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NIMH - National Institute of Mental Health

PROJECT SUMMARY/ABSTRACT The proposed project will investigate the menstrual cycle as a predictable and recurrent risk factor for mood episodes and suicidality during adolescence. Female individuals exhibit a threefold increase in suicide risk during the peripubertal period compared to males, and emerging evidence in adults suggests that cyclical fluctuations in ovarian hormones may be a biological trigger for suicidality in those with a brain sensitivity to hormonal changes. Cross-sectional studies indicate that the two weeks surrounding menses onset represent a window of elevated suicide risk, including increased attempts and hospitalizations, and longitudinal work from the primary mentor’s lab has demonstrated corresponding spikes in suicidal ideation during this timeframe. Critically, adults with hormone sensitivity frequently report that their symptoms began during adolescence, highlighting the potential of early identification to substantially reduce life-long patient burden. Despite this, it remains unknown whether this phenomenon begins during adolescence—an urgent knowledge gap this study will be the first to address. This work also directly aligns with the NIMH Priority Research Areas by addressing the urgent public health crisis of rising suicide rates. Building on the primary mentor’s recently completed R01 (MH-122446), which followed 125 adolescent females at high suicide risk across the menstrual cycle, the proposed study adds 40 days of high-density hormone data to the 70 days of daily mood and suicidality assessments. This innovative project seeks to determine who is at risk for cyclical suicidality, when risk escalates, and how hormonal mechanisms contribute to that risk. Specifically, the study aims to: (1) estimate the prevalence of premenstrual symptoms in adolescence, (2) identify differences in symptom timing and trajectories across the menstrual cycle, and (3) examine dynamic networks between hormones and psychiatric symptoms to uncover how ovarian hormones influence adolescent suicidality. To achieve these aims, the candidate will use gold-standard diagnostic methods, novel computational modeling approaches (such as flexible nonlinear models and idiographic symptom networks), and exploratory machine learning techniques. This research will not only generate novel insights into hormone-linked suicidality but will also serve as a robust training platform for the candidate—a physician-scientist in training with research and clinical interests in reproductive mood disorders across the lifespan. Through expert mentorship in menstrual cycle research, adolescent psychopathology, and advanced quantitative methods, the candidate will gain critical skills in conducting observational and experimental research and clinical care related to reproductive mental health, suicide prevention, and adolescent medicine. This project thus aims to advance both scientific discovery and promote the career development of a future physician-scientist in foundational research on adolescent reproductive psychiatry.

IL Dept of Veterans Affairs

Grants to nonprofits providing housing, employment, and mental health services to Illinois veterans.

NIMH - National Institute of Mental Health

Project Abstract Sleep is essential for brain function and health. Over 50 million Americans have sleep disorders, and disrupted sleep causes impairments in attention and cognition. Furthermore, over the long term, disrupted sleep raises the risk of neurological and psychiatric disorders, including Alzheimer's disease, anxiety, and depression. Identifying the brain circuit activity that regulates healthy sleep in humans is a key step needed to enable understanding and addressing sleep disorders. However, the subcortical brain regions thought to regulate sleep have not yet been imaged with high spatial precision in the human brain during sleep, limiting our understanding of how these networks contribute to modulating sleep architecture and vigilance levels. This project will use advanced neuroimaging technologies to map the subcortical (including brainstem, thalamic, and hypothalamic) circuit activity underlying sleep-wake states in humans. We will employ high spatiotemporal resolution 7T fMRI and precise individual-level analysis strategies to distinguish activity in individual nuclei, in combination with simultaneous EEG using a novel net that allows for use at ultra-high magnetic field strengths. We will identify the circuit activity underlying the descent into non-rapid eye movement (NREM) sleep, and the activity pattern that underlies arousals from sleep. Furthermore, we will investigate which subsets of these circuits are linked to distinct EEG rhythms that appear during increasingly deep stages of NREM sleep. We will then test which dynamics are predictive of sleep depth and sensory responses in cortical networks. Finally, we will determine whether this sleep-associated activity is overlapping or distinct from the activity patterns that underlie fluctuations in vigilance and microsleeps that impair daytime cognition, using a sustained attention task. Overall, these studies will identify the subcortical activity dynamics that underlie sleep and vigilance levels in the human brain, providing new insight into the intricate networks that regulate sleep architecture in humans. This knowledge will provide an essential scientific foundation for understanding the circuits that are involved in disrupted sleep and vigilance states, and identifying potential targets for clinical populations.

NIMH - National Institute of Mental Health

Project Summary A form of accelerated transcranial magnetic stimulation (aTMS) with patented imaging-based targeting called Stanford Accelerated Intelligent Neuromodulation Therapy (AINT) has shown rapid and substantial antidepressant benefits that rival or exceedthose of electroconvulsive therapy. However, the public health impact of aTMS may be limited by the time, cost, and complexity of using imaging-based targeting. Access to an MRI scanner with an optimized functional connectivity sequence may be limited by geography or insurance. Even with MRI data, most clinicians lack the expertise to derive targets and the neuronavigation equipment to stimulate them. Increasingly, consultants and companies are offering to remotely derive imaging-based targets for fees despite the paucity of prospective trials verifying that they yield significant clinical benefits over conventional scalp-based targets. In July 2023, we launched a pilot trial (NCT05680727) to estimate the effect size of imaging- based targeting for aTMS. This trial leveraged our publicly available, evidence-based, and reproducible imaging- based targeting algorithm. A blinded interim analysis (n=21) revealed 69.8% (34% SD) vs. 52.9% (27% SD) Montgomery–Åsberg Depression Rating Scale (MADRS) improvement one month after aTMS (Cohen’s d=0.52). Based on these results, a sample size of 60 per group provides 99% power to detect a between-group difference. Here, we propose a fully powered, double-blind, confirmatory efficacy trial (n=120) for imaging- vs. scalp-targeted aTMS for MDD. Aim 1 compares clinical outcomes between imaging- vs. scalp-targeted aTMS for TRD. First, we hypothesize that the imaging-targeted group will show a significantly greater MADRS reduction (%) than the scalp-targeted group. Second, we hypothesize that a larger response (≥ 50% MADRS improvement) in the imaging- vs. scalp-targeted group will reveal the “number needed to scan” for a single person to benefit from imaging-based targeting. Aim 2 investigates the relationship between target location and response in scalp-targeted aTMS for TRD. We hypothesize that clinical improvement will negatively correlate with distance between the actual scalp-based target and the predicted imaging-based target. SAINT could impact psychiatric care in many ways if it proves to be reproducible and scalable. However, we cannot address these issues until we begin to dissect SAINT into its component parts and grow aTMS in a brand-agnostic manner. The results of this study will estimate the “number needed to scan” to get a single person better with imaging- vs. scalp-targeted aTMS. Future studies could examine effectiveness, build freely available apps for imaging-based targeting (similar to Beam F3 app for scalp-based targeting), analyze cost effectiveness, or randomize people who do not respond to scalp-targeted aTMS to imaging-targeted aTMS vs. another intervention like esketamine or ECT (i.e., an interventional psychiatry equivalent of STAR*D). This trial is a step toward a future with a wider variety of scalable, publicly available, non-proprietary aTMS treatment options.

