Pilot Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (R01 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-25-206
- 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
-
- State Governments
- Other
- Tribal Organizations (Not Federally Recognized)
- Higher Education Inst. (Public)
- 501(c)(3) Nonprofits
- Public or Indian Housing Auth.
- City/Township Governments
- Independent School Districts
- Non-501(c)(3) Nonprofits
- For Profit Organizations
- Special District Governments
- County Governments
- Higher Education Inst. (Private)
- Small Businesses
- Tribal Governments (Federally Recognized)
- Points of contact
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- 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 seeking applications for pilot effectiveness trials evaluating therapeutic and service delivery interventions for post-acute management of mental health conditions, with an application due date of January 7, 2028. The trials must be designed as clinical trials and must evaluate feasibility, tolerability, acceptability, safety, and potential effectiveness of post-acute phase approaches to inform the design of larger-scale definitive effectiveness studies.
Eligible applicants include state governments, tribal organizations (federally and non-federally recognized), higher education institutions (public and private), 501(c)(3) nonprofits, non-501(c)(3) nonprofits, for-profit organizations, small businesses, city and county governments, independent school districts, public or Indian housing authorities, special district governments, Alaska Native and Native Hawaiian serving institutions, Asian American Native American Pacific Islander serving institutions, faith-based and community-based organizations, Hispanic-serving institutions, historically Black colleges and universities, tribally controlled colleges and universities, eligible federal agencies, regional organizations, non-domestic entities, and U.S. territories or possessions.
The intervention must be matched to the stage of illness in both focus (consolidating and maintaining gains from initial treatment, managing residual symptoms or impairment, preventing relapse, promoting adherence and appropriate service use) and intensity or burden. The pilot phase should address whether the intervention engages the target mechanisms presumed to underlie intervention effects and obtain preliminary data needed as a prerequisite to a larger-scale effectiveness trial such as a comparative effectiveness study or practical trial. The program provides funding under CFDA 93.242 (Mental Health Research Grants). Fully-powered, definitive effectiveness studies focused on post-acute phase interventions are supported separately via a distinct R01 opportunity (TEMP-24813). Support is recommended for a project period not exceeding 5 years.
Synopsis
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. This Notice of Funding Opportunity (NOFO) supports pilot effectiveness research to evaluate the feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches and inform the design of definitive effectiveness trials. Support for fully-powered, definitive effectiveness studies focused on post-acute phase interventions is provided via the R01 currently TEMP-24813.
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-25-206-Full-Announcement.html | HTML file | |
| PKG00288341.pdf |
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