelsdóttir, MSc, of the University of Iceland, Reykjavik, Iceland, wrote.
The findings were published online on March 6 in JAMA Psychiatry.
Dose-Dependent Effect
Previous research has shown a robust link between childhood abuse and an increased risk for psychiatric disorders in adulthood, but evidence of this association in studies that adjust for familial confounding is “completely lacking,” the investigators wrote.
To learn more about how genetic factors may affect the relationship between ACEs and later psychiatric diagnoses, the investigators used data from the nationwide Swedish Twin Registry, which includes data on more than 25,000 identical and nonidentical twins.
The twin registry is linked to the Swedish National Patient Registry, which includes information on inpatient or outpatient psychiatric diagnoses after age 19.
The twins responded to a large web-based questionnaire about past-week depressive symptoms as a measure of current mental health and distinct types of ACEs including family violence, emotional abuse or neglect, physical neglect, physical abuse, sexual abuse, rape, and hate crime.
Three birth cohorts from the twin registry were surveyed between 2005 and 2016 and followed up in the national registry from age 19 until the end of 2016.
Among the sample of 25,000 twin pairs (15,000 female; mean age at assessment, 29 years), 9750 (39%) participants reported exposure to at least one ACE, while 2000 (8%) reported exposure to three or more ACEs. Most respondents — 61% — reported no ACE exposure.
More than 2300 participants received a psychiatric diagnosis as an adult. The incidence of any psychiatric disorder increased from 503 individuals (6.4%) among participants without any ACEs to 993 individuals (24.6%) among those reporting three or more.
At the cohort level, a greater number of ACEs was associated with increased odds of any psychiatric disorder in a dose-dependent manner, the investigators noted (odds ratio [OR], 1.52; 95% CI, 1.48-1.57).
Untangling Genes and Environment
To determine how much of the increased risk for adult mental illness is due to ACEs and how much can be attributed to genetics and environment, the researchers focused on twin pairs where one had exposure to one type of ACEs and the other did not. This analysis revealed that the association remained but was attenuated. In identical twins, the effect of each ACE raised the odds of having a psychiatric condition by 20% (1.20; 95% CI, 1.02-1.40), and for nonidentical twins, the odds increased by 29% (1.29; 95% CI, 1.14-1.47).
The weakening of the risk “suggests that familial confounding contributed to the association between ACEs and adult mental health outcomes,” the authors wrote.
Of all the ACEs, sexual abuse carried the highest risk for adult psychiatric disorders. Children who were exposed to sexual abuse, compared with those who were not, had up to a 200% higher risk for any psychiatric disorder in the following comparisons: Full cohort (OR, 3.09; 95% CI, 2.68-3.56), dizygotic twin pairs (OR, 2.10; 95% CI, 1.33-3.32), and monozygotic twin pairs (1.80; 95% CI, 1.04-3.11).
“Our results demonstrated that familial factors contributed to a lesser extent to the association between sexual abuse and adult psychiatric disorders,” the authors wrote.
One major limitation of the study was that ACEs were based on retrospective report and thus may be subject to recall bias. Also, the findings cannot be generalized to other countries or cultures.
The study was funded by the European Research Council, the Icelandic Center for Research, and the European Union Horizon 2020. Disclosures are noted in the original article.
A version of this article appeared on Medscape.com.
Adverse childhood experiences (ACEs) are associated with a significantly increased risk for adult depressive, anxiety, and stress-related disorders, new data from a large registry study of twins showed.
Researchers found that each additional adverse event placed children at a 52% greater risk for a psychiatric disorder as an adult, with sexual abuse associated with the greatest risk.
The findings showed that the association held even after controlling for shared genetic and environmental factors.
The results suggested that “interventions targeting ACEs, including primary prevention and enhanced access to evidence-based trauma therapies to individuals who experienced ACEs, may be associated with reduced risk of future psychopathology,” the investigators, with first author Hilda Björk Daníelsdóttir, MSc, of the University of Iceland, Reykjavik, Iceland, wrote.
The findings were published online on March 6 in JAMA Psychiatry.
Dose-Dependent Effect
Previous research has shown a robust link between childhood abuse and an increased risk for psychiatric disorders in adulthood, but evidence of this association in studies that adjust for familial confounding is “completely lacking,” the investigators wrote.
To learn more about how genetic factors may affect the relationship between ACEs and later psychiatric diagnoses, the investigators used data from the nationwide Swedish Twin Registry, which includes data on more than 25,000 identical and nonidentical twins.
The twin registry is linked to the Swedish National Patient Registry, which includes information on inpatient or outpatient psychiatric diagnoses after age 19.
The twins responded to a large web-based questionnaire about past-week depressive symptoms as a measure of current mental health and distinct types of ACEs including family violence, emotional abuse or neglect, physical neglect, physical abuse, sexual abuse, rape, and hate crime.
Three birth cohorts from the twin registry were surveyed between 2005 and 2016 and followed up in the national registry from age 19 until the end of 2016.
Among the sample of 25,000 twin pairs (15,000 female; mean age at assessment, 29 years), 9750 (39%) participants reported exposure to at least one ACE, while 2000 (8%) reported exposure to three or more ACEs. Most respondents — 61% — reported no ACE exposure.
More than 2300 participants received a psychiatric diagnosis as an adult. The incidence of any psychiatric disorder increased from 503 individuals (6.4%) among participants without any ACEs to 993 individuals (24.6%) among those reporting three or more.
At the cohort level, a greater number of ACEs was associated with increased odds of any psychiatric disorder in a dose-dependent manner, the investigators noted (odds ratio [OR], 1.52; 95% CI, 1.48-1.57).
Untangling Genes and Environment
To determine how much of the increased risk for adult mental illness is due to ACEs and how much can be attributed to genetics and environment, the researchers focused on twin pairs where one had exposure to one type of ACEs and the other did not. This analysis revealed that the association remained but was attenuated. In identical twins, the effect of each ACE raised the odds of having a psychiatric condition by 20% (1.20; 95% CI, 1.02-1.40), and for nonidentical twins, the odds increased by 29% (1.29; 95% CI, 1.14-1.47).
The weakening of the risk “suggests that familial confounding contributed to the association between ACEs and adult mental health outcomes,” the authors wrote.
Of all the ACEs, sexual abuse carried the highest risk for adult psychiatric disorders. Children who were exposed to sexual abuse, compared with those who were not, had up to a 200% higher risk for any psychiatric disorder in the following comparisons: Full cohort (OR, 3.09; 95% CI, 2.68-3.56), dizygotic twin pairs (OR, 2.10; 95% CI, 1.33-3.32), and monozygotic twin pairs (1.80; 95% CI, 1.04-3.11).
“Our results demonstrated that familial factors contributed to a lesser extent to the association between sexual abuse and adult psychiatric disorders,” the authors wrote.
One major limitation of the study was that ACEs were based on retrospective report and thus may be subject to recall bias. Also, the findings cannot be generalized to other countries or cultures.
The study was funded by the European Research Council, the Icelandic Center for Research, and the European Union Horizon 2020. Disclosures are noted in the original article.
A version of this article appeared on Medscape.com.
Adverse childhood experiences (ACEs) are associated with a significantly increased risk for adult depressive, anxiety, and stress-related disorders, new data from a large registry study of twins showed.
Researchers found that each additional adverse event placed children at a 52% greater risk for a psychiatric disorder as an adult, with sexual abuse associated with the greatest risk.
The findings showed that the association held even after controlling for shared genetic and environmental factors.
The results suggested that “interventions targeting ACEs, including primary prevention and enhanced access to evidence-based trauma therapies to individuals who experienced ACEs, may be associated with reduced risk of future psychopathology,” the investigators, with first author Hilda Björk Daníelsdóttir, MSc, of the University of Iceland, Reykjavik, Iceland, wrote.
The findings were published online on March 6 in JAMA Psychiatry.
Dose-Dependent Effect
Previous research has shown a robust link between childhood abuse and an increased risk for psychiatric disorders in adulthood, but evidence of this association in studies that adjust for familial confounding is “completely lacking,” the investigators wrote.
To learn more about how genetic factors may affect the relationship between ACEs and later psychiatric diagnoses, the investigators used data from the nationwide Swedish Twin Registry, which includes data on more than 25,000 identical and nonidentical twins.
The twin registry is linked to the Swedish National Patient Registry, which includes information on inpatient or outpatient psychiatric diagnoses after age 19.
The twins responded to a large web-based questionnaire about past-week depressive symptoms as a measure of current mental health and distinct types of ACEs including family violence, emotional abuse or neglect, physical neglect, physical abuse, sexual abuse, rape, and hate crime.
