FDA Requires Stronger Warnings for Common Insomnia Medications

On Tuesday, the Food and Drug Administration (FDA) announced that several prescription sleep aids must now include a boxed warning—the FDA’s strongest safety warning—following reports of sleepwalking and other rare sleep behaviors that have led to serious injuries and deaths.

Sleep aids containing eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist) must carry the boxed warning as well as another warning against the use of the medications by patients with a history of sleepwalking or other rare sleep behaviors like sleep driving.

This is not the first time that the FDA has issued a safety alert regarding these medications. In 2013 and 2014, the FDA warned of next-morning impairment associated with zolpidem and eszopiclone.

"We have closely watched the safety profile of these drugs since they were approved," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "When our ongoing safety monitoring recently reflected the risk of more serious injuries and deaths from patients on these medications who experienced complex sleep behaviors, we determined there was a need to take stronger steps to inform the public."

The FDA reviewed 66 reports of serious injuries and deaths that occurred while patients were sleepwalking, sleep driving, or engaging in other activities (such as using a stove) while not fully awake, and most had no memory of the incident. The 46 nonfatal injuries reported included falls, burns, near-drownings, and apparent suicide attempts; causes of death included carbon monoxide poisoning, motor vehicle collisions, and apparent suicide.

"While these incidents are rare, they are serious and ... can occur after the first dose of these sleep medicines or after a longer period of treatment, and can occur in patients without any history of these behaviors and even at the lowest recommended doses," said FDA Acting Commissioner Ned Sharpless, M.D.

For related information, see the Psychiatric News article “Self-Reports of Poor Sleep Not Always Accurate.”

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Suicide Deaths, Calls to Hotlines Increased Dramatically Following Robin Williams' 2014 Suicide

Suicide deaths increased in the 30-day period following the suicide of Robin Williams on August 11, 2014, according to a report today in Psychiatric Services. In addition, the number of calls to the National Suicide Prevention Line (NSPL) nearly tripled during this time period, though the number that were answered dropped significantly.

"As a critical component of crisis mental health services in the United States, suicide prevention hotlines need to develop contingency plans to accommodate anticipated increases in demand, including for at least 2 days after a celebrity suicide,” wrote Rajeev Ramchand, Ph.D., senior vice president for research at the Cohen Veterans Network, and colleagues.

Using data from the National Center for Health Statistics, they compared U.S. daily suicides in the 30 days before and after August 11, 2014, as well as for the same periods in 2012 and 2013. Suicide deaths were between 113 and 117 a day for the 30 days before Williams' death but increased to 142 a day in the 30-day period beginning August 12. Approximately two-thirds of the additional suicide deaths involved a method similar to the one used by Williams.

The researchers also analyzed call volume data from the NSPL, a national network of crisis centers connected to a series of toll-free numbers. Finally, they analyzed data on daily visits to two Web sites: the Suicide Prevention Resource Center and Suicide Awareness Voices of Education.

In the week prior to Williams' death, the NSPL received 4,000 to 6,000 calls per day. That number increased to almost 13,000 calls on August 12, 2014, and decreased incrementally thereafter. But the number of those calls that were answered dropped from 71% in the 30-day period before August 11 to 57% on August 12.

Both websites also experienced dramatic increases in visits in the period after Williams' suicide compared with before.

“Research is needed to estimate the potential cost savings that investing in the NSPL and other crisis mental health services, and building surge capacity specifically, may have on reduced emergency department admissions, hospital readmissions, overuse of law enforcement, and the loss of human life,” the researchers said.

For related information see the Psychiatric News article, "Suicide Deaths Climb Dramatically in U.S., Nearly Double for Women."

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Exposure Therapy for PTSD Benefits Patients With Comorbid Alcohol Use Disorder, Study Shows

People with co-occurring posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) can tolerate and benefit from prolonged exposure therapy, according to a study published online April 24 in JAMA Psychiatry. Among veterans with both disorders, prolonged exposure therapy more effectively reduced PTSD symptoms than a therapy focused on coping skills and did not increase alcohol problems.

“This information is critical because having an AUD continues to be a barrier to receiving exposure therapy because of therapist perceptions of patients’ fragility (i.e., beliefs that patients will not be able to handle trauma-related memories and may have an increase in alcohol use),” wrote Sonya Norman, Ph.D., of the Veterans Affairs San Diego Healthcare System, and colleagues.

Veterans with PTSD and AUD (N=119) were randomly divided to receive 12 sessions of either prolonged exposure therapy or coping skills therapy; both therapies were integrated to focus on both PTSD and substance use symptoms. The exposure program, known as COPE, combines live and image-based exposure to traumatic memories alongside cognitive-behavioral therapy (CBT) techniques to strengthen relapse prevention skills. The coping skills therapy combines CBT with case management to develop coping skills to manage trauma and substance use in a patient’s daily life. The participants were asked to attend at least one session a week but were allowed up to six months to finish therapy.

At the end of the study, participants in both treatment groups showed significant reductions in their PTSD severity (measured with the Clinician Administered PTSD Scale for DSM-5 [CAPS-5]) and total number of heavy drinking days. The prolonged exposure group did have greater CAPS-5 reductions on average, as well as a higher rate of remission for PTSD (22.2% vs. 6.8% in the coping skills group), despite attending fewer sessions on average (8.4 vs. 11.4 in the coping skills group).

