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NSF

The objective of this project is to establish and operate an Interdisciplinary Network of Networks for Well-being in the Built Environment (IN2WIBE 2.0) to advance research where human health, building design, and performance intersect. To move beyond siloed efforts, a unifying platform is critical to connecting diverse perspectives and translate them into integrated, scalable solutions. Building on the success of IN2WIBE 1.0, which engaged engineers, architects, and designers, IN2WIBE 2.0 seeks to expand to include cognitive scientists, neuroscientists, environmental psychologists, ergonomists, healthcare professionals, and others whose joint efforts are essential to understanding and improving humans’ well-being in the built environment. By integrating 10 core networks and 21 supporting partners, this network of networks aims to catalyze cross-disciplinary collaborations, support evidence-based design, and inform future standards and policies for healthier, more resilient, and human-centric buildings and livable communities. It embarks on a suite of coordinated activities, including TEDx events, Pecha Kucha research exchanges, roundtables, and thematic workshops. The project looks to raise awareness of the importance of healthy built environments, educates building occupants and professionals, and supports long-term improvements to public health and quality of life. IN2WIBE 2.0 seeks to generate new scientific knowledge by advancing understanding of how individuals perceive and process spatial features, multisensory cues, and social affordances in the built environment, and how these shape mental models, risk awareness, and interpersonal interactions. More broadly, it looks to serve as a scientific accelerator that integrates diverse disciplinary insights, from cognitive science to engineering to public health, to develop holistic frameworks, methodologies, and tools. Focusing on health, comfort, and work performance, the network intends to drive innovation that improves productivity, cognition, convenience, and well-being across populations and contexts. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

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 Sexual strangulation (often called “sexual choking” by those who engage in it, even though it is technically a form of neck compression or strangulation) has become highly prevalent among young adults, is usually described as consensual, and disproportionately impacts females. Our survey of randomly sampled college students showed that 58% of females had ever been choked/strangled during sex. A series of pilot studies have begun unraveling the effects of this emerging and risky sexual behavior, where females with frequent exposure to sexual choking/strangulation showed elevations in brain injury blood biomarkers, increases in mental health symptoms such as feeling depressed and anxious, alterations in brain morphology, and changes in neuronal connectivity. While relentless efforts through epidemiological, qualitative, and experimental studies have greatly advanced the scientific knowledge of this sexual behavior, the current understanding of neurological consequences has been limited by cross-sectional designs and small sample sizes. Therefore, the proposed prospective cohort study moves the field forward by examining acute and chronic neurological effects of sexual choking/strangulation while a structured interview aim will help us to better understand why people engage in this risky sexual behavior, despite its risks. The proposed study is guided by the following 3 specific aims. (1) To identify the acute neurological effects of sexual choking/strangulation through the response profile of multimodal neuroimaging, blood biomarkers, and cognitive assessments. (2) To determine the associations between cumulative exposure to sexual strangulation and neural cellular, physiological, and functional integrities. (3) To characterize young adults’ experiences with sexual choking/strangulation. The longitudinal design will allow us to examine acute effects of this sexual practice (Aim 1), observe the cumulative impacts of multiple choking/strangulation events (Aim 2), and establish temporality between sexual choking/strangulation and neurological outcomes. Our rigorous interview will help characterize this sexual behavior (Aim 3), which is vital for developing guidelines and educational intervention. The proposed study will not only characterize the impact of sexual choking/strangulation on brain health but also lay the foundation for the development of empirically supported sexual health educational guidelines to mitigate neurodegenerative conditions.

NIMH - National Institute of Mental Health

PROJECT SUMMARY Reducing the high burden of death by suicide in low- and middle-income countries requires the effective implementation of evidence-based practices for suicide prevention. In Botswana, suicide disproportionately affects youth. Specifically, high school and university-age students experience elevated rates of suicide-related thoughts and behaviors. The Safety Planning Intervention (SPI) is an established practice for suicide prevention. To maximize successful implementation of SPI among youth in Botswana, there is a need to adapt SPI for use in the target setting and to use participatory methods to co-design implementation strategies. Schools offer an ideal setting to implement SPI to increase reach to individuals in greatest need. This research will focus on youth aged 15-24 years in the public educational sector. Through a partnership with the University of Botswana and local public schools, we will employ rigorous participatory methods to culturally adapt SPI and inform implementation of SPI. Specifically, over the three-year period, we will adapt SPI through linguistic and content modifications, task-shift delivery of SPI to guidance and counselling (G&C) teachers, co-create strategies to implement the adapted SPI into schools, and pilot implementation strategies. First, we will apply the World Health Organization guidelines to employ a three-step process of forward translation, back translation, and focus group discussions to complete linguistic and content adaptations. Second, we will develop implementation strategies for SPI. We will elicit perspectives on determinants of implementation (e.g., barriers and facilitators) of SPI through semi-structured interviews with a multi-partner group of implementers (e.g., teachers) and leadership (e.g., Ministry of Education and Skills Development (MoESD) officials). A group of experts (e.g., implementation scientists, Ministry of Health and Wellness leadership, MoESD leadership, G&C teachers, mental health clinicians, youth, and educational leadership) will operationalize the input gleaned from the interviews through the systematic process of implementation mapping that integrates theory, participatory input, and context. This work will yield a menu of contextually and partner-informed implementation strategies for the adapted SPI among youth in schools in Botswana. Third, we will conduct a pilot hybrid type III effectiveness-implementation trial to test the implementation strategies among six public schools in the South East region of Botswana, during which we will measure the impact on feasibility, acceptability, appropriateness, fidelity, and preliminary effectiveness (suicidal ideation and behavior). This work will yield generalizable insights for other regions and community engagement engendered through the research process. Leveraging the new partnerships formed for this proposal, future efforts can systematically evaluate the impact of the strategies on reducing death by suicide and increasing the uptake of SPI across Botswana.

