Analysis of implementation processes in a hybrid effectiveness-implementation trial of interpersonal psychotherapy (IPT) for major depressive disorder in prisons: Training, supervision, and recommendations.

BACKGROUND: There are 10 million admissions to U.S. prisons and jails each year. More than half of those admitted have mental health problems. The goal of this article is to inform: (1) implementation of evidence-based mental health treatments in prisons and jails, an important effort that needs more evidence to guide it; (2) psychotherapy and interpersonal psychotherapy (IPT) training efforts, especially in low-resource settings. METHODS: A randomized hybrid effectiveness-implementation trial of group IPT for major depressive disorder (MDD) in state prisons found that IPT increased rates of MDD remission and lowered posttraumatic stress disorder symptoms relative to prison treatment as usual. The trial used prison counselors, only some of whom had prior psychotherapy training/experience, to deliver IPT. IPT treatment adherence was high (96%), but trial training and supervision were too costly to be scalable outside the trial. The current article reports results from a planned qualitative analysis of 460 structured implementation and supervision documents in that trial to describe training and supervision processes and lessons learned, inform training recommendations, and facilitate future work to optimize training and supervision for under-resourced settings. RESULTS: Themes identified in implementation and supervision process notes reflected: work on psychotherapy basics (reflective listening, focusing on emotions, open-ended questions, specific experiences), IPT case conceptualization (forming a conceptualization, what is and is not therapeutic work, structure and limit setting, structure vs. flexibility), IPT techniques (enhancing social support, role plays, communication analysis), psychotherapy processes (alliance repair, managing group processes), and managing difficult situations (avoidance, specific clients, challenging work settings). Counselors were receptive to feedback; some relied on study supervisors for support in managing stressful prison working conditions. CONCLUSIONS: Findings can be used to make future training and supervision more efficient. Based on our results, we recommend that initial and refresher training focus on IPT case conceptualization, steps for addressing each IPT problem area, and reflective listening. We also recommend supervision through at least counselors' first two rounds of groups. More low-cost, scalable training methods are needed to get mental health treatment to individuals who need it most, who are often served in challenging, low-resource settings such as prisons. This is a mental health access and equity issue. TRIAL REGISTRATION: The trial was registered at clinicaltrials.gov (NCT01685294).

Correlates of Sexual Victimization Among Community College Women.

The current study documents the correlates associated with the severity of sexual victimization among women enrolled in a 2-year community college. Comparisons between women with a history of severe sexual victimization (i.e., rape and attempted rape), moderate sexual victimization (i.e., unwanted contact and sexual coercion), and no history of sexual victimization revealed that women with a history of severe sexual victimization endorsed more drinks per week, increased problem drinking behavior, and more use of drug before sex and higher levels of self-protective dating behaviors compared with women with no history of sexual victimization. These findings suggest that programs should target the intersection of alcohol and drug use as correlates of sexual victimization among community college women.

Demographic and Support Interest Differences Among Nonbirthing Parents Using a Digital Health Platform With Parenthood-Related Anxiety: Cross-Sectional Study.

