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The purpose of this Funding Opportunity Announcement (FOA) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs or drug candidates for the treatment of psychiatric disorders in areas of unmet medical need. The FOA will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase Ib studies of novel Agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drug's impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The FOA also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private funding for further clinical development as FDA-approved treatments.

NIMH seeks applications for pilot effectiveness projects to evaluate the preliminary effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden. In this pilot phase of effectiveness research, the trial should be designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach; to address whether the intervention engages the target(s)/mechanisms(s) that is/are presumed to underlie the intervention effects; and to obtain preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., comparative effectiveness study, practical trial) designed to definitely test the effectiveness of interventions to improve post-acute outcomes.

The purpose of this Funding Opportunity Announcement (FOA) is to: identify new, information technology (IT)-enabled delivery models that support systematic screening and treatment of depression in cancer patients; test the feasibility of implementing these new delivery models in a variety of oncology practice settings, especially those serving under-served populations; and test the usability and potential effectiveness of the IT-specific components of these new delivery models. Also listed under R01

This funding opportunity announcement (FOA) encourages exploratory /developmental research grant applications (R21) to investigate the fundamental science of mind and body approaches, including mind/brain-focused practices (e.g., meditation, hypnosis), body-based approaches (e.g., acupuncture, massage, spinal manipulation/mobilization), meditative exercise (e.g., yoga, tai chi, qi gong), art and music therapies, or integrative approaches combining several components. Studies of pharmacologic approaches exclusively are not included in the scope of this FOA.

The announcement seeks applications from public and private nonprofit entities to establish and operate voluntary family planning services projects, which shall provide family planning services to all persons desiring such services, with priority for services to persons from low-income families. The Title X statute specifies that local and regional public or private nonprofit entities may apply directly to the Secretary for a Title X family planning services grant under this announcement. Family planning services include clinical family planning and related preventive health services; information, education, and counseling related to family planning; and, referral services as indicated. Copies of the Title X statute, regulations, legislative mandates, Program Guidelines, and Program Policy Notices may be downloaded from the Office of Population Affairs web site at http://www.hhs.gov/opa/familyplanning.

The purpose of this funding opportunity announcement is to solicit research to develop, optimize and test mental health telehealth methods (i.e., without involving in-person interaction between a mental health clinician and the patient) to help evaluate and treat emergency department (ED) patients with suicide risk, compared to usual care of such patients in emergency departments without adequate on-site mental health specialty consultation. Primary research questions include if the use of telehealth methods affects the proportion of ED patients who are (1) considered at imminent risk for suicide, (2) boarded in the ED due to suicide risk, and (3) require hospitalization for suicide risk; (4) whether use of telehealth methods affects the rate of within-encounter provision of evidence-based suicide prevention interventions; and whether use of telehealth methods affects (5) the rates of suicide ideation, attempts and deaths, and (6) health care use and costs, in the year after an index ED visit in which a patient was identified with suicide risk. To inform future implementation of telehealth enabled suicide prevention practices in the ED, qualitative data on patient and provider views of telehealth provision of suicide prevention practices (feasibility and acceptability of clinical decision making; clinical workflows; ease of use of technology) are sought.

This Funding Oopportunity Aannouncement (FOA) invites pilot feasibility studies testing rapid-acting interventions to reduce severe suicide risk through clinical trials that are based in appropriate/specialized healthcare settings(e.g., emergency departments [ED], psychiatric inpatient units, other settings that meet Risk Evaluation and Mitigation Strategy approaches).

NIMH seeks applications for innovative research projects to test strategies to increase the reach, efficiency, effectiveness, and quality of digital mental health interventions. This FOA is intended to support the development of digital health test beds that leverage well-established digital mental health platforms ,to rapidly refine and optimize existing evidence-based digital health interventions and conduct clinical trials testing digital mental health interventions that are statistically powered to provide a definitive answer regarding the intervention's effectiveness.

To support projects that apply new or existing tools to monitor and/or manipulate the 4D nucleome in the context of human health and disease. Any human disease or biological process relevant to NIHs mission may be proposed including environmental exposures (e.g. addictive substances, toxins, psychosocial stress), or studies across development or lifespan. Other relevant timeframes may include but are not limited to: circadian rhythms, fasting and feeding cycles, reproductive cycles, and sleep/wake cycles.