Three birth cohorts from the twin registry were surveyed between 2005 and 2016 and followed up in the national registry from age 19 until the end of 2016.
Among the sample of 25,000 twin pairs (15,000 female; mean age at assessment, 29 years), 9750 (39%) participants reported exposure to at least one ACE, while 2000 (8%) reported exposure to three or more ACEs. Most respondents — 61% — reported no ACE exposure.
More than 2300 participants received a psychiatric diagnosis as an adult. The incidence of any psychiatric disorder increased from 503 individuals (6.4%) among participants without any ACEs to 993 individuals (24.6%) among those reporting three or more.
At the cohort level, a greater number of ACEs was associated with increased odds of any psychiatric disorder in a dose-dependent manner, the investigators noted (odds ratio [OR], 1.52; 95% CI, 1.48-1.57).
Untangling Genes and Environment
To determine how much of the increased risk for adult mental illness is due to ACEs and how much can be attributed to genetics and environment, the researchers focused on twin pairs where one had exposure to one type of ACEs and the other did not. This analysis revealed that the association remained but was attenuated. In identical twins, the effect of each ACE raised the odds of having a psychiatric condition by 20% (1.20; 95% CI, 1.02-1.40), and for nonidentical twins, the odds increased by 29% (1.29; 95% CI, 1.14-1.47).
The weakening of the risk “suggests that familial confounding contributed to the association between ACEs and adult mental health outcomes,” the authors wrote.
Of all the ACEs, sexual abuse carried the highest risk for adult psychiatric disorders. Children who were exposed to sexual abuse, compared with those who were not, had up to a 200% higher risk for any psychiatric disorder in the following comparisons: Full cohort (OR, 3.09; 95% CI, 2.68-3.56), dizygotic twin pairs (OR, 2.10; 95% CI, 1.33-3.32), and monozygotic twin pairs (1.80; 95% CI, 1.04-3.11).
“Our results demonstrated that familial factors contributed to a lesser extent to the association between sexual abuse and adult psychiatric disorders,” the authors wrote.
One major limitation of the study was that ACEs were based on retrospective report and thus may be subject to recall bias. Also, the findings cannot be generalized to other countries or cultures.
The study was funded by the European Research Council, the Icelandic Center for Research, and the European Union Horizon 2020. Disclosures are noted in the original article.
A version of this article appeared on Medscape.com.
RA Outcomes Worsened by Depression and Anxiety, Signaling Need for Multidisciplinary Action
Patients diagnosed with rheumatoid arthritis (RA) and co-occurring anxiety or depression are less likely to achieve low disease activity (LDA) and better symptom control after 3 months of treatment, according to new research presented at the at the annual meeting of the Canadian Rheumatology Association.
The findings emphasized the importance of taking a multidisciplinary approach to RA treatment, said presenter Susan Bartlett, PhD, a professor in the Divisions of Clinical Epidemiology, Rheumatology, and Respiratory Epidemiology at McGill University in Montreal, Quebec, Canada.
“In the absence of directly addressing anxiety and depression, people are not going to improve to the same extent we hope that they will,” she told this news organization.
Symptom Clusters in RA
In her research, presented on February 29, Dr. Bartlett explored how certain symptom clusters in RA predicted prognosis.
Symptom clusters are related symptoms that occur together and can be associated with worse outcomes than one symptom alone. Symptom science has been a growing interest in precision medicine, particularly for cancer, Dr. Bartlett noted, and this same approach could help pinpoint RA subtypes, disease trajectories, and personalized treatment.
In the study, Dr. Bartlett and colleagues used data from the Canadian Early Arthritis Cohort (CATCH), a multisite prospective research study following individuals with new-onset RA. They identified patients starting methotrexate (MTX) therapy who also had clinical and patient-reported outcome measures available. Individuals included in the analysis may have also been taking additional disease-modifying antirheumatic drugs beyond MTX.
Across the 310 selected individuals, researchers identified four key symptoms: Pain, fatigue, anxiety, and depression. Pain and fatigue were defined as physical symptoms, while anxiety and depression were classified as emotional symptoms. Results showed that the patients could be sorted into four distinct symptom clusters: Minimal symptoms (12%), mild physical and emotional symptoms (11%), moderate to severe pain and fatigue (40%), and moderate to severe physical and emotional symptoms (37%).
Researchers then followed patients during the first 6 months of treatment to evaluate if patients’ symptoms improved.
Symptom improvement mostly occurred during the first 3 months of treatment and remained consistent at 6 months. Overall, patients with moderate to severe emotional symptoms had a worse prognosis and were less likely to achieve milder symptoms than those who had only pain and fatigue or mild emotional symptoms. While 64% of patients in the moderate to severe physical symptoms group achieved minimal symptoms after 3 months of treatment, only 13% of patients with moderate to severe physical and emotional systems reported minimal symptoms during this same time frame.
The study builds on previous work that “suggests that there are different factors that we can identify around the time of diagnosis that point to how well a person is likely to respond,” Dr. Bartlett added. “What our work is showing pretty clearly [is that] the presence of anxiety and depression is one of those important markers.”
Patients With Depression Report Worse Disease Activity
In a related study, researchers from the University of Ottawa explored how depression in RA affected subjective and objective disease measures.
The study included patients from the Ottawa Rheumatology Comprehensive Treatment and Assessment (ORCHESTRA) clinic at The Ottawa Hospital, Ottawa, Ontario, Canada, which sees patients with inflammatory arthritis who are starting biologic therapy or switching to another biologic. The clinic is designed to take a more comprehensive approach to managing inflammatory arthritis, including addressing comorbidities such as cardiac disease, depression, and cancer. Patients seen at the clinic can opt to be included in the ORCHESTRA cohort to be a part of ongoing research.
From this cohort, researchers identified 98 patients with RA. At enrollment, patients were screened for depression using patient health questionnaire scores and asked about duration of morning stiffness and tender joint counts. Swollen joint counts, ultrasound, and clinical scores were used to evaluate disease activity.
In the study group, 47 patients had no depression, 21 patients had mild depression, and 30 patients had moderate to severe depression. Researchers found that subjective disease measures, including visual analog pain scale, health assessment questionnaire, and disease activity score in 28 joints were all higher in patients with depression; however, depression did not appear to affect objective disease measures, such as the Global OMERACT-EULAR Synovitis Score or Doppler scores.
While there is a known link between inflammation and depression, these findings suggest that depression is “a concomitant comorbidity just like cardiovascular disease, just like fibromyalgia, just like some other comorbidity that also needs to be addressed in its own right to improve the outcomes,” noted Elliot Hepworth, MD, a rheumatologist and ORCHESTRA clinic lead at The Ottawa Hospital, in an interview.
Dr. Hepworth presented the findings on March 1.
The data also suggested that patients with depression had poorer outcomes. For the 79 patients who had 3-month follow-up visit data, 43.9% of patients with no or mild depression achieved LDA and remission compared with 21.7% of patients with moderate to severe depression, though this difference was not statistically significant (P = .064). There was a similar trend for the 39 patients with 6-month follow-up data: Only 20% of patients with moderate to severe depression had reached LDA and remission compared with 37.9% of patients with no or mild depression (P = .445). The researchers noted this could be an issue with a smaller sample size.
“Every time more patients get added we approach closer to significance,” Dr. Hepworth added.
Some Disagreement, Same Takeaway
Commenting on the Ottawa study, Dr. Bartlett was skeptical of the conclusion that depression may not directly influence disease activity. “There’s just too much good evidence these days that [depression] very much coexists with worse disease activity,” she said. “It is not in the person’s head.”
Dr. Hepworth added that patient-reported outcomes are important for clinicians to address during treatment.
“There’s the tender joints, there’s the pain, there’s the fatigue, there’s the patient global assessment, which are subjective,” he said, “but that does not mean that they are not important. Those are important to the patient: That is how they’re living their life, and that is how they’re experiencing their disease.”
This is why efforts to treat depression in patients with RA such as cognitive behavioral therapy are so important, he said, to which Dr. Bartlett agreed.
“A comprehensive approach is required, which includes addressing depression,” she said. Otherwise, data show “that people just never make it to remission.”
The studies looked at different patient populations but ultimately complement each other, added Sibel Aydin, MD, a professor of medicine in the Division of Rheumatology at the University of Ottawa, Ottawa, Ontario, Canada, and senior author of the Ottawa study.
“Two different cohorts with different patient populations still reached the same result,” she said. “If you don’t address the emotional aspect, you are not going to achieve the good outcomes.”
“It’s remarkable when you have two independent researchers coming to the same conclusion without ever talking to each other,” added Dr. Hepworth. “That really shows that this is something that’s pervasive, and it’s not just within our patient population.”
