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NIMH - National Institute of Mental Health

PROJECT SUMMARY Major depressive disorder (MDD) has long been theorized to reflect an overly broad disorder class that collapses across heterogenous risk pathways. A rate limiting factor to examining the divergent validity of MDD subtypes using genomic methods is a lack of sufficiently powered data. As part of the proposed project, we will utilize Co-I Dr. Lewis’ role as a leader in depression genetics and co-chair of the PGC MDD working group to put together the largest genome-wide association study (GWAS) yet performed for various MDD subtypes, including sex-stratified, atypical, postpartum, and severe MDD. In addition, we will employ Genomic LOSEM, a novel method introduced in the grant for examining non-linear changes in genetic signal that we will use to examine how different ages at onset and socioeconomic status shift MDD genetic architecture. The subtype GWAS and Genomic LOSEM package will be made available as public resources. Standard univariate approaches that focus strictly on either meta-analyzing across MDD in all its forms or analysis of a particular subtype are unable to parse genetic risk pathways that are broadly relevant to MDD from those that are unique to a specific subtype. In addition, family-based approaches are pragmatically limited to examining a handful of subtypes at a time and cannot describe underlying biology. Genomic Structural Equation Modeling (Genomic SEM) is an innovative, multivariate framework developed by the grant PI Dr. Grotzinger for modeling genetic overlap derived from GWAS data. The well-powered GWAS of MDD subtypes will be used as input to Genomic SEM models that will formally disambiguate shared and subtype-specific genetic signal. A unique advantage of Genomic SEM is that even mutually exclusive subtypes can be included in the same statistical model. The remaining analyses will characterize subtype-specific genetic signal at varying levels of biological granularity, including estimating genetic overlap with clinically relevant external correlates (e.g., cognition, other psychiatric disorders). By applying Stratified Genomic SEM, a novel extension for estimating multivariate functional enrichment, we will characterize biological pathways involved in subtype specific risk. These biological pathways can include, for example, genes expressed early in development, in certain brain regions, or in specific types of neurons. At the gene expression level, Transcriptome-wide SEM will be used to identify the lists of genes uniquely associated with an MDD subtypes. These results will be cross-referenced with the Connectivity Map drug repurposing dataset to identify existing pharmacological interventions that may have therapeutic benefit. By utilizing sex-stratified GWAS summary statistics we will explicitly consider biological sex as a moderator of relevant genetic pathways. In addition, expanding African, East Asian, and LatinX ancestry GWAS datasets, LD-scores, functional annotations, gene expression weights and cross-ancestry methods will allow us to extend the grant aims across diverse samples. Our analyses will collectively provide the most comprehensive evaluation to-date of subtype-specific etiology within MDD.

NIMH - National Institute of Mental Health

PROJECT SUMMARY/ABSTRACT People with HIV (PWH) who experience challenges with antiretroviral therapy (ART) adherence are at increased risk for suboptimal treatment outcomes, including viral non-suppression and disengagement from care. Despite advancements in ART delivery options, personalized treatment approaches that integrate patient preferences remain underutilized, particularly among PWH facing psychosocial and documented barriers. Clinical decision support (CDS) tools offer a promising avenue to address this gap by tailoring treatment recommendations based on patient-specific needs and barriers. However, current CDS tools often fail to incorporate rich patient insights available from unstructured electronic health record (EHR) notes or systematically integrate directly reported preferences, limiting their potential to enhance adherence and outcomes. The proposed training and research plan for this K23 will enable José I. Gutierrez, Jr., PhD, FNP- BC, to acquire the expertise necessary to become an NIH-funded independent investigator who designs patient-informed CDS interventions that optimize HIV treatment delivery. Under the mentorship of an experienced multidisciplinary team, Dr. Gutierrez will use a mixed-methods approach to develop foundational components of a CDS prototype that integrates natural language processing (NLP)–derived EHR information with patient-reported preference data. Building on prior work in HIV treatment delivery and preference evaluation, he will pursue the following specific aims: (1) explore HIV treatment delivery preferences, barriers, and facilitators within EHR notes using NLP; (2) identify and quantify patient preferences, barriers, and facilitators using qualitative interviews and MaxDiff; and (3) develop the key features of a CDS prototype that generates tailored suggested actions informed by EHR and patient-preference data, and evaluate its acceptability, feasibility, usability, and intended adoption in a 9-month, cross-sectional, non-clinical user-testing study using standardized vignettes and de-identified/fictionalized cases (no live EHR). This research plan aligns with Dr. Gutierrez's career development goal to gain advanced skills in clinical informatics and NLP, qualitative and mixed-methods research, and patient-informed intervention design. Findings will provide the foundation for a subsequent NIH R01 to rigorously evaluate effectiveness in clinical settings, with the overarching goal of improving ART adherence and treatment outcomes among PWH. 1