Background: The transition to parenthood is a period of major stressors and increased risk of anxiety for all parents. Though rates of perinatal anxiety are similar among women (4%-25%) and men (3%-25%), perinatal anxiety research on nonbirthing partners remains limited. Objective: We aimed to examine whether demographic characteristics or digital perinatal support preferences differed among nonbirthing partners with compared to without self-reported high parenthood-related anxiety. Methods: In this large cross-sectional study of nonbirthing partners using a digital perinatal health platform during their partner's pregnancy, users reported their parenthood-related anxiety through a 5-item Likert scale in response to the prompt "On a scale of 1=None to 5=Extremely, how anxious are you feeling about parenthood?" High parenthood-related anxiety was defined as reporting being very or extremely anxious about parenthood. During the onboarding survey, in response to the question "Which areas are you most interested in receiving support in?" users selected as many support interests as they desired from a list of options. Chi-square and Fisher exact tests were used to compare demographic characteristics and support interests of nonbirthing partners with low versus high parenthood anxiety. Logistic regression models estimated the odds ratios (ORs), with 95% CIs, of high parenthood-related anxiety with each user characteristic or digital support interest. Results: Among 2756 nonbirthing partners enrolled in the digital platform during their partner's pregnancy, 2483 (90.1%) were men, 1668 (71.9%) were first-time parents, 1159 (42.1%) were non-Hispanic White, and 1652 (50.9%) endorsed an annual household income of >US $100,000. Overall, 2505 (91.9%) reported some amount of parenthood-related anxiety, and 437 (15.9%) had high parenthood-related anxiety. High parenthood-related anxiety was more common among non-White nonbirthing partners: compared to those who identified as non-Hispanic White, those who identified as Asian, Black, or Hispanic had 2.39 (95% CI 1.85-3.08), 2.01 (95% CI 1.20-3.23), and 1.68 (95% CI 1.15-2.41) times the odds of high parenthood-related anxiety, respectively. Lower household income was associated with increased odds of reporting high parenthood anxiety, with the greatest effect among those with annual incomes of US $100,000 (OR 2.13, 95% CI 1.32-3.34). In general, nonbirthing partners were interested in receiving digital support during their partner's pregnancy, but those with high parenthood-related anxiety were more likely to desire digital support for all support interests compared to those without high parenthood anxiety. Those with high parenthood-related anxiety had more than 2 times higher odds of requesting digital education about their emotional health compared to those without high parenthood-related anxiety (OR 2.06, 95% CI 1.67-2.55). Conclusions: These findings demonstrate the need for perinatal anxiety-related support for all nonbirthing partners and identify nonbirthing partners' demographic characteristics that increase the odds of endorsing high parenthood-related anxiety. Additionally, these findings suggest that most nonbirthing partners using a digital health platform with high parenthood-related anxiety desire to receive perinatal mental health support.

Integrated Alcohol Use and Sexual Assault Prevention Program for College Men Who Engage in Heavy Drinking: Randomized Pilot Study.

BACKGROUND: Sexual assault is prevalent on college campuses and most commonly is perpetrated by men. Problematically, there is a dearth of evidence-based prevention programs targeting men as perpetrators of sexual aggression. The Sexual Assault and Alcohol Feedback and Education (SAFE) program is an integrated alcohol and sexual assault prevention intervention for college men who engage in heavy drinking that aims to address sexual aggression proclivity and alcohol use outcomes by incorporating social norms theory, bystander intervention, and motivational interviewing. OBJECTIVE: This study aims to examine the initial feasibility-, acceptability-, and efficacy-related outcomes of a randomized pilot trial of an integrated alcohol and sexual assault prevention program for college men who engage in heavy drinking. METHODS: This study included 115 college men who engaged in heavy drinking, who were randomly assigned to the SAFE program or a mindfulness-based control condition (MBCC). The feasibility of implementation, adequacy of participant retention, fidelity and competency of program administration, and satisfaction and utility of the intervention were evaluated. The primary outcomes of alcohol use and sexual aggression were evaluated at 2 and 6 months after baseline. The secondary outcomes of perceived peer norms, risks for sexual aggression, and bystander intervention were also assessed. The extent to which the motivational interviewing session with personalized normative feedback facilitated changes in the proximal outcomes of drinking intentions, motivation to change, and self-efficacy was also examined. RESULTS: The study procedures resulted in high program completion and retention (>80%), high fidelity to the program manual (>80% of the content included), high competency in program administration, and high ratings of satisfaction and program utility in addressing sexual relationships and alcohol use. Both groups reported declines in the number of drinks per week and number of heavy drinking days. Compared with the MBCC participants, the SAFE participants reported higher motivation to change alcohol use after the program, as well as greater use of alcohol protective behavioral strategies at 6 months. Compared with the MBCC participants, the SAFE participants also reported lower perceived peer engagement in sexual coercion, perceived peer comfort with sexism, and peer drinking norms at 2 and 6 months. However, no group differences were observed in sexual aggression severity, rape myth acceptance, or the labeling of sexual consent. Results regarding bystander intervention intentions were mixed, with the MBCC group showing decreased intentions at 2 months and the SAFE group reporting increased intentions at both 2 and 6 months. CONCLUSIONS: The findings provide promising evidence for the feasibility, acceptability, utility, and preliminary efficacy of the SAFE program in reducing alcohol use and positively influencing perceived peer norms and intentions for bystander intervention among college men who drink. TRIAL REGISTRATION: ClinicalTrials.gov NCT05773027; https://clinicaltrials.gov/study/NCT05773027.

Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention.

PURPOSE: To examine the effectiveness, cost-outcome, equity, scalability, and mechanisms of the Reach Out, Stay strong, Essentials for mothers of newborns (ROSE) postpartum depression prevention (PPD) program as universal versus selective or indicated prevention. BACKGROUND: The United States Preventive Services Task Force (USPSTF) currently recommends PPD prevention for pregnant people at risk of PPD (i.e., selective/indicated prevention). However, universal prevention may be more scalable, equitable, and cost-beneficial. DESIGN: Effectiveness of ROSE for preventing PPD among people at risk is known. To assess ROSE as universal prevention, we need to determine the effectiveness of ROSE among all pregnant people, including those screening negative for PPD risk. We will enroll 2320 pregnant people, assess them with commonly available PPD risk prediction tools, randomize everyone to ROSE or enhanced care as usual, and assess ROSE as universal, selective, and indicated prevention in terms of: (1) effectiveness (PPD prevention and functioning), (2) cost-benefit, (3) equity (PPD cases prevented by universal prevention that would not be prevented under selective/indicated for minority vs. non-Hispanic white people), (4) quantitative and qualitative measures of scalability (from 98 agencies previously implementing ROSE), (5) ROSE mechanisms across risk levels. We will integrate results to outline pros and cons of the three prevention approaches (i.e., universal, selective, indicated). CONCLUSION: This will be the first trial to assess universal vs. selective/indicated PPD prevention. Trial design illustrates a novel, efficient way to make these comparisons. This trial, the largest PPD prevention trial to date, will examine scalability, an understudied area of implementation science.

Computer-based intervention for residents of domestic violence shelters with substance use: A randomized pilot study.

BACKGROUND: Intimate Partner Violence (IPV) is a significant public health problem often associated with serious mental health and physical health implications. Substance use disorders (SUDs) are one of the most common comorbidities among women with IPV, increasing risk of subsequent IPV. METHODS: The current study examined the feasibility, acceptability, and preliminary effectiveness of a brief computerized intervention to reduce alcohol and drug use among women with IPV. Fifty women with recent IPV and alcohol and drug use risk were recruited from domestic violence shelters and randomized to the experimental computerized intervention or to an attention and time control condition. The primary outcome was percent heavy drinking or drug using days in 3 month increments over the 6 months after leaving the shelter. Receipt of substance use services and IPV severity were evaluated as secondary outcomes. RESULTS: The computerized intervention was feasible and acceptable, with high (n = 20, 80%) completion rates, engagement with the intervention, and satisfaction scores. As expected in this pilot trial, there were no significant differences between conditions in percent heavy drinking/drug using days or receipt of substance use services and large individual differences in outcomes. For example, receipt of substance use services decreased by a mean of 0.05 times/day from the baseline to the 6-month time period in the control condition (range -1.00 to +0.55) and increased by a mean of 0.06 times/day in the intervention condition (range -0.13 to +0.89). There were large decreases in IPV severity over time in both conditions, but directions of differences favored the control condition for IPV severity. CONCLUSION: A computerized intervention to reduce the risk of alcohol/drug use and subsequent IPV is feasible and acceptable among residents of a domestic violence shelter. A fully powered trial is needed to conclusively evaluate outcomes.

Preventing sexual violence among high school students through norms correction and bystander intervention: A school-based cluster trial of Your Voice Your View.