NIMH - National Institute of Mental Health

PROJECT SUMMARY During adolescence, individuals with attention-deficit/hyperactivity disorder (ADHD) often show escalating academic and social impairments and comorbid psychopathology, a rapid decline in medication use and adherence, less engagement in psychosocial treatments, and limited data to guide those treatments. Sleep has emerged as a promising new intervention target to mitigate this confluence of undertreatment and risk. Even compared to their notoriously sleep-deprived typically-developing (TD) peers, adolescents with ADHD have worse sleep, irrespective of whether they are taking ADHD-targeting medications. Growing evidence links this poor sleep to functional impairment, and our team has shown these links to be causal. Experimentally shortened sleep causally degrades core inattentive symptoms and common comorbid symptoms for adolescents with ADHD. Conversely, the effects of lengthening sleep in these studies rivaled those of more intensive behavioral treatments. Sleep-targeted interventions show tremendous promise for adolescents with ADHD, but other observational data from our group also highlight a crucial puzzle to unlock this promise: how to best integrate sleep duration with sleep timing. Adolescents with later chronotypes (“owls,” who prefer later bedtimes and rise times) perform worse in school than those with earlier chronotypes (“larks”), even after controlling for sleep duration and quality. We assert that this reflects a “misalignment effect”: a timing mismatch between the early demands of school and the late circadian phase (internal body clock) of owls. Emerging data from our labs suggest that attention in TD adolescents is improved by lengthening sleep only if it is timed to align with the individual’s circadian phase. If this also holds true for adolescents with ADHD, it would light new paths towards individualized interventions that address misalignment. In addition, evidence suggests that adolescents with ADHD may have delayed circadian phase, which would make morning activities (e.g., school) misaligned. If so, it would point to circadian-informed interventions for adolescents with ADHD as a group. To guide and justify circadian-informed intervention development, we propose two concurrent studies that will yield complementary data. The first is an observational school-year study that will determine, for the first time, test whether adolescents ages 13-17 with ADHD (n=85) average a later circadian phase than sex- and age- matched TD peers (n=85), and whether misalignment is linked to real-world deficits in attention and functional outcomes. The second is a summer mechanistic clinical trial that will test, also for the first time, the causal impact of circadian misalignment on attention in adolescents with ADHD (N=50). Findings will provide unique insight into the role of circadian factors in adolescent ADHD, concurrently testing cause-effect relationships and real-world implications. If, as we predict, circadian misalignment is common amongst adolescents with ADHD, causally impacts attention, and is linked to real-world functional impairment, it would open important new avenues for intervention in a difficult-to-treat population at high risk for poor outcomes.

National Institutes of Health

The National Institute of Mental Health (NIMH) intends to publish a notice of funding opportunity (NOFO) to solicit biphasic research applications to evaluate the impact of HIV immunotherapies on central nervous system (CNS) outcomes in people with HIV and to identify mechanisms, benefits, and risks associated with their use in the CNS compartment. The primary goal is to generate evidence that informs whether HIV immunotherapies can safely and effectively target CNS HIV persistence while minimizing neurotoxicity and neuroinflammation. By addressing CNS-specific barriers such as blood brain barrier penetration, compartmentalized viral dynamics, and immune-mediated effects, this NOFO will support the development of strategies that contribute to sustained virologic remission across anatomical compartments and improve long-term neurologic and cognitive outcomes in people with HIV. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Investigators with expertise and insights into the impact of HIV immunotherapies on the CNS and viral reservoirs are strongly encouraged to apply to this new NOFO. This NOFO will utilize the R21/R33 activity code.

National Institutes of Health

<p style="margin-left:0in;">The National Institute of Mental Health (NIMH) intends to publish a notice of funding opportunity (NOFO) to solicit biphasic research applications to evaluate the impact of HIV immunotherapies on central nervous system (CNS) outcomes in people with HIV and to identify mechanisms, benefits, and risks associated with their use in the CNS compartment. The primary goal is to generate evidence that informs whether HIV immunotherapies can safely and effectively target CNS HIV persistence while minimizing neurotoxicity and neuroinflammation. By addressing CNS-specific barriers such as blood brain barrier penetration, compartmentalized viral dynamics, and immune-mediated effects, this NOFO will support the development of strategies that contribute to sustained virologic remission across anatomical compartments and improve long-term neurologic and cognitive outcomes in people with HIV. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Investigators with expertise and insights into the impact of HIV immunotherapies on the CNS and viral reservoirs are strongly encouraged to apply to this new NOFO. This NOFO will utilize the R21/R33 activity code.</p>

