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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

PROJECT SUMMARY A joint analysis of the genetic architecture of major psychiatric disorders published in 2022 revealed four broad factors (neurodevelopmental, psychotic, internalizing, and compulsive) that underlie genetic correlations among these disorders. The compulsive factor is largely driven by three disorders that, until quite recently, have been understudied in psychiatric genetics: obsessive-compulsive disorder (OCD), Tourette syndrome (TS), and anorexia nervosa (AN). Thankfully, thus far in 2025, the Psychiatric Genomics Consortium (PGC) working groups for all three of these disorders have published or submitted significantly expanded genome-wide association studies (GWAS), creating an opportunity to gain etiological insights into these ‘compulsive disorders.’ This is significant because we have a limited understanding of the neurobiology of OCD, TS, and AN, and no FDA-approved medications have been specifically developed for any of these conditions. Furthermore, all three conditions are increasingly being treated with brain stimulation methods (e.g., transcranial magnetic stimulation and deep brain stimulation), yet the neurostimulation field has a poor understanding of which brain regions to target, leading to non-response in many patients. In this study, we will combine the latest genomic data for OCD, TS, and AN with the most recent single-cell gene expression atlases to enhance our understanding of the brain regions and cell types associated with these disorders and identify rational brain targets for stimulation. In Aim 1, we will test for enrichment of factor-level and disorder-specific OCD, TS, and AN summary statistics with cell types defined by a recent transcriptomic census of the entire human brain (>3 million cells). We expect this analysis to prioritize specific neuronal clusters involved in one or more of these conditions. In Aim 2, we will add a developmental context by extending these analyses to single-cell transcriptome data from human fetal and childhood brains. We will also introduce a spatial context by developing novel approaches to assess the enrichment of human genomic findings with a new single-cell spatial transcriptomic atlas of the whole mouse brain. We expect these analyses to refine our understanding of the neurocircuitry of OCD, TS, and AN. All analyses will include all major psychiatric disorders included in the aforementioned joint factor analysis to compare and contrast compulsive disorders with neurodevelopmental, psychotic, and internalizing disorders. Overall, we believe that integrating the latest genomic data on compulsive disorders with novel transcriptomic atlases will enhance our understanding of the etiology of these conditions and ultimately impact the treatment of these understudied disorders.

NIMH - National Institute of Mental Health

Project Summary Early adolescence is a critical developmental period marked by rapid socio-emotional changes and increased vulnerability to mental health issues, with long-term implications into adulthood. This stage involves biological maturation that heightens sensitivity to social rewards and prompts a shift toward peer-oriented relationships, which are closely linked to the onset of stress-related disorders such as depression and anxiety. In the U.S., this period often overlaps with the transition from elementary to middle school, presenting additional social challenges. At the same time, digital technology has transformed the adolescent social environment: 95% of adolescents have smartphone access, and 96% use the internet daily. Social media use during this stage interacts with neurodevelopmental sensitivity to social cues, amplifying both risks and opportunities for mental health. While much research has focused on the negative impacts of social media (e.g., cyberbullying), its features can also support healthy peer connections and foster a sense of belonging that can help mitigate against stress-related psychopathology and help build resilience. Despite the growing role of social media in adolescents’ life, however, little is known about how early adolescents, as new users, engage with social media to navigate peer relationships and promote well-being. This proposal investigates how approach-oriented social media behaviors (e.g., reacting to and sharing content with peers) foster social connection and reduce mental health risks in early adolescence. We take a multimodal approach that integrates physiological tools, ecological momentary assessment (EMA), and community-based participatory research (CBPR), and focuses on early adolescence (ages 12–14 years) which represents a critical period for emerging social media use and vulnerability. In Aim 1, we examine behavioral and physiological responses to adaptive social media use in a lab setting, using developmentally-relevant stimuli co-created with a youth advisory board. We will assess how engaging with peers online promotes connectedness, reduces distress (via self-report and physiological measures), and builds resilience to depression and anxiety. In Aim 2, we explore how these behaviors, along with social connectedness and mental health symptoms, unfold in daily life through EMA. By combining lab-based and real-world methods, we aim to identify digital behaviors that strengthen peer relationships, reduce momentary distress, and support mental health. Taken together, this research will highlight the potential benefits of positive social media use during a critical time of transition for adolescents and lay the groundwork for a longitudinal program on adolescent development and mental health.

