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¡GANAS!: A Men’s Health Intervention to Improve Sleep, Increase Social Connectedness and Reduce Stress Among Low-Income Men

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NIMHD - National Institute on Minority Health and Health Disparities

Low-income men experience elevated chronic disease burden and chronic stress, yet few prevention programs are designed to strengthen stress coping, social connection, sleep, and wellbeing in this population. In our previous NIMHD-funded research with low-income men in the U.S. Northeast, stress emerged as a key link between unemployment, housing insecurity, limited social support, stress-related behavioral responses, and chronic disease risk. Sleep is a particularly important prevention target because chronic stress can disrupt sleep through physiological arousal and altered stress regulation, while poor sleep is associated with hypertension, cardiometabolic disease, mental health symptoms, and earlier mortality. Social connectedness is also strongly linked to quality of life and health, including psychological wellbeing, blood pressure, immune functioning, and mortality. Programs that strengthen coping, help-seeking, communication, social support, and health-promoting routines have strong potential to improve sleep and reduce chronic disease risk among low-income men, yet few scalable interventions have been tested with this population. The objective of this proposal is to test GANAS, a 10-week men’s health intervention designed to improve sleep, strengthen social connectedness, and reduce chronic stress among low-income men. Delivered through Facebook Groups and facilitated by trained peer mentors, GANAS brings together groups of men for weekly workshops, discussion, skill-building, and digital engagement focused on chronic stress, coping, sleep, relationships, help-seeking, social support, and health-protective routines. GANAS was developed through formative and pilot work with Latino men, and the revised trial will test whether its core mechanisms improve sleep, stress regulation, and social connection among low-income men more broadly. We will randomize 300 low-income men ages 25–64 in Philadelphia into a two-group waitlist-controlled trial. The primary outcomes are sleep duration, sleep quality, and sleep efficiency, assessed using Fitbit actigraphy and the Pittsburgh Sleep Quality Index. Mechanistic outcomes include fingernail cortisol, blood pressure, perceived stress, coping, and social connectedness. Changes in social connectedness will be assessed using egocentric and sociocentric social network analysis. Follow-up data will be collected immediately post-intervention and 9 months after intervention completion to assess maintenance of effects. Findings will inform scalable prevention strategies to improve sleep, strengthen stress regulation, and enhance social connection among low-income men.

Up to $781K
2030-11-30
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

1/2 Self-directed mobile mindfulness to address ICU survivors' psychological distress: the Lift RCT

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NCCIH - National Center for Complementary and Integrative Health

Cardiorespiratory conditions such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are among the most common causes of mortality and morbidity. They are also notable for high rates of persistent psychological distress symptoms including depression, anxiety, and PTSD that worsen quality of life and outcomes of the underlying conditions. Yet there are few effective strategies able to overcome barriers of limited access to mental health care. To address this gap, we developed Lift, a completely automated and self-directed mindfulness training intervention, from the ground up with patient input. First, Lift reduced depression symptoms and improved quality of life compared to an education program control in a multicenter pilot RCT (R34 AT008819) among those recently hospitalized with serious cardiorespiratory conditions. Next, a 247-person multicenter 2x2x2 factorial optimization trial (U01 AT00974) compared 8 intervention versions differing by program introduction (app vs. therapist), dose (standard vs. high), and approach to in-the-moment symptom management (app vs. therapist). This trial demonstrated that while all versions had a strong effect on depression, anxiety, and PTSD symptoms, the high dose, app-only version was optimized for effect, adherence, and retention. Given these promising findings, a formal test of the optimized Lift mobile mindfulness intervention’s efficacy is needed. Therefore, we propose a 4-site multicenter RCT with 6-month follow up among 450 cardiorespiratory failure survivors with elevated post-discharge symptoms of psychological distress. Our specific aims will: (1) Test Lift vs. an education program control delivered by similar platforms on symptoms of depression, anxiety, PTSD, and quality of life; (2a) Determine patient-level characteristics associated with a greater treatment response among a priori-defined subgroups using a heterogeneity of treatment effects analysis; (2b) Explore novel adherence metrics and outcomes; and (3) Ensure off-the-shelf intervention readiness with an exploratory mixed-methods hybrid type 1 implementation framework analysis that integrates quantitative trial implementation data with semi-structured trial participant interviews. Innovative and unique elements include a fully automated mobile health delivery system that personalizes content in response to changes in symptom trajectories, a focus on enrolling a population representative of the US, and strong community engagement with formalized roles. This project addresses national research priorities and could advance the field with a personalizable yet population-scalable therapy that has the potential to broadly improve mental health access.