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

Over 55% of the world’s population resides in urban areas, a figure projected to rise to 68% by 2050. Urban living is linked to an elevated risk of mental illness in adults, likely due to the combined effects of physical and social stressors. Exposure to urban environments during infancy and early childhood, a critical period of brain development, is associated with higher risks of schizophrenia, autism, substance dependence, and mood and anxiety disorders. These vulnerabilities likely originate early in life when the brain is rapidly developing and highly sensitive to environmental influences. However, the mechanisms by which urbanicity affects early brain development remain poorly understood. Our primary objective is to address this critical gap by identifying the neural correlates of urbanicity in infants and investigating the gut microbiome as a potentially modifiable mechanism in this relationship. The gut microbiome, a diverse community of microorganisms in the digestive tract, plays an important role in regulating stress responses. Our central hypothesis is that urban environments alter infants’ gut microbiome composition and function. Gut microbiome changes, in turn, disrupt neurodevelopmental processes occurring during the first year of life, altering brain structure and connectivity, and increasing the risk of mental health challenges. To test this hypothesis, we will use data from the NIH-funded Organization for Imaging Genomics in Infancy (ORIGINs) consortium, which includes over 4,000 infants and young children from six countries with high-resolution structural MRI, diffusion tensor imaging, and resting-state fMRI scans. Urban environment variables will be assessed using geocoded residential addresses and will encompass both physical and social features, including air quality, green spaces, blue spaces (water bodies), street connectivity, and access to specific facilities, infrastructures, and destinations such as health care, supermarkets, and convenience stores. We will test whether urbanicity is associated with brain structure and function in systems related to stress, reward, and emotional processing. Gut microbiome data, already extracted and sequenced from a subset of ORIGINs cohorts, will be analyzed to generate diversity metrics and assess their associations with urban exposure, as well as their potential mediating role in the relationship between urban exposure and neuroimaging phenotypes. This research is significant because it will provide critical insights into biological pathways linking urbanicity to early brain and gut development, guiding strategies to create healthier urban environments that reduce psychiatric risks and promote mental health.

OD - NIH Office of the Director

PROJECT SUMMARY Access to quality health care is a persistent public health challenge for children living with disabilities (CWD) and contributes to elevated rates of poor physical and mental health, especially for CWD who live in low- income households, live in rural areas, or are Black or Hispanic. School-based health centers (SBHCs) are a promising health care delivery intervention for children and families that provide primary care and other preventive services at no or reduced costs and on or near school grounds, thereby overcoming financial and transportation barriers to care. Prior studies suggest that SBHCs improve health care access and health and academic outcomes but benefits to CWD have not been examined. This proposed study will address this gap using a sequential explanatory mixed methods design to examine the impacts of SBHCs on outcomes among CWD in California and Oregon, states with longstanding SBHC programs and diverging approaches to SBHCs. Using multiple years of health insurance claims data and survey data, we will: (Aim 1) characterize access to and use of SBHCs and (Aim 2) estimate SBHC impacts on health care utilization and health outcomes among CWD (overall and by impairment type) and examine differences by income, urbanicity, and race and ethnicity. Using in-depth interviews with CWD, parents of CWD, and clinicians at SBHCs (Aim 3), we will elicit stakeholder perspectives on the perceived barriers and facilitators to SBHC utilization among CWD. The proposed research is timely and important due to the rapid expansion of SBHCs (128% increase between 1998 and 2017) and recent increases in funding to support SBHCs ($25 million increase between Fiscal Years 2021 and 2022). Elucidating whether and how CWD benefit from SBHC access and use is critical to understanding whether continued expansion and funding will contribute to (or exacerbate) health care access barriers and poor health in CWD.

NIMH - National Institute of Mental Health

PROJECT SUMMARY/ABSTRACT Suicidal thoughts and behaviors are increasingly prevalent among youth in the United States. Pediatric outpatient mental healthcare settings are critical sites for suicide prevention. Despite changes in clinical practice guidelines and accreditation standards recognizing pediatric mental health providers’ responsibility to implement evidence-based practices (EBPs) for suicide prevention, little is understood about how to optimize such practices for the outpatient context. Further, minimal research has captured the perspectives of youth patients who have received suicide prevention EBPs during treatment or those of their caregivers, who are often at the forefront of suicide prevention efforts. The specific aims of the proposed study are to: (1) Understand the lived experiences of key constituents and identify contextual determinants of implementation of a evidence-based suicide prevention pathway within outpatient pediatric mental healthcare, and (2) Develop a set of contextually tailored implementation strategies to optimize and sustain suicide prevention implementation in pediatric mental healthcare using a community-engaged approach. The current study proposes to recruit a sample of pediatric mental health clinicians, youth patients (ages 12-18), and patient caregivers from public, outpatient child psychiatry clinics to participate in qualitive interviews. Additionally, the current study proposes to form a group of implementation leaders (pediatric clinicians and clinic directors) to participate in the Implementation Mapping process. Researchers and leaders will partner to operationalize implementation strategies that are: responsive to the needs of youth patients and families and enhance EBP fit with the outpatient care context. Research aims support the applicant’s training goals to: (1) Enhance knowledge of dissemination and implementation science with a focus on qualitative research and Implementation Mapping, (2) Develop specialized expertise in suicide prevention research and practice in health systems, and (3) Gain foundational training in community-engaged research methods with a specific focus on partnering with community members to develop strategies to increase access to evidence-based mental health services. The applicant’s mentorship team is comprised of experts in youth mental health services and community-engaged research methods (Dr. Meinzer), implementation science and qualitative methods (Dr. Rudd), and suicide prevention research (Dr. Weinstock). The mentoring team will advance the applicant’s goals to pursue research training at the intersection of suicide prevention and implementation science and to utilize participatory methods. The proposed research and training plan ultimately supports the candidate’s long-term goal of pursuing a career as an NIH-funded, independent researcher dedicated to understanding strategies for enhancing suicide prevention within youth-serving systems. The proposed study centers the lived experiences of frontline clinicians, youth, and families in the development of implementation strategies that can be harnessed in future clinical research trials of suicide prevention interventions.