CATCH is funded by unrestricted research grants from programs with Pfizer, AbbVie, Roche, Sandoz, Fresenius Kabi, Organon, Viatris, JAMP, and Celltrion. Dr. Bartlett is president of the PROMIS Health Organization. She is a member of speakers bureaus or has consulted for Pfizer, Sandoz, Merck, Janssen, and Organon. Dr. Hepworth and Dr. Aydin declared no conflicts of interest.
A version of this article appeared on Medscape.com .
Patients diagnosed with rheumatoid arthritis (RA) and co-occurring anxiety or depression are less likely to achieve low disease activity (LDA) and better symptom control after 3 months of treatment, according to new research presented at the at the annual meeting of the Canadian Rheumatology Association.
The findings emphasized the importance of taking a multidisciplinary approach to RA treatment, said presenter Susan Bartlett, PhD, a professor in the Divisions of Clinical Epidemiology, Rheumatology, and Respiratory Epidemiology at McGill University in Montreal, Quebec, Canada.
“In the absence of directly addressing anxiety and depression, people are not going to improve to the same extent we hope that they will,” she told this news organization.
Symptom Clusters in RA
In her research, presented on February 29, Dr. Bartlett explored how certain symptom clusters in RA predicted prognosis.
Symptom clusters are related symptoms that occur together and can be associated with worse outcomes than one symptom alone. Symptom science has been a growing interest in precision medicine, particularly for cancer, Dr. Bartlett noted, and this same approach could help pinpoint RA subtypes, disease trajectories, and personalized treatment.
In the study, Dr. Bartlett and colleagues used data from the Canadian Early Arthritis Cohort (CATCH), a multisite prospective research study following individuals with new-onset RA. They identified patients starting methotrexate (MTX) therapy who also had clinical and patient-reported outcome measures available. Individuals included in the analysis may have also been taking additional disease-modifying antirheumatic drugs beyond MTX.
Across the 310 selected individuals, researchers identified four key symptoms: Pain, fatigue, anxiety, and depression. Pain and fatigue were defined as physical symptoms, while anxiety and depression were classified as emotional symptoms. Results showed that the patients could be sorted into four distinct symptom clusters: Minimal symptoms (12%), mild physical and emotional symptoms (11%), moderate to severe pain and fatigue (40%), and moderate to severe physical and emotional symptoms (37%).
Researchers then followed patients during the first 6 months of treatment to evaluate if patients’ symptoms improved.
Symptom improvement mostly occurred during the first 3 months of treatment and remained consistent at 6 months. Overall, patients with moderate to severe emotional symptoms had a worse prognosis and were less likely to achieve milder symptoms than those who had only pain and fatigue or mild emotional symptoms. While 64% of patients in the moderate to severe physical symptoms group achieved minimal symptoms after 3 months of treatment, only 13% of patients with moderate to severe physical and emotional systems reported minimal symptoms during this same time frame.
The study builds on previous work that “suggests that there are different factors that we can identify around the time of diagnosis that point to how well a person is likely to respond,” Dr. Bartlett added. “What our work is showing pretty clearly [is that] the presence of anxiety and depression is one of those important markers.”
Patients With Depression Report Worse Disease Activity
In a related study, researchers from the University of Ottawa explored how depression in RA affected subjective and objective disease measures.
The study included patients from the Ottawa Rheumatology Comprehensive Treatment and Assessment (ORCHESTRA) clinic at The Ottawa Hospital, Ottawa, Ontario, Canada, which sees patients with inflammatory arthritis who are starting biologic therapy or switching to another biologic. The clinic is designed to take a more comprehensive approach to managing inflammatory arthritis, including addressing comorbidities such as cardiac disease, depression, and cancer. Patients seen at the clinic can opt to be included in the ORCHESTRA cohort to be a part of ongoing research.
From this cohort, researchers identified 98 patients with RA. At enrollment, patients were screened for depression using patient health questionnaire scores and asked about duration of morning stiffness and tender joint counts. Swollen joint counts, ultrasound, and clinical scores were used to evaluate disease activity.
In the study group, 47 patients had no depression, 21 patients had mild depression, and 30 patients had moderate to severe depression. Researchers found that subjective disease measures, including visual analog pain scale, health assessment questionnaire, and disease activity score in 28 joints were all higher in patients with depression; however, depression did not appear to affect objective disease measures, such as the Global OMERACT-EULAR Synovitis Score or Doppler scores.
While there is a known link between inflammation and depression, these findings suggest that depression is “a concomitant comorbidity just like cardiovascular disease, just like fibromyalgia, just like some other comorbidity that also needs to be addressed in its own right to improve the outcomes,” noted Elliot Hepworth, MD, a rheumatologist and ORCHESTRA clinic lead at The Ottawa Hospital, in an interview.
Dr. Hepworth presented the findings on March 1.
The data also suggested that patients with depression had poorer outcomes. For the 79 patients who had 3-month follow-up visit data, 43.9% of patients with no or mild depression achieved LDA and remission compared with 21.7% of patients with moderate to severe depression, though this difference was not statistically significant (P = .064). There was a similar trend for the 39 patients with 6-month follow-up data: Only 20% of patients with moderate to severe depression had reached LDA and remission compared with 37.9% of patients with no or mild depression (P = .445). The researchers noted this could be an issue with a smaller sample size.
“Every time more patients get added we approach closer to significance,” Dr. Hepworth added.
Some Disagreement, Same Takeaway
Commenting on the Ottawa study, Dr. Bartlett was skeptical of the conclusion that depression may not directly influence disease activity. “There’s just too much good evidence these days that [depression] very much coexists with worse disease activity,” she said. “It is not in the person’s head.”
Dr. Hepworth added that patient-reported outcomes are important for clinicians to address during treatment.
“There’s the tender joints, there’s the pain, there’s the fatigue, there’s the patient global assessment, which are subjective,” he said, “but that does not mean that they are not important. Those are important to the patient: That is how they’re living their life, and that is how they’re experiencing their disease.”
This is why efforts to treat depression in patients with RA such as cognitive behavioral therapy are so important, he said, to which Dr. Bartlett agreed.
“A comprehensive approach is required, which includes addressing depression,” she said. Otherwise, data show “that people just never make it to remission.”
The studies looked at different patient populations but ultimately complement each other, added Sibel Aydin, MD, a professor of medicine in the Division of Rheumatology at the University of Ottawa, Ottawa, Ontario, Canada, and senior author of the Ottawa study.
“Two different cohorts with different patient populations still reached the same result,” she said. “If you don’t address the emotional aspect, you are not going to achieve the good outcomes.”
“It’s remarkable when you have two independent researchers coming to the same conclusion without ever talking to each other,” added Dr. Hepworth. “That really shows that this is something that’s pervasive, and it’s not just within our patient population.”
CATCH is funded by unrestricted research grants from programs with Pfizer, AbbVie, Roche, Sandoz, Fresenius Kabi, Organon, Viatris, JAMP, and Celltrion. Dr. Bartlett is president of the PROMIS Health Organization. She is a member of speakers bureaus or has consulted for Pfizer, Sandoz, Merck, Janssen, and Organon. Dr. Hepworth and Dr. Aydin declared no conflicts of interest.
A version of this article appeared on Medscape.com .
Patients diagnosed with rheumatoid arthritis (RA) and co-occurring anxiety or depression are less likely to achieve low disease activity (LDA) and better symptom control after 3 months of treatment, according to new research presented at the at the annual meeting of the Canadian Rheumatology Association.
The findings emphasized the importance of taking a multidisciplinary approach to RA treatment, said presenter Susan Bartlett, PhD, a professor in the Divisions of Clinical Epidemiology, Rheumatology, and Respiratory Epidemiology at McGill University in Montreal, Quebec, Canada.
“In the absence of directly addressing anxiety and depression, people are not going to improve to the same extent we hope that they will,” she told this news organization.
Symptom Clusters in RA
In her research, presented on February 29, Dr. Bartlett explored how certain symptom clusters in RA predicted prognosis.
Symptom clusters are related symptoms that occur together and can be associated with worse outcomes than one symptom alone. Symptom science has been a growing interest in precision medicine, particularly for cancer, Dr. Bartlett noted, and this same approach could help pinpoint RA subtypes, disease trajectories, and personalized treatment.
In the study, Dr. Bartlett and colleagues used data from the Canadian Early Arthritis Cohort (CATCH), a multisite prospective research study following individuals with new-onset RA. They identified patients starting methotrexate (MTX) therapy who also had clinical and patient-reported outcome measures available. Individuals included in the analysis may have also been taking additional disease-modifying antirheumatic drugs beyond MTX.