Up to $989K
2027-03-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

2026 Sleep Regulation and Function Gordon Research Conference and Gordon Research Seminar

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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.

Up to $20K
2027-03-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

2026-2030 International Congress on Integrative Medicine and Health (ICIMH)

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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.

Up to $30K
2031-03-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A Brief Mobile Intervention to Address Prenatal Cannabis Use

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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).

Up to $751K
2029-03-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A community-based trial of a voluntary smoke-free home intervention in permanent supportive housing for formerly homeless adults

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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.

Up to $680K
2028-02-29
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A Day in the Life of the Human Brain: Investigating the Dynamic Interrelationship Between Brain, Cognition, Behavior, and Physiology

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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.

Up to $1.0M
2029-02-28
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A Foot in Each World: Bridging the Divide Between Clinical Research and the Mobile Apps That Support It

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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.

Up to $157K
2029-01-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A genetic strategy to identify neural circuits that regulate social attachment in prairie voles

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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.

Up to $458K
2028-03-14
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A hierarchical factorial cluster-randomized controlled trial to evaluate a multi-level intervention to address stigma for women living with HIV

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NIMH - National Institute of Mental Health

Achieving durable viral suppression among women living with HIV (WLWH) is critical to decreasing HIV transmission and ending the HIV epidemic in the United States and globally. However, for a subset of the population, sustained engagement in HIV services remains challenging. This situation is a primary contributor to persistent HIV transmission and a fundamental barrier to eradicating HIV. Stigma has been associated with suboptimal antiretroviral therapy adherence and viral load suppression. HIV stigma is a complex, multilevel barrier that has not been adequately addressed in existing service delivery. Although other barriers exist, stigma is a driving factor in low engagement of WLWH in HIV care, and evidence suggests that addressing stigma will improve sustained engagement in HIV care. Despite the well-documented negative impacts of stigma on HIV outcomes, there is a critical gap in innovative, evidence-based, multilevel interventions to reduce stigma. To address stigma and support lifetime HIV viral suppression among WLWH, we need multilevel strategies that can be readily implemented at scale. Our interdisciplinary and experienced team of Investigators will address this key gap. To support the multi-factorial research design required to rigorously evaluate multilevel stigma reduction interventions in a time- and cost-efficient manner, the following conditions are required: (1) A high geographical concentration of WLWH who struggle to engage with HIV care residing in the catchment area of a large enough number of HIV clinics to support randomization of health facilities and; (2) evidence-based stigma reduction interventions at both the health care facility (HCF) and individual WLWH levels to combine into a multilevel intervention. With all these conditions present, Tanzania offers a unique opportunity to evaluate the impact of a multilevel HIV stigma reduction intervention and generate translatable evidence for other settings where stigma is a significant barrier to sustained HIV care engagement but the conditions to evaluate a multilevel intervention are not present (e.g., the southern U.S.). This project builds on our team’s pioneering research on HIV stigma reduction interventions at the HCF and individual levels. We have previously adapted two complementary HIV stigma reduction interventions in Tanzania. The first, the Total Facility Approach (TFA), addresses HIV stigma among HCF staff. The second intervention, the Labda Siku Moja (LSM), is an internalized stigma reduction intervention. We will refine and combine these two interventions into a multilevel stigma reduction intervention to address HIV stigma faced by WLWH. In Aim 1, we will implement a hierarchical 2×2 factorial cluster-randomized controlled trial to determine the effectiveness of the multilevel stigma reduction intervention on quality of life and HIV viral suppression among WLWH who have missed scheduled clinic visits. In Aim 2, we will conduct a prospective mixed-methods process evaluation to assess implementation processes, theorized mediators influencing intervention effectiveness, and preliminary costs. In Aim 3, we will convene a series of study advisory group workshops to interpret Aims 1 and 2 findings and refine the intervention for broader implementation. The proposed research will fill a critical gap in our knowledge for supporting sustained engagement in lifetime HIV care, essential to eradicating HIV from the U.S. and globally. HCF and internalized stigma are significant barriers to maintaining viral load suppression and preventing onward transmission of HIV. This study provides the unique conditions necessary to evaluate a multilevel stigma reduction intervention and, if effective, will provide a translatable multilevel stigma reduction approach to fill the significant unmet need for stigma reduction in the U.S., thereby improving the lives of American WLWH and their families while advancing public health.

