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NIDA - National Institute on Drug Abuse

PROJECT SUMMARY Adolescent substance use is a significant public health issue with costly consequences. Youth exposed to household challenges (i.e., parental substance use, parental incarceration, and parental mental health challenges) are more likely to use substances compared to those who are unexposed. Youth exposed to negative neighborhood contexts (e.g., neighborhood violence and low social cohesion) are more likely to use substances compared to those who are unexposed. The nine selective substance use prevention programs have had little success changing outcomes for this group. None were informed by the lived experiences of children, who experience both household challenges and negative neighborhood contexts. Most programs have struggled to attract and retain these youth. Mechanisms such as social connections have primarily been ignored despite their relevance for substance use prevention among youth. Thus, additional selective prevention programs are needed to prevent substance use among youth at this intersection. The PI (Powell) partnered with families exposed to household and neighborhood challenges to develop the Better Together (BT) intervention. BT is an 8-session, age-appropriate intervention designed to prevent substance use among adolescents (ages 11 to 13) exposed to household and neighborhood challenges. BT is a novel and promising strategy to enhance internal and external assets and help youth abstain from substance use. Qualitative findings from a process evaluation suggest that BT is acceptable and feasible. Quantitative findings from a pilot study also provide strong preliminary evidence that our team can recruit, retain, and engage youth affected by household and neighborhood challenges. We propose a hybrid type 1 study with two aims to achieve our long-term goal of preventing drug use and its consequences among youth exposed to household and neighborhood challenges. In Aim 1, we will conduct a randomized trial to evaluate the effectiveness of the Better Together Intervention, compared to a time-matched control group, in preventing alcohol and marijuana use over 18 months. We will also examine individual and interpersonal factors that mediate the relationship between the intervention and substance use using the Karlson-Holm-Breen method for mediation. In Aim 2, we will examine contextual factors that impact effective program implementation using surveys, interviews, and geospatial data. In Aim 4, we will assess how contextual factors impact effective program implementation, youth participation, and substance use outcomes. This research addresses high-priority topics for NIDA and NIH, including personalized interventions informed by people with lived experiences as well as scaling and implementing an innovative evidence-based interventions that address poor health outcomes. This study will address key effectiveness, implementation, and cost questions critical for widescale dissemination. Study processes and findings can inform future research, practice, and policies on substance use prevention in other populations and across settings.

NIMH - National Institute of Mental Health

Project Summary/Abstract The overarching aim of the proposed project is to develop and validate novel, multimodal, scalable, time- and cost-efficient assessment protocol for comprehensive characterization of key subdomains of restricted and repetitive behaviors (RRB) that can assist in the diagnostic process, facilitating etiologically oriented research, the treatment selection, and monitoring symptomatology over time. Although RRB are a core, clinically impactful feature of autism spectrum disorder (ASD), existing measures are limited by poor ability to comprehensively capture all relevant RRB subdomains and currently, there are no dedicated clinician interviews nor protocols to capture and quantify daily variations of distinct RRBs in ASD or in neurogenetic disorders. In the proposed project, we will build on the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB), an informant-report questionnaire developed and validated by our group following the NIH Patient-Reported Outcome Measurement Information System framework. DARB has a comprehensive item bank developed to assess eight distinct RRB subdomains and has been shown to have a stable and replicable 8-factor structure, strong model and conditional reliability, invariance across age, sex and diagnostic status, and excellent test-retest replicability. In the current proposal, we will aim to: develop and validate the computerized adaptive test (CAT) version of the DARB (DARB-CAT) to maximize precision and reduce patient burden by individually tailored item selection and administration (Specific Aim 1), refine and validate a clinician interview version of the DARB (DARB-I) (Specific Aim 2) and develop an ecological momentary assessment (EMA) RRB protocol (DARB-EMA) to capture daily and weekly changes in specific RRB and contexts in which they occur (Specific Aim 3). We will also develop and pilot a platform that will integrate the administration, scoring and reporting of the DARB-CAT, DARB-I and DARB-EMA components (Exploratory Aim 4). Finally, we will explore mechanisms underlying RRB subdomains (Exploratory Aim 5). This project will generate the world’s first comprehensive, multimodal RRB assessment ecosystem incorporating state-of-the-art psychometric principles that will have a significant potential to enhance the pathway from screening to clinical and neurobiological characterization to treatment tailoring and tracking.

NIMH - National Institute of Mental Health

Abstract The objective of this study is to increase access to psychotherapy among mothers with lower income via a novel digital intervention called GroupChatMB. It is an adaptation of the group-based psychotherapy modality Mothers and Babies to delivery via the Text Message Group Therapy (TMGT) platform, delivered by a psychotherapist to mothers at-risk for developing peripartum depression (PPD) in synchronous, live, written text message exchange in a group chat format. Specific Aim 1: Develop the GroupChatMB app by adapting Mothers and Babies to delivery via the TMGT platform Specific Aim 2: Refine the GroupChatMB app using iterative, user-centered design to ensure usability and acceptability among mothers with lower income Specific Aim 3a: Conduct a pilot, waitlist-controlled RCT using the intention to treat principle to establish feasibility Specific Aim 3b: Conduct a pilot RCT to determine preliminary efficacy of the GroupChatMB app to improve the primary outcome of maternal mood and secondary outcome of maternal parenting This research furthers NIMH Strategic Plans: Goal 4.3.A (adapting Mothers and Babies to delivery via the TMGT platform to increase access for mothers with lower income). Goal 3.3.A (developing GroupChatMB and evaluating impact maternal mood and parenting, with future research on infant mental health and development outcomes). Goal 4.1.A (GroupChatMB as a novel service delivery target to prevent PPD). Goal 4.2.A (the iterative, user-centered design and research as a physician-scientist with extensive clinical experience serving this population strengthens partnerships with key end users). Dr. Guiroy’s career development plan includes Goal (#1): Extend my expertise in the adaptation of psychotherapy to digital delivery (Specific Aim 1); Goal (#2): Extend my expertise in conducting community research (Specific Aim 2); Goal (#3): Gain expertise in conducting clinical RCT research (Specific Aim 3); Goal (#4): Continue to increase my scientific productivity including publishing manuscripts. Dr. Guiroy long-term career goals are to be an NIH-funded independent investigator who adapts psychotherapies to digital delivery tailored to community needs and who will rigorously test them with clinical trials with the goal of improving the mental health of two-generations (caregiver and child), starting with mothers and their infants. She will obtain this career development training and execute this research at Stanford University School of Medicine.