“It is not clear whether some participants in the I-PE [integrated prolonged exposure] arm attended fewer sessions because they found I-PE treatment to be too difficult, if they completed treatment more quickly because they felt better, or for other reasons,” Norman and colleagues wrote. “Future research is needed to understand why participants had better PTSD outcomes with I-PE treatment even though they attended significantly fewer sessions, and who is most likely to benefit from each treatment under which conditions.”

To read more about PTSD therapy, see the Psychiatric Services article, “Factors Associated With Receipt of Cognitive-Behavioral Therapy or Prolonged Exposure Therapy Among Individuals With PTSD.”

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Political Rhetoric on Immigration Found to Affect Mental Health

Politicians and pundits may want to consider the emotional impact their words have not only on the groups they’re targeting, but also on the nation as a whole. A study on immigration rhetoric in Social Science & Medicine finds that negative rhetoric can cause feelings of hurt, anger, and distress in its targets, but positive rhetoric fosters perceptions of greater health, well-being and feelings of belonging.

Leo R. Chavez, Ph.D., and colleagues at the University of California, Irvine, examined the impact of political rhetoric on 280 Mexican-origin young adults (average age approximately 21 years). Study participants were born in Mexico or had at least one ancestor who was born in Mexico. The researchers collected data between August 2016 and June 2017.

Participants were randomly divided into three groups. One group viewed positive rhetoric, such as a snippet of former President Barack H. Obama’s 2011 State of the Union address in which he described immigrant students as talented, responsible young people who could enrich the nation. One group viewed negative rhetoric, such as President Donald J. Trump’s campaign-trail characterization of Mexicans who come to the U.S. as drug carriers, criminals, and rapists. The control group viewed neutral rhetoric about the color of university buildings. The researchers then asked participants open-ended questions about their feelings and reactions to what they had viewed; participants further indicated their feelings on several rating scales.

Participants who viewed political rhetoric of both types reacted strongly compared with participants who viewed neutral rhetoric. Participants who viewed positive rhetoric reported higher positive emotions and perceptions of health and well-being and lower levels of perceived stress. They used words such as proud, contribute, good, happy, community, benefit, work, success, empower, and help to describe their reactions.

In contrast, negative rhetoric was associated with higher negative emotions and perceived levels of stress and lower perceptions of health and well-being. Participants in this group used words like racist/racism, stereotype, sad, angry, upset, ignorant, offended/offensive, unfair, hate, discrimination, and hurt to describe their feelings.

“These findings suggest that negative political rhetoric about immigrants and Mexican-origin people adversely affected the emotions and the mental health of the targets of the rhetoric. Such rhetoric elicits feelings of hurt, anger, distress, and anxiety,” Chavez and colleagues wrote.

In their conclusion, the researchers noted the broad impact of political rhetoric on the nation. “When words wound, they tear at the body of the nation, creating divisions that reinforce systems of prejudice and inequality,” they wrote. “On the other hand, … moderating political rhetoric could have a salutatory effect not just on the targets of that rhetoric but for the nation as a whole. … [It] can be integrative, enhancing a sense of community and belonging, and easing stress about one's relationship to the larger society.” 

For related information, see the Psychiatric News article, “APA Maintains Pressure on Administration Regarding Welfare of Migrant Children.”

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Population Study Finds Link Between Childhood Infections and Later Eating Disorders

Severe infection in childhood was associated with a significantly increased risk of being diagnosed with a later eating disorder, including anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified (EDNOS), according to a Danish population study published in JAMA Psychiatry.

The cohort, which included the entire female population of Denmark born between 1989 and 2006, involved more than half a million adolescent girls. More than 4,000 were eventually diagnosed with an eating disorder, using International Classification of Disease criteria. Researchers compared eating disorder incidence among adolescent girls who had at least one hospital admission for infection with those who were not hospitalized for infection and among girls treated with an anti-infective medication compared with those who were not, according to Lauren Breithaupt, M.A., of the Department of Psychology at George Mason University and colleagues.

Specifically, being hospitalized for a severe infection as a child was associated with a 22% increased risk of anorexia, a 35% increased risk of bulimia, and a 39% increased risk of EDNOS. The risk of an EDNOS diagnosis may be greatest after a hospital stay, specifically for a gastrointestinal infection, which was associated with a 60% increased risk, researchers wrote. However, the rates of other specific infections were too low to provide a valid estimate of risk.

Adolescent girls treated with an anti-infective medication during childhood also had an increased risk of all eating disorders: 23% increased risk for anorexia, 63% increased risk for bulimia, and 45% increased risk for EDNOS.

Risk of eating disorder onset was greatest within the first three months after a hospitalization or taking the last anti-infective agent. Similarly, the risk increased as the number of hospitalizations or anti-infective prescriptions increased.

“The association observed with a broad range of infections provides support for the emerging immunologic hypothesis in AN and, with previous work, suggests that the immune system may also be involved in other eating disorder subtypes,” researchers wrote. “Future studies that can establish more explicit links between infections and eating disorders may aid in the diagnosis and treatment of eating disorders.”

