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NHLBI - National Heart Lung and Blood Institute

Project Summary / Abstract Coronary artery bypass grafting (CABG) is the most commonly performed adult cardiac surgery procedure, and the standard of care for patients with severe coronary artery disease. CABG can be performed using either arterial or venous grafts, with arterial grafts being associated with better outcomes in observational studies, but not in the only published randomized trial. The Randomized comparison of the Outcomes of single vs Multiple Arterial grafts (ROMA) trial will evaluate whether multiple arterial grafts (MAG) compared with single arterial graft (SAG) have better outcomes in the general CABG population (84.5% men). Women represent a minority of patients in CABG trials, and there are important biological and surgical differences between men and women undergoing CABG, so that ROMA as currently funded will not allow a meaningful assessment of the effect of MAG in women. However, ROMA provides a unique opportunity to leverage the existing trial infrastructure to realize the first cardiac surgery trial dedicated to women (ROMA:Women). By enrolling 2,000 women, we will have enough statistical power to determine 1) the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing CABG and 2) the impact of MAG vs SAG on generic and disease-specific quality of life (QOL) as well as physical and mental health symptoms in women undergoing CABG. Enrolled patients are randomized 1:1 to MAG or SAG. The inclusion and exclusion criteria, the interventions, outcome definitions and the follow-up protocol are identical to those of the ROMA trial. The only exception is that the 70 years age cut-off that was used in ROMA and will not be used in ROMA:Women. ROMA:Women leverages the existing ROMA infrastructure including clinical trial unit, database, case report forms, randomization system, site training resources, regulatory approvals, network of participating sites, and study coordinators. The trial primary outcome is a composite including death, stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure at a minimum follow-up of 2.5 years. The secondary outcome is the absolute change in the Seattle Angina Questionnaire (SAQ) at 12 months compared to baseline. The trial is designed to have >90% power to demonstrate a 25% relative risk reduction in the primary composite outcome in the MAG group. Generic QOL (SF-12, EQ-5D), and symptoms (PROMIS-29) as well as key clinical events will also be captured.

NHLBI - National Heart Lung and Blood Institute

Project Summary / Abstract Coronary artery bypass grafting (CABG) is the most common adult cardiac surgery procedure, and the standard of care for patients with severe coronary artery disease. CABG can be performed using either arterial or venous grafts, with arterial grafts being associated with better outcomes in observational studies, but not in the only published randomized trial. Women represent a minority of patients in CABG trials, and there are important biological and surgical differences between men and women undergoing CABG ROMA:Women is the first trial comparing arterial vs. venous graft in a exclusive women population. In a rigorous randomized trial that focus enrollment exclusively in women we will determine 1) the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing CABG and 2) the impact of MAG vs SAG on generic and disease- specific quality of life (QOL) as well as physical and mental health symptoms in women undergoing CABG. We will enroll 2,000 women randomized 1:1 to MAG or SAG. ROMA:Women will leverage the existing infrastructure of ROMA (conducted on both Women and Men) including the clinical trial database, case report forms, randomization system, site training resources, regulatory approvals, network of participating sites, and study coordinators. The trial primary outcome will be a composite of death, stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure at a minimum follow-up of 2.5 years. The secondary outcome will be the absolute changes in the Seattle Angina Questionnaire (SAQ) at 12 months compared to baseline. The trial is designed to have >90% power to demonstrate a 25% relative risk reduction in the primary composite outcome in the MAG group. Generic QOL (SF-12, EQ-5D), and symptoms (PROMIS-29) as well as key clinical events will also be captured.

NINDS - National Institute of Neurological Disorders and Stroke

SUMMARY: The 2026 Gordon Research Conference (GRC) on Sleep Regulation and Function, themed “Sleep for the Whole Organism,” will mark the seventh installment of this highly successful series. Over the course of the last decade, sleep research has experienced remarkable growth across a variety of disciplines, spanning molecular biology, systems neuroscience, and mental health. Advances in state-of-the-art technologies have enabled significant progress in our understanding of the neurocircuitry underlying non-REM and REM sleep, wakefulness, the roles of neurotransmitters and neuromodulators, genetic contributions to sleep regulation, and the impact of sleep loss on transcriptional and translational dynamics. The 2026 GRC will build on this strong foundation while expanding into new frontiers. The program will explore sleep as a whole-organism behavior, integrating both brain and body perspectives. In addition to core sessions on sleep regulatory mechanisms and emerging findings from non- mammalian species, the conference will highlight recent findings on sleep’s roles in cognition, consciousness, interoception, and waste clearance from the brain. A session will examine the interplay between sleep and post- infectious disease states, reflecting growing interest in how immune challenges—including long-term consequences of viral infections—impact sleep regulation and homeostasis. The program will further emphasize bidirectional brain-body communication, with discussions on the bi-directional interaction between sleep and peripheral physiology, metabolic state, and systemic signals. Finally, the growing interface between artificial intelligence/machine learning (AI/ML) and sleep science will be showcased, illustrating how advanced computational tools are transforming data analysis, predictive modeling, and mechanistic discovery in the field. This GRC will comprise 50 invited speakers and discussion leaders, poster sessions, in the main meeting. It will be preceded by the GRS, which will provide opportunities specifically for graduate students and post-docs. The GRC and GRS will bring together scientists of all career stages in an interactive and safe environment.

NCCIH - National Center for Complementary and Integrative Health

This proposal aims to support the International Congress on Integrative Medicine and Health (ICIMH) annual meeting from 2026-2030, sponsored by the Academic Consortium for Integrative Medicine & Health (“Academic Consortium”), which currently represents over 80 academic health centers and health systems in the U.S. and around the World. The overall goal of the Congress is to provide the premier venue for bringing together rigorous scientific research on a broad range of topics including integrative approaches to cancer, mental health, pain, metabolic health, aging, pediatrics, women’s health, oral health, and substance use disorders. It has provided a key venue for grantees of the NCCIH and other NIH centers and institutes to network and present their scientific work and has been a significant catalyst for growth of the science of the integrative medicine field since the inception of the Congress. This grant is specifically aimed at increasing attendance at the conference of students, trainees, new investigators, and others with financial barriers to attendance and supporting the publication of early investigators abstracts. Most of the funding will be directed at reducing the student registration rate and providing travel scholarships. Travel scholarships will be awarded based on submission of an abstract with strong reviewer ratings, financial need, and bringing trainees from different health disciplines to the conference. The 2026 ICIMH is to be held in Salt Lake City, UT from April 20- 23, 2026; in Minneapolis, MN from April 12-15, 2027; and the 2028, 2029 and 2030 ICIMH will be determined closer to the date. ICIMH will showcase original scientific research involving integrative medicine and whole person health, using keynote and plenary presentations, oral and poster abstracts, symposia, and workshops. Basic science, clinical, and health service researchers will present original research and moderate panel presentations selected through a de-identified peer-review process, using a pool of over 60 expert reviewers. Leaders in whole health and integrative medicine are invited to provide keynote addresses and moderate concurrent research presentations. The oversight of conference planning is a collaboration between an Organizing and Scientific Review committee, Academic Consortium Board of Directors, student advisory group, and NCCIH. The 18-member Organizing Committee, representing diverse leaders in research, education, and clinical communities, has key responsibility for planning the meeting content, including selecting the plenary speakers and meeting symposia. This proposal aims to ensure that the Congress continues to provide a rigorous scientific venue for grantees of the NCCIH and other NIH institutes engaged in research related to whole person health to network and present their scientific work and to advance the meeting’s role as an important catalyst for growth of the science of the integrative medicine field.