NIAAA - National Institute on Alcohol Abuse and Alcoholism

ABSTRACT Hazardous alcohol use among people with HIV occurs at nearly twice the rate of the general population and contributes to poor antiretroviral therapy adherence, reduced retention in care, neurocognitive complications, and increased mortality. These health risks are amplified by co-occurring negative affect symptoms (e.g., anxiety, depression), which are highly prevalent among people with HIV and associated with more severe alcohol use and functional impairment. Despite the syndemic nature of these challenges, scalable, mechanism-focused interventions that simultaneously target hazardous drinking and negative affect within HIV care are lacking. One promising strategy is to target transdiagnostic mechanisms that drive hazardous drinking and negative affect. Anxiety sensitivity, the fear of anxiety-related sensations, is one such mechanism contributing to anxiety, depression, and hazardous drinking, and is elevated among people with HIV. Anxiety sensitivity is modifiable, and reducing anxiety sensitivity improves drinking severity, emotional functioning, and related health outcomes. Our team has developed brief, computer-delivered personalized feedback interventions (PFIs) targeting anxiety sensitivity and hazardous drinking, demonstrating reductions in both anxiety sensitivity and alcohol use in at-risk populations. In parallel, we developed a PFI specifically for hazardous drinking among people with HIV, which was feasible, acceptable, and revealed promising findings. We have integrated these components to create a unified, scalable digital intervention (I-PFI) designed for people with HIV. I-PFI is a single-session (20–30 minute), computer-delivered intervention providing personalized feedback on hazardous alcohol use, negative affect, and HIV-related health, combined with interactive psychoeducation and evidence-based strategies (e.g., interoceptive exposure, physical activity). Aim 1 will refine I-PFI and evaluate it among 20 adult people with HIV with hazardous drinking and elevated negative affect, using mixed methods to assess acceptability, clarity, and perceived relevance. Aim 2 will conduct an RCT comparing I-PFI to 1) an active alcohol-only PFI and 2) a content-matched nutrition control PFI among 300 adult people with HIV with hazardous drinking and elevated negative affect from two HIV clinics. Participants will complete twice-daily ecological momentary assessments for 30 days post- intervention and follow-up assessments at 1, 3, and 6 months post-intervention. Primary outcomes include hazardous drinking (phosphatidylethanol biomarker), alcohol consumption, and alcohol-related consequences; secondary outcomes include HIV-related outcomes (high-risk sexual behavior, antiretroviral therapy adherence, quality of life) and reductions in anxiety sensitivity, anxiety, and depression. This project directly addresses PAS-25- 208 by advancing a scalable, mechanism-focused behavioral intervention integrated within HIV care settings, targeting alcohol use and mental health to improve HIV outcomes.

NIH

Significance to VA: Women Veterans are exposed to interpersonal violence at high rates throughout their lifespans which may escalate risk for psychosocial impairment and suicidal behavior. Facets of social functioning such as connectedness and social support can mitigate suicide risk. Given their risk for suicide and barriers to engaging in Veterans Administration (VHA) healthcare, violence-exposed women Veterans represent a specialized population for which expansion of VHA programming to include opportunities for socialization and community building as a key component of holistic health are needed. Coinciding with a congressional mandate for women-only retreat-based rehabilitation following military service, retreats are increasingly offered by community organizations. Retreats are associated with significant improvements in mental health and quality of life; however, no research to date has examined retreat programming as an upstream suicide prevention strategy for a high priority, high risk population of Veterans. The pilot will examine Growth, Resilience, Insight, and Togetherness (GRIT), a retreat program developed with and for Veteran women who have experienced interpersonal violence, relative to Growth, Resilience, and Insight (GRI), a self- guided version of the program, as an intervention for improving social functioning. Innovation and Impact: In preliminary work conducted by our team, violence-exposed women Veterans expressed a clear preference for a VHA-endorsed retreat program and were drawn to such a program by its use of non-clinical, nature-based environment. A retreat, grounded in Whole Health, provides women Veterans with many benefits such as time to reflect, connect, and access mental health programming that may be challenging to receive in their daily lives. The offering of a retreat in collaboration with an established community partner heeds the call for tailored, trauma-informed, community-based innovative prevention strategies within VHA to address the problem of suicide among women Veterans. Specific Aims: Aim 1: Determine feasibility of study methods and implementation of GRIT and GRI including the use of VHA clinicians. Aim 2: Establish relative acceptability of GRIT and GRI and study methods by assessing credibility, satisfaction, and perceived usefulness and burdensomeness among study clinicians and participants. Aim 3: Collect preliminary data on social functioning before, following, and two months after program completion along with indicators of suicide risk (i.e., overall risk, suicide ideation, posttraumatic stress symptoms, depression, emotional dysregulation, sleep quality). Data on therapeutic processes and social functioning during program participation will be gathered to identify key program components and potential adaptations for a larger multi-site randomized clinical trial. Methodology: Using a selective suicide prevention strategy, we will recruit women Veterans (N = 48) who have experienced interpersonal violence and endorse difficulties in at least two areas of social functioning to be randomly assigned to GRIT or GRI. Feasibility and acceptability will be evaluated using mixed-method data collection and synthesis of research tracking, self-report surveys and/or assessor-administered questionnaires, and semi-structured interviews with participants and VHA clinicians serving as facilitators. Path to Translation/Implementation: The pilot will establish infrastructure and methods, gather preliminary data, and build partnerships that will provide a foundation for expansions of retreat-based programming and a model for use within VHA. The pilot be an opportunity to: a) further engage key interdisciplinary collaborators; b) determine what settings are most ideal for and in need of retreat program implementation (e.g., rural regions, Women's Mental health clinics); and c) ensure that measures and evaluation plans match selective suicide prevention program goals for improving social functioning. Data gathered will be used to inform a multi- site randomized clinical trial.

NIAAA - National Institute on Alcohol Abuse and Alcoholism

The United States is facing a suicide crisis. Despite investments by national agencies, suicide death rates rose 37% between 2001 and 2023. This pattern signals a critical need to alter existing prevention strategies. Rising rates of alcohol use disorder (AUD), along with co-occurring mental illnesses and drug use disorders, are an important contributor to rising rates of suicide. However, which subgroups are at highest risk of suicidal thoughts and behaviors (“suicidality”) and the types and combinations of mental and substance use disorders (MSUDs) that place distinct subgroups at greater risk are not well understood. Increasing uptake of behavioral health services to treat MSUDs is a critical component of the 2024 National Strategy for Suicide Prevention and the NIAAA Strategic Plan. Yet most adults with MSUDs do not receive evidence-based treatments, such as naltrexone for AUD or therapy for depression, and we do not know which types of treatment gaps mediate suicide risk for distinct subgroups. For example, co-occurring AUD and depression may drive suicide risk for urban women, whereas untreated opioid use disorder may put disabled male veterans at higher suicide risk. Health departments and health systems have evidence-based interventions to address barriers to accessing MSUD treatment, such as health insurance enrollment outreach, telehealth, stigma reduction campaigns, and mental health service navigators. However, we do not know which barriers or interventions are the most important for distinct subgroups. To maximize impact with limited resources, a precision prevention approach would develop tailored interventions that address the unique barriers to care faced by each subgroup. This study aims to address the suicide crisis by identifying the optimal tailoring and targeting of interventions to expand MSUD treatment uptake among the subgroups at highest risk of suicide. We will leverage data from the National Surveys on Drug Use and Health and machine learning tools developed by our team to: (1a) Characterize the subgroups of the US population at highest risk of suicidal ideation, plans, and attempts across a range of intersecting characteristics (e.g., age, sex, education, geography, employment, disability, military service); (1b) Identify the specific MSUDs (e.g., AUD, depression) that affect suicidal individuals within each subgroup; (2) Assess the mediating effects of unmet need for treatment for each MSUD, and co-occurring combinations of MSUDs, as mechanisms underlying disparities in suicidality; (3) Determine the optimal combinations and targeting of evidence-based interventions that increase MSUD treatment uptake to maximally reduce population suicidality. Aim 3 will generate a tool that models the hypothetical impacts of alternative interventions and, given a target population, indicates which combinations of interventions should be used, to whom they should be targeted, and for what MSUDs to effectively mitigate barriers to MSUD treatment and maximize population-level reductions in suicidality. The tool will be piloted with several already- recruited suicide prevention agencies and disseminated via a web-based dashboard.