NIMH - National Institute of Mental Health

Mental health (MH) disorders affect over 970 and 59.3 million people worldwide and the U.S, respectively, and remain the leading cause of disease burden across the lifespan, driving significant disability, premature mortality, and elevated risk for comorbid physical health conditions and a staggering national economic impact. Despite decades of research, the burden has not measurably decreased since 1990. In the U.S., nearly half of individuals with mental illness and over 70% with substance use disorders do not receive adequate care. Structural obstacles—including workforce shortages, high costs, negative attitudes, and fragmented care systems—continue to impede access. Implementation Science (IS) offers vital evidence-based approaches to close the persistent gap between evidence-based MH research and routine practice, yet few proven interventions have been scaled successfully to benefit large populations. The IMPACT-MH T32 Training Program (Implementation Science and Partnerships Advancing Care and Training in Mental Health) seeks to cultivate the next generation of MH IS researchers committed to sustainably reducing the U.S. treatment gap. Postdoctoral fellows will engage in intensive mentorship and a fully integrated curriculum spanning all research phases: pre-intervention design, intervention delivery, and post-implementation evaluation. Early emphasis on sustainability and partnerships with communities and policymakers will inform design choices—ensuring that interventions can be effectively delivered, scaled up, and rigorously evaluated over time. Training domains include deployment-focused research—contextual adaptation and stakeholder co-design of evidence-based interventions (EBI) across varied settings—and dissemination, implementation, scale-up, and policy research aimed at securing sustainable MH services. Through tailored mentorship and collaborative training with faculty experts in public health, psychology/psychiatry, IS, and health policy, fellows will develop the interdisciplinary perspectives and the conceptual, methodological, and technological competencies necessary to advance MH IS research. Mentored by experienced faculty, a cohort of four fellows, appointed for two to three years, will partner with communities and policymakers to design projects and pursue competitive NIH awards (including K-series and R-series proposals) will enhance the relevance, feasibility, and impact of their research. Leveraging well-established multisectoral partnerships with community service organizations, health networks, faith-based coalitions, and government programs, IMPACT-MH T32 ensures that fellows’ research informs real-world services and policy. Graduates of IMPACT-MH will be equipped to translate emerging discoveries into sustainable, evidence-informed mental health care systems and policies that strengthen the public health impact of NIMH-supported research (NIMH objective). By training leaders, fostering cross-disciplinary collaboration, building multi-sector partnerships, tailoring and scaling EBI, and advancing sustainable solutions, this program will make significant strides toward closing the U.S. mental health treatment and research gap.

NIH

Significance to VA. Half of the 500,000 Veterans receiving cancer care in VA will encounter distress, a multifactorial psychological, social, spiritual, and/or physical experience that may interfere with one’s ability to cope effectively with cancer. Distress has major implications – decreased likelihood of completing cancer therapy, worse quality of life, more emergency room visits and hospitalizations, and higher mortality, including suicide. The collaborative care model (CoCM) is a proven delivery mechanism for evidence-based treatments that can reduce the negative impacts of distress. However, despite its evidence base, no VA medical centers (VAMCs) currently use CoCM to treat distress. Meanwhile, two out of three Veterans with distress do not receive care. To improve the quality of life and overall survival of Veterans living with cancer, the proposed research aims to understand why CoCM is not widely implemented and how CoCM could be successfully utilized in VA’s diverse care settings. This research directly addresses the major challenge facing VA of providing high-quality, highly-efficient mental health care for a rapidly growing population of Veterans facing life with cancer. It tackles top HSR and VA priorities – mental health & suicide prevention; access to high-quality, integrated health care; and use of foundational learning health systems methods in implementation science and engagement science. Innovation & Impact. This project will use innovative, patient- and clinician-centered implementation science techniques to create key constituent-informed, feasible, and acceptable implementation strategies for use of CoCM in VA cancer care. Specific Aims. Aim 1: Identify current distress care practices and potential determinants (i.e., barriers and facilitators) of CoCM in VA cancer care. Aim 2: Develop implementation strategies for use of CoCM in cancer care with key constituents. Aim 3: Assess the feasibility and acceptability of implementation protocols and materials at three VISN 10 sites. Methodology. Aim 1 uses a two-part study design: 1) semi-structured interviews with key constituents (patients (n=15), clinicians (n=18)) from three VAMCs currently participating in the VA Office of Mental Health’s Mental Health Integration in Oncology Clinics pilot project to understand acceptability and potential determinants of CoCM and 2) a national survey of VA medical oncologists to identify the workforce and workflows currently used to address distress across VA. Aim 2 uses a panel of key constituents (n=18 including two patients) to identify implementation outcomes, select implementation strategies, and produce implementation protocols and materials supporting CoCM use in VA cancer care. Aim 3 uses a mixed-methods, user-centered design approach to determine the feasibility and acceptability of the protocols and materials designed in Aim 2 through “think-aloud,” semi-structured interviews with and quantitative surveys of end-users (n=12, oncology and mental health clinicians) from three different VISN 10 sites. Path to Translation/Implementation. Future work will aim to 1) determine the quality of and preferences for distress care among women and young adult Veterans living with cancer – two quickly growing populations within VA who may have unique distress care needs that CoCM will need to meet (Year 3 IIR) and 2) conduct a multi-site, randomized, hybrid effectiveness-implementation trial in VISN 10 of the implementation strategies created in this proposal (Year 5 IIR). Understanding how to implement CoCM in cancer care will impact individuals with cancer broadly as non-VA health care settings also face gaps in distress care. The long-term goal of this research is widespread implementation of CoCM in VA cancer care to ultimately improve the quality and quantity of life of Veterans living with cancer. .