NIMH - National Institute of Mental Health

PROJECT SUMMARY / ABSTRACT Specific Aims: This proposal aims to identify opportunities to improve the prevention and mitigation of risks associated with cognitive impairment among people aging with HIV. Aim 1 will estimate the proportion of cognitive impairment cases potentially attributable to psychosocial and behavioral risk factors to prioritize those, which if intervened upon, could hypothetically result in the greatest prevention of cognitive impairment. Aim 2 will determine whether cognitive impairment increases the risk of losing one’s durable (sustained) viral suppression so we may mitigate this adverse outcome. Significance: As people with HIV (PWH) live longer due to treatment advances, they face a growing burden of age-related conditions, including cognitive impairment. PWH experience higher rates of cognitive impairment than people without HIV despite widespread viral suppression, which implicates non-HIV-related factors in their cognitive risk. Focusing on psychosocial and behavioral risk factors, which are prevalent in PWH and causally linked to cognitive impairment, can help to prioritize fruitful prevention strategies. In addition, cognitive impairment may threaten the durability of viral suppression, which could hinder cognitive maintenance and prevention of HIV transmission. Considering these issues in tandem can inform preparations for the long-term healthcare needs of people aging with HIV. Approach: These aims will leverage the Multicenter AIDS Cohort Study (MACS) (Aim 1), which includes 10 years of longitudinal cognitive screening data, and the Johns Hopkins HIV Clinical Cohort (JHHCC) (Aim 2), an urban cohort of PWH with rich clinical data. In Aim 1, we will estimate population attributable fractions for incident cognitive impairment, using longitudinal data and methods to account for time-varying risk factors, censoring, and competing risks. In Aim 2, we will employ a longitudinal closed cohort design to estimate the risk ratio for loss of durable viral suppression in PWH by cognitive impairment status. Training Information: The proposed research encompasses the dissertation of Madeline Brooks, a PhD student in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. The training plan consists of coursework, mentorship, and professional development to support the successful completion of these aims and prepare Ms. Brooks to become an independent research epidemiologist. These aims address priorities of the NIH Office of AIDS Research to address the role of non-infectious comorbidities in central nervous system complications and subsequent implications for HIV transmission.