NIDA - National Institute on Drug Abuse

PROJECT SUMMARY Prenatal cannabis use (PCU) is a growing public health concern, linked to fetal harms and risks to the pregnant woman, including depression and cannabis use disorder. The American Academy of Pediatrics and the American College of Obstetricians and Gynecologists advise against PCU, yet its prevalence continues to rise. Despite some understanding of the risks associated with PCU, pregnant women often choose to use cannabis to offset physical and mental health symptoms. The desire to manage adverse symptoms is often accompanied by inconsistent and/or limited unsolicited information offered by healthcare providers on PCU harms or alternatives, and pregnant women are hesitant to disclose PCU to providers even if asked. In this proposed pilot randomized controlled trial (RCT), we will incorporate feedback from experts and pregnant women who use cannabis to tailor our team’s existing, evidence- based, brief, mobile phone-based intervention to target PCU. The intervention will: (1) present accurate information in a motivational enhancement format to reduce resistance around health messaging, correct misperceptions, and provide instruction around discerning credible and accurate information from other sources in the future; and (2) offer harm reduction and cognitive behavioral skills proven to be efficacious in reducing cannabis use in other groups (e.g., use of protective behavioral strategies and distress tolerance skills) to teach alternate strategies to manage physical and mental health symptoms during pregnancy. In an initial phase of the project, we will beta-test our screening, recruitment, and intervention procedures with 15 pregnant women in the first trimester who use cannabis. We will conduct interviews to evaluate feasibility and acceptability of the intervention and refine content based on feedback. We will then pilot test the intervention in a second phase by randomly assigning first trimester pregnant women who use cannabis to the intervention condition (N = 50) or a brief information-only control condition (i.e., treatment as usual; N = 50) to be delivered in the first trimester, with a booster in the third trimester. Follow-up will occur during subsequent trimesters and 3-months post-pregnancy. This first-ever stand-alone, self-directed mobile intervention for PCU has potential for large-scale reduction of cannabis use among an at-risk population. This mobile phone-based intervention can reach pregnant women who may have otherwise received no intervention, or who would have sought information from less credible sources. This and future projects can help identify and address individual-, policy- and system-level barriers to harm reduction services among pregnant women as we develop and test new digital health technologies to deliver novel prevention, treatment, and recovery interventions to a vulnerable population (two NIDA priority areas).

NIAAA - National Institute on Alcohol Abuse and Alcoholism

Unhealthy alcohol use is increasingly prevalent among women, and women Veterans in particular, and is associated with extensive functional impairment, especially when it co-occurs with psychiatric symptoms (e.g., insomnia). Psychosocial functioning can improve independently of alcohol use, but much alcohol treatment research evaluates primarily alcohol use. Women have been less involved in alcohol treatment research, which is harmful because of known differences among men and women related to alcohol use, including greater risk of some alcohol-related medical conditions, more comorbid psychiatric symptoms, and more alcohol-related stigma among women than men. Women are more likely than men to experience “telescoping,” a pattern of rapid progression from initiation to problematic use that narrows the window for intervention. Integrated Primary Care (IPC) may narrow the treatment gap for women Veterans. Developing brief interventions in IPC is an established and effective practice for other psychiatric symptoms (e.g., PTSD, insomnia), yet we do not know of a comparable intervention for unhealthy alcohol use among women Veterans. This proposal aims to combine effective elements of interventions for alcohol and comorbid psychiatric symptoms into a single, brief intervention in IPC and evaluate the intervention with respect to psychosocial functioning. Dr. Katherine Buckheit is a clinical psychologist at the Veterans Affairs (VA) Center for Integrated Healthcare (CIH), a VA Mental Health Center of Excellence focused on improving healthcare by incorporating mental health treatment into medical settings. This K01 Mentored Research Scientist award will enable Dr. Buckheit’s transition to an independent investigator with a long-term goal of improving alcohol treatment by designing, evaluating, and implementing brief interventions in medical settings. Her short-term goal and specific focus of this K01 is to obtain expert mentorship and formal training and conduct a series of research projects to develop and evaluate a brief intervention for women Veterans with unhealthy alcohol use in IPC. This K01 will provide Dr. Buckheit with training in key areas: 1) designing and evaluating brief interventions in IPC, 2) evidence-based alcohol treatment in IPC and specialty care, 3) intervention development among groups with unmet healthcare needs, and 4) mixed-methods and advanced longitudinal statistical analyses. Specific aims are: 1) Combine elements of evidence-based interventions for alcohol use and co-occurring symptoms into a single brief (≤ 6, 30-minute sessions) intervention that includes content for women Veterans. We will engage subject matter experts (IPC, substance use, women’s health) to solicit feedback and refine the intervention. 2) Conduct an open trial (N=10) to gather patient feedback and finalize the intervention. 3) Conduct a pilot randomized controlled trial (RCT; N=60) to evaluate research and clinical feasibility, acceptability, and preliminary effectiveness in improving quality of life, alcohol problems, and alcohol-related functional impairment compared to primary care usual care. Results will inform an R01 application to be submitted by the end of Year 4.

Sail Sand Point

Demand for Sail Sand Point (SSP)'s programming is rapidly increasing. The diverse community of Magnuson Park deserves premier access to the unique asset it has at its back door: waterfront access to Lake Washington. Current boathouse facilities are unsafe, unwelcoming and not fully accessible to all members of our community. SSP seeks to create a welcoming, inclusive, fully ADA accessible and world-class community boating center that will allow more people to experience the mental and physical health benefits of recreating in the outdoors, and to provide safe access and oversight to the lake. After completing an extensive feasibility study (including predesign) and community engagement process, we now seek NMF funds to conduct the next critical steps in our project: site surveys, permitting and tribal and other stakeholder consultation and community outreach.

