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NIA - National Institute on Aging

PROJECT SUMMARY Aging is characterized by the gradual loss of physiological integrity, and this process may be accelerated in the presence of obesity, increasing susceptibility to disease, frailty, and death. Although the shared molecular pathways involved have not been fully elucidated, adipose tissue dysfunction is likely a key contributor to multisystem functional decline in aging and obesity. Despite growing evidence that β3 adrenergic receptor {β3AR) mediated activation of brown adipose tissue {BAT) may alter pathophysiological pathways implicated in various aging-related diseases including metabolic, cardiovascular, and neurodegenerative diseases, BAT has been largely ignored in aging research. In this highly innovative study, we propose to conduct a randomized, double-blind, placebo-controlled trial to investigate whether treatment with a β3AR agonist (vibegron) can improve energy metabolism, cardiometabolic risk factors, and physical and cognitive function. Vibegron {Gemtesa) was FDA-approved in 2020 for the treatment of overactive bladder and has greater selectivity, potency, and activity at the β3AR than other agonists studied to date. This presents a timely opportunity to explore pharmacological activation of β3ARs as a way to improve multiple health outcomes relevant in aging and obesity. To test our hypothesis, 40 middle-aged and older adults {45-75 yrs) with obesity will be randomized to vibegron {75 mg/day) or placebo for 12 weeks to compare their effects on various bioenergetic, cardiometabolic, physical function, and cognitive outcomes. Specifically, in Aim 1 we will assess the effects of vibegron vs. placebo on energy expenditure, core body temperature, mitochondrial bioenergetics, and thermogenic protein expression. In Aim 2 we will assess the effects of vibegron vs. placebo on glucose and insulin indices, lipid levels, body composition, and body fat distribution. In Aim 3 we will assess the effects of vibegron vs. placebo on self-report and objective measures of lower extremity function, muscle strength and pOY1er, global cognition, memory, executive function, quality of life, and depression. Notable innovations include blood-based bioenergetic profiling to assess systemic mitochondrial function, isolation and characterization of adipose tissue-derived small extracellular vesicles to assess target engagement, and continuous monitoring of core body temperature to assess circadian thermoregulation. In exploratory analyses we will compare the effects of vibegron vs. placebo on the accumulation of health deficits {i.e., frailty) and the preservation of physical and mental abilities {i.e., intrinsic capacity), two integrated measures of phenotypic aging that will provide estimates of the potential for vibegron to impact multisystem functional decline. This unique study will be the first clinical trial to explore the potential to repurpose vibegron for the treatment of aging-related obesity and associated comorbidities. If successful, the results of this study will be used to inform the design of a larger, longer trial to confirm the efficacy of vibegron as a novel treatment to IOY1er risk for multisystem functional decline in both aging and obesity.

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

PROJECT SUMMARY / ABSTRACT This project will improve best practice care delivery and psychosocial outcomes for families of critically ill children hospitalized in the pediatric intensive care unit (PICU). The focus of this proposal is family-centered rounds (FCR), which is recognized as a best practice for hospitalized children. FCR enhances family-centered communication, engagement, understanding of the care plan, and trust in providers. Importantly, these benefits are also strategies to mitigate PICU-related psychosocial harms to family members of the critically ill child. However, FCR is only possible when parents or guardians (“parents” hereafter) can be physically at bedside during rounds. Yet circumstances that prevent physical presence (e.g., work, travel) hinder some families. PICUs lack evidence-based strategies to promote parents’ access to and attendance at FCR. We address this critical gap by testing a telehealth intervention to expand access to and attendance at FCR. We propose a dual cluster randomized trial, which is two simultaneous randomized trials: one testing the intervention of inviting families to use virtual FCR and one testing implementation strategies. Families will be randomized to one of three arms: (1) virtual FCR plus digital navigators (active implementation strategy), (2) virtual FCR plus informative handouts/videos (control implementation strategy), and (3) usual care. In this proposal, we pursue three Specific Aims: Evaluate and compare the impact of providing parents the option of virtual FCR versus usual care on parent FCR attendance, utilization, and psychosocial outcomes (Aim 1). Evaluate and compare two implementation strategies for virtual FCR (Aim 2). Conduct a mixed methods implementation evaluation of the virtual FCR intervention (Aim 3). Aims 1 and 2 will measure heterogeneity of intervention effects and implementation effects, respectively, by pre-specified subgroups. Our team’s preliminary research found that the option to use telehealth to conduct virtual FCR improved parent FCR attendance. All groups benefited from the intervention except for those with the lowest digital literacy and those without a smartphone. We thus build on our prior work to now propose a type 2 hybrid study utilizing the rigorous but underused dual randomized trial design. Our team’s expertise encompasses hospital care delivery interventions, clinical trials, implementation science, community engagement, linguistically appropriate care, mixed methods, and advanced statistics. Our team also includes two patient/provider advisory groups. This application is responsive to NICHD priorities in that it focuses on psychosocial issues related to the care of critically ill children and their families by transforming the delivery of PICU care to be more family- centered and accessible. In summary, this project will advance an innovative FCR solution in the PICU to address families’ unmet needs; and improve parent FCR attendance, healthcare utilization, parent mental health, and sibling well-being.