NICHD - Eunice Kennedy Shriver National Institute of Child Health and Human Development

Project Summary/Abstract In the US, more than one out of every ten babies are born prematurely (before < 37 weeks of gestation) each year, accounting for 10-11% of live births.1 Globally, an estimated 15 million babies are born preterm each year, which is likely underestimated, given difficulties with tracking in low- and middle-income countries.2 Medical breakthroughs before the turn of the century dramatically increased survival of babies born at earliest stages.3 The field now faces increased prevalence rates of mental health disorders among adult survivors of preterm birth,6,7 which comes at great cost to individuals, families, and society. Annually, the US spends over $26 billion dollars in direct and indirect costs related to preterm birth.8,9 This reality underscores the need for investment in services that can better promote long-term mental health of this growing population. Early parenting interventions are among the most promising and cost-effective solutions to support long term mental health and well-being. Few programs deliver services starting in early infancy shortly after hospital discharge– or use scalable approaches that can engage multiple parents. Efforts that better engage fathers are especially needed. Fathers are severely underserved for their own needs and are underrecognized as critical supporters for mother and infant well-being. Developmental studies indicate that brain dysmaturation in frontal-limbic pathways is a secondary consequence of preterm birth and may contribute to long term sequalae. Programs that show positive effects on both behavioral and neurodevelopmental levels may be essential for supporting lasting change in infants, which motivates hypotheses in our study. Our objective is to test the effectiveness of a web-based, scalable parenting program, Play and Learning Strategies (ePALS), for parents and prematurely born infants, to improve parental responsiveness, promote early childhood mental health, and examine mechanisms of effectiveness through changes in neurodevelopmental pathways. Parents of infants born preterm (between 3-9 months of age, corrected for prematurity) will be randomly assigned to our target intervention, ePALS versus an active control program of the same duration and format. We will use an innovative, multimodal approach to examine behavioral pathways (socio-emotional and emotion regulation) and associated neurodevelopmental substrates, using EEG electroencephalography/event related potentials (EEG/ERPs), structural and functional magnetic resonance imaging (sMRI, rsfMRI), diffusion tensor imaging (DTI), and autonomic nervous system (ANS) recordings. Aim 1 will test whether participation in infant ePALS improves parental responsiveness in the first years of their infants’ life. Aim 2 will test the effects of ePALS on reducing risk for poor emotion regulation based on 2A) behavioral outcomes (parent report and standardized assessments), 2B) neurophysiological processes (EEG, ERP, ANS) and 2C) and frontal-limbic brain pathways (structural, functional, MRI, DTI). Aim 3 will examine mediators and moderators, to understand mechanism of change driving intervention related improvements in parenting and child outcomes.

NCI - National Cancer Institute

Project Summary/Abstract: By 2040, 73% of cancer survivors will be ≥65 years old, with up to 35% of them developing clinically significant depression. Depression is problematic for many reasons, including its potential to interfere with the ability to engage in preventive and follow-up healthcare. National Comprehensive Cancer Network guidelines strongly recommend the management of depression among cancer survivors. However, older adults are the least likely age group to utilize mental health services, and Hispanic older adults are even less likely, despite being at higher risk for depression. Older adult cancer survivors (OACs; ≥65, post-cancer treatment) also have unique challenges relative to their peers without cancer (e.g., fatigue, cognitive changes, mobility issues, pain, social distancing and isolation). These issues often create additional barriers to benefitting from existing evidence-based depression treatment, which is ineffective for many OACs. Brief Behavioral Activation (BBA) is an evidence-based psychotherapy for healthy adults that has a strong theoretical rationale for use with OACs and the potential to overcome the limitations of conventional psychotherapies in this age group. It is adaptable for a range of functional statuses, and thus may be especially helpful for OACs given their typically faster rate of functional decline. Moreover, in OACs, BBA has the potential to promote cancer survivorship self-efficacy and improve health behaviors. We developed a BBA manual for OACs (BBA-OACs) with cancer-specific psychoeducation and modified worksheets with a focus on cancer survivorship, self-efficacy, and American Cancer Society (ACS)-recommended preventive health behaviors (i.e., healthy weight, exercise, healthy eating, avoiding alcohol and tobacco). In a fully remote (i.e., recruitment, intervention, and assessment) pilot RCT of telehealth BBA-OACs (N=81) we demonstrated its excellent feasibility, acceptability, and initial superiority to an active control, Supportive Psychotherapy, for improving OACs’ depression, anxiety, and coping. While this demonstrates the promise of BBA-OACs for reducing depression in this medically vulnerable group, we need to ensure its efficacy in a fully powered trial with a diverse sample that will have the ability to identify mediators and moderators of change. For this NIH Stage II RCT of telehealth BBA-OACs (N=502) with 4-month follow-up, we will partner with Cancer Support Community to recruit a diverse nationwide sample of English- and Spanish-speaking OACs with three aims: 1) Determine the efficacy of BBA-OACs for improving depressive symptoms; 2) Determine the efficacy of BBA- OACs for improving anxiety, loneliness, coping, and cancer-related health behaviors; 3) Determine the extent to which behavioral activation, general self-efficacy, and cancer-survivorship self-efficacy mediate the relationship between BBA-OACs and depressive symptoms. By expanding viable, evidence-based telehealth treatment options for depression, these results will ultimately improve the quality of life and cancer survivorship trajectories of OACs.