NCI - National Cancer Institute

PROJECT SUMMARY The focus of this extension proposal is on expanding access to voluntary smoke-free homes to formerly homeless residents residing in permanent supportive housing and examining the role of the built environment and commercial determinants of tobacco use on smoke-free home adoption. Permanent supportive housing is subsidized housing with closely linked or on-site medical and/or social services for individuals with a history of chronic homelessness and who are living with disabilities, mental health, and/or substance use disorders. Approximately 50% of people living in permanent supportive housing report current smoking, yet there are no mandated smoke-free policies in permanent supportive housing. In the parent study, we conducted a multi-site, community-based cluster-randomized wait-list controlled trial of our multi-faceted smoke-free home intervention among 400 permanent supportive housing residents residing in 40 permanent supportive housing sites across the San Francisco Bay Area. The multi-faceted intervention, delivered by study staff includes: 1) one-on-one counseling to permanent supportive housing residents who are smokers on how to adopt a smoke- free home, and 2) training for permanent supportive housing staff on how to provide referrals to cessation services. We are in the process of completing efficacy and cost-effectiveness analyses and examining barriers to and facilitators of successful adoption of smoke-free homes from the parent RCT. In the qualitative evaluation of the parent proposal, we used the Consolidated Framework of Implementation Research to understand inner and outer setting factors linked with smoke-free home adoption. The aims of the extension proposal are to expand on these inner and outer setting factors from the Aim 3 analyses in our parent proposal to better understand the role of built environment factors and commercial determinants on smoke-free home adoption using environmental mapping and participatory action research methods. Our specific aims are: 1) Explore how self-reported perceptions of commercial determinants, the built environment, and treatment access shape smoke-free home adoption among smoke-free home RCT participants, 2) Identify commercial determinants of smoke-free home adoption using environmental mapping of tobacco, alcohol, and cannabis retailer density in neighborhoods where PSH are located, 3) Evaluate the influence of built environment factors such as neighborhood safety and walkability, housing quality, and environmental cues to tobacco use on smoke-free home adoption using participatory action research methods. The long-term impact of this work will be to create best practices and action-oriented implementation guidance for housing authorities, non-profit housing providers, and local, state, and federal authorities to increase smoke-free policy implementation and tobacco treatment in subsidized multi-unit housing.

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

Despite almost all postpartum women wanting to delay their next pregnancy by at least two years, contraceptive use remains inconsistent, particularly in Ghana, which has one of the highest levels of unmet needs for family planning in sub-Saharan Africa. Prior research has shown the quality of contraceptive care in Ghana is poor, with many women adopting methods known to cause side effects women indicated were unacceptable to them. Contraception is a preference-sensitive health service; there are often multiple medically appropriate options available to women, and so their own preferences ought to drive the decision of whether or not to use contraception, and if so, which method. Increasing client autonomy has been recognized as the next frontier in improving the quality of contraceptive care women receive. In this project, our longstanding collaborative, cross-national, interdisciplinary team will tailor an mhealth intervention to postpartum women and follow them for two years post-delivery to determine the impact of the tablet-computer based decision-support tool on contraceptive autonomy, maternal mental and physical health, and health of the index baby. This study, conducted by a collaborative team from the University of Michigan and the Kwame Nkrumah University in Ghana, aims to improve the understanding and usage of postpartum contraceptives and the impacts of using My Family Planning-Ghana (MFPG), an adaptation of a US-based decision-support tool. To achieve this, the project focuses on three objectives. The first aim is to adapt MFPG for postpartum women, including those undecided about contraception, using the ADAPTITT framework. By testing the tool in postnatal and child welfare clinics, our goal is to make the tool feasible, acceptable, and sensitive to the needs of postpartum women. In the second aim, we will assess the tool's impact on contraceptive behavior through a cluster-randomized controlled trial. This study will enroll pregnant women in their third trimester and follow them for twenty-four months to determine whether the tool increases contraceptive autonomy, access to preferred methods, and selection of methods that meet users’ preferences. It will also assess the tool's impact on birth spacing, pregnancy outcomes, maternal health, and contraceptive autonomy over a two-year period. The third aim will examine whether using the decision-support tool is associated with improved health outcomes and resource investment for infants and children. The study will assess whether children of women in the intervention group have superior nutritional status, growth, health, breastfeeding duration, and healthcare usage compared to those in control group. This project provides an opportunity to improve contraceptive autonomy in the postpartum period, a global issue of which poor quality contraceptive care is a significant part. The intervention seeks to empower women to use contraception that meets their preferences if they want to and assists in achieving their fertility goals and healthy birth spacing, and could be adapted for use in other countries, including the United States. The research team combines expertise and exceptional research infrastructure to conduct a feasible, rigorous study of a tool with potential for high impact.

NIMH - National Institute of Mental Health

Abstract Copy number variants (CNVs) involve deletions and duplications of genomic segments spanning more than 50 basepairs and represent one of the most penetrant sources of pathogenic variants in neuropsychiatric disorders, with myriad impacts on many other human phenotypes as well. However, the relative impact of CNVs at the resolution of individual genes, exons, or functional categories, and especially across diverse global populations, has never been systematically assessed in neuropsychiatric disorders at scale. This omission can be attributed to the technical barriers in CNV discovery as well as the lack of large-scale, diverse neuropsychiatric cohorts. Traditional cytogenetic methods for CNV detection, such as chromosomal microarrays (CMA), are relatively low- resolution, and have largely precluded gene and exon resolution analyses. Recent advances in sequencing with whole exome (ES) and whole genome sequencing (GS) have dramatically improved our resolution, including the discovery of exon and sub-exon level CNVs. However, neither GS nor ES are perfect. While GS can interrogate the whole spectrum of CNVs across frequency and size, it is expensive. ES on the other hand, though affordable, can only query the rare coding portion of the genome for CNVs. Promisingly, the blended genome exome (BGE) sequencing approach has recently undergone heavy development and rapid adoption in a number of large-scale, diverse neuropsychiatric sequencing efforts, including in the Populations Underrepresented in Mental Illness Association Studies (PUMAS) project, NeuroDev, and Akili studies. BGE is composed of a high coverage ES (~30x) with a low coverage GS backbone (~2-3x), at a cost comparable to traditional exome sequencing. With this blend, BGE has delivered on marrying the affordability of ES with the full range of variant detection of GS when used to detect single nucleotide variants (SNVs) across the entire genome. Leveraging our expertise in computational methods development for CNV detection and association across GS and ES, we believe that in addition to SNVs, BGE is the perfect platform to capture the full range of CNVs across the genome at: a significantly improved resolution compared to CMA and ES; a significantly lower reference-bias compared to CMA; and a dramatically lower cost compared to GS. To achieve this, we will extend our GATK-gCNV pipeline for rare CNV detection in conjunction with our ancestry-aware SV imputation pipeline for use with BGE data. Preliminary results have already shown great promise. We will apply this pipeline to the more than 110,000 available BGE samples across PUMAS, NeuroDev, and Akili to generate a large-scale, diverse CNV callset. These variants will be made publicly available and can immediately be leveraged to significantly advance our understanding of the genetic architecture of neuropsychiatric conditions, especially in context of diverse genetic ancestry groups.