NIMH - National Institute of Mental Health

PROJECT SUMMARY Exposure to war, persecution, and forced migration put FDPs at disproportionately high risk for IPV and mental health problems. Many FD women arrive from countries where IPV is prevalent, and face increased risk before, during, and after displacement. Foreign-born women who experience IPV are more likely to be severely injured or killed, and report worse mental health than US-born women. Financial and social stressors, and persistent sex-based inequities in the US can exacerbate both IPV and poor mental health outcomes among FDPs. Yet, US-based programs primarily focus on connecting survivors to services once IPV occurs, overlooking strategic opportunities to prevent IPV and poor mental health among FDPs. In contrast to the US context, there is a rapidly evolving evidence-base of interventions developed globally that show promise in reducing IPV among FDPs. The EA$E (Economic And Social Empowerment) intervention (developed by IRC and MPI Wachter), has been shown to reduce IPV and PTSD symptoms in a randomized controlled trial (RCT) conducted in West Africa led by MPI Gupta. The International Rescue Committee (IRC), a global humanitarian organization, developed EA$E to address two underlying drivers of IPV in crisis settings--household financial strain and sex-based inequity in decision-making--innovatively diminishing risk factors associated with IPV. EA$E addresses IPV at the individual and interpersonal levels by leading couples engaged in economic activities through an 8-session discussion series on household financial wellbeing, budgeting, spousal communication, and alternatives to violence. US-based programs for FDPs are in need of evidence-based curricula to address IPV and mental health. Our overall objective is to advance the nascent science of IPV prevention among FDPs in the US. Our interdisciplinary team (public health, social work, and clinical psychology) is uniquely positioned to conduct the proposed study based on our combined expertise in IPV and mental health research and practice with FDPs across settings and longstanding partnership with the IRC. Guided by the ADAPT-ITT framework, Cascade Implementation Framework, and the NIMH experimental therapeutics approach, we will develop EA$E-US, examine preliminary effectiveness on intervention and intermediary outcomes, and assess implementation outcomes via a hybrid type 2 pilot study design.

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

Abstract The objective of this K23 proposal is to enhance the supports available to students returning to school after mental health related Emergency Department (ED) visits. Many youth are referred to the ED because school personnel feel unprepared to meet their needs, yet ED clinicians deem that the youth do not require hospitalization thus facilitating their prompt return to school. There is a growing literature base on supports for students after psychiatric hospitalization, but the number of students returning directly to school after an ED visit is much higher than the number of students who are actually hospitalized. Therefore, the focus of this proposal is on adapting Safe Alternatives for Teens and Youths–Acute (SAFETY-A), a cognitive behavioral therapy- informed intervention that has been delivered in the ED, for students returning to school. Further, completing the proposed study and meeting the identified career development goals will establish Dr. Lora Henderson Smith as an implementation scientist and mixed-methodologist with an expertise in ED to school transitions. This project is unique in that it is the first to propose an intervention to specifically meet the needs of the growing number of youth with significant mental health concerns who require an ED visit, but do not meet criteria for hospitalization. Adapting SAFETY-A will provide schools with a tool to better support these youth. There is often minimal communication between the ED and schools; however, cross-system communication can facilitate optimal care for youth. As such, Aim 1 includes the examination of discharge summaries to identify what recommendations ED clinicians are making for schools to support youth. It is hypothesized that there will be few recommendations made for how schools can best support youth returning directly to school. Improving discharge summaries can help facilitate care for youth. We will use data from Aim 1 and principles of user-centered design to adapt SAFETY-A for students returning to school after an ED visit. The adaptation will be informed by interviews with key informants including families, school leaders, school mental health professionals (SMHPs), and ED clinicians. In Aim 3, a cluster randomized controlled trial will be conducted. We expect to enroll 4 schools and randomly assign 2 to the SAFETY-A condition. We will assess SMHP knowledge and skills pre- and post- training and implementation as well as SMHP adherence to the adapted SAFETY-A protocol. A small number of SMHPs will be interviewed about their experiences implementing SAFETY-A. We will also test the feasibility of methods to assess youth clinical outcomes. The proposed study, aligns with Objective 3.2 of strategic plan NIMH’s strategic plan (i.e., develop strategies for tailoring existing interventions to optimize outcomes) and other priorities related to youth suicide and school mental health and will significantly improve SMHP capacity to support students after mental health ED visits.