For related information, see the Psychiatric News article “First Genetic Variant Identified For Anorexia Nervosa.”

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Study Looks at Predictors of Violence in High-Risk Schizophrenia Patients

A study published today in AJP in Advance confirms that patients with schizophrenia have low rates of violent behavior. While uncommon, the study found that a history of violence toward others is the strongest predictor of future violent behavior among this patient population. That said, the study authors concluded that improving medication adherence may be a better way to prevent violence than admitting potentially violent patients to a hospital.

“This study is … the first, to our knowledge, to describe the correlates of subsequent injurious violence among patients being treated for schizophrenia in which the independent variables include recent violence toward others,” wrote Alec Buchanan, Ph.D., M.D, of Yale University School of Medicine and colleagues.

The analysis included 1,435 participants in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study. Researchers assessed participants’ clinical condition and violent behavior at baseline and every six months for the duration of the 18-month study.

Violent behavior was self-reported using the 19-item MacArthur Community Violence Interview, which included questions about behavior (“Have you pushed, grabbed, or shoved anyone?”) and injury (“Did you physically hurt or injure anyone?”). Based on initial responses, participants were placed into these categories: no violence, noninjurious violence, or injurious violence. Other potential predictors of violent behavior that were assessed included childhood abuse, alcohol and substance use, recent victimization, hospitalizations, arrests, and socioeconomic factors such as income and food or housing instability.

An analysis of all participants found that baseline injurious violence was the strongest predictor of future violence leading to injury. Other strong predictors included drug use severity and childhood sexual abuse. Medication nonadherence was the only clinical factor associated with future violent behavior.

When limiting the analysis to participants with no history of violence leading to injury, baseline noninjurious violence was the strongest predictor of future violent behavior. Other predictors included childhood sexual abuse, drug use severity, and medication nonadherence.

“The association with treatment adherence, while smaller in hazard ratio terms, … speaks to the important contribution of maintaining a therapeutic alliance in the management of violence risk,” Buchanan and colleagues wrote.

The researchers also found that self-reported violent behavior decreased over the course of the CATIE study, even among individuals with a history of violence. “[T]hese results … do not suggest that violence risk could be more successfully managed by identifying individuals who will act violently and by admitting them to the hospital,” the researchers concluded.

For related information, see the Psychiatric News article “Experts Advise Focus on Modifiable Risk Factors in Managing Violence Risk.”

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Readmissions of Youth for Suicidality Rise After Missouri Medicaid MCO Expansion

Children and adolescents on Medicaid in Missouri were almost twice as likely to be readmitted for suicidal behavior following an initial hospitalization after the state transferred almost all of its Medicaid population into managed care plans in 2017, according to a Missouri Hospital Association (MHA) report released in March.

In May 2017, the Missouri General Assembly expanded the Medicaid Managed Care Organization (MCO) service area from 54 counties in the middle of the state to the entire state. As a result, approximately 160,000 children were shifted to Medicaid MCO coverage. Among them were 2,152 children and adolescents ages 5 to 19 who were hospitalized for psychiatric reasons with Medicaid fee-for-service coverage before, and Medicaid MCO coverage after, May 1, 2017.

These children and adolescents formed a distinct cohort to study how a change of insurance coverage might affect hospital length of stay and subsequent rehospitalization. Suicidality rates for children and adolescents within 30, 60 and 90 days of discharge from a Missouri psychiatric hospital were evaluated using hospital claims data between Oct. 1, 2015, and June 30, 2018.

After the expansion, the rates of rehospitalization for suicidal behavior roughly doubled for all three postdischarge periods studied: The 30-day postdischarge rate jumped from 5.3% to 9.7%; the 60-day rate increased from 7.8% to 15%; and the 90-day suicidality rate rose from 10.4 % to 18.8%.

Mental health professionals in the state said that the data substantiated a problem that had been apparent to them well before the expansion: MCOs are authorizing hospital days children for children based on criteria that reflect resolution of only the most acute symptoms.

“The proprietary tools used by managed care organizations [for determining authorization of hospital days] consider only current symptom severity and risk to self or others,” said psychiatrist Joe Parks, M.D., medical director of the National Council for Behavioral Health and former director of Medicaid in Missouri.

For in-depth coverage of the MHA report see the Psychiatric News article, “Missouri Report Finds Rise in Readmission for Suicidal Behavior in Teens on Medicaid.”

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FDA Clears First Device for Treatment of ADHD

On Friday, the Food and Drug Administration (FDA) announced that it is permitting the marketing of the first medical device for the treatment of attention-deficit/hyperactivity disorder (ADHD). The device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, will be available by prescription only and is indicated for children aged 7 to 12 years who are not taking prescription ADHD medications.

“This new device offers a safe, nondrug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, Ph.D., director of the FDA’s Division of Neurological and Physical Medicine Devices, in the agency press release. “Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe, and effective medical devices that meet their unique needs.”

The Monarch eTNS System delivers low-level electrical pulses to a child’s trigeminal nerve while the child sleeps via wires and a small patch adhered to the child’s forehead. The exact mechanism of eTNS is not yet known, but neuroimaging studies have shown that the trigeminal nerve connects to brain regions that are important in regulating attention, emotion, and behavior.