NIMH - National Institute of Mental Health

Summary/Abstract Whether we are fatigued from a teleconference call, eager to read a book, energetic and ready to start our day or tired and preparing for sleep, anxious or happy, in the real world key neurocognitive processes and moods fluctuate over minutes-to-hours. Hunger, circadian rhythms, hormone levels, blood sugar, heart rate, body temperature, all fluctuate at the mesoscopic timescale of minutes-to-hours modulating how we respond to the world. For example, the response of the brain to the odor of fresh cookies just out of the oven is different when one is hungry versus for someone who just ate. These state fluctuations also influence why the same event will trigger pathological symptoms at some times, but not others, in individuals with neurological or psychiatric disorders. Despite the critical importance of interrelated brain, cognitive, behavioral, and physiological fluctuations at the timescale of minutes-to-hours in the real world, nearly everything we know about human brain function mostly comes from highly controlled experiments lasting milliseconds-to-seconds, or longitudinal studies from months-to-years. This has left a critical gap in scientific knowledge regarding the dynamics of brain, cognitive, behavioral, and physiological interactions at the timescale of minutes-to-hours in real world settings. To fill this gap, we will develop a platform for measuring and analyzing brain activity, cognitive states, behavior, and physiology leveraging the unique opportunity to record multiday neural activity during natural behavior in the real world in individuals undergoing the surgical treatment for epilepsy. We will integrate cutting- edge wearable and artificial intelligence technology for rich behavioral and physiological monitoring along with neural network and dynamical systems learning approaches. We will rigorously quality control and validate this platform to ensure the highest quality data. We will also perform a bioethics study to develop a paradigm that addresses the unique privacy concerns that arise in using ubiquitous measurements for real-world neuroscience in this participant population. In the R33 phase of this project, we will then use this platform to examine how brain, cognitive, behavioral, and physiological interrelationships fluctuate with circadian rhythms and relate to brain network excitability. Given the ubiquity of circadian rhythms across the brain and body, their influence on cognition and behavior, and their relationship with many neurological and psychiatric disorders, the R33 study has broad implications for both our understanding of the brain and for potential treatment strategies for many disorders. For example, knowing when brain networks are in high or low excitability states can suggest windows of opportunity for maximally beneficial clinical interventions. The development of this integrated brain, cognitive, behavioral, and physiological measurement and analysis platform in the R61 phase of this project will open up new neuroscientific and translational research opportunities. The studies on circadian rhythms and brain network excitability in the R33 phase will lead to new understanding of these important neurobiological processes and provides insights with broad clinical and translational implications.

NIMH - National Institute of Mental Health

Modified Project Summary/Abstract Section Santiago Arconada Alvarez, MS is an emerging leader in translational research software at Emory University who serves as the Associate Director of the AppHatchery initiative within the Georgia Clinical and Translational Science Alliance (Georgia CTSA) under the direction of Dr. Wilbur Lam, MD, PhD. The core of his productive and successful career as a Research Software Engineer is in the development of digital health platforms to support research projects. He has developed over 11 digital health solutions publicly available in domain areas such as: 1) user-center designed software for patient and provider education in pediatric cardiovascular health (HerHeart), symptom based decision-making in the perinatal period (MAMALOVE), new onset pediatric Type 1 diabetes (TypeU), and pediatric tonsillectomy surgeries (Ready for Tonsillectomy); 2) public health information dissemination with a digital resource for Tuberculosis guidelines (Georgia TB Reference Guide) sponsored by the Georgia State Department of Public Health; 3) improving health access by breaking down language barriers for a broad range of individuals with an easily accessible and quick mobile interpretation tool; 4) modernizing traditional qualitative research methodologies with a first-of-its-kind mobile app (Fabla) to conduct speech-based Ecological Momentary Assessment (EMA) research, increasing adoption and study compliance from participants and streamlining and enriching data collection for researchers. This Research Software Engineer (RSE) award would provide 3 years of funding to deepen his software expertise and enable him to evolve into a leader in translational research software. Specifically, he will focus on 1) enhancing data security and ensuring greater transparency in existing projects to promote reproducible research; 2) integrating advanced analytics to support Principal Investigators’ primary research goals; 3) making his platforms and methods accessible to researchers at other institutions and within the broader research software community; and 4) building capacity in the RSE community by mentoring junior engineers, taking on leadership roles in collaborative initiatives, and championing user-centered design in research. Growing into these areas will cement him as a leader to contribute significantly to NIMH’s mission of transforming our understanding and treatment of mental illnesses through innovative, scalable, and widely available software platforms, ultimately improving mental health outcomes and advancing research.

NIMH - National Institute of Mental Health

PROJECT SUMMARY/ABSTRACT We form attachments at many levels of social interactions, including with spouses, family members, friends, and other members of the community. The neurobiological mechanisms that control the formation and maintenance of social attachment remain poorly understood. This is in part because traditional genetic model systems such as mice, fish, flies, and worms do not exhibit social attachment as adults, precluding the use of powerful molecular genetic approaches to dissect mechanisms underlying this behavior. Prairie voles are small rodents that form an enduring social bond (referred to as pair bonds) between adults, and they also display other related affiliative behaviors. Pharmacologic studies in prairie voles have implicated vasopressin and oxytocin signaling through their receptors OXTR and AVPR1A in the control of social attachment, providing a potential entry-point into the neural circuits that govern this behavior. However, in our published and unpublished work, we find that neither OXTR nor AVPR1A are genetically required for pair bonding. To realize our goal to understand how the brain encodes pair bonding, we propose a genetic approach that is independent of OXTR or AVPR1A to gain a new entry-point into the neural circuits underlying this behavior. In brief, we will use the FosTRAP approach first developed in mice to achieve our goal. This approach relies on using FOS to genetically tag neurons that are activated during a specific behavior, and in mice, this has revolutionized identification and functional characterization of neural circuits underlying diverse behaviors and physiology in health and disease. For the current project, we will generate genetically modified voles that have a small molecule-inducible Cre recombinase inserted into the prairie vole Fos locus and a Cre-dependent fluorescent reporter inserted into the prairie vole Rosa locus (Specific Aim 1); in Specific Aim 2, we will validate the use of these knock-in vole strains and identify neuronal populations that are activated during pair bonding. As with the FosTRAP strategy in mice, voles bearing the modified Fos and Rosa genes will enable genetic tagging of neurons activated during a specific behavior, pair bonding in our case for this project. Taken together, our studies will enable identification and functional studies of neural pathways that govern social attachment behavior in prairie voles. Health relatedness: Social attachments are thought to be critical for our mental health and personal and professional success. Failure to form or maintain social attachments is often an early indicator of a serious mental illness such as autism spectrum disorder, depression, and schizophrenia. Our proposal seeks to develop genetic means to access the neural circuits underlying social attachment in prairie voles, which have long been considered the premier mammalian model for these complex social interactions. Our projection may therefore provide a useful model system to study social behaviors relevant to human health and mental illnesses.