NIMH - National Institute of Mental Health

Sustainability of evidence-based mental health intervention (EBI) implementation is a challenge to increasing access to mental health services. Funding is a common barrier to sustainment. EBIs, while cost effective, are expensive to implement. The Fiscal Mapping Process is a strategic planning tool designed for behavioral health agencies to plan the financial sustainment of specific EBIs. Financial planning at an organizational level is required to enable mental health implementation and provider organizations to sustainably operate. Without careful consideration, mental health organizations’ business models could unintentionally decrease access to care for some individuals if profit is prioritized or if only certain patient populations are reached. Research is needed to help implementation and mental health organizations identify financing strategies to sustainably increase access to EBIs. The proposed K08 will adapt the Fiscal Mapping Process for implementation and mental health organizations to plan for financial sustainability of their organization (rather than a specific EBI), without sacrificing implementation of EBIs. The study uses human-centered design methods and has three aims: (1) Identify aspects of the Fiscal Mapping Process to adapt for use with implementation and mental health organizations; (2) Iteratively adapt the Fiscal Mapping Process for implementation and mental health organizations; and (3) Assess the preliminary impact and usability of the Fiscal Mapping Process for implementation and mental health organizations financial sustainability. To ensure its successful execution and to build the investigator’s capacity for independent research, the following training aims are proposed: (1) Acquire training in factors that affect the sustainability of EBI implementation, with an emphasis on financing strategies; (2) Develop knowledge of how implementation and mental health organizations function to increase access to EBIs; (3) Deepen expertise in D&I science by learning human-centered design methods; and (4) Deepen expertise of qualitative methods and learn mixed methods approaches. Training and research will be overseen by co-mentors Dr. Rani Elwy (Brown University), Dr. Alex Dopp (Rand Institute), Dr. Aaron Lyon (University of Washington), Dr. Bo Kim (Boston VA), Dr. David Mohr (Northwestern), Dr. William Aldridge (University of North Carolina Chapel Hill), and consultant Dr. Joshua Kemp (Brown University). The project will create a financial planning tool (the adapted Fiscal Mapping Process) to improve organizational financial sustainability while promoting access to evidence-based interventions.

NIMH - National Institute of Mental Health

The objective of the proposed K23 research and training plan is to support Dr. Emily Tilstra-Ferrell in obtaining training needed to become an independent clinical scientist with a program of research focused on developing highly scalable, efficient evidence-based treatments (EBTs) for adolescents with posttraumatic stress disorder (PTSD) that can be delivered in accessible, real-world, multidisciplinary settings. Over four million adolescents in the United States (US) have PTSD. Although PTSD EBTs are available, only one third (37%) of adolescents access these treatments. Among the few who access PTSD EBTs, over one-third (34%) prematurely drop out due to barriers including lengthy protocols (the majority of dropout occurs before session seven). The proposed study directly addresses this clinical gap by adapting Written Exposure Therapy (WET), an EBT for adult PTSD, for adolescents. WET is an efficient, five-session PTSD treatment that is non-inferior to lengthier gold-standard PTSD EBTs for adults. WET addresses many barriers faced by adolescents who seek EBTs for PTSD due its brevity and related cost-effectiveness. However, WET has not been formally adapted or rigorously tested with adolescents. In Aim 1, WET will be adapted following a systematic model: Assessment, Decisions, Administration, Production, Topical Experts, Integration, Training, and Testing (ADAPT-ITT). In Aim 2, a proof- of-concept randomized controlled trial (RCT) will be employed to compare WET to Trauma-Focused Cognitive Behavior Therapy (the gold-standard PTSD EBT for youth) delivered in a pediatric primary care setting to adolescents with PTSD. The final exploratory aim will examine the potential emotional (fear extinction) and cognitive (changes in ruminative cognition) mechanisms of action in WET. The mentorship team is comprised of numerous highly experienced mentors with NIH-funded research related to the proposed project including RCTs for adolescents with PTSD (Primary Mentor: Dr. Carla Kmett Danielson), ADAPT-ITT (Dr. Cristina López), advanced qualitative and mixed methods (Dr. Byron Powell), WET (Dr. Christine Hahn), dissemination and implementation science and EBTs for trauma-exposed youth in primary care settings (Dr. Rochelle Hanson), and longitudinal data analysis (Dr. Naomi Brownstein). The research opportunities, mentorship, and formal coursework afforded by the proposed K23 will ensure Dr. Tilstra-Ferrell gains the following skills needed to achieve her career goals: (1) conducting clinical trials with trauma-exposed adolescents, (2) using qualitative and mixed methods design to adapt and implement EBTs, (3) longitudinal data analysis, (4) dissemination and implementation science methods, and (5) improved scientific communication. The candidate will complete all proposed activities at the Medical University of South Carolina in the National Crime Victims Research and Treatment Center, which is internationally renowned for research on adolescent PTSD EBTs with a strong history of catapulting early career scientists to independence. The proposed K23 will ultimately prepare Dr. Tilstra-Ferrell to launch a program of research developing efficient and scalable PTSD EBTs for adolescents.

NIDA - National Institute on Drug Abuse

PROJECT ABSTRACT Nearly half of those with opioid use disorder (OUD) experience co-occurring PTSD (co-OUD/PTSD). Among people with OUD, untreated PTSD is associated with more severe clinical profiles and higher rates of suicide attempts and drug overdoses. Exposure therapy for PTSD, delivered alongside medication for OUD improves both OUD and PTSD outcomes, but low uptake and high levels of dropout are common, resulting in sub- optimal outcomes. Reasons for poor uptake and retention include the scarcity of mental health providers resulting in long wait lists, patient avoidance, and uncertainty about the optimal timing of PTSD treatment. Interventions to increase access to and retention in trauma therapy are essential and must include primary care. Responding to both NOT-DA-23-007 and NOT-DA-23-008, this study aims to develop a scalable, equitable, and optimal adaptive treatment strategy for PTSD in patients with OUD by answering three questions: 1) Is Written Exposure Therapy (WET), an evidence-based therapy for PTSD, feasible and appropriate for delivery by community health workers? 2) What is the optimal timing of therapy for PTSD in patients with OUD? and 3) Are PTSD treatment interventions provided entirely by a collaborative care team more effective than interventions that include a referral to a licensed mental health provider? We will answer the first question by assessing the “fit” of WET for delivery by community health workers and the feasibility of different adaptive treatment strategies (R61 phase—preparation), and the latter two questions using a two- stage, Sequential Multiple Assignment Randomized Trial (SMART) design that allows us to vary the timing of when therapy is offered and by whom (R33 phase—optimization). Our study is a collaboration among RAND, the University of New Mexico, Stanford University, Boston University and the New Mexico Office of Community Health Workers. Our long-term goal is to increase access to a scalable, equitable and optimized adaptive treatment strategy for PTSD in people with OUD that improves PTSD and OUD outcomes and reduces morbidity and mortality. We also seek to shift clinical practice paradigms about what appropriate care for PTSD requires. The end-users of our research are clinicians faced with decisions about how to treat co-OUD/PTSD and policymakers searching for ways to solve the mental health workforce shortage. Our study is significant because it will equip providers with evidence-based guidance about how to address PTSD in patients with OUD at critical decision points: initial treatment and the point of non-response or symptom worsening for two synergistic and co-occurring disorders with high lethality. By testing a scalable and sustainable solution to the mental health workforce shortage—using a community health worker to deliver WET as part of a collaborative care team—it will equip policy makers with data about ways to accelerate the movement of an effective treatment for PTSD into routine use, increasing access to an effective and life-saving treatment for individuals with co-OUD/PTSD.