Across the 310 selected individuals, researchers identified four key symptoms: Pain, fatigue, anxiety, and depression. Pain and fatigue were defined as physical symptoms, while anxiety and depression were classified as emotional symptoms. Results showed that the patients could be sorted into four distinct symptom clusters: Minimal symptoms (12%), mild physical and emotional symptoms (11%), moderate to severe pain and fatigue (40%), and moderate to severe physical and emotional symptoms (37%).
Researchers then followed patients during the first 6 months of treatment to evaluate if patients’ symptoms improved.
Symptom improvement mostly occurred during the first 3 months of treatment and remained consistent at 6 months. Overall, patients with moderate to severe emotional symptoms had a worse prognosis and were less likely to achieve milder symptoms than those who had only pain and fatigue or mild emotional symptoms. While 64% of patients in the moderate to severe physical symptoms group achieved minimal symptoms after 3 months of treatment, only 13% of patients with moderate to severe physical and emotional systems reported minimal symptoms during this same time frame.
The study builds on previous work that “suggests that there are different factors that we can identify around the time of diagnosis that point to how well a person is likely to respond,” Dr. Bartlett added. “What our work is showing pretty clearly [is that] the presence of anxiety and depression is one of those important markers.”
Patients With Depression Report Worse Disease Activity
In a related study, researchers from the University of Ottawa explored how depression in RA affected subjective and objective disease measures.
The study included patients from the Ottawa Rheumatology Comprehensive Treatment and Assessment (ORCHESTRA) clinic at The Ottawa Hospital, Ottawa, Ontario, Canada, which sees patients with inflammatory arthritis who are starting biologic therapy or switching to another biologic. The clinic is designed to take a more comprehensive approach to managing inflammatory arthritis, including addressing comorbidities such as cardiac disease, depression, and cancer. Patients seen at the clinic can opt to be included in the ORCHESTRA cohort to be a part of ongoing research.
From this cohort, researchers identified 98 patients with RA. At enrollment, patients were screened for depression using patient health questionnaire scores and asked about duration of morning stiffness and tender joint counts. Swollen joint counts, ultrasound, and clinical scores were used to evaluate disease activity.
In the study group, 47 patients had no depression, 21 patients had mild depression, and 30 patients had moderate to severe depression. Researchers found that subjective disease measures, including visual analog pain scale, health assessment questionnaire, and disease activity score in 28 joints were all higher in patients with depression; however, depression did not appear to affect objective disease measures, such as the Global OMERACT-EULAR Synovitis Score or Doppler scores.
While there is a known link between inflammation and depression, these findings suggest that depression is “a concomitant comorbidity just like cardiovascular disease, just like fibromyalgia, just like some other comorbidity that also needs to be addressed in its own right to improve the outcomes,” noted Elliot Hepworth, MD, a rheumatologist and ORCHESTRA clinic lead at The Ottawa Hospital, in an interview.
Dr. Hepworth presented the findings on March 1.
The data also suggested that patients with depression had poorer outcomes. For the 79 patients who had 3-month follow-up visit data, 43.9% of patients with no or mild depression achieved LDA and remission compared with 21.7% of patients with moderate to severe depression, though this difference was not statistically significant (P = .064). There was a similar trend for the 39 patients with 6-month follow-up data: Only 20% of patients with moderate to severe depression had reached LDA and remission compared with 37.9% of patients with no or mild depression (P = .445). The researchers noted this could be an issue with a smaller sample size.
“Every time more patients get added we approach closer to significance,” Dr. Hepworth added.
Some Disagreement, Same Takeaway
Commenting on the Ottawa study, Dr. Bartlett was skeptical of the conclusion that depression may not directly influence disease activity. “There’s just too much good evidence these days that [depression] very much coexists with worse disease activity,” she said. “It is not in the person’s head.”
Dr. Hepworth added that patient-reported outcomes are important for clinicians to address during treatment.
“There’s the tender joints, there’s the pain, there’s the fatigue, there’s the patient global assessment, which are subjective,” he said, “but that does not mean that they are not important. Those are important to the patient: That is how they’re living their life, and that is how they’re experiencing their disease.”
This is why efforts to treat depression in patients with RA such as cognitive behavioral therapy are so important, he said, to which Dr. Bartlett agreed.
“A comprehensive approach is required, which includes addressing depression,” she said. Otherwise, data show “that people just never make it to remission.”
The studies looked at different patient populations but ultimately complement each other, added Sibel Aydin, MD, a professor of medicine in the Division of Rheumatology at the University of Ottawa, Ottawa, Ontario, Canada, and senior author of the Ottawa study.
“Two different cohorts with different patient populations still reached the same result,” she said. “If you don’t address the emotional aspect, you are not going to achieve the good outcomes.”
“It’s remarkable when you have two independent researchers coming to the same conclusion without ever talking to each other,” added Dr. Hepworth. “That really shows that this is something that’s pervasive, and it’s not just within our patient population.”
CATCH is funded by unrestricted research grants from programs with Pfizer, AbbVie, Roche, Sandoz, Fresenius Kabi, Organon, Viatris, JAMP, and Celltrion. Dr. Bartlett is president of the PROMIS Health Organization. She is a member of speakers bureaus or has consulted for Pfizer, Sandoz, Merck, Janssen, and Organon. Dr. Hepworth and Dr. Aydin declared no conflicts of interest.
A version of this article appeared on Medscape.com .
FROM CRA 2024
Drug Derived from LSD Granted FDA Breakthrough Status for Anxiety
The US Food and Drug Administration (FDA) has granted breakthrough designation to an LSD-based treatment for generalized anxiety disorder (GAD) based on promising topline data from a phase 2b clinical trial. Mind Medicine (MindMed) Inc is developing the treatment — MM120 (lysergide d-tartrate).
In a news release,
The company previously announced statistically significant improvements on the HAM-A compared with placebo at 4 weeks, which was the trial’s primary endpoint.
“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” study investigator David Feifel, MD, PhD, professor emeritus of psychiatry at the University of California, San Diego, and director of the Kadima Neuropsychiatry Institute in La Jolla, California, said in the news release.
“These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future phase 3 trials,” Dr. Feifel added.
MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study.
MM120 100 µg — the dose that demonstrated optimal clinical activity — produced a 7.7-point improvement over placebo at week 12 (P < .003; Cohen’s d = 0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to week 12.
Also at week 12, Clinical Global Impressions–Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at week 12 (P < .004), the company reported.
Improvement was noted as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between 4 and 12 weeks.
MM120 was generally well-tolerated with most adverse events rated as mild to moderate and transient and occurred on the day of administration day, in line with the expected acute effects of the study drug.
The most common adverse events on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis, and hyperhidrosis.
The company plans to hold an end-of-phase 2 meeting with the FDA in the first half of 2024 and start phase 3 testing in the second half of 2024.
“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” Robert Barrow, director and CEO of MindMed said in the release.
The primary data analyses from the trial will be presented at the American Psychiatric Association (APA) annual meeting in May.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has granted breakthrough designation to an LSD-based treatment for generalized anxiety disorder (GAD) based on promising topline data from a phase 2b clinical trial. Mind Medicine (MindMed) Inc is developing the treatment — MM120 (lysergide d-tartrate).
In a news release,
The company previously announced statistically significant improvements on the HAM-A compared with placebo at 4 weeks, which was the trial’s primary endpoint.
“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” study investigator David Feifel, MD, PhD, professor emeritus of psychiatry at the University of California, San Diego, and director of the Kadima Neuropsychiatry Institute in La Jolla, California, said in the news release.
“These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future phase 3 trials,” Dr. Feifel added.
MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study.
MM120 100 µg — the dose that demonstrated optimal clinical activity — produced a 7.7-point improvement over placebo at week 12 (P < .003; Cohen’s d = 0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to week 12.
Also at week 12, Clinical Global Impressions–Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at week 12 (P < .004), the company reported.
Improvement was noted as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between 4 and 12 weeks.
MM120 was generally well-tolerated with most adverse events rated as mild to moderate and transient and occurred on the day of administration day, in line with the expected acute effects of the study drug.
The most common adverse events on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis, and hyperhidrosis.
The company plans to hold an end-of-phase 2 meeting with the FDA in the first half of 2024 and start phase 3 testing in the second half of 2024.
“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” Robert Barrow, director and CEO of MindMed said in the release.
The primary data analyses from the trial will be presented at the American Psychiatric Association (APA) annual meeting in May.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has granted breakthrough designation to an LSD-based treatment for generalized anxiety disorder (GAD) based on promising topline data from a phase 2b clinical trial. Mind Medicine (MindMed) Inc is developing the treatment — MM120 (lysergide d-tartrate).