NIA - National Institute on Aging

Project Summary/Abstract Each year, more than three million adults aged 35 and older are admitted to intensive care units (ICUs) in the United States. Most require a surrogate decision-maker (SDM) to make timely, emotionally charged treatment decisions. Often unprepared for this responsibility, SDMs frequently experience significant psychological distress that can impair their ability to make informed, value-congruent decisions. Long-term psychological consequences, such as post-traumatic stress disorder (PTSD) and decision regret, often follow these acute effects. Despite decades of research, few evidence-based and scalable interventions effectively address the SDMs’ emotional needs during ICU stays. This project will evaluate the efficacy and mechanisms of REFRAME, a brief, self-directed, tablet-based intervention grounded in cognitive reappraisal theory. REFRAME is designed to help SDMs recognize, reinterpret, and regulate their emotional responses in real time as they navigate high-stakes decisions. The intervention includes interactive psychoeducation and emotional assessments, guided strategy selection, emotionally relevant ICU scenarios, and structured planning to apply reappraisal techniques to real-world decision-making. In a two-arm, parallel-group randomized controlled trial, 387 SDMs of critically ill patients will be enrolled and randomized to either the REFRAME intervention or an attention-matched informational support (IS) control condition. Participants will complete standardized outcome measures at baseline (T0), 24-48 hours post- intervention (T1), 24-48 hours post-T1 (T2), and 90 days post-baseline (T3). Aim 1 will evaluate the effects of REFRAME on depressive symptoms (primary outcome at T2) and PTSD symptoms and decision regret (secondary outcomes at T3). Aim 2 will examine differences between groups in state emotion regulation (cognitive reappraisal and expressive suppression) at T1. Aim 3 will test whether changes in state emotion regulation mediate the effect of the intervention condition on psychological outcomes. By targeting a core, modifiable mechanism—emotion regulation—this trial aims to enhance psychological resilience, decision-making quality, and overall family-centered outcomes. The study findings will guide the development of scalable, mechanism-focused interventions to alleviate mental health burdens and improve care experiences in critical care and other surrogate decision-making contexts.

NIDA - National Institute on Drug Abuse

Project Summary/Abstract In the current landscape of increasing access to adult-use cannabis via legalization and lower-than-ever cannabis-related risk perceptions, cannabis use and cannabis use disorder (CUD) are increasing in the United States. CUD, occurring in about 22% of people who use cannabis, is associated with serious consequences on health and wellbeing, including worsened mental health. Despite these outcomes, fewer than 10% of people living with CUD receive treatment or care for this chronic condition. To improve engagement and accessibility of CUD care, we urgently need to develop and study new care models with proactive outreach and provision of new, appealing interventions that meet the goals of the large population of patients with CUD who are not actively seeking traditional substance use disorder treatments. Virtually-delivered care (herein: synchronous videoconferencing between providers and patients across locations) can potentially improve accessibility and appeal of different intervention strategies while reducing stigma about engaging in treatment for substance use disorders. Our proposed strategy seeks to increase involvement in CUD care by delivering interventions in patient-preferred locations and reducing barriers to attending traditional treatments, including by supporting harm reduction and wellbeing outcomes. Behavioral economics-based interventions as applied to CUD bring novel approaches to substitute alternative, healthier behaviors for cannabis use. There is an untapped potential for virtually-delivered, behavioral economic approaches to engage the large majority of individuals who have CUD, who otherwise do not receive treatment, but could benefit from change. Building on our prior work engaging non-treatment-seeking adults in virtual substance use interventions, we piloted a novel behavioral economic intervention, infused with motivational interviewing principles (MI-BE). The MI-BE intervention engages adults with CUD into a virtual intervention focused on enhancing valued activities (with reinforcement for cannabis-free activity sampling) and reducing cannabis use. Using a Hybrid Type 1 efficacy-implementation design, we will evaluate the virtually-delivered behavioral economic-based intervention for CUD compared to an enhanced usual care (EUC) control condition. Patients with CUD will be recruited from a large health system and randomized to either MI-BE or an EUC and followed over 1 year. We will then evaluate the effect of MI-BE vs. EUC on cannabis and health outcomes (e.g., quality of life/functioning), and explore behavioral economic mechanisms of change (e.g., cannabis demand, cannabis-free reinforcement). With consideration for future translation, we will also collect and evaluate qualitative data from clinicians/administrators (N=10) and selected participants (N=20) on barriers and facilitators to future implementation in healthcare settings using a rapid analysis process. Impact: The findings from this study will have a significant public health impact and move the field forward as a novel, patient-centered, scalable approach to address the gap in care that is urgently needed in the context of rising CUD rates.

NIMH - National Institute of Mental Health

Project Summary/Abstract Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder affecting 1 in 36 children. A dyad of impairments in social interaction and flexibility of thoughts manifests early in these individuals’ lives. The heterogeneous clinical presentation of ASD arises in part due to disturbances in serotonin (5-HT) signaling. While a standard therapeutic regimen for ASD does not currently exist, 5-HT-based medications provide variable benefit for disorder relief, highlighting the need for better elucidation of specific serotonergic circuits and mechanisms contributing to ASD behaviors. Indeed, 5-HTergic signaling is derived from a widespread network of axonal projections that influence neural activity throughout the brain. Neurexins (Nrxns) are presynaptic cell-adhesion molecules and are involved in synapse formation and regulation through trans-synaptic protein interactions with postsynaptic adhesion molecules such as neuroligins. Importantly, Nrxns are a well-accepted risk factor for ASD and schizophrenia (SCZ), and both Nrxn and 5-HT mutant mouse models display deficits in social cognitive behaviors reminiscent of ASD. However, the role of Nrxns in 5-HT synaptic transmission remains unknown. The overarching goal of this proposal is to elucidate molecular mechanisms underlying 5-HT circuit formation and identify a specific 5-HT circuit responsible for social behavior by focusing on Nrxn genes. This proposal is supported by strong preliminary data demonstrating, i) social behavior deficit in 5-HT neuron-specific Nrxn triple knockout (5-HT NrxnTKO) and 5-HT Nrxn1 KO mice, and ii) altered 5-HT projections to the interpeduncular nucleus (IPN) by whole-brain imaging of serotonin transporter (SERT)-positive fibers in 5- HT Nrxn TKO mice. As recent studies have implicated the IPN as a critical node for social behavior, our data highlight the potential significance of the 5-HT→IPN circuit in regulating social behavior under normal conditions but also in the context of ASD. Thus, in this proposal, we will address our central hypothesis that Nrxns are essential for proper serotonergic innervation in the IPN, and their expression in 5-HT neurons is required for social behavior. To test this hypothesis, we will use a multidisciplinary approach that includes whole-brain imaging (Aim 1), in vitro fast scan cyclic voltammetry (Aim 1), and in vivo photometry (Aim 2) to investigate the molecular and circuit-level mechanisms underlying social behavior. The proposed studies will shed light on the fundamental role of Nrxn-mediated 5-HT synaptic function for the appropriate development of 5-HT circuits that influence social novelty behavior. In the long term, exploring the consequences of abnormal 5-HT signaling due to impaired Nrxn regulation may reveal novel therapeutic targets to treat social deficits in ASD.