NIH

Background: There have been sharp increases in stimulant use disorder among Veterans nationally over the past twenty years, including co-occurring opioid and methamphetamine use disorder. Our previous research shows a high prevalence of multimorbidity among people who use stimulants, which has important implications for delivering healthcare for this high-risk population. Since 2011, the Veterans Health Administration (VHA) has prioritized the availability of contingency management (CM) programs for all Veterans with a stimulant use disorder as a standard of care. Meanwhile, several recent studies have been conducted or are being done to examine how CM may improve other health outcomes. However, limited work has been done to consider CM as a method for delivering integrated care for patients with multimorbidity. This study will fill this knowledge gap by examining patterns of multimorbidity and healthcare utilization among Veterans with stimulant use disorders to develop an integrated intervention to improve health outcomes for this population. Significance: Given the elevated risks of poor health outcomes among Veterans with stimulant use disorders, VHA must provide integrated interventions to address the complex needs of this population. This study directly responds to multiple priorities of the VHA, Health Systems Research, Office of Mental Health and Suicide Prevention, and Veterans Justice Programs (VJP) to improve the health delivery of this high-risk population. Innovation & Impact: Addressing multimorbidity among high-risk patient populations necessitates an integrated approach to care rather than disease-specific treatment. Veterans with stimulant use disorders have unique health needs, given the complex interplay between substance use disorders, mental illness, and medical multimorbidity. Improving health outcomes for this population involves innovative approaches that must be patient-centered and recognize the stigma related to SUDs. This study will utilize multidisciplinary expertise in geriatric and addiction medicine to develop innovative interventions to improve a vulnerable population's health and healthcare delivery. Specific Aims: The three aims are scientifically important and reflect input from Veterans and VHA staff: (1) To describe the prevalence and predictors of multiple chronic conditions, outpatient care fragmentation, and high acute healthcare utilization among Veterans with stimulant use disorders; (2) Adapt VA contingency management (CM) programs to integrate team-based intensive chronic disease management to improve health outcomes and reduce acute healthcare utilization among Veterans with stimulant use disorders; (3) Pilot test an intervention that integrates CM with intensive chronic disease management. Methodology: In Aim 1, we will conduct a retrospective longitudinal cohort study using VHA national data to describe comorbidities and identify predictors for high acute healthcare utilization among Veterans with stimulant use disorders (n=~177,714). For Aim 2, we will conduct qualitative interviews with 35 Veterans with stimulant use disorders and 45 VHA staff and providers and elicit expert feedback from our VHA operational partners to develop an intervention. Finally, Aim 3 will involve pilot testing an intervention coupled with CM programs for the treatment of stimulant use disorders. Next Steps/Implementation: The goal is to have a fully developed protocol for use in a multi-site randomized trial of an integrated model of care intervention to improve health outcomes among Veterans with stimulant use disorders within the VHA that will be evaluated in a subsequent IIR. An evidence-based integrated intervention to address multimorbidity among a high-risk Veteran patient population will have important implications for sustained care delivery for a high-risk patient population.