NIMH - National Institute of Mental Health

Project Summary / Abstract Water insecurity (WI) is a major challenge in sub-Sharan Africa (SSA), where the number of people living with HIV (PLWH) is disproportionately higher, and where populations are most likely to bear the impact of climate- sensitive exposures. The effects of WI on health are well-documented in SSA: emotional distress is associated with lack of safe water, including fear of contamination, worry over safety, and anxiety, increased migration and thus HIV risk, as well as disruptions to health, care engagement, livelihoods, and relationships. Further, the prevalence of WI among PLWH is high, and household WI and food insecurity (FI) lead to poor mental and physical health. WI is also an important determinant of FI, suggesting multiple causal pathways to poor health outcomes. While SSA least contributes to global warming, especially as compared to more industrialized nations, it is expected to be amongst the hardest by climate-sensitive exposures. Water is required for food production and preparation, and WI may directly and indirectly influence health outcomes by impacting FI and health. Among PLWH, WI can lead to dehydration and undermine PLWH’s ability to manage unpleasant side effects associated with ART, including diarrhea, nausea, and vomiting. In Ghana, one of the most vulnerable countries to climate- sensitive exposures in SSA, flooding affects around 45,000 Ghanaians annually while nearly half of Ghana’s coastline is vulnerable to erosion and flooding as a result of sea-level rise and atypical rainfall. Further, an estimated 70% of all disease burden in Ghana is attributed to WI. To effectively intervene, a deeper understanding of the drivers of and sequelae of WI is critical. Therefore, we propose one of the first longitudinal convergent mixed-methods study to quantify and elucidate the impact of WI on HIV, related to climate-related drivers, infrastructure challenges, water accessibility, to inform interventions to address WI among PLWH. In response to our initial R01 submission, NIMH expressed strong enthusiasm for our program of research and awarded our team a 1-year R56 award to collect preliminary data to further support this application. In Aim 1, we will utilize innovative remote sensing technologies to investigate the role of climate-sensitive patterns (droughts, precipitation anomalies, and floods, capitalizing on state-of-the-art satellite technologies) and seasonality on WI in Ghana. In Aim 2, we will determine the impact of WI on HIV treatment outcomes (ART adherence/viral suppression) and opportunistic infections and comorbidities, and the mechanisms through which WI may influence these outcomes (nutritional, mental health, water, hygiene and sanitation, and empowerment pathways). We have already recruited and enrolled a cohort of 503 PLWH for Aims 1 and 2. In aim 3, using intervention mapping framework, we will develop intervention options to mitigate WI and improve health for PLWH, synthesized from theory and literature. Findings from this R01 will a) provide initial data on the drivers of and sequelae of WI and it impact on HIV treatment outcome; b) guide the integration of HIV and water access programs; and c) help identify and prioritize intervention development to address WI among PLWH.

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.

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

Differential susceptibility theory proposes that children’s temperament confers greater susceptibility to both supportive and harsh family environments. Subsequent studies have provided compelling support for the designation of children’s environmental sensitivity (ES) as a top differential susceptibility factor. ES precisely captures differential susceptibility in its identification of behaviors that reflect a low threshold of environmental stimulation and responses that are finely tuned to varying environmental properties within and across contexts. Relative to the weak, inconsistent results of temperamental characteristics, the moderating role of ES has been consistently expressed in a susceptibility manner by both potentiating children’s risk for psychological problems in harsh family conditions and magnifying their better mental health outcomes in supportive family contexts. However, little is known about how ES confers child susceptibility across these varying socialization conditions. To address this significant gap, the present application is designed to break new ground by providing the first empirical delineation of the mechanisms that underpin the susceptibility of children who are high in ES. Guided by a synthesis of temperament and resource allocation theory, the aims of the proposal are designed to examine whether the moderating role of children’s ES in associations among family functioning and their psychological adjustment (i.e., internalizing and externalizing symptoms; social adjustment) is mediated by three classes of susceptibility mechanisms: (1) stress responses to family adversity across behavioral and representational dimensions; (2) emotion processing characteristics of preferential attention to specific types of emotion cues, emotion recognition, and emotion situation knowledge; and (3) exploratory approaches that vary in prioritization of securing short-term or long-term resources. Building on a strong foundation of theory and promising preliminary findings, this application will examine plasticity mechanisms underpinning ES by following a sample of 265 4-year-old children and their parents over three annual measurement occasions. The multi-method, multi-informant measurement battery, longitudinal design, and powerful quantitative analyses are designed to generate rigorous tests of hypotheses on the mechanisms mediating the moderating effects of ES in prospective associations among family functioning and children’s psychological sequelae. High methodological innovation and rigor are evident in the use of the latest, sophisticated measures of ES (e.g., observational and Q-sort assessments) and the proposed mediators (e.g., eye tracking measures of emotion-biased attention; novel and theoretically informed assessments of stress reactivity, computational modeling of exploratory strategies). Thus, by offering the first systematic tests of the child plasticity mechanisms underpinning ES, our application is poised to provide valuable theoretical and scientific knowledge on how children express differential susceptibility over time and translational guidance on modifiable mechanisms for optimizing the full psychological potential of susceptible children.

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.

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

<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>

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.

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.