The efficacy of the Monarch system was shown in a recently published clinical trial of 62 children with ADHD. The participants randomly received either eTNS or sham nerve stimulation nightly for four weeks. At the study’s completion, the children using the eTNS device had a statistically significant improvement in their ADHD symptoms compared with the sham group, as measured with the clinician-administered ADHD Rating Scale. The device was well tolerated; the most common side effects observed with eTNS were drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue.

The FDA cautions that the Monarch eTNS System should not be used in children with active implantable pacemakers, active implantable neurostimulators, or body-worn devices such as insulin pumps. The eTNS System also should not be used in the presence of cellular phones, since the low levels of electromagnetic energy emitted by the phone may interrupt the therapy.

The Monarch eTNS System will be marketed by NeuroSigma. To read more about the Monarch eTNS clinical study, see the Psychiatric News article, “NoninvasiveElectrical Stimulation Shown Effective for ADHD.”

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Repeated Media Exposure to Mass Violence Linked to Posttraumatic Stress Symptoms

Tomorrow marks the 20th anniversary of the school shooting in Columbine, Colo., that claimed the lives of 15 people, and the media have already begun to bombard viewers with images and footage of the massacre’s aftermath. Although it’s natural to turn to the news to get information about such events, watching coverage of them over and over may be harmful to mental health, according to a study in Science Advances. The researchers, led by Roxane Cohen Silver, Ph.D., at the University of California, Irvine, found that media exposure to traumatic events may make viewers more emotionally sensitive to news reports of other, similar events, and cause anxiety and worry about future occurrences.

In the study, 4,165 U.S. adults responded to four surveys over the span of three years. They completed the first survey two to four weeks after the bombings at the Boston Marathon in 2013, with subsequent surveys six months later, at the second anniversary of the bombings, and five days after the Pulse nightclub shootings in Orlando, Fla., in 2016. The surveys were designed to capture participants’ responses to both tragedies and examine how responses to the Boston bombings affected their reactions to news coverage of the Orlando shootings.

The researchers found that media exposure to the Boston bombings was associated with symptoms of posttraumatic stress and with worry about future events, even two years after the bombings. Furthermore, the more worry and posttraumatic symptoms participants had, the more coverage of the Orlando shootings they watched, which led to even more distress.

“Given the apparent role that worry about the future plays in perpetuating this cycle of sensitivity to distress, this cycle may contribute to a prolonged physiological stress response that heightens risk for stress-related diseases,” Silver and colleagues wrote.

The researchers called upon the media to consider how it covers mass violence and traumatic events.

“Our findings suggest that media organizations should seek to balance the sensationalistic aspects of their coverage (e.g., providing more informational accounts as opposed to lengthy descriptions of carnage) as they work to inform the public about breaking news events,” they wrote. “This may reduce the impact of exposure to one event, reducing the likelihood of increased worry and media-seeking behavior over time.”

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Certain Variations of CBT Found as Effective as Individual CBT

Group, telephone, and guided self-help formats of cognitive-behavioral therapy (CBT) are as effective as individual CBT to treat depression, according to a study published yesterday in JAMA Psychiatry. However, guided self-help CBT is associated with a higher rate of dropouts than the other formats.

“This study suggests that group, telephone, and guided self-help treatments … may be considered as alternatives to individual CBT,” wrote Pim Cuijpers, Ph.D., of Vrije University in the Netherlands and colleagues. “Applying effective and acceptable CBT in a range of different formats will make CBT easier to implement, disseminate, and deliver across different settings and diverse patient populations.”

Cuijpers and colleagues used a technique known as a network meta-analysis to compare 155 clinical trials involving CBT for the treatment of depression. These trials included CBT delivered in individual, group, telephone-based, guided self-help (in which a therapist provides some assistance), and unguided self-help (no therapist contact) formats. The self-help categories grouped together both internet and non-internet (for example, book) delivery methods. These studies also included two types of control groups: usual care and wait list.

The comparisons showed that individual, group, guided self-help, and telephone CBT were all statistically more effective than unguided self-help CBT, as well as wait-list and usual-care controls. No significant differences were found between individual, group, guided self-help, and telephone CBT.

“Unguided self-help differs from the others in that it is the only modality that does not involve at least some contact with a helping person,” wrote Holly Swartz, M.D., and Jay Fournier, Ph.D., of the University of Pittsburgh School of Medicine, in an accompanying editorial. “This finding is consistent with other reports suggesting that individuals with depression benefit more from psychotherapy when there is at least a modicum of human interaction.”

The researchers also assessed differences in acceptability based on the responses of participants who dropped out for any reason. There were no differences in acceptability between individual, group, telephone, and unguided CBT, but guided self-help CBT was less acceptable than both individual and group CBT and both control conditions.

“It is not clear why the acceptability of guided self-help CBT was lower compared with that for the other formats,” Cuijpers and colleagues wrote. “Maybe the absence of direct contact with a professional makes it easier to stop the treatment because there is less personal-relationship pressure to continue with the treatment or the study. However, lower acceptability would then also be expected to happen in unguided CBT, which we did not find. More research is needed to examine this issue.”