Risk for sexual violence begins early in the lifespan; thus, interventions are needed to decrease the risk for sexual violence among high school youth. The current study evaluates the Your Voice Your View (YVYV) sexual violence prevention program using a school-based cluster trial among 26 high schools in the Northeastern United States. YVYV, includes: 1) a series of four classroom workshops designed to engage students as allies in violence prevention through bystander intervention skills training, address risks for sexual aggression, and reduce risk for victimization; 2) a Lunch and Learn teacher training workshop; and 3) a 4-week social norms poster campaign based on normative data from the school. Schools were matched based on size and demographics and randomly assigned to the intervention group or a wait-list control group. A sample of 2685 10th grade students enrolled in the research and completed assessments at baseline, 2-month and 6-month follow-up periods. The magnitude of the difference in sexual aggression did not vary by condition at either follow-up period. The magnitude of 6-month differences in experiencing unwanted sexual intercourse varied significantly by condition (IRR = 0.33 [0.14-0.76]), demonstrating a small protective effect favoring intervention schools (Cohen's f2 = 0.012). These findings highlight the promise of multicomponent interventions grounded in bystander intervention skills training, risk reduction, and social norms theory as a promising, comprehensive approach for sexual violence prevention among youth.

Dating Violence Prevention for Juvenile-Justice Involved Females: A Hybrid Trial.

OBJECTIVE: The primary objective of this hybrid I clinical trial of Date SMART (Date Skills to Manage Aggression in Relationships for Teens) was to reduce adolescent dating violence (ADV) among juvenile-justice involved females over 1 year. Secondary objectives were to determine if the intervention reduced sexual risk behavior and delinquency. Last, we evaluate system buy-in vis à vis mandated referrals to the program. METHODS: Participants were females, ages 14 to 18 (N = 240), involved in a family court in the Northeast United States. The Date SMART group intervention consisted of cognitive-behavioral skill building, and the knowledge-only comparison group consisted of psychoeducation regarding sexual health, ADV, mental health and substance use. RESULTS: Court mandates to intervention were common (41%). Among those with ADV exposure, Date SMART participants reported fewer acts of physical and/or sexual ADV (rate ratio, 0.57; 95% confidence interval [CI], 0.33-0.99) and cyber ADV (rate ratio, 0.75; 95% CI, 0.58-0.96) at follow-up, relative to control. There were significant reductions in the number of vaginal and/or anal sex acts reported by Date SMART participants relative to control (rate ratio, 0.81; 95% CI 0.74-0.89). In the overall sample, within group reductions in some ADV behaviors and delinquency were observed in both conditions. CONCLUSIONS: Date SMART was seamlessly integrated into the family court setting and received stakeholder buy-in. Although not superior to control as a primary prevention tool, Date SMART was effective in reducing physical and/or sexual ADV, and cyber ADV, as well as vaginal and/or anal sex acts, among females with ADV exposure over 1 year.

'Sometimes, we don't know if we're getting abused': discussions of intimate partner violence and HIV risk among transgender women.

Transgender women are among the populations at highest risk for HIV in the USA and have elevated risk for intimate partner violence (IPV). There is an urgent need for integrated HIV-IPV prevention interventions for transgender women. Using qualitative methods, we explored transgender women's lived experiences of IPV and the relationship between IPV and HIV risk. Using thematic analysis, we identified four key concepts that warrant inclusion in the development of models for IPV and HIV interventions: (1) considering the boundaries of IPV; (2) normalising expectations of chronic violence; (3) relationship safety; (4) calls for trans-affirming and empowering services.

MOSAIC (MOthers' AdvocateS In the Community) for pregnant women and mothers of children under 5 with experience of intimate partner violence: A pilot randomized trial study protocol.