NIH

Significance to VA: Many Veterans who served on or after September 11, 2001 (post 9/11) experience impaired psychosocial functioning, due in part to high rates of posttraumatic stress disorder (PTSD) and major depressive disorder (MDD). Less than half of post 9/11 Veterans with these conditions seek mental health (MH) treatment, with key barriers being a preference to self-manage and lack of time. Veterans also report difficulty navigating the overwhelming array of resources available. To address a gap for post 9/11 Veterans with unmet MH needs, we propose a self-help intervention to provide skills for healthy self-management as well as curated guidance on recovery support services that address MH and broader whole-person functional challenges. There is ample evidence that self-help interventions improve MH symptoms, possibly with greater impact if clinicians provide support, but their impact on psychosocial functioning is understudied. Resilience Training for Veterans (REST-V) is a self-help intervention tailored for post 9/11 Veterans with MDD and/or PTSD symptoms who are not in psychotherapy. REST-V comprises 2 handouts per week for 6 weeks delivering (a) instruction and cues to use evidence-based self-management coping skills (to promote use of adaptive coping) and (b) information to educate, normalize, and navigate recovery support services (to promote use of MH treatment, Other relevant VHA care such as Whole Health, and Informal resources such as MH apps). Veterans may elect to receive optional support via brief calls or text reminders. Using a stepped care approach with low-cost self-help as the first step, REST-V aims to increase access to evidence-based coping skills and easy-to-understand guidance on recovery support services for Veterans who choose not to access MH treatment. Given high rates of untreated MDD and PTSD among post 9/11 Veterans, this proposal addresses a known gap to support VHA priorities, suicide prevention efforts, and Brain, Behavioral and Mental Health (BBMH) Portfolio priorities for clinical studies to improve functioning and reintegration in Veterans with MH conditions. Innovation & Impact: REST-V is innovative for its dual focus on psychosocial functioning/MH and recovery support services, examining whether self-help improves functioning and resource utilization, and accommodating patient preferences for format of delivery (mail, secure message, text) and support (telephone, text). REST-V aims to increase Veterans’ tools for recovery to reduce functional impairment impacting family, social, work, and other life roles. REST-V is being delivered through Primary Care Mental Health Integration (PCMHI) in this study but could be used in a variety of VHA care settings. Specific Aims: The specific aims of this clinical trial are to: Evaluate the efficacy of REST-V (vs. Control) at improving 1) psychosocial functional impairment, 2) MH outcomes, and utilization of 3a1) cognitive-behavioral coping skills and 3a2) recovery support services, with use of skills and services being 3b) explored as potential mediators. We hypothesize that REST-V will be more efficacious than Control. Methodology: This randomized controlled trial (RCT) will take place at 2 VHA healthcare systems (Syracuse and Durham). VHA-enrolled post 9/11 Veterans (N=200) who screen positive for MDD and/or PTSD symptoms and functional impairment but are not in psychotherapy will be randomized to the intervention (REST-V) or control (standard printed resource/ treatment information) condition and assessed at baseline, 8, 16, 24, 32, and 40 weeks using validated self-report scales and electronic health record (EHR) data (for VHA care utilization). The primary outcome is psychosocial functional impairment. Secondary MH outcomes are psychological distress, MDD and PTSD symptom severity, and suicidal ideation. Aims 1, 2, and 3a will be tested using generalized linear mixed models with an intent-to-treat analysis. Aim 3b will use exploratory mediation models with non-parametric bootstrapping procedures. Path to Translation/Implementation: If efficacy is confirmed, we will work with our national operations partners and use data collected in this trial to plan a hybrid II or III trial to facilitate implementation into VHA clinical practice.

NIMH - National Institute of Mental Health

Project Summary/Abstract Posttraumatic stress disorder (PTSD) is a common psychiatric condition that affects millions of people worldwide. Individuals with PTSD experience persistent fear and distressing memories of traumatic events that are often resistant to cognitive-behavioral treatments like exposure therapy. This impairment in fear regulation poses a major challenge to clinical interventions and may be driven in-part by dysregulation of amygdala-prefrontal interactions, two brain regions critical to fear and fear extinction. Despite some known molecular consequences of stress in the amygdala, there is a fundamental gap in our understand of what cell types are disproportionality affected by stress, and an even larger gap in understand how circuit-based findings in rodents translate to human disease. My long-term goal is to better understand how cellular and molecular function in neural circuits underlying fear regulation is affected by acute trauma, and to use this information to develop novel therapeutics targeting analogous circuits in humans. The overall objective of this proposal is three-fold: 1) determine how this cell type is impacted by acute trauma, 2) identify analogous cell types in the human amygdala, and 3) established a causal role for key genes in amygdala-prefrontal circuits in regulating fear extinction. Based on my previous findings that stress acts via the amygdala to disrupt prefrontal neural dynamics, my central hypothesis is that traumatic stress impair the cellular and molecular function of amygdala-prefrontal circuits, which are critically involved in extinction learning (the psychological basis of exposure therapy), and that this ultimately results in unregulated, pathological fear in individuals with PTSD. The rationale for the proposed research is that, once causal links between amygdala-prefrontal circuits and trauma-induced deficits are established in mice, identifying human analogs of amygdala-prefrontal circuits will facilitate the develop of novel therapeutics that specifically target these cells. The central hypothesis of this proposal will be tested by pursuing three specific aims: 1) investigate how traumatic stress impacts the molecular and cellular function of amygdala-prefrontal circuits, 2) determine if key marker genes in amygdala-prefrontal circuits play a causal roles in fear extinction in mice via transcriptional activation or repression, and 3) map trauma-impacted amygdala-prefrontal cell types from mouse to the human using our recently developed single nucleus and spatial atlases. This approach is innovative because it proposes to causally link trauma-induced deficits in fear extinction to precise cellular and molecular mechanisms, while also identifying and mapping trauma-susceptible cell types in the human brain with unprecedented resolution. The proposed research is significant because the results are expected to advance our understanding of the neural circuitry underlying fear regulation, as well as provide potential avenues for cell type-specific therapeutic targeting for treatment of fear- and anxiety-based disorders. It is likely that selective targeting of amygdala-prefrontal circuits will prove efficacious in reducing symptomology and improving the quality of life for individuals living with psychiatric disorders.