Up to $777K
2031-02-28
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A human-centered, multi-stakeholder approach to develop and test a digital intervention for Black male emerging adults with depression

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NIMH - National Institute of Mental Health

Depression affects over 21 million people in the U.S. each year, significantly diminishing quality of life and contributing to substantial health disparities in mental health outcomes. Among Black emerging adult men, there are well-documented disparities in depression detection, access to care, and engagement with traditional services. These differences are associated with exposure to multilevel stressors that may limit access to services, contributing to delayed care, reduced engagement, and poorer outcomes, underscoring the need for innovative, evidence-based, and community-informed approaches. My long-term goal is to develop scalable, technology-enabled mental health interventions for Black emerging adult men. This K01 project will use community-based participatory research (CBPR) as a guiding framework across all phases-from study design to dissemination. The project will design, develop, and pilot test a web­based digital mental health intervention (DMHI) informed by feedback from Black men with depression. Grounded in CBPR and human-centered design, the intervention will incorporate participant-informed digital features to support engagement. Theoretical foundations include Social Cognitive Theory (SCT), the PEN-3 model, and Cognitive Behavioral Therapy (CBT), integrated to support behavior change and improved mental health outcomes. Focus groups with Black men and key stakeholders will identify engagement preferences and factors influencing participation, and co-design and usability testing will guide iterative development. A pilot study will assess feasibility, acceptability, and estimate preliminary impact on engagement and depressive symptoms. This project advances NIMH Strategic Goal 4 by developing a scalable, community-rooted digital intervention to improve access, engagement, and mental health outcomes in real-world settings. It also supports national priorities to improve mental health outcomes among young adults through evidence-based approaches. With guidance from a multidisciplinary mentoring team, I will gain expertise in stakeholder-engaged implementation science, human-centered design, and DMHI development and evaluation. This work will strengthen the evidence base for improving mental health outcomes and reducing health disparities among Black emerging adult men and position me as an independent investigator in digital mental health services research.

Up to $176K
2031-05-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A Laboratory and Ambulatory Investigation of Trauma-related Dissociation, Interoceptive Accuracy, and Interoceptive Attention

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NIMH - National Institute of Mental Health