NCI - National Cancer Institute

Adolescent and young adult (AYA) cancer patients suffer unparalleled financial toxicity (FT), with devastating effects to their physical and mental health and quality of life (QOL). Despite growing evidence on the positive impact of Oncology Financial and Legal Navigation (OFLN) on FT, health system implementation challenges preclude widespread adoption, particularly in community oncology practices. Alternative, resource-efficient approaches are needed to ensure adoption, sustainability and reach of OFLN tailored for AYAs. To address these implementation gaps, we propose a stepped OFLN which leverages risk-stratified, low-intensity (supported self-management using web-based educational resources) and high-intensity (virtual, navigator-led management) OFLN. The long-term goal of this research is to improve patient FT and QOL during cancer treatment. Our overall objective is to test the effectiveness and implementability of stepped OFLN in a randomized trial with hybrid type 1 (effectiveness-implementation) design. Our central hypothesis is that stepped OFLN is non-inferior to standard OFLN in terms of improving FT among AYA cancer patients and will demonstrate high acceptability, appropriateness, and feasibility. Tailoring the intensity of OFLN to the severity of FT helps maximize resource allocation while ensuring optimal patient outcomes and addresses scalability and uptake constraints, a critical consideration given the gap between OFLN demand and supply in community oncology practices, which provides a clear rationale for this study. The specific aims of this project are to determine if stepped OFLN is non-inferior to standard OFLN in improving: 1) patient reported outcomes (FT, cost-related health literacy, and psychological distress, i.e., depression, anxiety) and 2) implementation outcomes (acceptability, appropriateness, feasibility, and cost). We will also conduct a qualitative evaluation on implementation determinants and sustainability drivers that influence future adoption and scale up of OFLN. To accomplish these aims, 294 AYA patients undergoing treatment for cancer at the University of Louisville’s Brown Cancer Center will be randomized to stepped or standard OFLN, with outcomes collected at baseline and 12-, 30-, and 48-weeks. This research tests an innovative intervention, delivered at the point of cancer care, whose content, design, and implementation strategy are novel. The proposed research is highly significant both for its potential to mitigate the deleterious effects of FT for survivors and its disseminability into routine supportive care in both high- and low-resourced settings. Findings will inform a future hybrid 2 implementation-effectiveness randomized trial, which will refine implementation strategies to enhance the intervention’s widespread dissemination into real-world practice settings. Findings are responsive to NIH’s Unified Strategy Priorities by testing a solution-oriented approach to address FT in AYA cancer patients while also focuses on scientifically valid, measurable health outcomes.

European Commission - HORIZON

Improve the Quality of Life of older cancer patients. Call: Supporting the implementation of the Cancer Mission. Programme: HORIZON. Keywords: Comparative effectiveness research, Homecare, Integrated care, Mechanisms of pain, Mental health, Patient care. Open call from the EU Funding & Tenders Portal.

NIA - National Institute on Aging

ABSTRACT An estimated 6.9 million Americans 65 years and older live with Alzheimer’s disease and related dementias (“dementia”). Advance Care Planning (ACP) conversations allow individuals to communicate their goals, values, and preferences to family members and healthcare providers. In the absence of these conversations, care partners must independently make difficult decisions to provide or to withhold treatments. Constructing an advance care plan requires individuals to predict their values, goals, and treatment preferences during future health states. Often, they use heuristics (i.e., mental shortcuts or intuitive judgments) to make these decisions. Unfortunately, several factors contribute to poor calibration of heuristics in advance care planning, with amplification in dementia. First, people inaccurately predict how they will feel in future health states (affective forecasting biases). Second, lack of knowledge of disease trajectory coupled with the insidious nature of dementia progression obscures recognition of terminal stages of the disease (representativeness biases). The objective of this application is to improve advance care planning by addressing these two sets of biases. We propose to develop a narrative video game that will provide insight into ways that people may adapt to the cognitive and functional limitations of dementia (mitigating affective forecasting biases) and into the trajectory of dementia (mitigating representativeness biases). We will test the feasibility of delivering the intervention in a pilot trial by recruiting a local sample of people at elevated risk of developing dementia and their care partners (N=60 dyads), randomizing them to receive the intervention or an active control, and then evaluating the fidelity of intervention delivery, acceptability, fidelity of intervention receipt, and fidelity of intervention enactment. This proposal advances the NIA's priorities to improve advance care planning among older adults with dementia and follows the NIH's goal of applying a mechanistic approach to the development of behavioral interventions.

NIMH - National Institute of Mental Health

PROJECT SUMMARY For the 20 million individuals with serious mental illness (SMI), limited access to evidence-based and coordinated treatments is associated with poor medical outcomes, higher costs, and devastating societal impacts, including suicide. Outpatient treatment plays an important role during the high-risk period following hospital discharge. However, only about 50% of discharged patients receive any outpatient follow-up within 30 days with lack of pre-crisis engagement with mental health care being the most important predictor of follow-up treatment. Outpatient mental health specialty clinics are a frequent source of treatment for patients who use hospital-based services, but many clinics do not offer the full continuum of evidence-based specialty mental health services, nor do they have the ability to share electronic medical records with other providers. More generally, little is known about existing patterns in hospitals’ formal and informal relationships with these clinics. New payment and delivery models that target specialty mental health clinics, such as the Certified Community Behavioral Health Clinic (CCBHC) program, have the potential to improve clinical capacity to deliver integrated and coordinated care for patients with SMI. Our proposal is designed to better understand these relationships and their effects on follow-up care for patients to inform future care coordination strategies between hospitals and specialty behavioral health clinics. Specifically, we propose to use Medicaid administrative claims from multiple states and a quasi-experimental approach to (1) assess whether CCBHC implementation was associated with changes in follow-up care after hospital-based treatment and (2) whether patterns of follow up care after hospital-based treatment improved for patients with no prior mental health treatment engagement. This will be supplemented by a mixed methods study in Texas, an early CCBHC adopter state with 44 CCBHCs, to assess organizational strategies that mediate the relationship between CCBHC and follow-up care. This grant is responsive to NOT-MH-24-270, “Notice of Special Interest: Impact of Financing and Payment Mechanisms to Improve Behavioral Health Access, Utilization and Outcomes,” and will provide information on outcomes targeted by federal and state agencies, and help to bridge the gap between those who need treatment and those who receive treatment. The significance of this study lies in its focus on how to optimize delivery systems to improve mental health treatment and outcomes for those with SMI.