NIMH - National Institute of Mental Health

Project Summary. As a result of chronic exposures to traumatic and stressful events, first responders are at elevated risk for experiencing post-traumatic stress disorder (PTSD) and other mental health problems. Resilience training can reduce the risk for developing mental health symptoms in first responders. The National Institute for Environmental Health Sciences and the Substance Abuse Mental Health Services Administration developed the Worker Resilience Training (WRT) program – a 4-hour interactive workshop to educate responders on the effects of traumatic exposures, PTSD and ways to increase adaptive coping resources and promote resilience. We completed a randomized clinical trial (RCT) of the WRT for active responders (n = 167). Results indicated that the WRT, as compared to a waitlist control group, helped prevent the development of PTSD and depression symptoms, and improved important resilience indicators (i.e., healthy lifestyle behaviors, stress management, physical activity) over the course of three months. The proposed multi-site RCT seeks to build on our initial study by conducting a Stage III efficacy trial of the WRT workshop in N=800 first responders in four demographically similar counties in New York (NY) and Houston, TX. Our specific aims are: Aim 1. To evaluate the efficacy of the WRT program for improving resilience indicators, defined as health promoting lifestyle behaviors, stress management and physical activity, and improving perceived resilience over the course of one year. Aim 2. To evaluate whether the WRT program serves to prevent the development or worsening of psychological symptoms and impairments in functioning over the course of one year among those first responders who are exposed to traumatic events after participation in the study workshop. Aim 3. To identify the target treatment mechanisms of the WRT (i.e., skills practice, promoting healthy behaviors, stress management, physical activity and perceived resilience) for preserving mental and occupational health outcomes and functioning over the course of one year in first responders who are exposed to traumatic events post-workshop. We will use a cluster RCT design and multi-modal assessments including self-report measures, a web-based stress reactivity performance task, and real-time accelerometry. Participants in both conditions will also receive a booster session at 3 months post workshop to reinforce skills and intervention knowledge. Overall, this study will contribute to our understanding of how resilience training may serve to protect the mental health and functioning of first responders. This study has important clinical and public health implications, including preserving and strengthening mental health and reducing overall personal and financial costs to first responders, their family and the community at-large. This study also takes a research to practice approach by working collaboratively with fire departments and EMS organizations from four demographically similar counties in NY and Houston, TX. If successful, we will work with these leaders to develop a method for annual WRT trainings to foster resilience and promote well-being long-term for first responders.

NIH

Background: Veterans experience high rates of posttraumatic stress disorder (PTSD) and depression, which are frequently comorbid and result in difficulties with psychosocial functioning substantially greater than either disorder alone. Functioning difficulties in Veterans have not been adequately addressed by most existing psychotherapies for PTSD and depression because they often focus on symptom improvement and are highly resource-intensive, requiring the training and time of skilled providers. To address this gap, mobile health (mHealth) apps can serve as a widely accessible, standalone or adjunctive intervention to target psychosocial functioning among Veterans with comorbid PTSD and depression. This RR&D CDA-2 proposal involves the development of a self-guided mHealth intervention based on Skills Training in Affective and Interpersonal Regulation (STAIR), an evidence-based psychotherapy that explicitly targets functioning improvements and also alleviates PTSD and depression symptoms among trauma survivors. As part of the intervention, real-time assessment will be incorporated to support Veterans in monitoring their functioning, symptoms, and potential benefits from STAIR. Aim 1 is to adapt the existing STAIR Coach mobile app to make it optimal for self-guided use and to enhance it with real-time assessment (i.e., ecological momentary assessment of functioning and symptoms and passive sensing of location and communication patterns). A user-centered iterative design process will be used to obtain feedback on the intervention from Veterans with PTSD and depression (N = 15) and VA STAIR providers (N = 5). Aim 2 is to evaluate self-guided STAIR Coach with real-time assessment in a pilot randomized controlled trial (RCT), focusing on determining feasibility and acceptability and exploring outcomes of psychosocial functioning, PTSD symptoms, and depression symptoms. Veterans with PTSD and depression (N = 40) will be randomized to self-guided STAIR Coach with real-time assessment (intervention condition) or to real-time assessment only (active control condition) for 12 weeks. Aim 3 is to apply idiographic analysis to each Veteran’s real-time assessment data to inform the timing and personalization of a future just- in-time adaptive intervention (JITAI) based on STAIR. A JITAI embodies a precision medicine approach to deliver the right type of support to the right person at the right time and has the potential to flexibly target the PTSD or depression symptom most linked to functioning for a Veteran. The candidate is applying as a clinical psychologist at the National Center for PTSD Dissemination and Training Division located at VA Palo Alto. Research and training will take place in the rich institutional environment of VA Palo Alto and its academic affiliate Stanford School of Medicine, with the guidance of an accomplished mentorship team comprised of mHealth and STAIR experts. The training goals of the proposal are directly relevant to the specific aims and include gaining expertise in app intervention development, clinical trial methodology, and idiographic quantitative data analysis. Additionally, the candidate will train in overall mHealth innovation and VA professional development skills. The research and training in this CDA-2 will prepare the candidate to achieve her immediate goal of obtaining a VA Merit Review Award that involves building and testing a STAIR JITAI to maximize functioning among Veterans with PTSD and depression. The candidate’s long term goal is to become an mHealth expert in timely and personalized interventions, including JITAIs, for enhancing psychosocial functioning in the everyday lives of Veterans with PTSD and depression. Significance and Innovation: This CDA-2 will address a high priority area of mental health for VA and is consistent with national VA priorities (e.g., Whole Health), with the goal of helping Veterans with PTSD and depression function more fully in their lives, which may in turn decrease suicide risk. It will target the improvement of functioning through cutting-edge mHealth technology and advanced analytic techniques. It may ultimately help to position the VA as a national leader in incorporating innovative technologies into recovery-oriented mental health care.

