Opportunity Information: Apply for PAR 25 181
The National Institute of Mental Health (NIMH), within the National Institutes of Health (NIH), is offering a discretionary grant opportunity titled Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required), Funding Opportunity Number PAR 25-181 (CFDA 93.242). This notice of funding opportunity sits within NIMH's clinical trials pipeline and is designed to support pilot-stage clinical trial work that moves promising psychosocial intervention ideas toward stronger evidence and clearer mechanisms. The overall aim is to accelerate translation from basic and mechanistic research in behavioral, cognitive, affective, and neuropsychological science into practical preventive or therapeutic psychosocial interventions for mental disorders.
A central feature of this opportunity is NIMH's experimental therapeutics approach. In practical terms, applicants are expected to define a measurable intervention target (for example, a cognitive process, emotion regulation mechanism, social process, learning mechanism, or other modifiable factor believed to drive symptoms or impairment), build or refine a psychosocial intervention specifically intended to engage that target, and then test whether the intervention actually engages it in people. Beyond simply showing symptom improvement, the program emphasizes demonstrating target engagement and examining whether changes in the target are associated with changes in clinically meaningful outcomes. The intent is to fund work that can tell a clear story about what the intervention is changing and why that change matters clinically, rather than only whether the intervention "works" on average.
The R33 mechanism will provide up to three years of support. Within that timeframe, the funded work is expected to (1) replicate target engagement that has been shown in prior studies and (2) test the association between target engagement and changes in clinical outcome(s). This makes the opportunity particularly relevant for teams that already have preliminary evidence suggesting a specific psychosocial strategy can move a hypothesized mechanism, and who are ready to test that mechanism-outcome link in a pilot clinical trial that is appropriately designed, measured, and analyzed.
Because this is an R33 clinical trial required opportunity, the proposed project must include a clinical trial component rather than being purely observational or preclinical. While the announcement language stresses pilot research, it is oriented toward rigorous early-stage testing of a novel psychosocial intervention and/or a novel target, with careful measurement of the putative mechanism and clinically relevant endpoints. Applicants should expect that study design decisions (such as comparison conditions, timing and frequency of assessments, fidelity monitoring, and analytic plans) will be scrutinized for how well they can answer the mechanistic questions about target engagement and its relationship to outcomes.
Eligibility is broad and includes many organization types. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; and Native American tribal organizations that are not federally recognized tribal governments. The program also allows applications from public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education), for-profit organizations other than small businesses, and small businesses. In addition, the opportunity explicitly highlights other eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This broad eligibility signals NIMH's interest in encouraging diverse institutional participation and potentially supporting intervention development and testing in a wide range of real-world settings and populations.
Key administrative details include an original closing date of 2027-10-15 and a creation date of 2024-11-26. The listing does not specify an award ceiling or expected number of awards in the source data provided, so applicants would need to consult the full NOFO for budget guidance, application due date structure, and any institute-specific limits or expectations. Overall, the opportunity is best understood as targeted support for mechanism-driven psychosocial intervention development and pilot clinical trial testing, with a strong preference for proposals that can convincingly measure and replicate target engagement and directly connect that engagement to meaningful clinical change.Apply for PAR 25 181
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
- This funding opportunity was created on 2024-11-26.
- Applicants must submit their applications by 2027-10-15.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required).
Who is offering this grant?
The funder is the National Institute of Mental Health (NIMH), which is part of the National Institutes of Health (NIH).
What is the Funding Opportunity Number?
The Funding Opportunity Number is PAR 25-181.
What is the CFDA number listed for this opportunity?
The listing includes CFDA 93.242.
What kind of grant mechanism is this?
This is an R33 mechanism, and it is specifically labeled Clinical Trial Required.
Is a clinical trial required, or can the project be observational?
A clinical trial component is required. The project cannot be purely observational or preclinical under this opportunity as described.
How long can the project be supported?
The R33 mechanism will provide up to three years of support.
Where does this opportunity fit within NIMH priorities?
This notice of funding opportunity sits within NIMH's clinical trials pipeline and is intended to support pilot-stage clinical trial work that strengthens evidence and clarifies mechanisms for psychosocial interventions.