In a news release,
The company previously announced statistically significant improvements on the HAM-A compared with placebo at 4 weeks, which was the trial’s primary endpoint.
“I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” study investigator David Feifel, MD, PhD, professor emeritus of psychiatry at the University of California, San Diego, and director of the Kadima Neuropsychiatry Institute in La Jolla, California, said in the news release.
“These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future phase 3 trials,” Dr. Feifel added.
MM120 was administered as a single dose in a monitored clinical setting with no additional therapeutic intervention. Prior to treatment with MM120, study participants were clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration of their participation in the study.
MM120 100 µg — the dose that demonstrated optimal clinical activity — produced a 7.7-point improvement over placebo at week 12 (P < .003; Cohen’s d = 0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to week 12.
Also at week 12, Clinical Global Impressions–Severity (CGI-S) scores on average improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at week 12 (P < .004), the company reported.
Improvement was noted as early as study day 2, and durable with further improvements observed in mean HAM-A or CGI-S scores between 4 and 12 weeks.
MM120 was generally well-tolerated with most adverse events rated as mild to moderate and transient and occurred on the day of administration day, in line with the expected acute effects of the study drug.
The most common adverse events on dosing day included illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis, and hyperhidrosis.
The company plans to hold an end-of-phase 2 meeting with the FDA in the first half of 2024 and start phase 3 testing in the second half of 2024.
“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” Robert Barrow, director and CEO of MindMed said in the release.
The primary data analyses from the trial will be presented at the American Psychiatric Association (APA) annual meeting in May.
A version of this article appeared on Medscape.com.
Is Adrenal Fatigue a Real Condition?
While TikTok overflows with images of influencers making “adrenal cocktails” to combat what they call adrenal fatigue, the Endocrine Society says “no scientific proof exists to support adrenal fatigue as a true medical condition.”
Even before influencers began touting it on social media, a 2016 systematic review concluded that there is “no substantiation that adrenal fatigue” is an actual medical condition. Therefore, adrenal fatigue is still a myth.
Lynette Nieman, MD, Senior Investigator and Chief of the Endocrinology Consultation Service at the National Institutes of Health Clinical Center, Bethesda, Maryland, concurs.
“There is no scientific evidence that adrenal fatigue exists or causes [general] fatigue, depression, or the many common symptoms that are said to result from this condition,” she told this news organization via email.
Still, the term has gained currency among not only social media influencers who blame it for everything from cortisol surges to estrogen imbalances but also functional and integrative medical practitioners as an explanation for chronic dysfunction related to stress.
Adrenal Fatigue, Burnout, or Adrenal Insufficiency?
Rather than “adrenal fatigue,” Marcelo Campos, MD, a primary care doctor at Atrius Health, said he prefers the medical term “burnout.”
Use of “burnout” shifts attention to the brain’s role in stress-related chronic dysfunction rather than the adrenal glands, said Dr. Campos, who also teaches at Harvard Medical School, Cambridge, Massachusetts.
More specifically still, the focuses might shift to the stress-response via the hypothalamic-pituitary-adrenocortical axis and its role in reducing levels of these cortisol and dehydroepiandrosterone sulfate.
He points out that part of the reason for the misuse of the term adrenal fatigue arises from the fact that burnout is often only associated with work stress.
“Recently, the ICD-11 [International Classification of Diseases-11] recognized burnout as a disease but focused only on work stress as a cause. The truth is that people can be burned out for many other reasons,” said Dr. Campos.
The Endocrine Society notes on their webpage dedicated to the topic that “adrenal fatigue” as a term, relates to long-term mental, emotional, or physical stress.
“The problem is not the adrenals — it is the exposure to stress in the brain. The brain — only one organ — is responsible for 40% of energy consumption in the body. As you can imagine, if you are under constant stress, you run out of gas very quickly and cannot function well,” he explained.
Adrenal fatigue theory suggests that, under stress, the adrenal glands produce too many short bursts of cortisol resulting in overall reduced cortisol levels and a feeling of being drained.
“As with many other psychiatric diseases, we do not have a way to measure biomarkers in the brain. The testing for cortisol does not work because it fluctuates too much from time to time. So, it is not reliable or reproducible,” Dr. Campos said.
This leads to the ongoing question of the best way to test and diagnose adrenal fatigue, whether it should be via blood, urine and/or saliva. And even if that is determined, there are still questions about the best time to test, how often, what the normal ranges are and how reliable the tests are.
While adrenal fatigue is not a recognized condition, adrenal insufficiency is medically recognized, resulting from an inability of the adrenal glands to make the life-essential hormones aldosterone and/or cortisol, with symptoms that include fatigue, belly pain, nausea, vomiting, diarrhea, and joint aches.
“Adrenal cocktails are not an effective treatment for adrenal insufficiency because they do not replace the missing hormones,” Dr. Nieman stated, pointing out that anyone with symptoms of adrenal insufficiency needs to see an endocrinologist.
Pratibha Rao, MD, MPH, an endocrinologist at the Cleveland Clinic, Ohio, and medical director of the Adrenal Center at Cleveland Clinic, agreed, advising that if people continue to feel exhausted beyond their normal exertion, then they should get checked for signs of adrenal insufficiency.
“In primary adrenal insufficiency, you can actually start seeing darkening of the gums and of the skin on the palms of the hands or the soles of your feet. Sometimes people can feel dizzy or experience some loss of consciousness,” she said. “If it’s sudden and severe, you may crave salt or have extreme heat or cold intolerance.”
Recognizing and Managing Patient Frustration
The lack of formal diagnostic criteria and medical evidence, however, doesn’t mean that such symptoms as fatigue and depression don’t present, often causing significant distress for patients. While the symptoms might not be associated with the adrenal glands, they still need addressing — but how that is done is, in essence, a bone of contention.
Dr. Rao empathizes with the situation that many people, often young women, find themselves in.
“Patients are frustrated. They’ve gone to multiple doctors across the country, and they feel convinced they have adrenal fatigue, but no medical doctor has endorsed it. They end up coming to us with a cry that has so often gone unanswered.”
This issue also highlights that there are millions of people experiencing mental, emotional, and physical distress of unknown cause who seek help, many of whom believe it is related to their adrenal gland function.
But rather than turning to a social media cure, Dr. Rao stresses that people would benefit more from paying greater attention to following a healthy lifestyle than regularly consuming sugar-rich drinks claimed to offer a solution. Adrenal cocktails are energy-rich, frothy blends of orange juice, coconut milk, cream of tartar, and Himalayan salt.
“We truly are what we eat, and we are what we think,” she noted.
The body is a miraculous machine, but “we forget that it does need maintenance,” Dr. Rao said. “Up to age 30, the body is so forgiving with drugs, alcohol, or whatever insult we do to it, but after the third decade, slowly every cell starts to degenerate instead of growing. We start to see the ill or beneficial effects of lifestyle habits.”
“We insult the body, and then we say, ‘oh, I have fatigue’ and seek a quick fix,” she added. “Everyone wants instant gratification.”
Dr. Rao cautioned that adrenal cocktails could be dangerous for someone who has other medical conditions.
“If someone has kidney disease, uncontrolled hypertension, or diabetes, for example, then adrenal cocktails are definitely not safe,” Dr. Rao said. “Loading up with potassium and sodium, which is found in high quantities in adrenal cocktails, will actually worsen any kidney damage, while consuming so much sugar will cause an unregulated rise in blood sugar and further damage in someone with diabetes.”
Dr. Rao also stressed that nonprofessional advice given on social media could take patient people down the wrong path with associated danger.
A version of this article appeared on Medscape.com.
While TikTok overflows with images of influencers making “adrenal cocktails” to combat what they call adrenal fatigue, the Endocrine Society says “no scientific proof exists to support adrenal fatigue as a true medical condition.”
Even before influencers began touting it on social media, a 2016 systematic review concluded that there is “no substantiation that adrenal fatigue” is an actual medical condition. Therefore, adrenal fatigue is still a myth.
Lynette Nieman, MD, Senior Investigator and Chief of the Endocrinology Consultation Service at the National Institutes of Health Clinical Center, Bethesda, Maryland, concurs.
“There is no scientific evidence that adrenal fatigue exists or causes [general] fatigue, depression, or the many common symptoms that are said to result from this condition,” she told this news organization via email.
Still, the term has gained currency among not only social media influencers who blame it for everything from cortisol surges to estrogen imbalances but also functional and integrative medical practitioners as an explanation for chronic dysfunction related to stress.
Adrenal Fatigue, Burnout, or Adrenal Insufficiency?
Rather than “adrenal fatigue,” Marcelo Campos, MD, a primary care doctor at Atrius Health, said he prefers the medical term “burnout.”