NIMH - National Institute of Mental Health

PROJECT SUMMARY/ABSTRACT Social anxiety disorder (SAD) is one of the most prevalent psychiatric conditions worldwide, with a lifetime prevalence of 12.1%. SAD is associated with immense societal burden, including poorer educational and occupational outcomes and reduced quality of life. A sizeable subset of SAD patients (~1/6) do not respond to evidence-based treatments, and even more (17-60%) experience relapse following effective treatment. Accordingly, there is a pressing need to identify novel mechanisms that may be effectively targeted in treatment to improve patient outcomes. Biases in the attentional system may hold promise for future translational work. Attentional bias (AB) describes the preferential allocation of attentional resources to certain types of stimuli over others. In SAD, an AB to external, social-evaluative threats (i.e., angry/disgusted faces) has been reliably observed in the laboratory. However, interventions targeting this bias do not meaningfully reduce SAD symptoms, suggesting that ABs to external threats may represent a disease correlate, not cause. A more meaningful form of AB in SAD may be the extent to which individuals attend internally vs. externally in social situations. Indeed, excessive internally focused attention (i.e., on one’s anxiety-laden thoughts, emotions, and interoceptive sensations) is reliably linked to SAD severity and may contribute to disorder maintenance by increasing perceptions of threat and thus triggering anxious responding across multiple levels. However, researchers have not yet identified if, how, and for whom excessive internally focused attention plays a causal role in SAD maintenance, which is essential to know to inform optimized interventions. The proposed research will utilize an ecological momentary assessment-delivered experimental manipulation to compare the role of internally vs. externally focused attention in the maintenance of SAD. Outcomes will be explored longitudinally across self-report, behavioral, and cognitive levels of analysis, and mechanisms (i.e., threat detection, state anxiety) and moderators (i.e., attentional control) of the effects will be tested. The overarching goal of this project is to identify patterns of attention that play a causal role in the maintenance of SAD to inform novel treatment targets. Specific training goals include conducting experimental psychopathology research from an RDoC-informed framework, acquiring a deeper knowledge of the theory, assessment, and modeling of cognitive systems, applying advanced quantitative methods, and developing professional skills needed for a successful career in clinical science. By integrating theory and methods from multiple areas of basic and clinical science, the PI will acquire a strong foundation for building an impactful program of translational research that investigates the role of cognitive systems in the maintenance of anxiety disorders.

NIMH - National Institute of Mental Health

Abstract High-speed, high-fidelity physiological readouts are critical to neuroscientists who aim to link these responses to behavioral or neuronal activity. Despite the importance of these measurements, the current “gold-standard” biometric monitoring technology in animal models greatly restricts the scope of experimental implementation. At present, simultaneous tracking of these physiological measurements requires multiple bulky devices that must be attached to the animal and synchronized with neural activity, inducing stress and limiting naturalistic animal behavior. Carolina Instruments’ lightweight, freely moving Biometric Ocular Photometry (BOP) system has the potential to address these challenges by simultaneously measuring multiple biometric readouts in real time with minimal impediment to the animal. Our BOP technology leverages photoplethysmography (PPG) techniques for the simultaneous measurement of pupil size, heart rate, and respiratory rate in mice. Infrared (IR) light emitted from an LED positioned on the head passes through the brain and exits via the pupil, where it is captured by a small sensor placed in front of the eye. IR light signal fluctuations are modulated by pupil size, absorption due to blood oxygenation, and brain movement linked to respiratory activity. The compact and lightweight nature of the LED and sensor enables this noninvasive approach to seamlessly integrate into both head fixed and freely moving mouse experiments. Furthermore, the simultaneous real-time measurement of each signal eliminates the need for complex and error-prone post-processing to synchronize the various signals. The goals of this project are to make improvements to the hardware and data processing to prepare for clinical translation. Aim 1: Optimize the BOP system to maximize testing durability and minimize animal stress. Devices with inadequate form factors can stress animals and limit the duration of experiments. We will address these limitations with hardware adjustments to optimize device size and durability, making the technology suitable for prolonged experiments in freely-moving mice. We will then validate the functionality of the freely-moving device by collecting simultaneous pupil size, heart rate, and respiratory rate measurements, and comparing the results to those from state-of-the-art biometric monitoring tools. Aim 2: Improve the reproducibility of data collection and reporting. In its current state, our technology requires an experienced user to perform surgery and to operate the device. We will implement hardware and software modifications to ensure that surgical device placement and data collection become robust, repeatable, and accessible to new users. A surgical placement tool will facilitate the repeatable placement of our baseplate across animals, and a turn key self-calibration step will ensure that the device is properly operational before starting experiments. Additionally, a signal processing algorithm will provide real-time assessments of data reliability along with all reported data. The completion of this project will lay the foundation for future work refining the device to prepare for large-scale manufacturing, finalizing software infrastructure, and expanding to additional animal models.

NIDCD - National Institute on Deafness and Other Communication Disorders

Project Summary / Abstract Tinnitus is the pervasive and often debilitating perception of ringing, buzzing, or hissing sounds in the absence of external stimuli. Sufferers face significant challenges that diminish quality of life, including sleep disturbances, cognitive difficulties, and reduced productivity. Additionally, the prevalence of mental health conditions, including anxiety, depression, and somatic symptom disorders, is significantly higher in patients suffering from tinnitus. Veterans suffering from tinnitus also have a higher likelihood of screening positive for PTSD. In the United States, up to 50 million people have tinnitus, among whom 20 million are chronic sufferers actively seeking relief. About 3 million veterans receive tinnitus disability compensation annually making it the number one service-connected disability for the Department of Veterans Affairs. Despite the overwhelming need for an effective treatment, today’s options are unsatisfactory to most patients; 20% report receiving no help when visiting their general practitioner for tinnitus, over 66% receive no tinnitus care or management after being discharged by ear, nose, and throat (ENT) specialists, and 40% of those discharged return to their general practitioner seeking further help. The major limitation of today’s treatment options is their failure to address the underlying pathology of tinnitus – dysregulated neural synchrony. Common treatments such as hearing aids and sound masking devices do not take this into consideration, instead treating tinnitus as if it were simply an ear disorder. As a result, these treatments can exacerbate symptoms in some patients. Auricle’s novel medical device is the first in-home neuromodulatory device that treats the root cause of tinnitus. Our internationally-patented technology is based on a strong body of peer-reviewed literature. The system applies auditory stimuli at tinnitus frequencies with precisely timed somatosensory stimuli in the neck or face to suppress the tinnitus-generating neurons that cause auditory symptoms. Our technology is supported by 33 peer-reviewed publications and has repeatedly been demonstrated to be safe and effective in clinical trials. Through this SBIR project, the validated technology will be refined for ease-of-ease and scalability, preparing it for commercialization in order to bring transformative relief to tinnitus sufferers.