To read more about different CBT modalities, see the Psychiatric News article “Guided Online CBT Benefits Patients With Depression, Anxiety.”

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APA Members: Register by May 1 to Vote in Caucus Elections

APA members have formed seven Minority and Underrepresented (M/UR) Caucuses, which provide networking opportunities, advance treatment of minority patient populations, advocate for minority mental health issues, provide representation in APA governance, and foster communication among members who share interests. To vote in one of the caucuses holding elections later this year—the Caucus of Black Psychiatrists and the Caucus of International Medical Graduates—members must join one of the caucuses and select it as the caucus in which they want to vote by May 1.

(Note: While APA members may join more than one caucus, they can vote for the leadership of only one caucus. APA members who are already a registered caucus member must still select the caucus in which they wish to vote.)

To join a caucus or update your caucus membership, please log in to your member profile. Details on the nominations and election processes will be provided to caucus members who register by May 1.

There are seven M/UR caucuses: American Indian/Alaska Native/Native Hawaiians, Asian Americans, Blacks, Hispanics, LBGTQ members, International Medical Graduates, and Women. Membership is open to all APA members who are interested in topics concerning psychiatrists or patients belonging to these seven groups.

For more information on the caucus leadership positions that will be open for election later this year, check out the Minority and Underrepresented (M/UR) Caucus Elections webpage or email caucuselections@psych.org. 

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Women Speakers Underrepresented at Medical Conferences but Numbers on Rise

The proportion of women speakers at medical conferences increased between 2007 and 2017 but continues to be well below 50%, reflecting continued underrepresentation of women in medicine generally, according to an analysis in JAMA Network Open.

“[T]he perceived gender gap in speakers at physician conferences likely represents the overall gender gap in academic medicine rather than a bias specific to conferences,” wrote Shannon M. Ruzycki, M.D., of the University of Calgary and colleagues.

Ruzycki and colleagues analyzed meeting programs and faculty lists of medical and surgical meetings in 2007 and from 2013 through 2017. Each list of names was analyzed using a validated web-based tool that can identify names in a text-based document and predict whether the first name belongs to a woman. The proportion of women speakers was compared with the average proportion of practicing physicians in the United States and in Canada.

There were 701 meeting programs available for analysis. Of those, 82 meetings (12%) had more than 50% women speakers. In addition, the average proportion of conference speakers who were women significantly increased from 2007 to 2017—24.6% to 34.1%.

The mean proportion of women physicians practicing in the United States and Canada saw a similar increase, from 26.1% in 2007 to 32.4% in 2015 (the last year for which data on the sex of practicing physicians were available, according to the study authors).

Ruzycki and colleagues noted that the presence of women role models in careers dominated by men can increase the engagement of young women.

“Exposure to female speakers at medical conferences may be a means of encouraging female medical students and residents to choose specialties that have historically been male dominated,” they wrote. “Strategies to promote inclusivity of female speakers at academic conferences may therefore represent an important opportunity to influence gender equity within medicine."

For related information, see the Psychiatric News article “Panel Discusses Obstacles Facing Women in Medicine.”

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Smoking Cessation Program Tailored to Patients With SMI Reduces Smoking, Improves Health

A smoking cessation intervention tailored to people with severe mental illness (SMI) such as schizophrenia can lead to reduced smoking and improved physical health in the short term, reports a study published in Lancet Psychiatry.

Compared with patients with SMI who received standard smoking cessation treatment, patients who received the tailored intervention that combined behavioral and pharmacological therapy were more than twice as likely to have successfully quit smoking at six months. These improvements, however, were maintained by only 15% of the patients at the 12-month mark.

“The results of the SCIMITAR+ [Smoking Cessation Intervention for Severe Mental Illness] trial will be helpful in informing clinical practice, since we have shown that quitting can be achieved for people who use mental health services just as it can for the general population of smokers,” wrote Simon Gilbody, D.Phil., of the University of York and colleagues. “Clinicians should therefore ask all of their patients about smoking status and offer referrals to effective smoking cessation services.”

The study included 526 adults with SMI (which included schizophrenia, schizoaffective disorder, and bipolar disorder) who smoked at least five cigarettes a day. All study participants expressed an interest in reducing or quitting smoking. The participants were randomly assigned to receive usual care (access to smoking cessation medications and a telephone helpline) or a tailored cessation intervention for 12 months. The tailored intervention included cessation medications and behavioral therapy adapted to meet the needs of people with SMI; these adaptations included providing assessments and nicotine replacement before setting a quit date, providing home visits, and providing additional face-to-face support following smoking relapse.

The tailored intervention was well received; 234 of the 265 participants (88%) assigned to the intervention attended at least one therapeutic session over 12 months, with an average attendance of 6.4 sessions. After six months, 14% of the participants in the intervention group had successfully quit (which was confirmed with a carbon monoxide breath test) compared with 6% of participants in the usual care group. At 12 months, the participants in the intervention group maintained a higher quit rate compared with usual care (15% versus 10%), though the difference was no longer statistically significant.