To support projects from NIH-defined New Investigators that apply new or existing tools to monitor and/or manipulate the 4D nucleome (4DN) in the context of human health and disease. Any human disease or biological process relevant to NIHs mission may be proposed including environmental exposures (e.g. addictive substances, toxins, psychosocial stress), or studies across development or lifespan. Other relevant time frames may include but are not limited to: circadian rhythms, fasting and feeding cycles, reproductive cycles, and sleep/wake cycles.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage practice-based research aimed at testing the effectiveness of developmentally-focused theory-based efficacious prevention interventions which may impact mental health outcomes, including suicide behaviors and serious mental illness. The research should test prevention approaches that are both scalable and sustainable for implementation in pediatric-serving primary care settings, with an emphasis on populations experiencing mental health disparities. This FOA seeks to supports clinical trials to establish the effectiveness of scalable prevention interventions when implemented using available resources within pediatric-serving primary care settings.

This Funding Opportunity Announcement (FOA) invites applications to enhance screening and treatment for mental and substance use disorders in HRSA Ryan White HIV/AIDS Program funded sites through implementation research, to advance the goals of the National "End the Epidemic" (EHE) initiative. This FOA is intended to support applications seeking to conduct definitive studies on implementation approaches to enhance screening and treatment of substance use or mental health disorders in the HRSA Ryan White HIV/AIDS Program. Applications seeking to conduct pilot or feasibility implementation studies should consider the companion R34 FOA at RFA-MH20-521

Substantial progress has been made in the development and testing of efficacious theory-based developmentally focused prevention interventions designed to address modifiable proximal risk and protective factors with the goal of having an impact on distal mental health outcomes, including suicide behaviors and the occurrence of serious mental illness. Pediatric-serving primary care (including obstetrics/gynecological for pregnancy and post-partum, pediatric care, family practice, adolescent medicine) is a health care setting that holds potential for the implementation of mental health prevention interventions because it offers broad access and is non-stigmatizing. In addition, there is the potential for prevention interventions found to be efficacious in the primary care setting to be endorsed by the United States Preventive Services Task Force (USPSTF) and covered under insurance. Because pediatric primary care offers broad access and is non-stigmatizing, it may be an appropriate setting for reaching populations who experience mental health disparities, including racial/ethnic minority groups, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons, or any other subgroup with documented disparities in prevalence of mental illnesses, mental illness trajectories, access to prevention services, and quality and outcomes of mental health care. Accordingly, this Funding Opportunity Announcement (FOA) encourages studies that involve diverse populations, including groups that might experience health disparities, and as appropriate, it encourages examination of whether prevention services in primary care can potentially reduce or eliminate disparities.

Substantial progress has been made in the development and testing of efficacious theory-based developmentally focused prevention interventions designed to address modifiable proximal risk and protective factors with the goal of having an impact on distal mental health outcomes, including suicide behaviors and the occurrence of serious mental illness. Pediatric-serving primary care (including obstetrics/gynecological for pregnancy and post-partum, pediatric care, family practice, adolescent medicine) is a health care setting that holds potential for the implementation of mental health prevention interventions because it offers broad access and is non-stigmatizing. In addition, there is the potential for prevention interventions found to be efficacious in the primary care setting to be endorsed by the United States Prevention Services Task Force (USPSTF) and covered under insurance. Because pediatric primary care offers broad access and is non-stigmatizing, it may be an appropriate setting for reaching populations who experience mental health disparities, including racial/ethnic minority groups, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons, or any other subgroup with documented disparities in prevalence of mental illnesses, mental illness trajectories, access to prevention services, and quality and outcomes of mental health care. Accordingly, this Funding Opportunity Announcement (FOA) encourages studies that involve diverse populations, including groups that might experience health disparities, and as appropriate, it encourages examination of whether prevention services in primary care can potentially reduce or eliminate disparities.

Purpose NIMH seeks applications for innovative research projects to test strategies to increase the reach, efficiency, effectiveness, and quality of digital mental health interventions which may impact mental health outcomes, including suicide behaviors and serious mental illness. This FOA is intended to support the development of digital health test beds that leverage well-established digital mental health platforms/infrastructure to rapidly refine and optimize existing evidence based digital health interventions and conduct clinical trials testing digital mental health interventions that are statistically powered to provide a definitive answer regarding the intervention's effectiveness. Background The healthcare landscape in the United States is constantly changing, creating new challenges to the delivery of high-quality treatments and services to children, youth, adults, and older adults with unmet or under-met mental health needs. Epidemiological findings suggest that approximately one half of the United States population meets lifetime criteria for a mental disorder, and approximately one quarter of the population meets criteria in any given year. However, only one half of people with any mental health disorder and only two thirds of people with a serious mental health disorder received mental health services in the previous year. Of those that find their way into mental health care, many fall out of care and/or do not receive guideline concordant treatment, including suicide risk assessment and evidence-based preventive interventions. Disparities in population status (e.g., members of racial, ethnic, sexual, and gender minority communities), a fragmented healthcare system, provider shortages, healthcare affordability, and other factors moderate these findings.