NINR - National Institute of Nursing Research

Nearly one in three women have experienced physical or sexual violence. Women who have survived violence (WSV) demonstrate high rates of housing instability and health problems, including increased morbidity and mortality related to substance use, depression, and HIV. Housing influences long-term well-being and contributes to differences in health outcomes that can persist over time. Healthcare engagement for WSV is often limited by factors such as fragmented services, complex eligibility requirements, and inconsistent follow-up systems. Despite the established link between housing and health, there is a lack of evidence-based interventions designed to directly improve housing instability while simultaneously supporting improved connection to healthcare services. There is an urgent need for approaches that promote housing stability and improve engagement in care for WSV to reduce preventable negative health outcomes. Patient Navigation (PN) is an evidence-based intervention shown to support engagement in social and healthcare services among populations facing complex needs. Building on our prior research and adapting the core components of the Navigation Services to Avoid Re-hospitalization (NavSTAR) intervention, we propose to develop and test PATHH (Patient Navigation Trial for Housing and Health), a PN model focused on improving housing stability and health self-efficacy for WSV. Guided by a Community Advisory Board, we will adapt PN to support PATHH’s implementation across individual, organizational, and community levels (Aim 1). PATHH will then be evaluated as an augmentation to existing services in partnership with community organizations (Aims 2 and 3). To assess effectiveness, we will conduct a parallel, two-arm randomized controlled trial (N=300), randomly assigning WSV 1:1 to PATHH (N=150) or treatment-as-usual (N=150). Primary outcomes will include housing stability and health self-efficacy; secondary outcomes include substance use, mental health, and physical health. We will also evaluate implementation outcomes at the trial’s conclusion. This study is significant in testing a scalable PN approach designed to improve housing stability and health for WSV, and innovative in extending PN beyond traditional healthcare settings into community-based partnerships, while also generating evidence to guide future implementation of PN models.

NIDA - National Institute on Drug Abuse

Abstract This proposed study is a patient preference trial (PPT) of XR-B vs. SL-B in 8 rural jails in Maryland. A total of 500 adults with moderate/severe OUD soon-to-be-released from jail will be recruited and will choose to receive XR-B or SL-B treatment in jail via telemedicine followed by 6-months of post-release XR-B/SL-B treatment via telemedicine at community pharmacies, a 7-month safety visit, and 12-month follow-up. All individuals receiving XR-B will have their injection administered by a pharmacist, allowing the telemedicine treatment to be fully remote and equivalent to that of SL-B which will also be filled at a local pharmacy. In addition, the consolidated Framework for Implementation Research (CFIR) and Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework will be utilized to understand implementation of telemedicine of XR-B and SL-B in jails and continued at community pharmacies. Aim 1. Compare the effectiveness of XR-B vs. SL-B in terms of: Primary Outcome. (a) retention in buprenorphine treatment (i. days receiving buprenorphine and ii. time to treatment dropout). Secondary Outcomes. (b) illicit opioid use (i. urine toxicology; ii. self-reported days of opioid use; and iii. time to opioid relapse); (c) other illicit substance use (i. urine toxicology; ii. self-reported days of illicit substance use; (d) overdose events (non-fatal and fatal); (e) health-related quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual risk behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration). Aim 2a. Document factors relevant to implementation and sustainability of the telemedicine buprenorphine intervention in jails and pharmacy settings. Guided by CFIR and RE-AIM we will gauge 1) how to optimize key intervention components (e.g., dose induction, telemedicine procedures, medication preferences, continuity of care, inner and outer context factors, stigma, pharmacy procedures, improvement of the cascade of care for OUD) and 2) the RE-AIM of key implementation factors. To achieve this aim, we will conduct interviews with stakeholders (n = 10, e.g., pharmacists, telemedicine providers, jail staff per site; total n = 80). Aim 2b. We will contact and attempt to conduct qualitative interviews with the Chief Executive Officer (CEO) or a designated representative from state pharmacy associations in each of the 50 states to: 1) understand state-level policies and regulatory requirements regarding the provision of buprenorphine in pharmacies; 2) inform state-level implementation strategies among both big box and independent pharmacies relevant to the Federal 2025-SUPPORT ACT, which explicitly authorizes pharmacists to prescribe buprenorphine; and 3) understand how best to optimize implementation of an XR-B/SL-B collaborative care model in the pharmacy setting. Findings from these interviews, combined with qualitative data from interviews with our local MD pharmacies, will inform the development of the following deliverables: 1) best-practices toolkit/guide to support pharmacies nationwide in implementing injectable buprenorphine (XR-B) for opioid use disorder, expanding access to SL-B, and establishing collaborative care models with other providers for buprenorphine treatment; and 2) implementation guide to support coordination between jails (medical staff) and community pharmacies, enabling initiation of buprenorphine in correctional settings and continuity of care through post-release treatment at local pharmacies. The study will be innovative for two reasons: 1) it would be the first large scale PPT of XR-B/SL-B using telemedicine among individuals leaving jail; and 2) it would be the first study continuing XR-B injections with a re-entry population at pharmacies. The study will be highly significant because most individuals with OUD do not receive treatment while in jail, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration when they are released. A telemedicine program may improve the continuity of care between incarceration and re-entry which is the period in which individuals with an OUD are most vulnerable. Finally, understanding how to expand acceptance of MOUDs in jails using telemedicine and pharmacy administration of XR-B, has far-reaching implications for expanding treatment access.