“This finding is in line with research in the general population that shows that long-term cessation of smoking is difficult to achieve and remains a challenge in treatment for nicotine dependence in any population,” Gilbody and colleagues wrote.

Among secondary assessments, physical health scores were higher in the intervention group compared with the usual care group after six months, though this improvement also disappeared after 12 months. There were no differences in depression or anxiety scores between the two groups at either six or 12 months, which the authors noted as supportive evidence that smoking cessation interventions are not detrimental to mental health.

For related information, see the Psychiatric News article “Schizophrenia Patients Show Cognitive Improvements After Smoking Cessation.”

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Developmentally Adapted Cognitive Processing Therapy Effective for Youth With Abuse-Related PTSD

Adolescents and young adults with a history of childhood sexual and/or physical abuse and symptoms of posttraumatic stress disorder (PTSD) benefitted considerably from developmentally adapted cognitive processing therapy (D-CPT) compared with those in a wait-list group with treatment advice, according to a study published in JAMA Psychiatry. Both study groups showed a significant reduction in PTSD symptom severity, but the outcome of posttreatment assessment was enhanced for those participants receiving D-CPT.

Although cognitive processing therapy is one of the most extensively studied treatments for adult PTSD, “CPT has rarely been tested in traumatized youth and has not been adapted to the specific needs of young people with a history of abuse,” wrote Rita Rosner, D.Phil., of the Catholic University of Eichstätt-Ingolstadt in Germany and colleagues.

For the study, the researchers randomly assigned 88 adolescents and young adults (aged 14 to 21 years) who were seeking treatment in outpatient clinics in Germany to either the D-CPT group or wait-list group with treatment advice. Those in the D-CPT treatment group completed at least 30 50-minute sessions over the course of 16 to 20 weeks. CPT therapy was adapted for adolescents and young adults with childhood abuse by beginning with a commitment phase to enhance treatment motivation and therapeutic alliance as well as a phase on emotion-management techniques. These were followed by an intense CPT phase (15 sessions in four weeks) to address fluctuating motivation in adolescents. Special consideration to developmental tasks, such as career choice and romantic relationships, was also integrated. Participants in the control group were advised to seek treatment outside the trial until after the three-month follow-up, at which time they received D-CPT.

The primary outcome of PTSD severity was assessed using the Clinician-Administered PTSD Scale for Children and Adolescents for DSM-IV (CAPS-CA) before treatment, at eight weeks, posttreatment, and at a three-month follow-up. Participants in the D-CPT group had a lower posttreatment mean CAPS-CA score than controls (24.7 versus 47.5, respectively). These treatment effects were maintained through the three-month follow up. Secondary outcomes of self-reported PTSD severity, depression, borderline symptoms, behavior problems, and dissociation also showed greater and stable improvement in D-CPT participants.

These results were comparable to effect sizes reported for CPT in adults. However, treatment effects were not noted until the mid-treatment assessment during the high-intensity CPT phase. The authors wrote, “This finding further challenges the need for a stabilization phase or emotion-regulation training before trauma-focused treatment, at least in adolescents with abuse-related PTSD.”

For related information, see the Psychiatric News article “Beyond PTSD: The Complexity of Diagnosis and Treatment for Teens in Child Welfare Custody.”

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Pregnant Women May Be Less Likely to Get Depression Treatment Than Other Women

More than half of pregnant women who are depressed may not get depression treatment, according to a study published Wednesday in Psychiatric Services in Advance.

The researchers analyzed results from the 2011-2016 National Survey on Drug Use and Health, zeroing in on the 12,360 women of reproductive age (18 to 44 years) who reported symptoms of a major depressive episode during the past year according to DSM-IV criteria. These women were asked whether there was a time during the past year when they needed mental health treatment or counseling but did not get it and, if so, why not. Researchers then compared the responses of women in the sample who were pregnant (3%) with those who were not (97%).

The researchers found that 51% of pregnant women and 43% of nonpregnant women with depression did not get treatment. Financial concerns, including the cost of the treatment, were cited by both groups of women as the primary reason for not receiving needed mental health treatment or counseling, according to study author Maria X. Sanmartin, Ph.D. (pictured above), an assistant professor at Hofstra University, and colleagues.

“It is surprising that 51% of pregnant women with major depressive episode did not receive any mental health treatment,” Sanmartin told Psychiatric News. “OB-GYNs should be asking about patients’ mental health status, raising patient awareness, and at least be offering patients the opportunity to receive mental health treatment.”

Sanmartin said pregnant women with a major depressive episode reported high prevalence of past-month substance use, including alcohol use (23%), marijuana use (17%), and misuse of prescription pain relievers (6%).

These are among the other findings reported in the study:

• About 40% of pregnant women reported having an unmet need for mental health care treatment or counseling versus 34% of the nonpregnant women.
• Financial concerns, including cost of care, were the most commonly cited reason among the women for not getting mental health care (22% of pregnant women versus 18% of nonpregnant women). Pregnant women with a depressive disorder were more likely to be low income, receive public insurance benefits, and were less likely to have a college degree.
• Prescription medication was the most prevalent form of treatment among pregnant women (40%), despite treatment guidelines recommending evidence-based psychosocial interventions and contact with psychiatrists before initiating pharmacological treatment.