NIDA - National Institute on Drug Abuse

PROJECT SUMMARY/ABSTRACT Opioid use disorder (OUD), sexual victimization (SV), and posttraumatic stress disorder (PTSD) are significant co-occurring concerns with high morbidity and mortality. SV is often associated with PTSD. SV and PTSD each increase the odds of OUD. In addition, OUD treatment outcomes are worse among those with SV and PTSD. Women with SV are at high risk for IPV and substance use, which further worsen OUD outcomes. Despite the intersection of OUD, SV, and PTSD, individuals with OUD are rarely screened for SV or PTSD, and mental health treatment engagement is low among those with SV. A program for women seeking OUD treatment with a history of SV which integrates screening for SV, brief intervention for the aftereffects of SV (PTSD, IPV, substance use), and facilitates mental health treatment engagement has the potential to enhance OUD treatment outcomes for this vulnerable group. Consistent with the goals of NOT-DA-23-007 (HEAL Initiative: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence) the objective of this R61/R33 application (RFA-DA-23-053) is to adapt the Safe and Health Experiences (SHE) program for use in OUD care settings (SHE-OUD) and evaluate its feasibility, acceptability, and preliminary efficacy. SHE is a one-session, modular computer-based screening, brief intervention, and referral to treatment program developed for use among women veterans in primary care settings which: (1) screens for lifetime SV and comorbid harms (i.e., PTSD, IPV, substance use); and 2) provides tailored brief intervention focused on increasing mental health treatment use. In the R61 Phase, we will use information from informant interviews (N = 10), focus groups (N = 30), stakeholder interviews (N = 6), and a Research Advisory Board to adapt the program and research protocol. An open trial (N = 20) with a 1-month follow-up will be used to demonstrate the feasibility, safety, acceptability, and utility of SHE-OUD and the research protocol. If the Go/No Go Criteria are met, the team will proceed to the R33 Phase. In the R33 Phase, we will conduct a randomized trial of SHE-OUD (N = 120) with 3- and 6- month follow-up, to examine whether women randomized to SHE-OUD, relative to a control, demonstrate change in the primary outcome of mental health treatment engagement, as well as the secondary outcomes of: 1) PTSD, IPV, and polysubstance use; 2) OUD treatment outcomes (e.g., opioid use, non-fatal overdose, medication adherence, treatment retention); and 3) SV outcomes (e.g., shame, self-blame, revictimization). Putative mediators (i.e., readiness to change) and moderators (i.e., SV recency) will be examined. To prepare for a Hybrid I Efficacy/Implementation trial, we will conduct exit interviews with participants (N = 30), and practitioners (N = 10) to describe implementation factors. This research expected to produce a scalable strategy to promote mental health treatment engagement among women with SV and PTSD in OUD treatment, with the goal of promoting multiple domains of wellbeing and ultimately enhancing OUD outcomes.

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

PROJECT ABSTRACT The proposed research will assess the impact adolescent friendship networks have on the psychosocial health of immigrant youth (i.e., the 1st and 2nd generation). Immigrant youth are a vulnerable population, with disproportionately high prevalence of adverse psychosocial health outcomes, including higher rates of mental health disorders, and lower sense of belonging, self-esteem, and wellbeing. Adolescence is a critical developmental stage, marked by the ascension in the complexity and importance of peer friendships. Although immigrant youth’s friendship networks look different from non-immigrant youth’s networks in a variety of ways, very little research have examined whether and how these friendship patterns and processes may explain the immigrant-based disparities in psychosocial health. This proposed research will bring more contemporary data to the forefront of research on immigrant youth’s school friendships, generate new and rare data on immigrant youth’s non-school friendships, and use advanced social network analytical methods to provide a more comprehensive examination of the impacts adolescent friendship networks have on the psychosocial health of immigrant youth. During the K99 phase, Dr. Khuu will focus on friendships developed in school, a major peer context shared by both immigrant and nonimmigrant youth. AIM 1 is to identify and understand differences in friendship patterns and processes between immigrant and nonimmigrant youth. AIM 2 is to compare measures of psychosocial health between these two groups and test whether differential friendship patterns and processes explain differences in psychosocial health. During the R00 phase, Dr. Khuu will leverage her training in survey design and network sampling methods as well as in adolescent development and psychosocial health to lead a new data collection effort on immigrant youth’s friendship networks extending beyond school. AIM 3 is to understand how the social contexts of friendships shape friendship patterns and composition. AIM 4 is to test the relationship between immigrant youth’s psychosocial health and these friendship measures. As a sub aim, Dr. Khuu will also take the opportunity to examine heterogeneity among immigrant youth, focusing particularly on the distinctions between refugee and non-refugee youth. Dr. Khuu’s career goal is to become a leading research authority on the friendships, health, and critical life outcomes of immigrant youth. The training and findings of the proposed research will position her favorably to pursue an R01 grant, enabling her to propose a more expansive, longitudinal study that explores the social integration and health of immigrant youth, with a specific focus on refugee youth, who have resettled in a diversity of new immigrant destinations in the United States.

National Institutes of Health

Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers (P50 Clinical Trial Optional)

NIMH - National Institute of Mental Health

PROJECT SUMMARY/ABSTRACT Approximately 40% of community samples report binge eating attitudes/behaviors (BE) during pregnancy – far exceeding pre-pregnancy and postpartum estimates and nearly triple the rate observed among non-perinatal community samples. Importantly, BE, which comprise symptoms of binge eating disorder that may not constitute a full threshold diagnosis, are associated with adverse short- and long-term mental and physical health outcomes that increase cardiovascular disease risk for birthing individuals and their offspring. Despite their high prevalence and link to deleterious intergenerational health consequences, efforts to treat and prevent perinatal BE are lacking due to limited knowledge of underlying target mechanisms. The goal of the applicant’s proposed research is to advance understanding of whether and how changes in ovarian hormones and executive functioning (EF), two factors implicated in the development and maintenance of BE among non- perinatal individuals, contribute to changes in BE across the perinatal period. Based on findings from research with non-perinatal samples, perinatal-related increases in progesterone and decreases in EF are hypothesized to predict increases in perinatal BE, whereas perinatal-related increases in estradiol are hypothesized to predict decreases in perinatal BE. To test these hypotheses, and potentially identify malleable risk and protective factors crucial to intervention development, the proposed research will integrate two longitudinal studies, harnessing existing data from >300 participants spanning five timepoints across the perinatal period, and employ structural equation models (SEM) that can examine complex patterns of change in multiple variables over time and how these changes influence each other. The Specific Aims of the proposed research are to: (1) investigate (a) progesterone and (b) estradiol as predictors of perinatal BE; (2) investigate EF as a predictor of perinatal BE; and (3) explore the relative contribution of ovarian hormones and EF to perinatal BE. To accomplish these aims, the applicant will complete a comprehensive, personalized training plan comprised of journal article readings, seminars/workshops, scientific conferences, coursework, clinical work, and tailored mentoring from a committed team of researchers with expertise directly relevant to the proposed research. The Training Goals, which build upon the applicant’s prior research experiences and training, will focus on expanding knowledge and/or skills in: (1) perinatal disordered eating and mental health; (2) ovarian hormones and disordered eating; (3) the multidimensionality of EF and scoring/analysis of data from behavioral task measures of EF; and (4) longitudinal SEM procedures. Complemented by the dedicated research and training environment at the University of Pittsburgh, this F31 fellowship will accelerate the applicant’s trajectory toward becoming an independent researcher focused on identifying and modifying target mechanisms related to perinatal BE, the most prevalent form of disordered eating among perinatal individuals, to promote the mental and physical health of this vulnerable population.