Project Summary/Abstract Trauma-related dissociation is a common yet disabling experience characterized by a sense of detachment from the body during or following a traumatic event. Approximately 4% of community members and 20% of people with post-traumatic stress disorder (PTSD) report dissociation, meaning more than 13 million Americans experience this type of dissociation in their lifetime. Given that dissociation is characterized by detachment from bodily experiences and that many body-oriented symptoms occur alongside it (i.e., somatic symptoms, intentional harm to the body), it is plausible that interoception, the perception of internal bodily states, is regularly disrupted among these individuals. Indeed, recent theoretical models propose that greater trauma-related dissociation may be associated with poorer interoceptive skills. This is important because poor interoceptive skills are associated with negative mental health outcomes, like posttraumatic stress disorder and dissociative disorders. Unfortunately, there are several barriers that have prevented the progression of research on this topic. For example, past work has failed to capture the multifaceted nature of interoception and been methodologically limited (e.g., used only self-reports; not assessed in naturalistic settings). It is important to understand the interplay between trauma-related dissociation and interoception because no evidence-based treatments exist for dissociation, making this study a critical first step in identifying potential treatment targets. The proposed study will overcome previous limitations by combining self-report and physiological assessments both in laboratory and ambulatory settings to explore the ways in which trauma-related dissociation impacts interoceptive accuracy (i.e., ability to precisely and accurately monitor bodily sensations) and interoceptive attention (i.e., attentiveness to bodily sensations). Adult women between the ages of 18 and 59 with a history of childhood sexual trauma (N = 80), the population most likely to develop trauma-related dissociation, will be recruited from the community to explore whether interoceptive accuracy and attention are worsened by momentary trauma-related dissociation (Aim 1; within-person effects) and worse among people with higher trait trauma-related dissociation (Aim 2; between-person effects). In the laboratory session, participants will complete an interoceptive accuracy task (i.e., Heartbeat Counting Task) and interoceptive attention measure (i.e., Interoceptive Attention Scale) before and after dissociation is induced (i.e., Mirror Gazing Task). This laboratory assessment will be followed by a week of ambulatory assessment with passive physiological monitoring to understand how trauma-related dissociation impacts interoceptive accuracy and attention in naturalistic settings. This project is relevant to the mission of NIMH to identify how and when to intervene to reduce the burden of mental illness. The proposed project will facilitate critical training opportunities in interoception, ambulatory assessment, psychophysiological assessment, and multilevel modeling through planned coursework, workshops, experiential learning, and mentorship from a collaborative and multidisciplinary training team.

Up to $37K
2029-02-28
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A Mechanistic Analysis of the Transition from Nonsuicidal to Suicidal Self-Injury in Adolescents.

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NIMH - National Institute of Mental Health

PROJECT SUMMARY/ABSTRACT Nonsuicidal self-injury (NSSI) is the single strongest prospective predictor of suicidal behavior, yet only one longitudinal study has examined mechanisms that may be facilitating the transition from nonsuicidal to suicidal self-injury. Notably, adolescents may be a particularly high-risk group as both NSSI and suicide behavior often first occur during this developmental period. The onset of NSSI often precedes that of suicidal behavior, making it a key prevention target in adolescents. As 60% of individuals with a history of NSSI do not transition to suicidal behavior, the proposal aims to elucidate which factors predict transition risk among this high-risk subgroup (Aim 1). This proposal also aims to identify the underlying mechanisms of the relationship between NSSI and suicidal behavior, focusing on four candidate mediating processes underlying the NSSI to suicide attempt (SA) transition (intrapersonal distress, social connection, emotion regulation, and self-view) (Aim 2). We will leverage a multi- method approach to assess NSSI severity and candidate mediating factors by employing a traditional longitudinal design combined with burst ambulatory assessments, novel computer vision methodology to obtain an objective clinical assessment of NSSI severity, behavioral tasks, and gold-standard measures. Adolescents aged 13-17 will be followed for a 2-year period to capture the emergence of SAs in the sensitive period following recent NSSI onset. The research team, led by ESI MPIs Taylor Burke and Brooke Ammerman and supported by Co-Is Richard Liu, Ross Jacobucci, and Thomas Serre, brings exceptional proficiency to this project. They possess extensive expertise in adolescent self-injurious thoughts and behaviors, utilizing innovative data collection methodologies, including ecological momentary assessment and computer vision analysis of medical images, as well as the application of sophisticated data analysis strategies. Their combined knowledge also extends to understanding risk relationships among individuals with underrepresented identities and addressing the ethical and privacy concerns unique to high-risk populations. The potential impact of this ESI R01 proposal is significant. Findings will provide valuable information regarding the role and timescale of modifiable risk factors in the nonsuicidal to suicidal self-injury transition, facilitating the development of targeted suicide prevention interventions tailored for this high-risk adolescent population. This proposal is strongly in line with NIMH’s focus on suicide prevention research, as well as NIMH’s Strategic Goal 2 to “examine mental illness trajectories.” With its use of innovative computer vision methodology to objectively assess NSSI severity, this proposal is also in line with Strategy 2.2.B Interest Area 3.