NIMH - National Institute of Mental Health

Project Summary/Abstract To curb the rising rates of suicide, interventions that directly target the causal mechanisms for suicidal behaviors (SB; i.e., suicide capability) are needed. Virtual reality (VR) suicidal decision scenarios are a valid and safe proxy for SB among at-risk individuals and have enabled causal examinations of suicide capability mechanisms. Intriguingly, these studies, including our preliminary data (N = 63), show that exposure to VR suicidal decision scenarios may evoke clinically meaningful reductions in suicide risk via suicide capability mechanisms. These findings converge with mounting evidence for the effectiveness of VR-based exposure in treating numerous psychiatric disorders. We consider a putative suicide capability mechanism that can be safely therapeutically targeted using VR suicidal decision exposure: motivational relevance of the suicidal decision process that facilitates the development of non-threat associations (i.e., inhibitory learning) with suicide ideation (SI) and the reintegration of suicidal deterrents (i.e., negative consequences of SB; reasons for living). This aligns with recent electroencephalography (EEG) findings that suicide attempters, but not ideators, show decreased sustained reactivity to threat/violence, reflecting an ability to volitionally dampen fear-inducing aspects of SI (i.e., suicidal deterrents), temporarily increasing their ability to approach SB. Our pilot EEG data (N = 28 suicidal adults) show VR suicidal decision scenarios engage the target mechanism of motivational relevance. This K23 proposal will evaluate VR suicidal decision exposure as a mechanistic intervention for SB and is designed to make the next critical steps in intervention development: (1) provide preclinical evidence for the feasibility, acceptability, and safety of the intervention in a transdiagnostic sample of 100 adults with recent SI and 50% with a suicide attempt history; (2) test whether the intervention, relative to treatment as usual, effectively engages the proposed mechanistic targets (neural; increases in late-LPP to suicide-related images and fronto-central gamma during the VR decision scenarios) and behavioral indicators (subjective accessibility of suicidal deterrents; behavioral orientation toward death/life) both in lab and in daily life; and (3) test whether change in the mechanistic targets and behavioral indicators account for intervention-associated change in clinical outcomes related to SB. We will use a multi-method approach involving EEG, subjective and behavioral responses, ecological momentary assessment (EMA), and self-reports/interviews to assess changes pre-post the intervention. This K-award addresses crucial gaps in the candidate’s training and will prepare them to be a leader in suicide intervention science employing an experimental therapeutics approach. The candidate will receive advanced training from an expert mentorship team, including mentors Drs. Joiner, Siegle, and Scott and consultants Drs. Patrick and Krafty. Findings will inform future R-level studies focused on 1) intervention refinement and clinical translation and 2) integrative multi-method (neurophysiology, subjective, behavioral, EMA) approaches to further clarify suicide capability mechanisms and develop effective, mechanistically targeted, and scalable SB interventions.

NYS Office of Mental Health

1320 ? Vocational and Educational Services - Children and Family (Non-Licensed Program) The Vocational Program for Adolescents was designed to provide work training and clinical support services for those youth with poor academic performance and social adjustment in regular day treatment programs. The program identifies 5 goals on which to focus: ? Goal 1: Help youths identify problem areas and learn ongoing coping skills (i.e., involvement in support groups, recognizing need for relaxation and medication management); ? Goal 2: Provide Vocational Assessment and on-the-job training and experience; ? Goal 3: Improve Social Skills; ? Goal 4: Improve Educational Functions; ? Goal 5: Provide Family Education and Support Units of Service: Count the number of daily staff visits.

Wellcome Trust

Funds research to understand the science of mental health and develop new interventions. Focus on anxiety, depression, and psychosis across the lifespan.

Labor

Helps young adults build the skills necessary to explore and develop careers, pursue education and occupational skills training, and gain work experiences and employment. The programs support educational attainment through: (1) Educational opportunities that lead to a high school diploma or equivalency, (2) Basic and English-language learner skills development, (3) Post-secondary transition, technical training, or apprenticeship guidance. Prepare youth for employment success by: (1) Providing work readiness and life skills training (2) Connecting youth with paid and unpaid work experiences, including jobs, internships, job shadowing, pre-apprenticeship and on-the-job training (3) Supporting occupational skills trainings leading to industry-recognized credentials (4) Facilitating career exploration and development Build leaders by: (1) Cultivating entrepreneurial skills (2) Connecting participants with mentors (3) Offering peer learning opportunities (4) Facilitating financial education (5) Supporting civic engagement WIOA Youth Programs also link youth to support services, such as drug, alcohol and mental health treatment. The programs facilitate connections with community organizations, and address barriers like inaccessible transportation or childcare.

National Institutes of Health

-Purpose. This Funding Opportunity Announcement (FOA) solicits research project grant applications on the topic of women's mental health in relation to pregnancy and the postpartum period. The FOA encourages research on perinatal mood and other mental disorders in four areas: (1) clinical course, epidemiology and risk factors; (2) basic and clinical neuroscience; (3) interventions; and (4) services. Research is encouraged both on perinatal non-psychotic mood disorders and on psychotic disorders. Studies exploring the effects of current or lifetime drug abuse, including treatment status and comorbid conditions, on onset and course of mental disorders during the perinatal period are also encouraged. -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, PA-06-377, that solicits applications under the Exploratory/Developmental (R21) grant mechanism. -Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.