NIAAA - National Institute on Alcohol Abuse and Alcoholism

Program Director/Principal Investigator (Last, First, Middle): Cheatham, Carol Abstract and Public Health narrative of the Phase Summary of the Phase I/II: Abstract of the Phase Summary of the Phase I/II Prevention of and intervention in fetal alcohol spectrum disorders (FASD) requires a detailed knowledge of proximal and distal maternal and paternal risk factors that are associated with specific child traits common to FASD. In the completed R61 Phase, we created and piloted novel protocols for: 1) interviewing mothers (with biomarker validation) to determine maternal alcohol consumption on a weekly/monthly basis across pregnancy to assess their specific contributions to child traits and severity of FASD outcomes; 2) determining maternal experience with stress, trauma, and mental health status during pregnancy and their contribution to the severity of effect on FASD diagnostic traits in their offspring; 3) interviewing biological fathers of the index pregnancy regarding paternal traits that may contribute to the risk for FASD from exposure to teratogens such as alcohol, other drugs, environmental toxins, and social environment during pre-conception; and 4) establishing a comprehensive, summary FASD risk score from the above innovations when combined with other empirically-established risk factors. The R33 Phase will now initiate an exploration of a multivariate, comprehensive approach to FASD risk via two applications for better understanding FASD etiology. In the prospective study, 200 women and as many of their partners as we can consent (estimated to be a minimum of 100) will be recruited from prenatal clinics, and their offspring will be assessed at six weeks and nine months post-partum and diagnosed as to their status on the continuum of FASD by pediatric dysmorphologists and a multidisciplinary team. The second application of the new methods will gather the new data retrospectively and link the data to two existing cohorts of maternal/child dyads whom we have followed over time to assess their FASD status and the severity of their physical, neurodevelopmental, and behavioral traits. Both studies will add new insight to our long-term quest to understand more completely the respective contributions of a broad range of host, agent, and environmental factors to the etiology of FASD. This R33 Phase will provide substantial validation of the utility of collecting weekly alcohol use data, mental health status assessments, paternal information, and FASD risk score innovations via expert clinical assessment of the offspring of each pregnancy. In developing this more comprehensive approach to FASD risk, both study phases draw on our existing clinical epidemiology infrastructure, the experience of our multidisciplinary team, and the participants in existing longitudinal cohorts. RELEVANCE (See instructions):

NIEHS - National Institute of Environmental Health Sciences

Climate change constitutes “the single biggest health threat facing humanity”. Climate change exacerbates heat-related morbidity and mortality due to more frequent, longer and extreme heat events. It also increases wildfire occurrence and worsens air pollution, which is linked to thromboembolic and bleeding events. The health impacts of extreme heat and air pollution will only intensify as a result of the changing climate. Certain subgroups are disproportionately affected, including low-income populations. Pregnant women and their children, especially those from low-income communities, are particularly vulnerable to harms from extreme heat and air pollution, not only due to physiologic changes during pregnancy and social vulnerability, but also because of the medications that are taken in pregnancy to treat chronic diseases, mental health conditions, and pregnancy complications. Nearly two-thirds of pregnant women in the US take at least one prescription drug other than vitamins, and medication use is likely to play an important role in modifying the health effects of heat and air pollution and/or further increasing morbidity in vulnerable pregnant patients and their offspring. However, the current evidence assessing adverse perinatal outcomes in relation to heat and air pollution lacks adequate consideration of individual-level factors including medication use and interactions between medications and other risk factors. While the CDC recently published guidance for heat and medications recognizing the significance of environment-medication interactions, evidence is still limited, especially for pregnant women. In the present proposal, an interdisciplinary team of experts in climatology, environmental and pharmacoepidemiology, obstetrics, congenital abnormalities, data science, and biostatistics will work closely to design a series of observational epidemiologic studies. We will link temperature/humidity and air pollution data with national Medicaid data as well as birth registry data from New Jersey, Massachusetts and California and analyze the linked data using the state-of-the art study designs and analytic methods. Our study aims to: (1) assess the independent and synergistic effects of extreme heat and prescription opioids and other heat-sensitizing medications on heat-related adverse events in low-income pregnant women; (2) assess the independent and synergistic effects of air pollution, i.e., particulate matter (PM2.5), and medications associated with thromboembolic and bleeding events on these outcomes; and (3) assess the independent and synergistic effects of extreme heat/air pollution and potentially teratogenic medications on the incidence of congenital abnormalities. The results of our study will quantify the effects of extreme heat and air pollution exposure and their potential interactions with medication use in low-income pregnant women while also shedding light on potential mechanisms that confer increased risk to certain individuals. The evidence generated from our study will have a direct impact in shaping adaptation strategies and policies for climate change to protect vulnerable populations from the effects of extreme heat and air pollution.