Up to $822K
2031-02-28
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A Mobile Health Intervention to Improve Psychosocial Functioning in Veterans with Posttraumatic Stress Disorder and Depression Symptoms

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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.

2030-09-30
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A Mobile Mindfulness-Based Intervention for Unhealthy Alcohol Use in People with Anxiety

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NIAAA - National Institute on Alcohol Abuse and Alcoholism

PROJECT SUMMARY/ABSTRACT This Mentored Patient-Oriented Research Career Development application (K23) will provide protected time for Dr. Natalia Van Doren to strengthen her trajectory as an independent researcher at the University of California, San Francisco (UCSF) and the Kaiser Permanente Northern California (KPNC) Division of Research. Her career goal is to become an expert in developing and testing digital health interventions to address the spectrum of unhealthy alcohol use in people with chronic mental health comorbidities, an area of critical public health importance aligned with NIAAA Strategic Plan, Goal 4. Building on her existing training in clinical psychology and health services research, the integrated training and research plans proposed in this application will provide Dr. Van Doren with advanced training in several critical areas needed to enhance her program of research. Under the mentorship of leaders in alcohol treatment and digital health, training includes: (1) tailoring evidence-based alcohol interventions for mobile platforms (Dr. Maureen Walton; Dr. Sarah Bowen), (2) qualitative methods for treatment research (Dr. Karen Osilla), (3) conducting randomized clinical trials (RCTs) (Dr. Derek Satre; Dr. Stacy Sterling), (4) advanced longitudinal data analysis (Dr. Nicholas Jacobson). These training objectives will be achieved through a combination of didactic and applied activities and through the application of these skills in a Stage 1 behavioral treatment development trial involving the adaptation and initial pilot testing of a novel mindfulness-based ecological momentary intervention (MEMI) targeting unhealthy alcohol use in people with anxiety. Target areas for learning in each training domain are directly linked to the specific aims of this research study, which include (1) iteratively tailoring and optimizing the MEMI to address unhealthy alcohol use in people with anxiety; (2) conducting a pilot RCT to (2a) assess feasibility/acceptability and (2b) generate initial effect size estimates of intervention efficacy compared to a self- monitoring placebo, in preparation for a future R01 trial; and (3) using intensively collected ecological momentary assessments (EMA) to examine within-person mechanisms of change, aligned with the NIH Science of Behavior Change (SOBC) framework. UCSF and KPNC provide ideal environments for the attainment of these training and research objectives, including an established digital health ecosystem within KPNC, seminars and courses in designated training areas, and a highly active Clinical and Translational Science Center at UCSF with a wide array of resources for career development and training. This K23 Award will provide Dr. Van Doren with a repertoire of advanced skills designed to complement her prior training and to provide an essential bridge between her prior experience and her career goal to conduct an active program of patient-oriented research as an independent scientist, toward the ultimate goal of reducing the public health burden of unhealthy alcohol use.

Up to $203K
2031-06-30
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A Multi-site Randomized Controlled Trial of Psilocybin for Treatment-Resistant Depression (TRD) in Veterans