BACKGROUND: Pregnancy and motherhood increase the risk for long-term exposure to physical, psychological and sexual intimate partner violence (IPV; sexual or physical violence by current or former partners). Pregnant women and mothers with children under 5 who have experienced IPV exhibit poor physical and mental health and obstetric outcomes. Depression and posttraumatic stress disorder (PTSD) are the two most common mental health consequences of IPV. There is good evidence that women with good social support have better mental health and IPV outcomes. METHODS: This study will develop MOthers' AdvocateS In the Community (MOSAIC) Plus intervention for pregnant women and mothers with children under the age of 5. MOSAIC uses trained mentor mothers and has been found to reduce subsequent IPV. This study will blend the original MOSAIC intervention with principles of interpersonal psychotherapy (IPT) to address symptoms of depression, PTSD, and prevent subsequent risk of IPV. We will conduct a pilot randomized trial of the MOSAIC Plus intervention compared to the traditional MOSAIC intervention to determine its feasibility and acceptability. Study samples include focus groups (n = 36), open trial (n = 15), and a randomized pilot trial including 40 pregnant women and mothers with children under 5 who report current/recent of IPV and elevated symptoms of maternal depression and/or PTSD. The study's primary outcome will be changes in maternal depressive and PTSD symptoms. Secondary outcomes will include reduction in subsequent IPV, improvement in functioning, changes in social support and effectiveness in obtaining resources. DISCUSSION: This is a formative study evaluating the feasibility and acceptability of a mentor mother intervention for pregnant women and mothers with children under 5. Promising results of this study will be used for a larger, fully-powered randomized trial evaluating the effectiveness of a mentor mother intervention in preventing subsequent IPV and reducing depressive and PTSD symptoms in this population.

Protocol for the Healing After Loss (HeAL) Study: a randomised controlled trial of interpersonal psychotherapy (IPT) for major depression following perinatal loss.

INTRODUCTION: This protocol describes a study testing the efficacy of interpersonal psychotherapy (IPT) for major depressive disorder following perinatal loss (early and late fetal death and early neonatal death). Perinatal loss is associated with elevated risk of major depressive disorder and post-traumatic stress disorder (PTSD). Perinatal loss conveys specific treatment needs. The trial will be the first fully powered randomised trial of treatment for any psychiatric disorder following perinatal loss. METHODS AND ANALYSIS: A sample of 274 women in Flint and Detroit areas in Michigan who experience a major depressive episode following a perinatal loss will be randomised to group IPT for perinatal loss or to group coping with depression. We anticipate that 50% of the sample will have co-occurring PTSD. Assessments occur at baseline, mid-treatment (8 weeks), post-treatment (16 weeks) and follow-up (28 weeks). Clinical outcomes include time to recovery from major depressive episode (primary), depressive symptoms, PTSD symptoms and time to recovery from PTSD. Additional outcomes include social support, social role functioning (including parental functioning for those with living children), well-being, grief (including complicated grief and fault beliefs) and fear of subsequent pregnancies. Social support and grief are hypothesised mediators of IPT effects on time to recovery from major depressive episode. ETHICS AND DISSEMINATION: The trial was approved by Michigan State University's Biomedical Institutional Review Board. It has a data and safety monitoring board and has been submitted to the community-based organisation partners community ethics review board. Written operating procedures outline methods for protecting confidentiality, monitoring and recording adverse events, and safeguarding participants. We will share study results with research and clinical communities, community organisations through which we recruited, and will offer results to study participants. Deidentified datasets will be available through the National Institute of Mental Health Data Archive and to qualified investigators on request. TRIAL REGISTRATION NUMBER: NCT04629599.

Web-based intervention to reduce intimate partner violence during perinatal period: A modified protocol in response to the COVID-19 pandemic.

Perinatal women are at increased risk of intimate partner violence (IPV), associated with psychiatric disorders and partner revictimization. We describe changes that were made, in response to the COVID-19 pandemic, to an in-person randomized controlled study of perinatal women with IPV who had sought mental health treatment in the last year. All phases of the study's in-person delivered computerized protocol were modified for remote delivery. Special attention was given to study participants' privacy and safety, especially with regard to the use of technology. We describe study protocol and consent procedures that were made to accommodate remote delivery of the study. All phases of remote delivery of the study have been implemented successfully and safely. Compared to the first three months of in-person delivery, the first three months of remote recruitment found that more participants were screened (69% vs. 36%) and more were enrolled in the study (13% vs. 8%). To our knowledge, this is the first remote delivered study involving participants with IPV to use the 5-item Danger Assessment and a spyware and stalkerware survey as screening tools. We demonstrate that remote delivery can reduce the risk of compromising the safety and privacy of study participants with IPV.