NIH

SUMMARY/ABSTRACT Significance to VA: Improving rehabilitation outcomes for Veterans with comorbid posttraumatic stress disorder (PTSD) and history of mild traumatic brain injury (mTBI) is an urgent need. These conditions frequently co-occur and are associated with worse cognitive performance, mental health, everyday functioning, community integration, quality of life, and response to evidence-based psychotherapies than in PTSD or mTBI alone. Additional comorbidities, such as depression and sleep disturbance, are common and further contribute to poor outcomes. Innovation and Impact: Our proposed study addresses the significant gap in services and evidence-based treatments for Veterans with mTBI+PTSD. Cognitive rehabilitation treatments emphasizing cognitive strategy training, such as Compensatory Cognitive Training (CCT), are associated with improvements in cognitive functioning, functional capacity, and quality of life in Veterans with mTBI and mTBI+PTSD. However, CCT is an intensive cognitive intervention requiring highly motivated, fully engaged participants. Concomitant depression and sleep disturbance, in addition to contributing directly to cognitive impairment, may reduce the ability of participants to engage in the treatment and learn and practice the strategies taught. Thus, novel intervention combinations directly targeting depression and sleep disturbance may improve treatment effects. Morning bright light therapy (MBLT) has well documented effects on both mood and sleep. We thus propose to enhance CCT by adding MBLT to target depression and sleep disturbance in Veterans with mTBI+PTSD. Our combined expertise in VA behavioral trials, cognitive rehabilitation, TBI, PTSD, neurology, sleep medicine, and biostatistics has led to the development of this proposal and this comprehensive, Whole Health-congruent approach. Our pilot data demonstrate the feasibility and acceptability of CCT+MBLT, as well as the efficacy of CCT and MBLT for Veterans with mTBI, PTSD, and mTBI+PTSD. Specific Aims: We aim to determine (1) whether CCT+MBLT is more efficacious than CCT+sham for improving cognition, functioning, and secondary outcomes such as PTSD and postconcussive symptom severity and quality of life; (2) whether improved rehabilitation outcomes are mediated by improvements in mood and sleep; and (3) whether there are factors that moderate outcomes. Methodology: Our proposed randomized controlled trial will compare CCT+MBLT with CCT+sham in a representative sample of 144 post- 9/11 Veterans with mTBI+PTSD at two VA sites (San Diego and Portland). Assessments will be conducted at baseline, mid-treatment (5 weeks), post-treatment (10 weeks), and three-month follow-up. Path to Translation/Implementation: Our study has the potential to yield a manualized, empirically validated, pragmatic, Veteran-centered intervention that meets the needs of Veterans with mTBI+PTSD across the United States. Thus, the project is a low-risk/high-reward proposal with clear relevance to the mission of VA Rehabilitation Research, Development and Translation. If found to be efficacious, our study team will work with VA Central Office leaders toward national dissemination and scale-up of CCT+MBLT for Veterans with mTBI+PTSD.

National Institutes of Health

-Purpose. Diet and physical activity are lifestyle and behavioral factors that play a role in the etiology and prevention of many chronic diseases such as cancer and coronary heart disease. Both also play roles in preventing overweight/obesity and in maintaining weight loss. Therefore, diet and physical activity are assessed for both surveillance and epidemiologic/clinical research purposes. The measurement of usual dietary intake or physical activity over varying time periods or in the past, by necessity, has relied on self-report instruments. Such subjective reporting instruments are cognitively difficult for respondents, and are prone to considerable measurement errors that may vary among population subgroups and depend on the time frame considered and the characteristics of the respondents. -The National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Aging (NIA), the National Institute of Child Health and Human Development (NICHD), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Mental Health (NIMH), the National Institute of Nursing Research (NINR), and the National Institutes of Health (NIH) Office of the Director (OD) Office of Dietary Supplements (ODS), are interested in promoting innovative research to enhance the quality of measurements of dietary intake and physical activity. Applications submitted under this Funding Opportunity Announcement (FOA) may include development of: novel assessment approaches and/or better methods to evaluate instruments assessment tools for culturally diverse populations across various age groups including older adults; improved technologies and/or applications of existing technologies; and/or statistical methods to assess or correct for measurement errors or biases. -Mechanism of Support. This FOA will utilize the NIH Research Project Grant (R01) award mechanism and runs in parallel with an FOA of identical scientific scope, PAR-06-103, that solicits applications under the Exploratory/Developmental Grant (R21) award mechanism.

NIH

There are >8 million older Veterans (>65 years) in the United States, and nearly half of them self-report having a disability such as impaired mobility that impacts their ability to perform self-care. Among older Veterans with mobility disability, common self-care tasks like food shopping, meal preparation, and cooking are barriers to consuming a healthy diet, resulting in poor dietary intake. Poor dietary intake contributes to chronic disease risk and loss of muscle mass and strength, consequently limiting function and increasing immobility. Teaching older Veterans with impaired mobility how to overcome barriers limiting these diet-related self-care tasks provides an opportunity to significantly impact this group’s dietary intake. Lack of social support has also been associated with negative health outcomes and poor nutritional intake; thus, effective, age-friendly intervention strategies to improve dietary quality as a strategy to delay further progression of disability and maintain functional independence among this population are needed. In this randomized controlled trial, we will determine if a 3-month virtual group nutrition intervention paired with produce delivery and virtual teaching kitchen cooking demonstrations tailored for older Veterans with impaired mobility will improve diet and functional mobility. The intervention group will be compared to a contact control group. Our overarching hypothesis is that virtual group nutrition education classes and cooking demos, personalized to include considerations of this population’s physical limitations, age-related taste changes and technological barriers, will result in favorable improvements in dietary quality and functional mobility while promoting social interaction. In Specific Aim 1, we will determine the impact of our virtual intervention paired with produce delivery and virtual cooking demonstrations on objective measures of diet quality compared to contact control among a diverse sample of older Veterans with impaired mobility. Additionally, we will assess the sustained effects of the program on dietary quality at a 6-month follow-up, 3-months after the virtual intervention ends. If no treatment effects are observed at the end of the 3-month intervention, we will explore reasons why the intervention was ineffective. In Specific Aim 2, we will determine the impact of the 3-month virtual nutrition intervention on measures of social isolation, health-related quality of life and mental health using validated questionnaires. Specific Aim 3 will determine associations with changes in dietary quality and frailty-related physical function outcomes and body composition among those who benefit from a virtual nutrition education and cooking program. Through this randomized controlled trial, we will learn how to improve dietary intake among older Veterans with impaired mobility, and how to provide Veterans with skills that will allow them to connect virtually with their social networks. Identifying strategies that improve dietary quality of older Veterans and maintain social engagement likely will be beneficial not only for chronic disease management; but may also reduce the risk of further functional decline and promote functional independence in the growing aging population.