“Although care and intervention before pregnancy would be ideal, greater barriers exist among pregnant women and warrant attention,” the researchers wrote. “Integrated health care delivery models between primary health care and behavioral health, mental health screening during pregnancy, and telepsychiatry services are important tools to pursue in tackling major depressive episodes among women.”

For more information, see the Psychiatric News article “APA Releases New Statement on Perinatal Disorders.”

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APA Protests New Policy Against Transgender Military Service Members

APA is protesting the implementation of a ban that goes into effect on Friday, April 12, on transgender individuals serving in the military. As of that day, the Department of Defense (DoD) is requiring transgender service members to follow the standards of their biological sex or be removed from service.

DoD policy under former President Barack Obama allowed transgender service members to seek treatment; now DoD intends to discriminate against those who came forward, APA said in a statement released yesterday.

“APA has long fought against discrimination against any patient population,” said APA President Altha Stewart, M.D. “This ban perpetuates discrimination and stigma against transgender people. Furthermore, this ban harms the military by depriving the service branches of willing and capable members.”

President Donald Trump signed the ban last March, which disqualifies individuals who are transgender from serving in the military except under certain limited circumstances. In response, four federal courts issued preliminary injunctions to block it. But in January, a 5-4 Supreme Court decision lifted the injunctions and allowed the ban to take effect while the cases challenging the policy continue to wind their way through the courts.

“As physicians providing treatment for mental illness and substance use disorders, we affirm that being transgender or gender diverse implies no impairment in judgment, stability, reliability, or ability to serve in the military,” APA said in its statement. “We urge the administration to eliminate this policy and instead work with our organization to ensure policy decisions are informed by medical evidence.”

A position statement first approved by the APA Board of Trustees in 2012 and re-approved last year opposes discrimination against transgender and gender-diverse individuals and urges the repeal of laws and policies that discriminate against these individuals.

For related information, see the Psychiatric News article “APA Opposes Ban on Transgender Military.”

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Recurrent Phone Call Intervention May Reduce Suicidality in Adolescents Following Hospitalization

Adolescents who have been hospitalized for suicidal behaviors may benefit from recurrent follow-up calls following hospital discharge, according to a report in Psychiatric Services.

Compared with adolescents receiving a single post-discharge call, adolescents receiving recurrent phone calls had a significantly lower rate of suicidal behavior and greater confidence in their suicide safety plan.

For the study, Manviel Rengasamy, M.D., a resident at the University of Pittsburgh Medical Center (UPMC), and Garrett Sparks, M.D., an assistant professor of psychiatry at UPMC, randomly assigned 142 youth aged 12 to 18 who had been hospitalized for suicidal thoughts or suicide attempts to receive either a single telephone call intervention or an intervention involving up to six telephone calls over 90 days

The telephone intervention consisted of a 10- to 20-minute phone call to participants and guardians from a member of the hospital’s child psychiatry house staff. In the call with guardians, staff reviewed parental concerns about suicidality and treatment follow-up. During the call with the adolescents, staff and adolescents assessed suicidality using the Columbia Suicide Severity Rating Scale and reviewed the youth’s confidence in a safety plan (based on the National Suicide Prevention Lifeline’s safety plan). They also reviewed short- and long-term goals and discussed reasons for living.

Adolescents in the recurrent-intervention group received calls at approximately 1, 7, 14, 30, 60, and 90 days post-discharge, whereas those in the single call-intervention group received one call at approximately 90 days post-discharge.

Overall, 16 participants (11%) exhibited suicidal behavior within the 90-day period: four participants were in the recurrent-intervention group and 12 were in the single-call group. The participants receiving recurrent calls reported higher average confidence in their safety plan (95.4%) compared with participants receiving a single call (73.6%).

“Given the urgent need for effective treatments to reduce adolescent suicides, cost-effective and telephone-based, post-discharge interventions should be evaluated in larger trial,” the researchers wrote.

For related information, see the American Journal of Psychiatry article “As Safe as Possible (ASAP): A Brief App-Supported Inpatient Intervention to Prevent Postdischarge Suicidal Behavior in Hospitalized, Suicidal Adolescents.”

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Study Suggests Effective Next-Step Treatments for Treatment-Resistant Depression

A new study of predictors and moderators of remission for treatment-resistant major depressive disorder (MDD) found two subgroups of patients who may benefit from specific next-step treatments with aripiprazole or bupropion, according to a report in AJP in Advance.

The study by Sidney Zisook, M.D. (pictured left), a distinguished professor of psychiatry at the University of California, San Diego, and colleagues involved 1,500 mostly older white men with nonpsychotic MDD who were enrolled in the Veterans Affairs Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D) study. To be included in VAST-D, participants had to have previously failed to respond to at least one course of antidepressant treatment.

VAST-D focused on the effectiveness and safety of three next-step treatment strategies over a 12-week trial: switching to sustained-release bupropion, combining the current medication with sustained-release bupropion, or augmenting the current medication with the antipsychotic aripiprazole. VAST-D participants took a battery of tests, including the Quick Inventory of Depressive Symptomatology—Clinician Rated (QIDS-C), the Clinical Global Impressions severity scale (CGI-S), and the Patient Health Questionnaire (PHQ-9) and had treatment visits at baseline and at weeks 1, 2, 4, 6, 8, 10, and 12.