The Association Between Demographic, Mental Health, and Intimate Partner Violence Victimization Variables and Undergraduate Women's Intimate Partner Violence Perpetration.

Addressing women's intimate partner violence (IPV) perpetration is essential not only to their partners' safety but also to their own as, for women who are victims of IPV, their IPV perpetration may be a risk factor for their own revictimization. Although many studies have examined risk factors for women's IPV perpetration, results diverge with regard to whether demographic and mental health variables are reliable predictors. Results of several studies have demonstrated that when IPV victimization is examined concurrently with perpetration, demographic and mental health variables are no longer significant correlates. However, this research has been limited in that the type of IPV examined has been restricted to physical, psychological, and sexual abuse. In addition, some demographic variables (e.g., sexual orientation) have yet to be adequately examined. The current study extends this literature by concurrently assessing demographic, mental health, and IPV victimization variables as correlates of IPV perpetration among undergraduate women. Furthermore, the current study examined a wide range of IPV types (i.e., threats of physical abuse, physical abuse, sexual abuse, psychological maltreatment, stalking, cyberstalking). Among a final sample of 398 undergraduate women at a Midwestern public university, results demonstrated that while all variables (i.e., demographic, mental health, IPV victimization) were correlated with at least one type of IPV perpetration, only IPV victimization remained a unique significant correlate of perpetration for each of the six IPV perpetration types when variables were analyzed concurrently in hierarchical regression models. Demographic and mental health variables were nonsignificant correlates for most IPV perpetration types. These results corroborate previous studies and provide additional evidence that targeting women's own victimization, safety planning, and de-escalation may be useful at decreasing violence against women's partners as well as women's own risk for revictimization.

Computerized Intervention in Primary Care for Women Veterans with Sexual Assault Histories and Psychosocial Health Risks: a Randomized Clinical Trial.

IMPORTANCE: Sexual assault is a public health concern for women and is associated with subsequent psychosocial health risks of posttraumatic stress disorder (PTSD), hazardous drinking, and intimate partner violence (IPV). Sexual assault is associated with social stigma and other barriers shown to inhibit one from seeking mental health care. Digital health technologies may overcome these barriers. OBJECTIVE: To test the impact of a brief computerized intervention delivered in primary care to reduce health risks and increase mental health treatment utilization among women with histories of sexual assault and current health risks. DESIGN, SETTING, AND PARTICIPANTS: The Safe and Healthy Experiences (SHE) program was tested in a randomized controlled trial with N = 153 women veterans at a Veterans Health Administration (VHA) medical center, and they completed assessments at baseline, 2 months, and 4 months. INTERVENTION: SHE is a brief motivational interviewing and psychoeducation-based computerized intervention. SHE was compared to a screen and referral-only control condition. MAIN MEASURES: Health risks were measured via validated self-report instruments. Treatment initiation and utilization were measured via self-report and chart review. RESULTS: SHE did not impact women's number of health risks (all p's > .05). However, women randomized to SHE showed significantly greater increases in treatment use compared to women in the control group, as measured by chart review (χ2 (1, n = 153) = 4.38, p = .036, rs = .16), and self-report (χ2 (1, n = 130) = 5.89, p = .015, rs = .21). SHE was found to be an acceptable intervention. CONCLUSIONS: SHE was effective in improving mental health treatment initiation and utilization compared to a control group. Computer-based interventions to address sexual trauma and its consequences are acceptable, are highly scalable, and can add value to primary care with little cost or increase in provider time. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT02957747.

Behavioral Therapy Teams for Obsessive-Compulsive Disorder: Lessons Learned From a Pilot Randomized Trial in a Community Mental Health Center.