What is the overall aim of the program?
The overall aim is to accelerate translation from basic and mechanistic research in behavioral, cognitive, affective, and neuropsychological science into practical preventive or therapeutic psychosocial interventions for mental disorders.
What does NIMH mean by an "experimental therapeutics approach" in this opportunity?
Applicants are expected to identify a measurable intervention target, develop or refine a psychosocial intervention designed to engage that target, and then test whether the intervention actually engages the target in people. The emphasis is not only on symptom change, but on demonstrating target engagement and examining whether change in the target is associated with change in clinically meaningful outcomes.
What is an "intervention target" in the context of this NOFO?
The target is a measurable, modifiable factor believed to drive symptoms or impairment. Examples mentioned include a cognitive process, emotion regulation mechanism, social process, learning mechanism, or another modifiable factor tied to clinical symptoms or functioning.
Does the program focus only on whether symptoms improve?
No. The description emphasizes telling a clear mechanistic story: showing what the intervention is changing (target engagement) and why that matters clinically, rather than focusing only on whether the intervention "works" on average.
What kinds of projects are a good fit for this R33?
This opportunity is positioned for teams with preliminary evidence that a psychosocial strategy can move a hypothesized mechanism, and who are ready to test the mechanism-outcome link in a rigorously designed pilot clinical trial with appropriate measurement and analysis.
What are the key expectations for what the funded work should accomplish within the project period?
Within the three-year timeframe, the funded work is expected to: (1) replicate target engagement that has been shown in prior studies, and (2) test the association between target engagement and changes in clinical outcome(s).
Does the NOFO allow novel interventions or novel targets?
Yes. The description indicates the opportunity is oriented toward rigorous early-stage testing of a novel psychosocial intervention and/or a novel target, with careful measurement of both the proposed mechanism and clinically relevant endpoints.
What design and methods issues are likely to be closely reviewed?
The description signals that reviewers will scrutinize how study design decisions support mechanistic conclusions, including comparison conditions, timing and frequency of assessments, fidelity monitoring, and analytic plans, particularly as they relate to target engagement and its relationship to outcomes.
What types of organizations are eligible to apply?
Eligibility is broad. Eligible applicants include: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; and Native American tribal organizations that are not federally recognized tribal governments.
Are nonprofits eligible?
Yes. Nonprofits with or without 501(c)(3) status are eligible as described, as long as they are not institutions of higher education.
Are for-profit organizations eligible?
Yes. The opportunity allows applications from for-profit organizations other than small businesses, and it also lists small businesses as eligible.
Are public housing authorities eligible?
Yes. The description includes public housing authorities/Indian housing authorities as eligible applicants.
Are faith-based or community-based organizations eligible?
Yes. The opportunity explicitly highlights faith-based or community-based organizations among eligible applicants.
Are minority-serving institutions mentioned as eligible?
Yes. The opportunity explicitly highlights multiple types of minority-serving institutions, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, and TCCUs.
Are federal agencies eligible to apply?
Yes. The opportunity mentions eligible federal agencies among eligible applicants.
Are U.S. territories or possessions eligible?
Yes. The opportunity highlights U.S. territories or possessions as eligible applicants.
Are non-U.S. (foreign) organizations eligible?
Yes. The opportunity explicitly includes non-domestic (non-U.S.) entities (foreign organizations) as eligible applicants.
When was this opportunity created?
The creation date listed is 2024-11-26.
What is the original closing date listed?
The original closing date listed is 2027-10-15.
Is the award ceiling (maximum budget) provided in the information shown?
No. The source information provided does not specify an award ceiling.
Is the expected number of awards provided in the information shown?
No. The source information provided does not list the expected number of awards.
Where should applicants look for budget guidance and due date structure?
The description indicates applicants would need to consult the full NOFO for budget guidance, application due date structure, and any institute-specific limits or expectations.
In plain terms, what kind of "story" is NIMH looking for in an application?
Based on the description, NIMH is looking for a proposal that can convincingly show: (1) the intervention engages a defined target, (2) that target engagement can be replicated (based on prior evidence), and (3) changes in the target are meaningfully linked to changes in clinical outcomes.
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