NIMH - National Institute of Mental Health

The purpose of this K23 Career Development Award is to support the applicant in becoming an independent investigator with expertise in implementation science, to study strategies that increase the uptake and use of evidence-based autism services, and to measure the system-level impact of these efforts. Building on the applicant’s existing background in autism health services research and mixed methods, the proposed career development plan will achieve this long-term goal through a combination of implementation science training program activities, coursework, workshops, seminars, and mentored research. These activities will serve as learning vehicles for new skills and knowledge across the following three short-term training goals: 1.) learn to use human-centered design with embedded community-engaged research methods to improve acceptability and usability of interventions and implementation strategies; 2.) gain expertise in the design and conduct of pragmatic, hybrid clinical trials that target effectiveness and implementation outcomes; 3.) learn to evaluate implementation strategies and interventions at the system-level. Training in these areas will support the applicant’s achievement of the following research aims: 1.) adapt the ECHO Autism: STAT Early Diagnosis (EDx) implementation strategy to utilize a biomarker-based diagnostic tool for patients 16-to 30-months old, in a manner that maximizes acceptability and usability; 2.) examine feasibility and acceptability of testing ECHO Autism: STAT EDx vs. ECHO Autism: Technology-Enhanced EDx through a pilot cluster randomized hybrid type 3 trial; 3.) explore differences in time from autism screen to diagnostic ascertainment between 3 groups of patients with positive autism screening results across a large network of pediatric primary care sites: those served by PCPs assigned to each of the two pilot study conditions, and those from all other network sites that did not enroll in the pilot. These research and training goals will be carried out under the co-primary mentorship of Dr. Lawrence Scahill, an expert in autism clinical trials, and Dr. Sarabeth Broder-Fingert, an expert in applications of implementation science to autism health services research; and co-mentorship from Dr. John Constantino, an expert in biomarker-based and environmental influences of autism as well as system-level change to improve mental and behavioral health care. These career development and research activities will occur within a robust infrastructure for training and community-engaged autism research, leveraging strengths of Emory University School of Medicine, Emory University Rollins School of Public Health, the Marcus Autism Center, Project ECHO, and a network of over 175 pediatric primary care practices across Georgia. This K23 proposal is aligned with the NIMH’s Strategic Plan Goal 4: to advance mental health services to strengthen public health. With further training, the applicant is poised to begin a trajectory of work as an independent investigator to promote accessible, early autism services, ultimately improving outcomes for children.

NIDCD - National Institute on Deafness and Other Communication Disorders

Aphasia is a language disorder caused by acquired brain injury that affects one third of stroke survivors and more than 2 million people in the United States. Improving mental health is identified as the #1 stroke recovery priority. Stroke survivors with aphasia (SSwA) experience disproportionately poor mental health compared to stroke survivors without aphasia, with high rates of depression, anxiety, and general psychological distress. Poor mental health affects aphasia recovery, and poor aphasia recovery affects mental health. Therefore, mental health services need to be offered as part of comprehensive aphasia rehabilitation to maximize recovery. Adjustment counseling is within the scope of practice for speech-language pathologists (SLPs), who are well-positioned to address the bi-directional relationship between mental health and aphasia as primary providers of interdisciplinary psychological care. Our team has developed Acceptance and Commitment Therapy (ACT) for Aphasia, an integrated aphasia- adapted counseling and communication strategy intervention provided by SLPs. ACT improves psychological flexibility, allowing people to lead lives consistent with their deeply held values, even in the face of persistent psychological distress. ACT pairs well with communication skills training because they help SSwA understand and express themselves during counseling. In turn, ACT helps SSwA become more willing to participate in meaningful life activities and apply communication skills in challenging situations, supporting skill generalization. Our completed Phase I pilot found good intervention acceptability, feasibility, and promising preliminary outcomes, with large effect sizes for reducing psychological distress. This proposal will evaluate the effectiveness of ACT for Aphasia for improving mental health and functional communication in stroke survivors with aphasia. Aim 1 will evaluate ACT for Aphasia via a well-powered Phase II Randomized Controlled Trial. Aim 2 will engage clinician and community end users and healthcare system experts in exploratory implementation research to inform future implementation and intervention refinement. We predict that a) ACT for Aphasia will significantly reduce psychological distress (the primary outcome) and improve functional communication (an exploratory secondary outcome), compared to an active control condition consisting of usual care intervention components, and b) will meet defined benchmarks to justify a large-scale Phase III efficacy trial. Study success will support continued development and evaluation of this novel intervention and determine optimal implementation pathways for improving access to interdisciplinary psychological aphasia care in the United States.

NIMH - National Institute of Mental Health

PROJECT SUMMARY This research proposal aims to enhance the effectiveness of machine learning (ML) in improving adherence to antiretroviral therapy (ART) among people living with HIV (PWH). Adherence to ART is critical for viral suppression, a key goal in the Ending the HIV Epidemic Plan for the United States. While modern ML methods have been shown to identify individuals at risk of missing their visits with HIV providers and potentially discontinuing ART, these ML models are only as effective as the data they are trained on. As a result, ML models can be ineffective when applied to different patient populations or different healthcare settings, potentially worsening health outcomes for PWH. To address this challenge, this project will study synthetic data augmentation (SDA), a method that uses generative artificial intelligence (AI) to create additional data to train ML models. This approach has shown promise in various applications of ML, but has yet to be evaluated in, or adapted for, the domain of HIV care. My hypothesis is that SDA can improve ML models' ability to predict retention in HIV care, ensuring the benefits of these technologies extend to all PWH. However, there are limitations to SDA that must first be addressed. First, SDA is a new method and can be performed with many different computational approaches. Thus far, these varied methodologies for SDA have produced mixed results, making it unclear what the precise mechanism is behind how SDA works and in what circumstances SDA will be most effective. Second, the generative AI models that SDA utilizes do not have any external knowledge, learning only what they observe in the data. This makes generative AI models prone to creating unrealistic or biomedically implausible synthetic data. While a well-trained generative model does this infrequently, this can still occur and harm the performance of ML models trained via SDA. The proposal is structured around three specific aims. Aim 1: develop a foundational framework for understanding the impact of SDA on ML performance, particularly in the presence of issues common to HIV datasets. Aim 2: enhance the quality of synthetic HIV data by embedding biomedical knowledge into generative AI models. Aim 3: apply SDA to a large cohort dataset of PWH in the United States and evaluate the effectiveness of SDA in improving ML performance across different healthcare sites and populations. Successful completion of this project will lead to more reliable and generalized ML systems, ensuring that advancements in ML technology benefit all individuals living with HIV.