Community mental health centers (CMHCs) provide the majority of mental health services for low-income individuals in the United States. Exposure and response prevention (ERP), the psychotherapy of choice for obsessive-compulsive disorder (OCD), is rarely delivered in CMHCs. This study aimed to establish the acceptability and feasibility of testing a behavioral therapy team (BTT) intervention to deliver ERP in CMHCs. BTT consisted of individual information-gathering sessions followed by 12 weeks of group ERP and concurrent home-based coaching sessions. The sample consisted of 47 low-income individuals with OCD who were randomized to receive BTT or treatment as usual (TAU). Symptom severity and quality-of-life measures were assessed at pretreatment, posttreatment, and 3- and 6-month posttreatment. Feasibility of training CMHC staff was partially successful. CMHC therapists successfully completed rigorous training and delivered ERP with high fidelity. However, training paraprofessionals as ERP coaches was more challenging. ERP was feasible and acceptable to patients. BTT participants were more likely than TAU participants to attend their first therapy session and attended significantly more treatment sessions. A large between-group effect size was observed for reduction in OCD symptoms at posttreatment but differences were not maintained across 3- and 6-month follow-ups. For BTT participants, within-group effect sizes reflecting change from baseline to posttreatment were large. For TAU participants, depression scores did not change during the active treatment phase but gradually improved during follow-up. Results support feasibility and acceptability of ERP for this patient population. Findings also underscore the importance of implementation frameworks to help understand factors that impact training professionals.

Adapting to the Pandemic: Protocol of a Web-Based Perinatal Health Study to Improve Maternal and Infant Outcomes.

BACKGROUND: The identification of interconnected health risks during the perinatal period offers an opportunity to prevent negative maternal and infant health outcomes. Marijuana, opioid, and other substance use during pregnancy is a rapidly growing public health concern with significant and costly health consequences for the woman and the developing fetus. Pregnant persons who misuse substances are disproportionately more likely to engage in risky sexual behaviors resulting in sexually transmitted infections (STIs), which are on the rise in this population and can lead to adverse effects on maternal health and on fetal development. OBJECTIVE: Our goal is to continue testing an innovative and low-cost technology-delivered intervention, the Health Check-Up for Expectant Moms (HCEM), which simultaneously targets alcohol and drug use and STI risk during pregnancy, both of which are on the rise during the COVID-19 pandemic. METHODS: We describe the ways in which we have adapted the web-based HCEM intervention to continue recruitment and study enrollment during the pandemic. RESULTS: Study recruitment, visits, and participant safety assessments were all successfully modified during the initial year of the COVID-19 pandemic. Compared to in-person recruitment that occurred prepandemic, remote recruitment yielded a greater proportion of women enrolled in the study (83/136, 61.0% vs 43/52, 83%) in a shorter period (12 months vs 7 months). CONCLUSIONS: Despite study challenges related to the pandemic, including time and effort adapting to a remote protocol, remote recruitment and visits for this study were found to constitute a successful approach. TRIAL REGISTRATION: ClinicalTrials.gov NCT03826342; https://clinicaltrials.gov/ct2/show/NCT03826342. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30367.

The efficacy of antidepressant medication and interpersonal psychotherapy for adult acute-phase depression: study protocol of a systematic review and meta-analysis of individual participant data.

BACKGROUND: Antidepressant medication and interpersonal psychotherapy (IPT) are both recommended interventions in depression treatment guidelines based on literature reviews and meta-analyses. However, 'conventional' meta-analyses comparing their efficacy are limited by their reliance on reported study-level information and a narrow focus on depression outcome measures assessed at treatment completion. Individual participant data (IPD) meta-analysis, considered the gold standard in evidence synthesis, can improve the quality of the analyses when compared with conventional meta-analysis. AIMS: We describe the protocol for a systematic review and IPD meta-analysis comparing the efficacy of antidepressants and IPT for adult acute-phase depression across a range of outcome measures, including depressive symptom severity as well as functioning and well-being, at both post-treatment and follow-up (PROSPERO: CRD42020219891). METHOD: We will conduct a systematic literature search in PubMed, PsycINFO, Embase and the Cochrane Library to identify randomised clinical trials comparing antidepressants and IPT in the acute-phase treatment of adults with depression. We will invite the authors of these studies to share the participant-level data of their trials. One-stage IPD meta-analyses will be conducted using mixed-effects models to assess treatment effects at post-treatment and follow-up for all outcome measures that are assessed in at least two studies. CONCLUSIONS: This will be the first IPD meta-analysis examining antidepressants versus IPT efficacy. This study has the potential to enhance our knowledge of depression treatment by comparing the short- and long-term effects of two widely used interventions across a range of outcome measures using state-of-the-art statistical techniques.