NIMH - National Institute of Mental Health

Identifying the Specific Reward Processes Underlying the Maintenance of Binge-Eating Disorder using EEG and EMA ABSTRACT Binge-eating disorder (BED) is the most common and most expensive eating disorder in the United States. Further, BED is associated with significant medical complications (e.g., obesity) and premature death. Treatments for BED have demonstrated limited effectiveness, signaling a critical need for improved understanding of the mechanisms underlying BED maintenance to help guide novel or enhanced interventions. Reward-related processes (e.g., wanting, liking, learning) are highlighted within the National Institute of Mental Health’s Research Domain Criteria (RDoC), and have been increasingly implicated in BED persistence. However, the specific reward processes that maintain BED are currently unknown. The incentive-sensitization theory suggests that food reward wanting, in particular, may serve as the primary maintenance factor underlying BED. Although preliminary data from our group indicate that food reward wanting may indeed play a critical role in BED maintenance, these data suggest that food reward liking and learning processes may also contribute to binge-eating persistence, highlighting their potential as novel targets for clinical intervention. Given this, research is critically needed to systematically evaluate the relative roles of food reward wanting, liking, and learning using both neural and naturalistic assessment approaches in BED, in order to pinpoint the specific reward mechanisms underlying BED persistence and guide treatment development. To address this need, the current proposal seeks to 1) evaluate the concurrent associations between binge-eating symptoms and food reward processes (i.e., wanting, liking, and learning) assessed at the neural level in the laboratory using electroencephalography (EEG); 2) evaluate the momentary prospective relationships between binge- eating symptoms and food reward processes (i.e., wanting, liking, and learning) assessed in the natural environment using ecological momentary assessment (EMA); and 3) evaluate the longer-term prospective associations between food reward processes (i.e., wanting, liking, and learning) assessed in the laboratory (via EEG) and the natural environment (via EMA), with change in binge-eating symptoms over 6-month follow-up. The research team includes experts in eating disorders, EMA, EEG, multilevel statistical modeling, and the neural basis of reward. Data from this study will clarify the specific neural and behavioral reward-related processes that contribute to binge-eating maintenance within BED. Knowledge gained from this study will help guide the development of targeted therapeutic approaches (e.g., neuromodulation, pharmaceutical, psychotherapy) that are designed to directly engage empirically-identified disorder-maintaining mechanisms, which will enhance the efficacy and efficiency of treatments for BED.

NIMH - National Institute of Mental Health

PROJECT SUMMARY/ABSTRACT Loneliness, characterized by the subjective feeling of social disconnection, has significant adverse effects on physical and mental health, including increased risks of premature death, anxiety, depression, and suicide. These consequences are particularly severe among individuals with serious mental illness (SMI), where over 80% report loneliness, and individuals die 15 to 25 years earlier than those in the general population. Current interventions for loneliness in SMI lack broad efficacy and are hindered by a lack of theoretical guidance and a one-size-fits-all approach, failing to address individual (idiographic) differences effectively. This project proposes a novel, theory-informed approach to understanding idiographic mechanisms of loneliness among SMI populations. It is based on the social homeostasis theory, which posits that loneliness results from deficits in social utility, a measure of the fulfillment of social needs. The theory suggests that both the quality and quantity of social interactions contribute to social utility, and discrepancies between actual and preferred states of these interactions lead to loneliness. This research aims to employ intensive longitudinal data collection on daily social experiences of individuals with SMI to model social utility ideographically. The project's aims are to, at the individual level, (1) characterize the heterogeneity of relationships between social utility and loneliness using individual connectivity networks produced with group iterative multiple model estimation, (2) establish extent to which decreases in social utility relate to increases in loneliness by applying response surface analysis within individuals, and (3) clarify the temporal dynamics between these constructs using time-varying network modeling and differential time-varying effects modeling for each participant. The study uses two samples of ecological momentary assessment (EMA) data: the first sample utilizes existing data from SMI patients to explore the theorized relationships in SMI directly. The structure of this existing data will allow for analysis of Aim (1) while a second, non-SMI sample is recruited online. The non-SMI sample will be enriched for loneliness and schizotypal personality traits to test and develop models of social utility more comprehensively. This second set of data is designed to be analyzed for all Aims, and results will generate hypotheses for similar research applied directly to SMI in future studies. By developing idiographic modeling techniques to study social utility, this research aims to advance personalized understanding of the heterogeneity of mechanisms to loneliness in SMI. This work not only progresses the field of clinical psychology by addressing a significant gap in the understanding and eventual treatment of loneliness among those with SMI but also enhances the researcher's skills in idiographic science through mentored training in sophisticated modeling techniques, thus empowering an independent program of future research investigating personalized treatment mechanisms for loneliness in SMI.

Indian Health Service

Supports substance abuse prevention, mental health services, and suicide prevention for American Indian and Alaska Native communities.