NIH

Background: Alcohol use disorder (AUD) is the most common non-tobacco substance use disorder among Veterans. Recognizing when patients have AUD is essential to providing appropriate care. Unfortunately, AUD is substantially under-recognized and inequitably recognized across age, race, and ethnicity in VA care. VA has implemented standardized alcohol use screening in primary care. VA clinical guidelines direct primary care providers (PCPs) to determine if patients with heavy alcohol use have AUD, but there is no standardized AUD assessment process. This places burden on PCPs and results in under- and inequitable AUD recognition. Standardized symptom assessment can help PCPs efficiently, consistently, and equitably recognize AUD, may increase AUD recognition and treatment initiation, and is recommended for primary care. An efficient, VA- centered AUD assessment process is needed that uses technology for digital, pre-visit assessment integrated with VA’s electronic health record, meets Veterans’ unique needs, and fits VA-specific primary care structures. Implementation strategies suited to VA are needed to ensure clinics are supported in conducting assessment effectively and consistently. Also, many patients who have AUD identified in primary care will not be ready for treatment immediately, thus a VA-suited tool and process for proactive outreach following AUD recognition is needed to support treatment engagement. This CDA will engage VA patients and personnel to inform Veteran- centered, equitable implementation of AUD assessment in VA primary care. We will develop and pilot a user- centered assessment process and implementation strategies. We will secondarily develop a novel outreach tool/process to support treatment engagement for patients who have AUD identified in primary care. Significance: This research provides a foundation for implementing standardized AUD symptom assessment in VA primary care with the goal of increasing and improving equity in AUD recognition. This work addresses multiple VA HSR priorities: improving mental health (including AUD and associated mental health risks, such as suicide), increasing equity, innovative technology in primary care, and implementation research. Innovation and Impact: This is the first study to examine patient perspectives on AUD assessment in primary care. We will apply innovative user-centered design methods, leverage under-used VA technology for digital, pre-visit assessment, and design a novel tool/process for outreach to support treatment engagement. Specific Aims: 1) Examine patient perspectives on AUD assessment in primary care and potential differences in perspectives across patient characteristics (secondarily, examine perspectives on outreach); 2) Design a user-centered assessment process and implementation strategies (secondarily, design a novel outreach tool/process); 3) Pilot clinic-wide implementation of AUD assessment and conduct mixed-methods evaluation. Methodology: In Aim 1 we will interview ~20 national VA primary care patients with heavy alcohol use to inform a survey, then survey a random sample of ~350; both samples will be balanced on demographics to examine differences across groups. Aim 2 involves qualitative interviews with ~40 personnel from 2 VA primary care clinics, iterative co-design sessions/usability testing to develop a user-centered assessment process (and secondarily, a novel outreach tool/process), and implementation mapping to plan strategies. Aim 3 involves piloting implementation of AUD assessment in 1 clinic and evaluation through qualitative interviews with ~20 clinic personnel and ~20 patients, a brief survey of PCPs, and analysis of electronic health record data. Next Steps/Implementation: This CDA will inform 2 multi-site, hybrid trials: a hybrid type 1 to test effectiveness of the novel outreach tool/process, and a hybrid type 2 to test implementation of AUD assessment. It will provide training in survey research, user-centered design, implementation science, and addressing racial and ethnic disparities, and will support the PI in becoming an independent VA investigator focused on improving substance use-related care through user-centered innovations and implementation.

NIMH - National Institute of Mental Health

PROJECT SUMMARY/ABSTRACT Early Life Adversity (ELA), including maltreatment and parental separation, is a significant public health issue, with nearly two-thirds of individuals experiencing at least one adverse event before age 18. Adolescents exposed to ELA are at increased risk for mental health disorders, including depression, anxiety, and post- traumatic stress disorder (PTSD). Sleep and circadian disturbances, such as insufficient sleep, social jetlag, poor sleep quality, and low sleep efficiency, are common among these adolescents and may further exacerbate their mental health challenges. Sleep disturbances may also contribute to systemic inflammation, as indicated by elevated levels of C-reactive protein (CRP), which is associated with mental health problems. This R34 project will adapt and pilot test the Transdiagnostic Sleep and Circadian Intervention (TranS-C) for adolescents aged 14-17 who have been exposed to ELA and experience sleep disturbances. In collaboration with the Olive View Clinic, a pediatric clinic serving adolescents with ELA (i.e., child welfare-involved youth), we will adapt TranS-C to ensure it is trauma-informed and meets the unique needs of this population. Aim 1 will involve adapting the intervention using focus groups with adolescents, parents, and behavioral health providers, along with usability testing among ELA-exposed adolescents with sleep disturbances (n = 5) to refine the intervention before the pilot randomized controlled trial (RCT) in Aim 2. Aim 2 will pilot an RCT with 60 adolescents, comparing the adapted TranS-C to a delayed treatment control. Primary outcomes include sleep duration, social jetlag, and depression. Secondary outcomes include sleep quality, sleep efficiency, sleep timing, daytime alertness, anxiety, PTSD symptoms, and daily affect (negative and positive affect). Exploratory outcomes will assess the feasibility of collecting salivary CRP as a marker of systemic inflammation. This study will inform the feasibility of a trauma-informed sleep intervention for adolescents exposed to ELA in a real- world clinic setting, laying the foundation for a future, adequately powered trial of a scalable and culturally- adapted intervention as well as a better mechanistic understanding of the sleep-inflammation-mental health nexus.