An Open Trial to Test Participant Satisfaction With and Feasibility of a Computerized Intervention for Women Veterans With Sexual Trauma Histories Seeking Primary Care Treatment.

Sexual trauma is prevalent among women veterans and associated with health risks including hazardous drinking, intimate partner violence (IPV), and post-traumatic stress disorder (PTSD). Safe and Healthy Experiences (SHE) is a computerized intervention to reduce these health risks. SHE was pilot tested in an open trial (N = 20) with women veterans with a history of sexual trauma and associated health risks. Women reported high satisfaction with the intervention and computerized delivery and they evidenced reductions in hazardous drinking, IPV, and PTSD at 4 months. SHE appears to be satisfactory, feasible, and potentially beneficial to women veterans.

Social Support and Suicidal Ideation Among Prisoners with Major Depressive Disorder.

This study explored the impact of social support on suicidal ideation in 169 prisoners with major depressive disorder, accounting for known demographic, criminological, and clinical risk factors. Greater social support was associated with a lower likelihood of the presence of current suicide ideation. This effect remained significant even after adjusting for other significant predictors of suicide ideation including sex, length of sentence served, severity of current depression, and having prior suicide attempts. This study is the first to explore social support and other known risk factors for suicide ideation in a prison population with major depressive disorder. Our findings demonstrate that, even in the presence of significant risk factors for suicidal ideation, social support remained a strong predictor, suggesting the importance of fostering social support in correctional settings.

"Give Me Proof": A Covert but Coercive Form of Non-partner Sexual Violence Contributing to Teen Pregnancy in Haiti and Opportunities for Biopsychosocial Intervention.

Adolescent girls in low-resource settings account for over 7.3 million births annually (generally unplanned). Unplanned teen pregnancies are increasing in low-resource settings. As part of a funded Round 20 Grand Challenges Exploration project (Healthy Minds for Adolescent Mothers), we investigated unplanned teen pregnancies in Haiti's Cité Soleil shantytown, teens' biopsychosocial challenges, and desirable interventions. Key stakeholders (N = 23): pregnant teens (13-17-year-olds, n = 8; 18-19-year-olds, n = 8) and health providers (18 or older, n = 7), participated by age group and role in focus groups (FGs). ATLAS.ti facilitated the analysis of transcribed FG audio recordings. Ninety-four percent (n = 15) of teens reported "Banm prèv," translated "Give me proof," as a cause of their unplanned pregnancies. Banm prèv describes when teens are propositioned by men who demand proof of their unpretentiousness or virginity. A subtle, covert, locally unchallenged phenomenon that is supported by damaging gender norms, Banm prèv constitutes an illusionary choice between teens' yielding non-consensual control of their bodies and the tacit alternative of gang rape. Banm prèv underscores teens' difficulty discerning consensual from coerced sex. Associated unplanned pregnancies occasion guilt, shame, stigma, depression, anxiety, and trauma in teens. Cité Soleil teens need contextually relevant, community-supported, age-appropriate interventions that challenge existing norms, build on cultural strengths, and include comprehensive sexuality education, including knowledge of reproductive rights. A traditional, contextually familiar, engaging, and humorous story-telling tradition, i.e., krik-krak, packaged in video format, is a useful framework for interventions to reduce depressive symptoms, stress, and anxiety for Cité Soleil teens experiencing unplanned pregnancies.