IL Dept of Veterans Affairs

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

Illinois Department of Veterans' Affairs

Grants to organizations providing direct services to Illinois veterans and their families including legal aid, mental health counseling, housing assistance, and employment support.

Illinois Veterans Commission

State grants for veteran service programs in Illinois including housing, employment, education, and mental health support.

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>

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. .

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.

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.

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.

NIH

SIGNIFICANCE TO VA: In the past decade, the number of women Veterans of childbearing age using VA has nearly doubled, and over forty percent of these women have a diagnosis of serious mental illness (SMI; major depressive disorder, posttraumatic stress disorder, bipolar disorder, schizophrenia, other psychotic disorders). Veterans experience worse pregnancy and birth outcomes than civilians, a disparity largely attributed to their high burden of mental illness and trauma. Pregnant and postpartum Veterans with SMI—who often have numerous mental health, medical, and social challenges—are at high risk for perinatal exacerbation of mental illness, with consequences including maternal morbidity and mortality, poor functioning, and impaired child development. Reach Out, Stay Strong Essentials (ROSE), a brief evidence-based psychoeducational intervention for prevention of postpartum depression in women without mental illness, is being implemented in over two dozen VA facilities; feedback from ROSE implementers supports its use, but with noted limitations for Veterans with SMI. Building on lessons learned from ROSE implementation, I propose to develop and pilot ROSE+, a psychosocial intervention blending ROSE with peer support (i.e., support provided by Veteran peer specialists with personal experience of mental illness). Peer support is a key component of VA mental health care; while evidence exists for peer support in non-SMI perinatal and non-perinatal SMI populations, existing interventions are limited in applicability to the complex social, medical, and mental health needs of perinatal Veterans with SMI. ROSE+ will comprise adapted and combined components of ROSE and evidence-based perinatal and SMI peer support models, tailored to the VA context and the unique needs of perinatal Veterans with SMI. Developed in partnership with VA Office of Women’s Health and Office of Mental Health, this proposal aligns with key VA operations and HSR priorities including women’s health, mental health, maternal health, peer support, and Veteran engagement, and will fill a key gap in care for perinatal Veterans with SMI. INNOVATION & IMPACT: This research will not only set the foundation for the first perinatal mental health intervention for Veterans with SMI, but will also identify additional opportunities to strengthen VA perinatal mental health services and care coordination via an IIR submission in Year 3. SPECIFIC AIMS: 1) Engage Veterans and key VA clinical staff in identifying potential components of ROSE+; 2) Develop and refine the ROSE+ intervention; 3) Assess the feasibility, acceptability, and exploratory outcomes of ROSE+ in a pilot study. METHODOLOGY: Intervention development will be guided by the Transcreation Framework, an implementation science framework for community-partnered development of behavioral interventions for vulnerable populations. Aim 1: To assess the experiences, needs, and care preferences of perinatal Veterans with SMI and inform potential intervention components, I will conduct semi-structured interviews with pregnant and postpartum Veterans with SMI and VA women’s mental health providers, followed by focus groups with VA Maternity Care Coordinators and women VA peer specialists. Aim 2: Using Delphi methodology, I will present potential intervention components—drawn from existing interventions and accompanied by data from the literature and Aim 1 findings—to an expert panel of VA multilevel constituents to identify final components as well as adaptations to optimize fit to the target population and VA women’s health settings. I will then develop and refine the intervention prototype and materials with iterative feedback from partners and mentors. Aim 3: I will conduct a randomized feasibility pilot of ROSE+ compared to usual care including standard ROSE, with approximately 24 perinatal Veteran participants with SMI. The pilot will assess implementation outcomes, including acceptability and feasibility; feasibility of study processes including recruitment and randomization; and exploratory clinical outcomes. PATH TO TRANSLATION/IMPLEMENTATION: Results will inform a subsequent multisite efficacy study, for which I will seek independent VA funding in Year 5.