National Institutes of Health

- This funding opportunity announcement (FOA) solicits exploratory/developmental (R21) research grant applications on women's mental health and sex/gender differences in mental health across the lifespan. The epidemiology and disability burden of mental disorders provide clear evidence of the value of a focus on sex differences research. There are differences in both the prevalence and clinical course of mental disorders between men and women. Starting in childhood, girls have higher rates of anxiety disorders than boys. Boys have higher rates of autism and attention deficit disorder. After puberty, women have higher rates than men of depression, eating disorders, and anxiety disorders, including post-traumatic stress disorder. Men are more likely to suffer from substance abuse disorders. For other serious mental disorders, such as schizophrenia and bipolar disorder, gender disparities in incidence are not found. However, significant differences in clinical course have been demonstrated across the lifespan. This pattern of disparities in the epidemiology of mental disorders in males and females provides indirect evidence of genetic, hormonal, biological, social, cultural and developmental factors in etiology and course. An increasing body of basic and clinical research also provides evidence of neurobiological sex differences that may predispose to clinical differences in mental disorders. The finding of sex/gender differences in epidemiological, basic, and clinical studies has also increased interest in the application of that knowledge to improving interventions and services for males and females. In recognition of the importance of studying sex/gender differences in health outcomes, NIH has provided guidelines to researchers for inclusion of women and men in clinical research and for gender analysis of clinical trials outcomes. Through research such as that called for in this FOA, NIMH seeks to increase the understanding of the significance of sex/gender differences in mental health outcomes and to assess their significance for mental health prevention, treatment and services.-This funding opportunity will utilize the R21 mechanism, but will be run in parallel with a program announcement of identical scientific scope that will utilize the traditional research project grant (R01) (PA-06-333).-Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.-The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.-Eligible organizations: For profit organizations; Non-profit organizations; Public or private institutions, such as universities, colleges, hospitals and laboratories; Units of State government; Units of local government; Eligible institutions of the Federal government; Domestic institutions; Foreign institutions; Faith-based or community-based organizations; Units of State Tribal government; and Units of Local Tribal government. -Eligible Project Directors/Principal Investigators (PD/PIs): Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.-Applicants may submit more than one application, provided each application is scientifically distinct.

Centers for Disease Control and Prevention - ERA

<p>The National Institute for Occupational Safety and Health (NIOSH) World Trade Center (WTC) Health Program K01 Award supports early-career investigators in developing independent research careers focused on improving the health and well-being of populations affected by the September 11, 2001, terrorist attacks (9/11). This award provides up to three years of mentored research and career development support, including at least 75 percent protected time. The program supports research that improves understanding of physical and mental health effects associated with 9/11 exposures, addresses diagnostic or treatment uncertainty, identifies emerging health concerns, examines aging among exposed populations, and informs improvements in clinical care, public health practice, and long-term health outcomes. Research that helps translate scientific findings into improved care and public health practice is encouraged. Responsive research may include epidemiologic, clinical, translational, preclinical, health services, health outcomes, diagnostic, treatment, prevention, quality-of-life, and implementation research. Generalizability to other populations is not required. The award also supports the development of the next generation of investigators needed to address health needs related to 9/11 exposure. More information, including the WTC Health Program Research Agenda and previously funded projects, is available at: <a href="https://www.cdc.gov/wtc/researchagenda.html">https://www.cdc.gov/wtc/researchagenda.html</a> and <a href="https://www.cdc.gov/wtc/fundingdashboard.html">https://www.cdc.gov/wtc/fundingdashboard.html</a>.</p>

Centers for Disease Control and Prevention - ERA

The National Institute for Occupational Safety and Health (NIOSH) World Trade Center (WTC) Health Program K01 Award supports early-career investigators in developing independent research careers focused on improving the health and well-being of populations affected by the September 11, 2001, terrorist attacks (9/11). This award provides up to three years of mentored research and career development support, including at least 75 percent protected time. The program supports research that improves understanding of physical and mental health effects associated with 9/11 exposures, addresses diagnostic or treatment uncertainty, identifies emerging health concerns, examines aging among exposed populations, and informs improvements in clinical care, public health practice, and long-term health outcomes. Research that helps translate scientific findings into improved care and public health practice is encouraged. Responsive research may include epidemiologic, clinical, translational, preclinical, health services, health outcomes, diagnostic, treatment, prevention, quality-of-life, and implementation research. Generalizability to other populations is not required. The award also supports the development of the next generation of investigators needed to address health needs related to 9/11 exposure. More information, including the WTC Health Program Research Agenda and previously funded projects, is available at: https://www.cdc.gov/wtc/researchagenda.html and https://www.cdc.gov/wtc/fundingdashboard.html.

Wounded Warrior Project

Grants for mental health treatment programs for post-9/11 veterans with PTSD, TBI, and combat-related injuries.