NIAID - National Institute of Allergy and Infectious Diseases

The increasing frequency of weather extremes such as flooding on the incidence of malaria and other vector-borne diseases is an issue of substantial public health importance. Therefore, there is an urgent need to develop effective mitigation and control strategies. In May 2020, we piloted a post-flood malaria chemoprevention intervention in rural western Uganda. When compared to two neighboring villages where no intervention was deployed, we estimated a 53% reduction (aRR 0.47, 95% CI 0.34 – 0.62, p<.01) in malaria incidence in the six months post-intervention. Building on these results, the scientific aim of this proposal is to evaluate the effectiveness of a targeted, time-limited malaria chemoprevention intervention with and without larval source management (LSM) to reduce excess disease burden in a perennial, high-transmission setting following severe flooding. Our premise is that the intervention will reduce the parasite reservoir during the critical “rebound” period, when vectors are re-establishing habitats thereby maintaining relatively low levels of transmission until conditions have returned to the pre-flood baseline. Specifically, we will: Aim 1: Determine the effectiveness of chemoprevention with or without peri-domestic larvicide application to reduce the incidence of P. falciparum malaria after severe flooding. We will conduct a cluster randomized trial in 50 villages (144 clusters) in rural western Uganda, where flooding relatively predictable, to compare: (i) LLIN distribution (control), (ii) LLIN distribution plus three, monthly rounds of DP provided to children ≤12 years of age (DP), and (iii) LLIN+DP with three months of bi-weekly application of larvicide in the peri-domestic space (DP+Bti). Hypothesis: Chemoprevention will achieve a sustained (≥6 months) reduction in malaria incidence of ≥30% compared to the control arm without the emergence of artemisinin resistance. Aim 2: Elucidate the evolution of vector populations, feeding behaviors, and sporozoite rate in affected villages up to one year after flooding. We will perform weekly surveillance for adult and juvenile Anopheles mosquitoes in sentinel households and within the peri-domestic space. Collected mosquitoes will be counted, and identified to species and tested for the presence of P. falciparum sporozoites. Hypothesis: Flooding will create innumerable small pools favored by An. gambiae complex resulting in predominance of An. gambiae s.s. with potential for emergence of An. arabiensis as important vector in setting of widespread LLIN use.23 Aim 3: Evaluate the relative cost-effectiveness of chemoprevention (Aim 3A) and assess social and economic impacts on households (Aim 3B). We will conduct baseline and longitudinal quantitative surveys in sample clusters to evaluate impacts of the interventions on (i) economic activities and income, (ii) health seeking and expenditures, and (iii) mental health and well-being. These data will inform a cost effectiveness analysis of chemoprevention compared to the control (i.e., relative cost per case averted). Hypothesis: Chemoprevention will mitigate negative effects of malaria in the aftermath of a flood.

NIA - National Institute on Aging

Project Summary/Abstract As the frequency, prevalence, and severity of extreme weather events and disasters increase, the long- term and life course consequences on the older population in the US of experiencing cyclones, heat waves, droughts, floods, and wildfires grows in terms of its significance for research, policy, and population well-being. Of particular urgency is developing a better understanding of the effects of disasters exposures and post-disas- ter experiences on disparities in well-being over the older life course years, on levels and differentials in health and mortality, and for policies aimed at mitigating long-term consequences of disasters. A predominant focus of the literature addressing disaster effects on health and well-being is the period in the immediate aftermath of the event. Much is known about short-term effects on mortality, mental health, displacement, living arrange- ments, and recovery. For subsequent post-disaster years, however, there is a dearth of data sources, and hence of population-level empirical research, on individual outcomes, especially among the elderly population. Key issues that remain uninvestigated include whether disaster effects are fleeting, whether they have long- term negative consequences, or whether individuals may actually be better off. This project will build on a ma- jor investment we have made to create a linked data source for addressing the medium- and long-run effects of Hurricane Katrina on the pre-disaster population of New Orleans. We will use these new linked data to exam- ine living arrangements, well-being, and mortality among the older population of New Orleans aged 60-plus years in the period following Hurricane Katrina. Using within-New Orleans comparisons along with an external counterfactual comparison group, we will address two aims. First, we will examine how exposure to Hurricane Katrina for the older New Orleans population affected long-term trajectories of living arrangements and resi- dential neighborhood attainment compared to the counterfactual comparison group. Second, we will examine post-Katrina mortality and disability disparities within the older New Orleans population by race, pre-Katrina social and economic characteristics, hurricane impact, and post-disaster experiences. This is a novel and ex- ploratory project to establish a general and broadly-applicable approach to studying the effects of disasters on the older population using linked census and administrative data. It will also make significant substantive con- tributions by combining stress and social vulnerability theories to generate and evaluate testable hypotheses about the effects of pre-disaster socioeconomic resources and disaster exposure on key health and well-being outcomes among the older New Orleans population. The project will set the stage for future replications for other disasters as well as for a variety of enhancements and extensions in order to answer pressing questions on the consequences of disasters on the health and well-being of the older US population.