The first report from the trial revealed that patients who took aripiprazole in addition to the antidepressant they were previously taking had the highest 12-week remission and response rates compared with patients who took bupropion in addition to antidepressants or switched to bupropion.

This latest study focused on helping clinicians predict the most effective treatment strategies for individual patients based on sociodemographic or clinical features, a subject on which Zisook told Psychiatric News there has been very little research to date. These features included age, ethnicity, and employment status; depressive symptom severity, chronicity, and subtype; level of anxiety; mixed hypomanic symptoms; childhood adversity; grief; co-occurring general medical and psychiatric conditions; positive mental health; and quality of life.

The analysis revealed that augmentation with aripiprazole was more effective for patients aged 65 years and older, compared with the bupropion regimens, whereas for patients with severe mixed hypomanic symptoms, augmentation with aripiprazole or combination of current treatment and bupropion was more effective than switching to bupropion.

The researchers also found that most patient demographic features did not predict overall remission at 12 weeks. However, remission was more likely for individuals who were employed, less severely and chronically depressed, less anxious, and not experiencing complicated grief symptoms and who had not experienced childhood adversity. Participants with longer durations of the initial antidepressant medication trial, better quality of life, and positive mental health were also more likely to achieve remission.

“Overall, it’s really a balancing act, and there’s no clear rule that’s going to apply to each patient,” Zisook said. “When considering what’s most likely to be effective versus potential side effects, you should always engage the patient when coming up with next-step treatments—because they’re the ones that need to be compliant in taking the medication. So they should be partners in making the decision.”

For more information, see the Psychiatric News article “Study to Answer What Comes Next When MDD Patients Don’t Respond.”

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Teachers’ Mental Health Linked to Students’ Well-Being, Study Shows

Teachers’ mental health and well-being can affect the mental health and well-being of their students, according to research published in the Journal of Affective Disorders.

Sarah Harding, M.Sc., of Bristol Medical School in the United Kingdom and colleagues collected data from 3,215 12- and 13-year-old students and 1,182 teachers in 25 secondary schools in England and Wales in June and July 2016. They measured all participants’ well-being with the Warwick Edinburgh Mental Wellbeing Scale, for which a higher score means greater well-being. They used standard questionnaires and scales to assess the teachers’ depressive symptoms and presenteeism (working while physically or psychologically ill or stressed) and student psychological distress. The researchers also created a questionnaire to measure the quality of teacher-student relationships in which students were asked to rate the following statement, “teachers and students generally have good relationships at this school” from “strongly disagree” to “strongly agree.”

The researchers found that greater teacher well-being and better teacher-student relationships were associated with greater student well-being and lower student psychological distress. They also found that higher teacher presenteeism and absence—but not teacher depressive symptoms—were associated with poorer student well-being and higher student psychological distress. Stronger teacher-student relationships appeared to offset the impact of teacher depressive symptoms on student psychological distress.

The researchers also noted that student mental health and well-being could affect teacher mental health and well-being as well.

“The relationships between teacher well-being, the quality of teacher-student relationships, teacher presenteeism, and student mental health outcomes are clearly complex and likely to be interrelated,” the authors wrote. “The results of this study suggest that improving teacher well-being may lead to better student well-being via more supportive relationships or reduced teacher presenteeism.”

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FDA Warns Some E-Cigarette Users Having Seizures, Particularly Youth

Psychiatrists may wish to ask patients about vaping, particularly adolescents and young adults, in response to a special announcement released yesterday by the Food and Drug Administration (FDA) regarding the incidence of seizures following use of e-cigarettes.

An FDA review of voluntary adverse event reports for e-cigarettes identified 35 cases of seizures following use of these products between 2010 and early 2019. Seizures or convulsions are known potential side effects of nicotine toxicity and have been reported following intentional or accidental swallowing of e-liquid. Some e-cigarettes deliver high concentrations of nicotine, with some containing as much nicotine as an entire pack of regular cigarettes.

“While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases,” wrote outgoing FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., in a joint statement.

Gottlieb and Abernethy asserted that e-cigarettes could “serve as an off-ramp for currently addicted adult smokers to completely switch to a potentially less harmful form of nicotine delivery.” At the same time, however, the pair acknowledged “tremendous concern for epidemic-level rises of youth e-cigarette use.” The results of the 2018 National Youth Tobacco Survey showed that e-cigarette use rose by nearly 80 percent among high schoolers and 50 percent among middle schoolers from 2017 to 2018.

“We also recognize that not all of the cases may be reported,” wrote Gottlieb and Abernethy. “We believe these 35 cases warrant scientific investigation into whether there is in fact a connection.” Such seizures have been reported among first-time e-cigarette users and experienced users, and after a few puffs or up to one day after use.

The FDA is asking health care professionals and the public to report any unexpected health or safety issues involving e-cigarettes through the agency’s Safety Reporting Portal at https://www.safetyreporting.hhs.gov.

For more information, see the Psychiatric News article “Experts Call For More Action to Thwart Youth Vaping ‘Epidemic.’”

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