NIMH - National Institute of Mental Health

Overall Study Abstract Comprehensive specialty care programs for young people in the initial phases of psychotic disorders, such as Coordinated Specialty Care (CSC), deliver superior clinical outcomes compared to usual care. However, CSC programs face challenges to utilize health care data to continually improve clinical decision-making and services delivery, and to develop innovative interventions that improve key outcomes. The Academic- Community EPINET (AC-EPINET): Enhancing outcomes through improved stress tolerance in early psychosis will address these challenges through a network of six early intervention (“spoke”) sites connected through advanced informatics to a central hub. Our network will implement and embed a Learning Healthcare System (LHS) in the everyday workflow of spoke clinics to identify performance gaps, drive continuous quality improvement and enable practice-based research. In Aim 1, the LHS will utilize the EPINET common assessment battery (CAB), and CSC-HONE will serve as the informatics platform. It consolidates data from electronic health records, minimizing dual entry and supporting a culture of measurement and continuous improvement. Dashboard displays of outcomes permit real-time comparisons within and across spoke clinics, driving patient outcomes towards international best practice standards, while maintaining critical privacy standards. In Aim 2, we will improve our LHS by expanding stakeholder involvement, integrating community partners with lived experience in the formation of a quality improvement incubator to improve care outcomes. Our six clinical spoke sites share the following: 1) established early psychosis programs following the CSC model; 2) deep expertise in data collection, assessments, and clinical trial research to enhance the conduct of the pilot research study; 3) community-based, “real-world” early psychosis clinics enrolling underserved populations, including urban poor and rural populations; and 4) strong interests in and experience with real world research. The Administrative Core will provide study governance, oversight, data management, training, adherence to timelines and milestones, and secure, de-identified data transfer to the NDCC. The leadership team has deep expertise in stress research, behavioral treatments, clinical trials and large data set outcomes analytics. Thus, the AC-EPINET is well positioned to achieve data-driven, improved clinical services through the use of the CAB. For Aim 3, we will conduct two research projects focused on increased stress sensitivity in early psychosis and treatment to improve stress tolerance. Using data from the CAB, the Clinical Practice Data Research Project will develop an analytic model of how stress sensitivity affects functional outcomes. The Prospective Practice-Oriented Research Project will examine the preliminary effectiveness of mindfulness-based stress reduction treatment on stress sensitivity in EP. This research will inform the identification of at-risk participants with high stress sensitivity and related functional deficits who may be good candidates for targeted interventions.

National Institutes of Health

This NOFO is a call to action in response to the mental health crisis in the United States. We seek applications that will study methods to increase access to evidence-based interventions and services for youth mental health, including those living in rural areas, inner cities, and other under-resourced areas, and youth experiencing housing and food insecurities and out-right homelessness. Applications should address research related to optimizing assessment, intervention and service strategies, overcoming challenges related to the workforce shortage, wait lists for treatment, integration of treatment and preventive interventions into settings where people are most likely to be best identified as needing care (eg: schools, social service, pediatric medicine and justice), and service interventions that address systemic barriers to access and quality of mental health care (structural, policy, organizational, value (cost/financing), management).

National Institutes of Health

This NOFO is a call to action in response to the mental health crisis in the United States. We seek applications that will study methods to increase access to evidence-based interventions and services for youth mental health, including those living in rural areas, inner cities, and other under-resourced areas, and youth experiencing housing and food insecurities and out-right homelessness. Applications should address research related to optimizing assessment, intervention and service strategies, overcoming challenges related to the workforce shortage, wait lists for treatment, integration of treatment and preventive interventions into settings where people are most likely to be best identified as needing care (eg: schools, social service, pediatric medicine and justice), and service interventions that address systemic barriers to access and quality of mental health care (structural, policy, organizational, value (cost/financing), management).

NICHD - Eunice Kennedy Shriver National Institute of Child Health and Human Development

SUMMARY Relevant to NICHD’s mission is prioritizing research to improve the health of American children and families. Similarly, reducing the prevalence of childhood chronic diseases by understanding and diminishing contributions to disease risk is a goal of the Make American Healthy Again initiative. The proposed conference is unique in that it focuses specifically on the relatively new field of prenatal pediatrics; that is, optimizing fetal well-being through maternal-fetal research and fetal interventions to improve outcomes in the neonatal period and beyond. Our MPI team at the Prenatal Pediatrics Institute (Adre duPlessis, MBChB) and the Developing Brain Institute (Catherine Limperopoulos, PhD, and Katherine L. Wisner, MD, MS) at Children’s National Hospital (CNH) has evolved a progressive model of in utero pediatric care to underscore the importance of pregnancy and the womb as the time and place where childhood chronic disease first takes hold. The fetal environmental milieu has a key role in defining the trajectory of life-long health. Our objective is to concentrate on the potential of prenatal pediatrics as a powerful conceptual framework to guide research to reduce the escalating rates of childhood chronic diseases. Examining the potential dietary, behavioral, medical, and socio- environmental factors associated with childhood chronic disease is crucial to encourage interdisciplinary, evidence-based research to inform interventions, societal change, and policy. This conference was developed with the goal of reducing institutional and research compartmentalization. We plan two days of presentations by speakers representing a broad array of prenatal pediatrics/neonatology and subspecialties, maternal-fetal medicine, perinatal mental health, translational scientists in non-invasive technologies to evaluate fetal health, genetics/epigenetics, nutrition, infectious disease and the microbiome, public health, artificial intelligence and data science. Conference meals include extended periods of time for lunch and a dinner to support delegate networking. A final panel including the MPIs and Dr. Yoel Sadovsky will synthesize the conference proceedings and generate recommendations to advance the field. Manuscripts will be developed from the lectures for publication in an issue of the journal Seminars in Perinatology focusing on the theme, Translational Research to Integrate Maternal, Fetal and Infant Health.

Seniors Creating Art

Access to Art Expansion- West Seattle is a free weekly art workshops for one-year for the residents living in four Seattle Housing Authority (SHA) Senior Living Buildings in the West Seattle/High Point Neighborhoods. As well as weekly art programming, there will be monthly Intergenerational Creative Nights held at a selected SHA building and a Summer Community-wide ArtWalk taking place in High Point. The purpose of this project is to improve the physical and mental health of participants and provide jobs for artists within the Seattle region.

NICHD - Eunice Kennedy Shriver National Institute of Child Health and Human Development

PROJECT SUMMARY (See instructions): Perinatal depression (PND) affects approximately 25% of women in India, with rates as high as 60% antenatally in preliminary data from the Vadu Health and Demographic Surveillance System (HDSS) — a population-based surveillance platform covering 220,000 individuals across 22 villages in Pune district, Maharashtra. Untreated PND has cascading consequences for the entire family unit, including diminished mother-infant bonding, low birth weight, and long-term child developmental impairments. In India, where marital and family dynamics are primary determinants of women’s mental health and health-seeking, couples-based approaches that engage husbands as active treatment partners are theoretically compelling yet entirely absent from South Asia. This R00 will adapt and pilot test JODI (Joint Outreach for Depression and gender Inequity), the first couples-based PND treatment intervention designed for lay counselor delivery in an LMIC, developed during the K99 phase through a global systematic review, formative qualitative research with perinatal couples in rural Rajasthan, and series of stakeholder intervention development steps. JODI integrates the Communal Coping Model and Bodenmann’s Systemic Transactional Model with a Gender Transformative Framework to address the structural and relational drivers of PND through dyadic coping skill-building and gender norm examination across weekly sessions delivered by trained female lay counselors. In Aim 1, JODI will be adapted for the Maharashtra context through stakeholder consultations and theater testing in KEM Hospital Research Centre (KEMRC), Pune. In Aim 2, a hybrid type 1 implementation-effectiveness pilot RCT (N=100 couples) at the Vadu HDSS will assess feasibility, acceptability, and preliminary efficacy of JODI versus enhanced usual care, guided by Proctor’s framework. Findings will directly inform a future R01 full-scale multisite efficacy trial and, if effective, position JODI as a scalable, low-cost model for addressing PND across South Asia and similar resource-limited settings.