NINR - National Institute of Nursing Research

PROJECT SUMMARY There are over 177,000 women detained in U.S. jails and prisons on any day and another 800,000 serving sentences in the community under custodial supervision. About 20% of women with criminal legal system involvement (CLSI) are age 50 or older. Rates of women and older adults have both risen dramatically in recent decades, 700% and 280%, respectively. For many women, incarceration and probation are profoundly stressful experiences, often overlapping with other life circumstances—trauma and abuse, homelessness, substance use, mental illness—that disrupt women's support systems and health services access. Many women who experience CLSI also do so repeatedly, cycling in and out of incarceration and probation over many years. The toll on health can be profound. CLSI is associated with disproportionately high rates of many chronic and infectious diseases and early mortality in women of all ages and is hypothesized to lead to acceleration of aging-related conditions. Most of what we know about the health of older women (age 50 and older) with CLSI is extrapolated from the groups of older men and younger women. We lack an understanding of how CLSI functions as a social determinant for aging-related health in the group, including how much, when, and in conjunction with what other factors over the life course experiences of incarceration and probation contribute. We also know almost nothing about the health in aging attitudes, goals, self-efficacy, and experiences of community-dwelling older women with CLSI. The objective of the Aging-Related Health and Aging Acceleration in Older Women with Criminal Legal System Involvement Study (AGELIS) is to fill critical gaps in our knowledge about how CLSI functions as a life course social determinant and what women with CLSI mean by and want from health in aging. Closing such gaps is crucial in moving the field toward intervention readiness and ultimately improved health outcomes. The specific aims of AGELIS are to (a) establish relationships between the health in aging construct, functional ability, life course factors, and CLSI in older women with CLSI, compared with a matched comparison group in the Health and Retirement Study and (b) characterize attitudes, goals, self-efficacy and experiences of health in aging in older women with CLSI using semi-structured interviews and ethnographic case study. In partnership with a community research team, we will bring results from the two aims together in an integrated model of health in aging with CLSI. AGELIS will provide an empirical and experiential basis for subsequent intervention design and point the way forward for investigation in aging with other groups that experience significant life course stress.

NSF

This project establishes the AI Research Institute on Interaction for AI Assistants (ARIA). ARIA will accelerate the development of next-generation AI assistants for mental and behavioral health—a field where trust, empathy and personalization are critical and where current AI systems fall short. ARIA embraces the integrated study of human cognition and machine cognition, treating them as inherently complementary scientific endeavors essential to achieving successful interaction with AI assistants. ARIA brings researchers in computer science, neuroscience, cognitive science, philosophy, law, and education together with mental health practitioners and civil society groups to forge new opportunities for synergistic scientific inquiry that advances technology and improves human well-being. The institute will grow a future-ready workforce through interdisciplinary education pathways from K-12 through postgraduate training, helping shape a generation that understands the technical and ethical dimensions of AI. ARIA’s research activities are centered around three pillars–Grounding, Instructability, and Alignment–that are interconnected and motivated by challenges of developing effective AI assistants for mental and behavioral health. In grounding, ARIA will develop new models for efficient learning and generalization, new learning algorithms leading to rich, causal models, computational theories for navigating the inherent trade-offs between learning algorithms or model architectures, and new evaluation metrics for tracking progress toward the goal of trustworthy AI assistants. In instructability, ARIA will design new paradigms centered on establishing trust in AI, new theories and models of how humans interact with AI, new methods for describing AI’s internal processing, and new models and training procedures for integration into a computational framework for the development of AI assistants. In alignment, ARIA will advance current best practices for human-centered design, establish precise definitions for what it means to be aligned, develop computational and experimental methods to operationalize these definitions, and develop cognitively and computationally sound metrics of alignment in complex ethical and social contexts. Across all activities, ARIA promotes integration between academia and industry, and between research and continuing education, enabling a holistic approach to AI conceptualization, development, and evaluation. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

NIDDK - National Institute of Diabetes and Digestive and Kidney Diseases

PROJECT SUMMARY Anxiety is a common comorbidity in inflammatory bowel disease (IBD), affecting up to 35% of patients, yet current IBD treatments focus primarily on clinical markers of disease activity and do not adequately address the mental health burden. This gap leads to decreased health-related quality of life (HRQoL), poor patient outcomes, and increased healthcare utilization. Despite the prevalence of anxiety in IBD, access to evidence-based treatments such as Cognitive Behavioral Therapy (CBT) is limited, particularly for patients in rural or underserved areas. Virtual reality (VR) and artificial intelligence (AI)-enhanced CBT represents a novel, scalable solution to overcome these barriers, offering a self-administered, immersive therapy experience that is accessible from the patient’s home. This proposal aims to conduct a pilot randomized controlled trial (RCT) to assess the feasibility and clinical impact of an 8-week home-based VR/AI CBT program versus sham VR control in 76 patients with IBD and anxiety. The study will be conducted at two leading IBD centers: Cedars-Sinai and the University of Chicago. Using the NIH-endorsed ORBIT Model for Developing Behavioral Treatments, our VR/AI CBT program has been refined in Phase I, and we are now ready to proceed with Phase IIa/b pilot testing. The program is designed to improve anxiety, HRQoL, and potentially inflammatory biomarkers in IBD patients. The following specific aims will be addressed: ¨Aim 1: Establish the feasibility of using an 8-week VR/AI CBT program in IBD patients with anxiety. ¨Aim 2: Acquire preliminary data on the clinical impact of the VR/AI CBT program compared to sham VR, focusing on improvements in anxiety, HRQoL (measured by IBDQ), and IBD symptoms (measured by PRO2). ¨Aim 3: Acquire exploratory data on the impact of VR/AI CBT on inflammatory biomarkers, specifically serum C-reactive protein (CRP) and fecal calprotectin (fCal). If successful, this pilot study will provide the foundation for a fully powered Phase IIc efficacy trial, advancing the development of scalable, evidence-based mental health interventions in IBD. By addressing both psychological and physiological dimensions of IBD, VR/AI CBT has the potential to significantly improve patient outcomes and fill a critical unmet need in the management of IBD.

National Institutes of Health

AIDS Research Center on Mental Health and HIV/AIDS (P30 Clinical Trial Optional)