Use of “burnout” shifts attention to the brain’s role in stress-related chronic dysfunction rather than the adrenal glands, said Dr. Campos, who also teaches at Harvard Medical School, Cambridge, Massachusetts.
More specifically still, the focuses might shift to the stress-response via the hypothalamic-pituitary-adrenocortical axis and its role in reducing levels of these cortisol and dehydroepiandrosterone sulfate.
He points out that part of the reason for the misuse of the term adrenal fatigue arises from the fact that burnout is often only associated with work stress.
“Recently, the ICD-11 [International Classification of Diseases-11] recognized burnout as a disease but focused only on work stress as a cause. The truth is that people can be burned out for many other reasons,” said Dr. Campos.
The Endocrine Society notes on their webpage dedicated to the topic that “adrenal fatigue” as a term, relates to long-term mental, emotional, or physical stress.
“The problem is not the adrenals — it is the exposure to stress in the brain. The brain — only one organ — is responsible for 40% of energy consumption in the body. As you can imagine, if you are under constant stress, you run out of gas very quickly and cannot function well,” he explained.
Adrenal fatigue theory suggests that, under stress, the adrenal glands produce too many short bursts of cortisol resulting in overall reduced cortisol levels and a feeling of being drained.
“As with many other psychiatric diseases, we do not have a way to measure biomarkers in the brain. The testing for cortisol does not work because it fluctuates too much from time to time. So, it is not reliable or reproducible,” Dr. Campos said.
This leads to the ongoing question of the best way to test and diagnose adrenal fatigue, whether it should be via blood, urine and/or saliva. And even if that is determined, there are still questions about the best time to test, how often, what the normal ranges are and how reliable the tests are.
While adrenal fatigue is not a recognized condition, adrenal insufficiency is medically recognized, resulting from an inability of the adrenal glands to make the life-essential hormones aldosterone and/or cortisol, with symptoms that include fatigue, belly pain, nausea, vomiting, diarrhea, and joint aches.
“Adrenal cocktails are not an effective treatment for adrenal insufficiency because they do not replace the missing hormones,” Dr. Nieman stated, pointing out that anyone with symptoms of adrenal insufficiency needs to see an endocrinologist.
Pratibha Rao, MD, MPH, an endocrinologist at the Cleveland Clinic, Ohio, and medical director of the Adrenal Center at Cleveland Clinic, agreed, advising that if people continue to feel exhausted beyond their normal exertion, then they should get checked for signs of adrenal insufficiency.
“In primary adrenal insufficiency, you can actually start seeing darkening of the gums and of the skin on the palms of the hands or the soles of your feet. Sometimes people can feel dizzy or experience some loss of consciousness,” she said. “If it’s sudden and severe, you may crave salt or have extreme heat or cold intolerance.”
Recognizing and Managing Patient Frustration
The lack of formal diagnostic criteria and medical evidence, however, doesn’t mean that such symptoms as fatigue and depression don’t present, often causing significant distress for patients. While the symptoms might not be associated with the adrenal glands, they still need addressing — but how that is done is, in essence, a bone of contention.
Dr. Rao empathizes with the situation that many people, often young women, find themselves in.
“Patients are frustrated. They’ve gone to multiple doctors across the country, and they feel convinced they have adrenal fatigue, but no medical doctor has endorsed it. They end up coming to us with a cry that has so often gone unanswered.”
This issue also highlights that there are millions of people experiencing mental, emotional, and physical distress of unknown cause who seek help, many of whom believe it is related to their adrenal gland function.
But rather than turning to a social media cure, Dr. Rao stresses that people would benefit more from paying greater attention to following a healthy lifestyle than regularly consuming sugar-rich drinks claimed to offer a solution. Adrenal cocktails are energy-rich, frothy blends of orange juice, coconut milk, cream of tartar, and Himalayan salt.
“We truly are what we eat, and we are what we think,” she noted.
The body is a miraculous machine, but “we forget that it does need maintenance,” Dr. Rao said. “Up to age 30, the body is so forgiving with drugs, alcohol, or whatever insult we do to it, but after the third decade, slowly every cell starts to degenerate instead of growing. We start to see the ill or beneficial effects of lifestyle habits.”
“We insult the body, and then we say, ‘oh, I have fatigue’ and seek a quick fix,” she added. “Everyone wants instant gratification.”
Dr. Rao cautioned that adrenal cocktails could be dangerous for someone who has other medical conditions.
“If someone has kidney disease, uncontrolled hypertension, or diabetes, for example, then adrenal cocktails are definitely not safe,” Dr. Rao said. “Loading up with potassium and sodium, which is found in high quantities in adrenal cocktails, will actually worsen any kidney damage, while consuming so much sugar will cause an unregulated rise in blood sugar and further damage in someone with diabetes.”
Dr. Rao also stressed that nonprofessional advice given on social media could take patient people down the wrong path with associated danger.
A version of this article appeared on Medscape.com.
While TikTok overflows with images of influencers making “adrenal cocktails” to combat what they call adrenal fatigue, the Endocrine Society says “no scientific proof exists to support adrenal fatigue as a true medical condition.”
Even before influencers began touting it on social media, a 2016 systematic review concluded that there is “no substantiation that adrenal fatigue” is an actual medical condition. Therefore, adrenal fatigue is still a myth.
Lynette Nieman, MD, Senior Investigator and Chief of the Endocrinology Consultation Service at the National Institutes of Health Clinical Center, Bethesda, Maryland, concurs.
“There is no scientific evidence that adrenal fatigue exists or causes [general] fatigue, depression, or the many common symptoms that are said to result from this condition,” she told this news organization via email.
Still, the term has gained currency among not only social media influencers who blame it for everything from cortisol surges to estrogen imbalances but also functional and integrative medical practitioners as an explanation for chronic dysfunction related to stress.
Adrenal Fatigue, Burnout, or Adrenal Insufficiency?
Rather than “adrenal fatigue,” Marcelo Campos, MD, a primary care doctor at Atrius Health, said he prefers the medical term “burnout.”
Use of “burnout” shifts attention to the brain’s role in stress-related chronic dysfunction rather than the adrenal glands, said Dr. Campos, who also teaches at Harvard Medical School, Cambridge, Massachusetts.
More specifically still, the focuses might shift to the stress-response via the hypothalamic-pituitary-adrenocortical axis and its role in reducing levels of these cortisol and dehydroepiandrosterone sulfate.
He points out that part of the reason for the misuse of the term adrenal fatigue arises from the fact that burnout is often only associated with work stress.
“Recently, the ICD-11 [International Classification of Diseases-11] recognized burnout as a disease but focused only on work stress as a cause. The truth is that people can be burned out for many other reasons,” said Dr. Campos.
The Endocrine Society notes on their webpage dedicated to the topic that “adrenal fatigue” as a term, relates to long-term mental, emotional, or physical stress.
“The problem is not the adrenals — it is the exposure to stress in the brain. The brain — only one organ — is responsible for 40% of energy consumption in the body. As you can imagine, if you are under constant stress, you run out of gas very quickly and cannot function well,” he explained.
Adrenal fatigue theory suggests that, under stress, the adrenal glands produce too many short bursts of cortisol resulting in overall reduced cortisol levels and a feeling of being drained.
“As with many other psychiatric diseases, we do not have a way to measure biomarkers in the brain. The testing for cortisol does not work because it fluctuates too much from time to time. So, it is not reliable or reproducible,” Dr. Campos said.
This leads to the ongoing question of the best way to test and diagnose adrenal fatigue, whether it should be via blood, urine and/or saliva. And even if that is determined, there are still questions about the best time to test, how often, what the normal ranges are and how reliable the tests are.
While adrenal fatigue is not a recognized condition, adrenal insufficiency is medically recognized, resulting from an inability of the adrenal glands to make the life-essential hormones aldosterone and/or cortisol, with symptoms that include fatigue, belly pain, nausea, vomiting, diarrhea, and joint aches.
“Adrenal cocktails are not an effective treatment for adrenal insufficiency because they do not replace the missing hormones,” Dr. Nieman stated, pointing out that anyone with symptoms of adrenal insufficiency needs to see an endocrinologist.
Pratibha Rao, MD, MPH, an endocrinologist at the Cleveland Clinic, Ohio, and medical director of the Adrenal Center at Cleveland Clinic, agreed, advising that if people continue to feel exhausted beyond their normal exertion, then they should get checked for signs of adrenal insufficiency.
“In primary adrenal insufficiency, you can actually start seeing darkening of the gums and of the skin on the palms of the hands or the soles of your feet. Sometimes people can feel dizzy or experience some loss of consciousness,” she said. “If it’s sudden and severe, you may crave salt or have extreme heat or cold intolerance.”