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NIH

Significance to VA: Treatment-resistant depression (TRD) is a serious mental health problem in Veterans, frequently comorbid with post-traumatic stress disorder (PTSD), and in need of novel and effective treatments. Also, TRD in Veterans is associated with a high risk of suicide, addiction, unemployment and medical morbidity. Innovation and Impact: Clinical studies have revealed antidepressant effects of psilocybin for depression and TRD in civilians, but less is known about its efficacy and safety in Veterans. Very limited data is available on the effects of psilocybin in the treatment of comorbid PTSD and when used in combination with serotonin reuptake inhibitor antidepressants. This state-of-art clinical trial will evaluate the safety and efficacy of psilocybin in the treatment of TRD with and without PTSD to advance knowledge in psychedelic therapy in Veterans. Methodology: This multi-site, double-blind, randomized controlled trial will evaluate the efficacy and risks of psilocybin for the treatment of TRD in U.S. military Veterans with and without (±) concurrent PTSD. Eligible and consenting Veterans will be randomized (N=240) and undergo two psilocybin dosing sessions along with preparation, administration, and integration psychological support. For the 1st psilocybin administration, participants will receive either a 1mg dose (control condition) or a 25mg dose (active) under blinded conditions. At their 2nd psilocybin dosing visit 4 weeks later, all participants will receive a 25mg dose. Outcomes will be measured by a centralized independent evaluator masked from all treatments at 2 and 4 weeks after each dosing session and over 6 months follow-up. Both expected and unanticipated adverse events will be collected by type, severity and relatedness to the study drug after each dosing session and at follow-up. Assessments of subjective experiences of psilocybin, expectancy and blinding are included in the protocol. Specific Aim 1 (Efficacy): Evaluate the short-term antidepressant effects of 25mg psilocybin compared to 1mg psilocybin for TRD under blinded conditions by centralized evaluator. Primary Hypothesis: Participants treated with the 25mg psilocybin dose (n=120) will show a significantly greater decrease on the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week-4 post-dose compared to the 1mg psilocybin dose control group (n=120). The Hamilton Depression scale is also collected as a common data element. Specific Aim 2 (Safety): Evaluate risks in participants who took ≥ one psilocybin dose with the Swiss Psychedelic Side Effects Inventory and other reported adverse events. Exploratory Aims (E): E1 PTSD: For the subgroup with TRD+PTSD (~50% of the sample), estimate the change from baseline to week 4 on Clinician-Administered PTSD Scale-Revised (CAPS- 5-R) by group. E2 2nd Dose: Examine the antidepressant effects of one vs two 25mg dosing sessions by comparing change in MADRS from baseline to week 8 (i.e., ~4 weeks after the 2nd dose) between the group receiving the 1mg dose followed by the 25mg dose versus the group treated with two 25mg doses. E3 Response & Remission: Explore rates of response (ΔMADRS ≥50% reduction) and remission (MADRS score ≤10) at week 4, week 8 and month 6, within group and between groups. E4 Other Relevant Outcomes: Explore potential effects of treatment on patient-reported and other outcomes over time, including expectancy, depression, PTSD, suicidality, psychological flexibility, and functional outcomes. Measure altered experience during psilocybin dosing sessions and explore impact on outcomes and functional unblinding. Qualitative Aim: Participants (~10 per site; n=50) will be interviewed on topics of acceptance, satisfaction, and facilitators/barriers of treatment with psilocybin to gain a better understanding of Veteran preferences on the treatment itself, the composition/structure of the psychological support model and future implementation of clinical psychedelic treatment programs in VA. Path to Translation/Implementation: Industry-sponsored studies seeking FDA approval are already underway. The timing of FDA-approval of psilocybin should align with the conclusion of this study. VA can use these results to make decisions on offering psilocybin treatment and to guide implementation within VA mental health systems.

2031-06-30
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A Multimethod Approach to Preventing Substance Use Among Youth

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NIDA - National Institute on Drug Abuse

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

Up to $686K
2031-03-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A Multimodal Assessment Protocol for Characterizing Restricted and Repetitive Behaviors in Autism

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NIMH - National Institute of Mental Health

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

Up to $767K
2031-06-30
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A Randomized Control Trial of a Scalable Parenting Program to support Candidate Brain Pathways, Autonomic Regulation, and Socio-Emotional Development in Preterm Infants

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

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

Up to $598K
2031-05-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

A Randomized Controlled Trial of Brief Behavioral Activation for Older Adult Cancer Survivors

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NCI - National Cancer Institute

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

Up to $732K
2031-05-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

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