NIMH - National Institute of Mental Health

Project Summary Ending the HIV epidemic in the United States will require innovative strategies focused on both HIV prevention and care. While pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention that can reduce HIV incidence, uptake has been modest, particularly among groups at highest risk for acquiring HIV (e.g., MSM, young people, racial/ethnic minorities, and women of color). Barriers to successful PrEP initiation include structural and individual-level issues as well as social determinants of health (SDoH). Innovative strategies are needed to improve PrEP awareness, access, and uptake in venues that routinely care for vulnerable patients. Emergency Departments (ED) serve as a safety net for underserved individuals that are unlikely to access or engage in routine health services. Efforts to scale-up PrEP and expand its reach have included ED-based PrEP prescribing, yet PrEP uptake, linkage to care and persistence have proven challenging. A focus on application of evidence-based interventions using implementation science (IS) to strengthen PrEP delivery in the ED and urgent cares (UC) to those who will benefit most has been limited to date. This project seeks to use established IS methods to develop, validate, and pilot test a patient-centered Decision Support Tool (DST) to promote PrEP persistence post ED/UC care. Based on the WHO SDoH framework, we seek to develop a DST that can be administered in ED/UC settings and will assist PrEP eligible persons to identify their HIV risk, promote self-efficacy, and provide support for SDoH needs identified through the tool. First, we will use pilot data, previously validated tools, and evidence from the ED PrEP implementation landscape to design a patient- centered PrEP DST using the Consolidated Framework for Implementation Research. We will then refine the DST using a participatory prototyping workshop engaging current, prior and potential PrEP users. The DST will be designed to optimize PrEP initiation, adherence and persistence post-ED/UC care by improving HIV risk assessment, self-efficacy, and by identifying and addressing the multifaceted medical and social needs of the individual patient. Next, we will determine the acceptability of the DST using the Normalization Process Theory across EDs and UCs in the DC-Baltimore region. Finally, we will conduct preliminary effectiveness testing of the DST among 120 PrEP eligible patients through a pilot implementation study at two EDs and one UC in Baltimore and DC comparing PrEP prescription only to PrEP and the DST. The primary outcome will be 4- month PrEP persistence; we will also measure PrEP linkage to care, initiation, persistence, and adherence at 1-week, 1- and 4-months using self-reported, clinical, and biological measures. This project aligns with NIH and EHE priorities as it seeks to improve the PrEP continuum of care in two urban areas with high HIV prevalence rates, reduce health inequities, and improve health outcomes. Implementation research will identify factors that support successful implementation with the goal of using these data to improve PrEP uptake, provide lessons learned, and seek to expand the program to other EDs both locally and nationally.

NIMH - National Institute of Mental Health

PROJECT SUMMARY The goal of this Phase I STTR is to enable the commercial readiness of an imaging platform for precision mental health. Despite significant federal investment, the translation of functional brain imaging technologies into clinical psychiatry remains elusive. Current methods, such as functional Magnetic Resonance Imaging (fMRI) and Electroencephalography (EEG), show poor reliability and reproducibility, in large part due to reliance on group-averaging and short-duration recordings. Accumulating evidence suggests that larger quantities and durations (i.e., highly sampled) of data are needed to fulfill the promise of functional neuroimaging in clinical psychiatry. Objective, highly reproducible measurements of brain function would empower clinicians and researchers to make more accurate characterization of mental illnesses and reliable monitoring of treatment efficacy. One way to meet the need for highly sampled data collection is to enable data collection by patients themselves or their parents/caregivers, out of the lab (e.g., at home), similar to at-home blood pressure monitoring. Unfortunately, current methods cannot scale because they are too costly and impractical. To this end, our interinstitutional, multidisciplinary team of experts in engineering, neuroscience, psychiatry, UX and software design has developed a functional prototype of a precision mental health platform appropriate for at-home use. The prototype integrates a low-cost, wireless, multi-sensor, wearable functional near infrared spectroscopy (fNIRS) device with a tablet app that delivers standard, neuroimaging-ready cognitive tests through a HIPAA-compliant cloud portal for researchers and clinicians to remotely monitor patient’s brain response during long sessions spanning multiple days or weeks. Importantly, our platform’s unique strategy for self-alignment and ultra-low cost are key features to enable scalable, at-home use by patients with high data accuracy. In contrast, hurdles of cost and usability limit scalability for at-home use of other commercial and emerging fNIRS systems, which are largely designed for use by researchers. Our preliminary study to collect highly sampled data in a small cohort of healthy adults in a home-like setting with our prototype showed (1) data reliability improves significantly with longitudinal use and (2) we can extract robust and reproducible individual- and group-level findings. In preparation for commercialization, this proposal aims to overcome two technical hurdles needed to ensure reliability of the data collected by patients at home: (Aim 1) Modify the prototype design for reliable data acquisition across inclusive physical differences such as varying head size and skin tone; (Aim 2) Evaluate the feasibility and usability of the developed platform in an at-home study. While our system is generalizable for a variety of illnesses and disorders, here we will validate its clinical relevance for attention deficit hyperactivity disorder (ADHD), a model disorder due to its clinical high significance, brain target accessibility and ease of recruitment. If successful, our Phase II proposal will aim to modify the device for scalable manufacturability and carry out larger clinical validation studies.

NIAAA - National Institute on Alcohol Abuse and Alcoholism

Project Summary/Abstract Alcohol use disorder (AUD) is among the top causes of disability globally. Although several treatment approaches are effective in helping those with AUD reduce their drinking, only 35-40% are asymptomatic a year after treatment, suggesting there is ample room to improve treatment efficacy. Innovation in counseling- based treatments for AUD has been slow, with treatment remaining largely unchanged since the mid-1990s. The core of many effective, counseling-based treatments for AUD, including cognitive behavior therapy and relapse prevention, is helping patients learn and use coping skills to avoid drinking when urges strike or in high-risk situations. Reviews suggest that these skills are also a core mechanism that explains why these treatments are effective. Traditionally, counselors have used verbal/written instruction, role play, and rehearsal to help patients learn these skills. Although helpful, this approach relies extensively on abstract thinking and memory and provides few opportunities to practice using these skills in situations that feel like those patients will experience in their daily lives. Virtual reality (VR) refers to computer-generated experiences that give users a convincing sense that they are physically present in a digital environment. A large body of research shows that simulation-based training involving VR improves skill learning and transfer. For this reason, VR has been used to enhance psychotherapy for a variety of mental health conditions, most notably anxiety disorders, since it can realistically immerse users in feared situations that are too difficult to recreate in vivo. Meta-analyses suggest that VR-assisted treatments for anxiety perform as well as in vivo treatments and are likely to be significantly easier to deliver. Despite the promise of VR in anxiety treatment, there have been few dedicated efforts to explore VR’s utility as a treatment tool for AUD. VR experiences that immerse users in situations and environments that are high-risk for relapse, like bars, celebrations, or general stressors, could provide more authentic context for helping AUD patients learn coping skills that elicit more genuine emotional and social responses – making coping strategies more memorable and transferable. At Real Recovery VR Inc., we have designed six environments that match common high-risk situations that patients with AUD report encountering while in recovery. In this Phase I SBIR application, we propose to complete the development of the Real Recovery VR platform and establish its technical merit with cycles of usability studies with AUD counselors and patients (Aim 1). Once the full platform is complete, we will use mixed methods (product demo, qualitative interview, follow-up survey) to evaluate its feasibility with AUD counselors and patients recruited from a partner treatment facility (Aim 2). We will then use similar methods with directors of addiction treatment facilities to evaluate its commercial potential (Aim 3). Accomplishing these aims would provide essential data needed to pursue a Phase II to evaluate the impact of the platform on AUD-related clinical outcomes and to begin exploring other potential applications of VR to addiction treatment.

National Institutes of Health

Accelerating Solutions to Improve Access and Quality of Empirically-Supported Practices for Youth Mental Health (R01 Clinical Trial Optional)