Recognizing and Managing Patient Frustration
The lack of formal diagnostic criteria and medical evidence, however, doesn’t mean that such symptoms as fatigue and depression don’t present, often causing significant distress for patients. While the symptoms might not be associated with the adrenal glands, they still need addressing — but how that is done is, in essence, a bone of contention.
Dr. Rao empathizes with the situation that many people, often young women, find themselves in.
“Patients are frustrated. They’ve gone to multiple doctors across the country, and they feel convinced they have adrenal fatigue, but no medical doctor has endorsed it. They end up coming to us with a cry that has so often gone unanswered.”
This issue also highlights that there are millions of people experiencing mental, emotional, and physical distress of unknown cause who seek help, many of whom believe it is related to their adrenal gland function.
But rather than turning to a social media cure, Dr. Rao stresses that people would benefit more from paying greater attention to following a healthy lifestyle than regularly consuming sugar-rich drinks claimed to offer a solution. Adrenal cocktails are energy-rich, frothy blends of orange juice, coconut milk, cream of tartar, and Himalayan salt.
“We truly are what we eat, and we are what we think,” she noted.
The body is a miraculous machine, but “we forget that it does need maintenance,” Dr. Rao said. “Up to age 30, the body is so forgiving with drugs, alcohol, or whatever insult we do to it, but after the third decade, slowly every cell starts to degenerate instead of growing. We start to see the ill or beneficial effects of lifestyle habits.”
“We insult the body, and then we say, ‘oh, I have fatigue’ and seek a quick fix,” she added. “Everyone wants instant gratification.”
Dr. Rao cautioned that adrenal cocktails could be dangerous for someone who has other medical conditions.
“If someone has kidney disease, uncontrolled hypertension, or diabetes, for example, then adrenal cocktails are definitely not safe,” Dr. Rao said. “Loading up with potassium and sodium, which is found in high quantities in adrenal cocktails, will actually worsen any kidney damage, while consuming so much sugar will cause an unregulated rise in blood sugar and further damage in someone with diabetes.”
Dr. Rao also stressed that nonprofessional advice given on social media could take patient people down the wrong path with associated danger.
A version of this article appeared on Medscape.com.
Parent-Led Digital CBT Effective for Childhood Anxiety
while substantially reducing cost and therapist time, new research showed.
In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.
“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.
“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”
The study was published online in The Lancet Psychiatry
Care Gaps for Common Problem
Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.
OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.
The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.
There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.
The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.
A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
‘Compelling’ Evidence
The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.
On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).
The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.
In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.
“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.
“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
‘Call to Action’
“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.
“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”
“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.
However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.
In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.
Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.
“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”
The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.
A version of this article appeared on Medscape.com.
while substantially reducing cost and therapist time, new research showed.
In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.
“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.
“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”
The study was published online in The Lancet Psychiatry
Care Gaps for Common Problem
Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.
OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.
The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.
There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.
The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.
A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
‘Compelling’ Evidence
The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.
On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).
The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.
In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.
“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.
“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
‘Call to Action’
“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.
“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”
“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.
However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.
In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.
Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.
“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”
The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.
A version of this article appeared on Medscape.com.
while substantially reducing cost and therapist time, new research showed.
In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.
“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.
“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”
The study was published online in The Lancet Psychiatry
Care Gaps for Common Problem
Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.
OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.
The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.
There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.
The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.
A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
‘Compelling’ Evidence
The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.
On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).
The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.
In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.
“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.
“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
‘Call to Action’
“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.
“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”
“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.
However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.
In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.
Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.
“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”
The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.
A version of this article appeared on Medscape.com.
FROM THE LANCET PSYCHIATRY
Lying-in No Longer: Staying Active Key to Healthy Pregnancy
A trio of studies (abstracts 1101, 1079, and 944) presented on February 14 at the meeting sponsored by the Society for Maternal-Fetal Medicine point to the power of staying physically active during pregnancy. The work highlights the beneficial effects of exercise on a variety of outcomes, including depression, anxiety, and reducing the rate of cesarean deliveries.
“Twenty-plus years ago, there were so many recommendations for bed rest in pregnancy,” said Danielle Panelli, MD, a maternal-fetal medicine physician and research scholar at Stanford University in Stanford, California. “We’ve really come full circle on that.” The American College of Obstetricians and Gynecologists recommends pregnant people get at least 150 minutes of moderate activity or 75 minutes of vigorous activity per week.
Dr. Panelli and colleagues looked at the association of physical activity and anxiety among three groups of pregnant people: 20 outpatients from low-risk obstetric clinics, 20 outpatients from high-risk obstetric clinics, and 19 inpatients. Participants wore accelerometer watches for up to seven days to measure physical activity. The primary outcome was mean daily step count, with secondary outcomes including metabolic equivalent tasks (METs), moderate to vigorous physical activity (MVPA), and anxiety as measured using the State-Trait Anxiety Inventory.
Low-risk outpatients had an average daily step count of 9090 compared with high-risk outpatients at 8898 and inpatients at 6493. Compared with outpatients, inpatients also had significantly lower METs (adjusted beta, -0.20; 95% CI -0.26 to -0.13; P < .001), and MVPAs (adjusted beta, -43.6; 95% CI, -61.2 to -25.9; P < .001). Over the course of a week, steps progressively decreased for inpatients but not for women in either of the outpatient groups. Among the entire cohort, lower step counts correlated with higher anxiety scores (r = 0.30; P = .02).
“These results highlight the need for physical activity interventions, particularly for hospitalized pregnant people,” Dr. Panelli said. That could be something as simple as asking patients to walk three laps around the unit per day, she suggested.
A second study investigated the effect of physical activity during pregnancy on peripartum depression. Researchers at the University of Alabama at Birmingham reviewed data from participants in nuMoM2b, a large cohort study of pregnant women who would be delivering for the first time and had at least one medical comorbidity, such as chronic hypertension, asthma, or cardiac disease. The investigators looked at activity logs maintained by study participants and turned in at three study visits: 6-13.6 weeks, 14-21.6 weeks, and 22-29.6 weeks.
Being physically active was associated with 15% lower odds of having an Edinburgh Postnatal Depression Score (EPDS) > 10 (adjusted odds ratio, 0.85; 95% CI, 0.72-0.99). Nine percent of people in the active group and 12% of people in the nonactive group had an EPDS > 10, which is suggestive of depression. However, a change in EPDS from visit one to three and treatment for perinatal depression did not differ by physical activity.
“One of the interesting findings are that we didn’t see any safety signals [from exercise], so there wasn’t an increase in suspected fetal growth restriction or low fluid or preterm birth, or actual birthweight being low in the people who were active,” said Charlotte McCarley, MD, a maternal-fetal medicine fellow at the University of Alabama at Birmingham, who led the research. “A lot of studies have been done that have looked at prospective exercise in pregnancy, but they exclude the cohort that we looked at for concern that there may be a safety issue.”
In a third study, researchers at the Rambam Health Care Campus in Haifa, Israel, looked at the effect of physical activity on mode of delivery. The prospective observational analysis included 401 women with singleton pregnancies attempting vaginal deliveries.
The researchers tracked the number of daily steps taken during gestation using validated phone apps. They adjusted their findings for age, parity, body mass index, and medical and obstetric history.
The investigators observed a gradual decrease in physical activity as pregnancy progressed (mean of 3184 steps in the first trimester, 2700 steps in mid-pregnancy, and 2152 steps in the third trimester). The overall incidence of cesarean delivery was 10.5%. However, women who were more active during pregnancy had a significantly lower incidence of cesarean delivery.
Area under the ROC curve, with a cut-off of 2093.5 daily steps, was 0.694 (95% CI, 0.615-0.773), resulting in a significant risk reduction in a 78% reduction in the rate of cesarean surgery (odds ratio, 0.22; 95% CI, 0.104-0.465).
More active patients also had a reduced composite outcome of gestational diabetes, gestational hypertension, and preeclampsia; less use of epidural analgesia during labor; and less postpartum hemorrhage. Preterm birth, labor induction, neonatal weight, and admission to the neonatal intensive care unit were not significantly affected, the researchers reported.
“Maintaining an active lifestyle during pregnancy should be strongly encouraged,” they wrote.
The investigators disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
A trio of studies (abstracts 1101, 1079, and 944) presented on February 14 at the meeting sponsored by the Society for Maternal-Fetal Medicine point to the power of staying physically active during pregnancy. The work highlights the beneficial effects of exercise on a variety of outcomes, including depression, anxiety, and reducing the rate of cesarean deliveries.