NICHD - Eunice Kennedy Shriver National Institute of Child Health and Human Development

PROJECT SUMMARY (See instructions): Perinatal depression (PND) affects approximately 25% of women in India, with rates as high as 60% antenatally in preliminary data from the Vadu Health and Demographic Surveillance System (HDSS) — a population-based surveillance platform covering 220,000 individuals across 22 villages in Pune district, Maharashtra. Untreated PND has cascading consequences for the entire family unit, including diminished mother-infant bonding, low birth weight, and long-term child developmental impairments. In India, where marital and family dynamics are primary determinants of women’s mental health and health-seeking, couples-based approaches that engage husbands as active treatment partners are theoretically compelling yet entirely absent from South Asia. This R00 will adapt and pilot test JODI (Joint Outreach for Depression and gender Inequity), the first couples-based PND treatment intervention designed for lay counselor delivery in an LMIC, developed during the K99 phase through a global systematic review, formative qualitative research with perinatal couples in rural Rajasthan, and series of stakeholder intervention development steps. JODI integrates the Communal Coping Model and Bodenmann’s Systemic Transactional Model with a Gender Transformative Framework to address the structural and relational drivers of PND through dyadic coping skill-building and gender norm examination across weekly sessions delivered by trained female lay counselors. In Aim 1, JODI will be adapted for the Maharashtra context through stakeholder consultations and theater testing in KEM Hospital Research Centre (KEMRC), Pune. In Aim 2, a hybrid type 1 implementation-effectiveness pilot RCT (N=100 couples) at the Vadu HDSS will assess feasibility, acceptability, and preliminary efficacy of JODI versus enhanced usual care, guided by Proctor’s framework. Findings will directly inform a future R01 full-scale multisite efficacy trial and, if effective, position JODI as a scalable, low-cost model for addressing PND across South Asia and similar resource-limited settings.

NIMH - National Institute of Mental Health

PROJECT SUMMARY/ABSTRACT Attention-Deficit/Hyperactivity Disorder (ADHD) is chronic and requires specific attention toward treatment disengagement at critical transition points (e.g., transition to adulthood) due to the steep reduction of parental and institutional supports. Left untreated, transition-age youth with ADHD are at risk for anxiety, depression, substance use, poor educational/vocational attainment, and suicide, resulting in medical, emotional, and financial costs to parents. Thus, there is a need to equip parents to effectively engage their youth with ADHD in treatment during this critical transition period (i.e., balance support and youth independence in a manner that does not further increase disengagement). Currently, no existing treatments directly target disengagement for transition-age youth with ADHD. The Community Reinforcement and Family Training (CRAFT) approach is an evidence-based behavioral treatment that works directly with concerned significant others (CSOs) of loved ones with substance use disorders to engage in treatment. Based on core components that focus on effective communication, operant conditioning/learning, and CSO’s own mental health, CRAFT has clear relevance for addressing ADHD-related executive functioning deficits (e.g., planning, goal persistence, procrastination) exacerbated by increased environmental demands for transition-age youth. The purpose of this study is to address the needs of disengaged transition-age youth with ADHD and their parents by adapting an intervention to support parents to effectively engage their youth into care through focus groups/interviews with parents, providers, and transition-age youth. This study also aims to recruit from local community college and university campuses, and community-based organizations, and engage members of the community through forums to provide feedback on focus group findings. Involving families and providers at the onset of adaption to explore feasibility and acceptability increases the potential for this intervention to be implemented and sustained in the future. Specific aims include: 1) Iteratively modify CRAFT to increase relevance to parents of disengaged transition-age youth with ADHD (CRAFT-ADHD) using 4-6 focus groups/qualitative interviews with up to a total of n=25 parents, n=15 providers, and n=10 transition-age youth, and 2) conduct usability testing of telehealth CRAFT-ADHD for parents (n=10) to assess feasibility and acceptability, and define potential targets of action at the individual and family level. Through community-engaged recruitment efforts and community forums, this study aligns with NIMH’s priority 4 to “advance implementation research to improve access to, and utilization of, quality care among underserved, underrepresented, and under-resourced populations by emphasizing community-based interventions and incorporating multilevel decision-making perspectives.” The long-term goal is to use the developed protocols and materials to 1) conduct future studies on efficacy and effectiveness testing of CRAFT-ADHD on identified target outcomes, and 2) test larger-scale effective implementation work in usual care settings.

FIC - John E. Fogarty International Center for Advanced Study in the Health Sciences

In Vietnam, adolescent and young men vulnerable to HIV through sexual behaviors are among those most affected by the infection, with an HIV prevalence that quadrupled from 3% in 2011 to 13% in 2020. More than 20% of Vietnamese young men living with HIV had moderate-to-severe depression and anxiety symptoms. These youths experienced extensive stigma related to their HIV status and sexual behaviors. There is a dearth of youth-friendly mental health services in Vietnam where there is less than one psychiatrist per 100,000 people. Project YES+ is an intervention integrating two evidence-based interventions, Project YES! and Self-Help+ to improve mental health, stigma, and HIV outcomes among youth living with HIV in Zambia (5R01TW012411). Youth Engaging for Success (Project YES!) is an HIV clinic-based peer mentoring CDC-designated intervention that successfully decreased HIV self-stigma and increased viral suppression. Self-Help+ is a group-based lay-delivered program endorsed by WHO that effectively prevents the onset of mental disorders and reduces mental health symptoms in different cultures. We propose to adapt Project YES+ for adolescent and young men living with HIV in Vietnam to create To Hieu (I Understand) and to pilot test the adapted intervention. The specific aims are to (1) Adapt Project YES+ to create To Hieu to improve mental health and reduce internalized HIV stigma for adolescent and young men living with HIV in Vietnam and (2) Examine acceptability and feasibility of To Hieu among adolescent and young men living with HIV through a pilot randomized controlled trial. In Aim 1, the adaption will follow the 8-step ADAPT-ITT framework.38 We will conduct in-depth interviews with adolescent and young men living with HIV (N=20) to explore preferences for the core components and formats of To Hieu. We will hold a human-centered design workshop to engage adolescent and young men living with HIV in co-design activities to refine To Hieu. In Aim 2, we will recruit 80 adolescent and young men living with HIV with depression or anxiety symptoms at two HIV clinics in Hanoi, Vietnam and randomize them 1:1 into two arms. The intervention arm will receive To Hieu in 4 months, while the control arm will receive standard of care at the clinics. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework will guide the measurement of the outcomes. We will calculate participation rates of participants (Reach) at baseline. We will assess acceptability through the Client Satisfaction Questionnaire and feasibility through intervention attendance (Adoption) at 4 months. Depression, anxiety symptoms, internalized HIV and sexual stigma, ART adherence and viral suppression of participants will be evaluated at baseline, 4 months and compared between groups (preliminary Effectiveness). We will conduct exit interviews with participants, youth peer mentors and HIV providers (N=30) to explore acceptability, feasibility (Implementation) and sustainability (Maintenance) of To Hieu. This research will build local capacity and develop networks for collaborative research on mental health and stigma among adolescent and young men living with HIV between Vietnam and the US.

