Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-25-179
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- 501(c)(3) Nonprofits
- County Governments
- Tribal Governments (Federally Recognized)
- Special District Governments
- For Profit Organizations
- Non-501(c)(3) Nonprofits
- State Governments
- Higher Education Inst. (Private)
- Small Businesses
- Other
- City/Township Governments
- Independent School Districts
- Public or Indian Housing Auth.
- Tribal Organizations (Not Federally Recognized)
- Higher Education Inst. (Public)
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institute of Mental Health is soliciting applications for confirmatory efficacy clinical trials of non-pharmacological and pharmacological interventions for mental disorders, with applications due October 15, 2027. This R01 activity funds testing of therapeutic and preventive interventions addressing unmet needs in adults and children, designed to advance understanding of disease mechanisms and intervention-induced therapeutic change through the experimental therapeutics approach.
Eligible applicants span 501(c)(3) and non-501(c)(3) nonprofits, for-profit organizations, state and local governments, tribal governments (federally recognized and other), higher education institutions (public and private), special district governments, city/township governments, independent school districts, public or Indian housing authorities, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, HBCUs, Hispanic-serving institutions, TCCUs, faith-based and community-based organizations, eligible federal agencies, regional organizations, and non-domestic entities.
The program operates under CFDA 93.242 (Mental Health Research Grants). Support is recommended for project periods not exceeding five years. Applications are evaluated on scientific and technical merit, program relevance, and program balance by peer review, with non-fellowship applications also reviewed by the National Advisory Mental Health Council. Award magnitudes for R01 and similar activities reach into seven figures; recent awards in the Mental Health Research Grants program have reached $3.09 million. Recent mental health research funding emphasizes neurobiological mechanisms, behavioral and intervention development, and implementation science approaches to service delivery, though overall program activity has contracted sharply from 978 awards in 2022 to 271 awards in the first four months of 2026.
Synopsis
Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required). As part of NIMH's clinical trials pipeline NOFOs, this announcement supports confirmatory efficacy testing of non pharmacological therapeutic and preventive interventions for mental disorders in adults and children that address unmet therapeutic needs, and are consistent with the NIMH emphasis on the experimental therapeutics approach. In this approach, clinical trials should be designed to increase knowledge of the relationship between underlying disease processes and the mechanisms of action through which any intervention produces therapeutic change.
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-179-Full-Announcement.html | HTML file | |
| PKG00289144.pdf |
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar grant opportunities
- Ask GovTribe AI about this opportunity