“Twenty-plus years ago, there were so many recommendations for bed rest in pregnancy,” said Danielle Panelli, MD, a maternal-fetal medicine physician and research scholar at Stanford University in Stanford, California. “We’ve really come full circle on that.” The American College of Obstetricians and Gynecologists recommends pregnant people get at least 150 minutes of moderate activity or 75 minutes of vigorous activity per week.
Dr. Panelli and colleagues looked at the association of physical activity and anxiety among three groups of pregnant people: 20 outpatients from low-risk obstetric clinics, 20 outpatients from high-risk obstetric clinics, and 19 inpatients. Participants wore accelerometer watches for up to seven days to measure physical activity. The primary outcome was mean daily step count, with secondary outcomes including metabolic equivalent tasks (METs), moderate to vigorous physical activity (MVPA), and anxiety as measured using the State-Trait Anxiety Inventory.
Low-risk outpatients had an average daily step count of 9090 compared with high-risk outpatients at 8898 and inpatients at 6493. Compared with outpatients, inpatients also had significantly lower METs (adjusted beta, -0.20; 95% CI -0.26 to -0.13; P < .001), and MVPAs (adjusted beta, -43.6; 95% CI, -61.2 to -25.9; P < .001). Over the course of a week, steps progressively decreased for inpatients but not for women in either of the outpatient groups. Among the entire cohort, lower step counts correlated with higher anxiety scores (r = 0.30; P = .02).
“These results highlight the need for physical activity interventions, particularly for hospitalized pregnant people,” Dr. Panelli said. That could be something as simple as asking patients to walk three laps around the unit per day, she suggested.
A second study investigated the effect of physical activity during pregnancy on peripartum depression. Researchers at the University of Alabama at Birmingham reviewed data from participants in nuMoM2b, a large cohort study of pregnant women who would be delivering for the first time and had at least one medical comorbidity, such as chronic hypertension, asthma, or cardiac disease. The investigators looked at activity logs maintained by study participants and turned in at three study visits: 6-13.6 weeks, 14-21.6 weeks, and 22-29.6 weeks.
Being physically active was associated with 15% lower odds of having an Edinburgh Postnatal Depression Score (EPDS) > 10 (adjusted odds ratio, 0.85; 95% CI, 0.72-0.99). Nine percent of people in the active group and 12% of people in the nonactive group had an EPDS > 10, which is suggestive of depression. However, a change in EPDS from visit one to three and treatment for perinatal depression did not differ by physical activity.
“One of the interesting findings are that we didn’t see any safety signals [from exercise], so there wasn’t an increase in suspected fetal growth restriction or low fluid or preterm birth, or actual birthweight being low in the people who were active,” said Charlotte McCarley, MD, a maternal-fetal medicine fellow at the University of Alabama at Birmingham, who led the research. “A lot of studies have been done that have looked at prospective exercise in pregnancy, but they exclude the cohort that we looked at for concern that there may be a safety issue.”
In a third study, researchers at the Rambam Health Care Campus in Haifa, Israel, looked at the effect of physical activity on mode of delivery. The prospective observational analysis included 401 women with singleton pregnancies attempting vaginal deliveries.
The researchers tracked the number of daily steps taken during gestation using validated phone apps. They adjusted their findings for age, parity, body mass index, and medical and obstetric history.
The investigators observed a gradual decrease in physical activity as pregnancy progressed (mean of 3184 steps in the first trimester, 2700 steps in mid-pregnancy, and 2152 steps in the third trimester). The overall incidence of cesarean delivery was 10.5%. However, women who were more active during pregnancy had a significantly lower incidence of cesarean delivery.
Area under the ROC curve, with a cut-off of 2093.5 daily steps, was 0.694 (95% CI, 0.615-0.773), resulting in a significant risk reduction in a 78% reduction in the rate of cesarean surgery (odds ratio, 0.22; 95% CI, 0.104-0.465).
More active patients also had a reduced composite outcome of gestational diabetes, gestational hypertension, and preeclampsia; less use of epidural analgesia during labor; and less postpartum hemorrhage. Preterm birth, labor induction, neonatal weight, and admission to the neonatal intensive care unit were not significantly affected, the researchers reported.
“Maintaining an active lifestyle during pregnancy should be strongly encouraged,” they wrote.
The investigators disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
A trio of studies (abstracts 1101, 1079, and 944) presented on February 14 at the meeting sponsored by the Society for Maternal-Fetal Medicine point to the power of staying physically active during pregnancy. The work highlights the beneficial effects of exercise on a variety of outcomes, including depression, anxiety, and reducing the rate of cesarean deliveries.
“Twenty-plus years ago, there were so many recommendations for bed rest in pregnancy,” said Danielle Panelli, MD, a maternal-fetal medicine physician and research scholar at Stanford University in Stanford, California. “We’ve really come full circle on that.” The American College of Obstetricians and Gynecologists recommends pregnant people get at least 150 minutes of moderate activity or 75 minutes of vigorous activity per week.
Dr. Panelli and colleagues looked at the association of physical activity and anxiety among three groups of pregnant people: 20 outpatients from low-risk obstetric clinics, 20 outpatients from high-risk obstetric clinics, and 19 inpatients. Participants wore accelerometer watches for up to seven days to measure physical activity. The primary outcome was mean daily step count, with secondary outcomes including metabolic equivalent tasks (METs), moderate to vigorous physical activity (MVPA), and anxiety as measured using the State-Trait Anxiety Inventory.
Low-risk outpatients had an average daily step count of 9090 compared with high-risk outpatients at 8898 and inpatients at 6493. Compared with outpatients, inpatients also had significantly lower METs (adjusted beta, -0.20; 95% CI -0.26 to -0.13; P < .001), and MVPAs (adjusted beta, -43.6; 95% CI, -61.2 to -25.9; P < .001). Over the course of a week, steps progressively decreased for inpatients but not for women in either of the outpatient groups. Among the entire cohort, lower step counts correlated with higher anxiety scores (r = 0.30; P = .02).
“These results highlight the need for physical activity interventions, particularly for hospitalized pregnant people,” Dr. Panelli said. That could be something as simple as asking patients to walk three laps around the unit per day, she suggested.
A second study investigated the effect of physical activity during pregnancy on peripartum depression. Researchers at the University of Alabama at Birmingham reviewed data from participants in nuMoM2b, a large cohort study of pregnant women who would be delivering for the first time and had at least one medical comorbidity, such as chronic hypertension, asthma, or cardiac disease. The investigators looked at activity logs maintained by study participants and turned in at three study visits: 6-13.6 weeks, 14-21.6 weeks, and 22-29.6 weeks.
Being physically active was associated with 15% lower odds of having an Edinburgh Postnatal Depression Score (EPDS) > 10 (adjusted odds ratio, 0.85; 95% CI, 0.72-0.99). Nine percent of people in the active group and 12% of people in the nonactive group had an EPDS > 10, which is suggestive of depression. However, a change in EPDS from visit one to three and treatment for perinatal depression did not differ by physical activity.
“One of the interesting findings are that we didn’t see any safety signals [from exercise], so there wasn’t an increase in suspected fetal growth restriction or low fluid or preterm birth, or actual birthweight being low in the people who were active,” said Charlotte McCarley, MD, a maternal-fetal medicine fellow at the University of Alabama at Birmingham, who led the research. “A lot of studies have been done that have looked at prospective exercise in pregnancy, but they exclude the cohort that we looked at for concern that there may be a safety issue.”
In a third study, researchers at the Rambam Health Care Campus in Haifa, Israel, looked at the effect of physical activity on mode of delivery. The prospective observational analysis included 401 women with singleton pregnancies attempting vaginal deliveries.
The researchers tracked the number of daily steps taken during gestation using validated phone apps. They adjusted their findings for age, parity, body mass index, and medical and obstetric history.
The investigators observed a gradual decrease in physical activity as pregnancy progressed (mean of 3184 steps in the first trimester, 2700 steps in mid-pregnancy, and 2152 steps in the third trimester). The overall incidence of cesarean delivery was 10.5%. However, women who were more active during pregnancy had a significantly lower incidence of cesarean delivery.
Area under the ROC curve, with a cut-off of 2093.5 daily steps, was 0.694 (95% CI, 0.615-0.773), resulting in a significant risk reduction in a 78% reduction in the rate of cesarean surgery (odds ratio, 0.22; 95% CI, 0.104-0.465).
More active patients also had a reduced composite outcome of gestational diabetes, gestational hypertension, and preeclampsia; less use of epidural analgesia during labor; and less postpartum hemorrhage. Preterm birth, labor induction, neonatal weight, and admission to the neonatal intensive care unit were not significantly affected, the researchers reported.
“Maintaining an active lifestyle during pregnancy should be strongly encouraged,” they wrote.
The investigators disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM THE PREGNANCY MEETING