NIH

The proposed CDA-2 will support Dr. Giff’s pursuit of a VA research career focused on improving the psychosocial functioning of Veterans with co-occurring post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD). Significance to VA: PTSD and AUD are highly comorbid, which presents a unique set of challenges for Veterans and their loved ones. Experiencing PTSD-AUD exponentially increases Veterans’ risk for debilitating mental health sequelae, poor physical health, and deleterious social and occupational outcomes. COPE is a robustly evidence-based treatment for PTSD-AUD that is widely used in VA clinics. While COPE outcomes related to PTSD symptom reduction are consistently outstanding, there is room to improve both AUD outcomes and rates of retention. COPE shows moderate effects on Veterans’ drinking reductions, indicating a critical need for research examining novel ways to bolster drinking outcomes. Innovation and Impact: Results from separate literatures indicate that integrating a family member or significant other (SO) is a promising method to improve AUD recovery and AUD and PTSD treatment retention. Veterans with AUD and PTSD often report conflictual relationships, which can interfere with AUD recovery, and including SOs is likely to foster more effective dyadic support and communication. The brief inclusion of SOs in Veterans’ treatment of PTSD-AUD is yet to be studied, despite strong potential for this model to improve treatment effectiveness, retention, and dyadic functioning. Pairing COPE with Brief Family-Involved Treatment for Alcohol Use Disorder (B-FIT) is one promising method to bridge this persistent gap in treatment programming for Veterans. B-FIT is a 3-session dyadic intervention designed to be delivered alongside evidence-based individual AUD treatments. Distilled from the original 12-session Alcohol Behavioral Couple Therapy, B-FIT focuses on enhancing family support for alcohol behavior change efforts and improving communication skills. A recent pilot of B-FIT demonstrated large effects for reductions in risky drinking. The objective of the proposed study is to examine the preliminary feasibility and acceptability of combining B-FIT with COPE among Veterans with co-occurring PTSD and AUD. Specific Aims: 1. Adapt the B-FIT manual to be delivered as an adjunct intervention to COPE; 2. Examine the feasibility and acceptability of BFIT + COPE through a one-armed open-label pilot trial as assessed by (a) rates of enrollment and treatment completion; and (b) participants’ quantitative ratings and qualitative perceptions of the intervention; and 3) Explore the effects of BFIT + COPE from pre- to posttreatment and at 3-month follow-up on (a) AUD outcomes, (b) psychosocial and relationship functioning, and (c) PTSD outcomes. Methodology: Aim 1 will include qualitative interviews with 10 Veteran-SO dyads and 10 VHA mental health clinicians to inform an adaptation of the B-FIT manual to be relevant for Veterans with PTSD-AUD. Once completed, the adapted manual will be piloted through a single-arm, open feasibility trial of 40 Veteran-SO dyads with primary outcomes of feasibility and acceptability. Secondary outcomes of AUD (AUDIT & TLFB); psychosocial functioning (B-IPF, Q-LES-Q-SF, DAS-7); and PTSD (PCL-5 & CAPS) will be explored. Path to Translation/Implementation: This project will provide critical pilot data on feasibility and implementation to support a subsequent Merit award testing the effectiveness and implementation of this intervention in VA clinics. The following training aims will ensure that the candidate is poised to continue this work: (1) Veteran-centered intervention development/adaptation and clinical trials management; (2) Knowledge of AUD; (3) Advanced statistical analysis; (4) Preliminary education in dissemination and implementation; and (5) Scholarly productivity and professional development. The candidate will accomplish these aims through devoted mentorship, didactic opportunities, and by leading the proposed project. She will conduct this work with support from the scientific community at the Ralph H. Johnson VAHCS and MUSC. The research and training proposed can address urgent needs within VHA and will prepare the candidate to be an expert in family-supported interventions to improve the lives of Veterans.

NIMH - National Institute of Mental Health

Globally, alcohol use disorders (AUD) cause 3.3 million deaths each year and account for nearly 100 million disability-adjusted life years (DALYs). Alcohol use is also one of the most prominent risk factors for death by suicide, as people with AUD have a lifetime risk of suicide more than 7 times higher than the general population. Efforts to prevent suicide can reduce disruptions and fragility of the U.S. health system and serve as a public health good to benefit Americans. We are developing innovative approaches to bridge mental health and substance use treatment gaps, including telehealth and nurse-led counseling interventions with clear potential to reduce suicide in the United States and other settings. In our preliminary study, 7% of patients with AUD were experiencing suicidal thoughts or behavior. Despite this high comorbidity, routine screening and treatment for both suicide risk and alcohol use disorder are extremely rare in emergency care settings. Thus, there is a critical need for innovative, resource-efficient treatments for suicide prevention among people with AUD. In an earlier NIMH-funded study, our team adapted an evidence-based Motivational Interviewing intervention, MI-SafeCope, to develop IDEAS for Hope, a telehealth intervention for suicide prevention in HIV care. In the current grant, we will revisit this process by adapting MI-SafeCope to reduce suicide risk among people with AUD who are presenting for care in a Tanzanian Emergency Department. The resulting intervention, IDEAS-AUD, will address suicide risk with a four-pillared approach: reducing alcohol-related harm, building social support, enhancing emotional health, and meeting basic needs. The pillars are integrated with Motivational Interviewing-enhanced safety planning and referral for psychiatric care as appropriate. Intervention refinement in a low-cost, high-burden global setting has great potential for adaptation and implementation in the rural U.S., where mental health needs are high. The aims of this grant are to: 1) adapt IDEAS-AUD for the AUD population; 2) rigorously evaluate the acceptability and feasibility of IDEAS-AUD; and 3) develop our intervention package for a future implementation evaluation and a clinical trial in the rural U.S. In Aim 1 of the current study, we will identify drivers of suicide risk and desired intervention characteristics to prevent suicide in the AUD population. In Aim 2, we will adapt an evidence-based suicide prevention intervention to existing AUD care, guided by a community coalition. In Aim 3, we will pilot test the telehealth intervention to assess its feasibility and acceptability for reducing suicide risk in the AUD population. By the end of this proposed project, we will have a framework-guided, resource-adapted, piloted protocol for IDEAS-AUD, including screening tools, programmatic, and implementation components. The research is innovative, yet fundamentally essential, and supports NIH Strategic Objectives to prevent suicide across the lifespan, address mental health comorbidities such as AUD, and develop interventions that can be rapidly implemented to strengthen mental health outcomes in the U.S. and improve the health of Americans.