Opportunity Information: Apply for PAR 21 134
The National Institute of Mental Health (NIMH), under 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 21-134; CFDA: 93.242). This funding announcement is a reissue of an earlier solicitation (RFA-MH-18-705) and sits within NIMH's clinical trials pipeline, meaning it is specifically meant to move promising psychosocial ideas into real-world testing through a required clinical trial component. The overall focus is on advancing new or improved psychosocial interventions, as well as sharpening and validating the intervention targets those programs are designed to affect, with the goal of improving prevention or treatment outcomes for mental disorders.
A central theme of this opportunity is NIMH's "experimental therapeutics" approach. In practical terms, applicants are expected to do more than show that an intervention helps people feel better; the project should identify a clear, theoretically grounded target (for example, a cognitive, affective, behavioral, or neuropsychological process that the intervention is designed to change) and then demonstrate that the intervention actually engages that target. The grant supports work that takes findings from basic and translational science areas such as behavioral science, cognitive science, affective science, and neuropsychology and turns them into intervention strategies that can be tested in humans. The intent is to shorten the time between discoveries about mechanisms of behavior and emotion and the creation of interventions that reliably prevent or reduce symptoms and impairment.
This R33 mechanism is structured to support pilot-stage clinical trial research for up to three years. The funded work is expected to replicate target engagement shown in prior studies (so, confirming that the intervention reliably changes the intended mechanism) and to test whether the degree of target engagement is associated with changes in clinical outcomes. In other words, the project should help answer questions like: Did the intervention change the specific process it was designed to change, and did that change track with meaningful improvements in symptoms, functioning, or other clinically important endpoints? This emphasis is meant to help the field distinguish between interventions that merely correlate with improvement and interventions that work through a measurable, changeable mechanism that can be optimized and scaled.
Eligibility is broad and includes many types of U.S. organizations and governmental units, such as state, county, and municipal governments; special district governments; independent school districts; federally recognized tribal governments; public housing authorities; public and state-controlled institutions of higher education; private colleges and universities; nonprofit organizations (both with and without 501(c)(3) status); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and certain tribal governments that are not federally recognized. Notably, the eligibility list also includes non-U.S. entities (foreign organizations), signaling that international applicants may apply when consistent with NIH policies and the goals of the program.
Key administrative details in the posted source information include an original closing date of 2024-10-15 and a creation date of 2021-03-02. While an award ceiling and expected number of awards are not specified in the excerpt provided, the core programmatic message is clear: NIMH is looking for carefully designed pilot clinical trials of psychosocial preventive or therapeutic interventions that can demonstrate target engagement and link that engagement to clinical change, thereby strengthening the mechanistic foundation for future intervention refinement, larger trials, and eventual implementation.Apply for PAR 21 134
- 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 2021-03-02.
- Applicants must submit their applications by 2024-10-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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)
1) What is the name of this grant opportunity?
The opportunity is titled "Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required)".
2) Which agency is offering this funding?
This grant is offered by the National Institute of Mental Health (NIMH), which is part of the National Institutes of Health (NIH).
3) What is the Funding Opportunity Number (FON) and CFDA listing?
Funding Opportunity Number (FON): PAR 21-134
CFDA: 93.242
4) Is this a new program or a reissue?
This funding announcement is described as a reissue of an earlier solicitation: RFA-MH-18-705.
5) What type of work is this program designed to support?
The program is designed to advance new or improved psychosocial interventions and to sharpen and validate the intervention targets those programs are intended to affect, with the goal of improving prevention or treatment outcomes for mental disorders.
6) Does this opportunity require a clinical trial?
Yes. This is an R33 Clinical Trial Required opportunity, and the description emphasizes that it sits within NIMH's clinical trials pipeline and is meant to move promising psychosocial ideas into real-world testing through a required clinical trial component.
7) What is the overall scientific approach NIMH emphasizes for this funding opportunity?
A central theme is NIMH's "experimental therapeutics" approach. Applicants are expected to define a clear, theoretically grounded target and demonstrate that the intervention engages (changes) that target, not only that participants improve.
8) What does "experimental therapeutics" mean in practical terms for applicants?
In practical terms, the project should:
- Identify a clear, theoretically grounded target (for example, a cognitive, affective, behavioral, or neuropsychological process).
- Show that the intervention actually engages (changes) that target.
- Test whether the degree of target engagement is associated with changes in clinical outcomes (such as symptoms, functioning, or other clinically important endpoints).
9) What kinds of targets are examples of what NIMH is looking for?
The description provides examples of targets such as cognitive, affective, behavioral, or neuropsychological processes that the intervention is designed to change.
10) What kinds of research areas may feed into intervention development under this program?
The program supports work that translates findings from basic and translational science areas such as behavioral science, cognitive science, affective science, and neuropsychology into intervention strategies that can be tested in humans.
11) What is the intended impact of supporting this kind of work?
The intent is to shorten the time between discoveries about mechanisms of behavior and emotion and the development of interventions that can reliably prevent or reduce symptoms and impairment.
12) What stage of research is this R33 mechanism meant to support?
This R33 mechanism is structured to support pilot-stage clinical trial research.
13) How long can the project period be under this R33?
The funded work can be supported for up to three years.
14) What does the program expect regarding prior evidence and replication?
The funded work is expected to replicate target engagement shown in prior studies, meaning applicants should confirm that the intervention reliably changes the intended mechanism.
15) What relationship should the project test between target engagement and outcomes?
The project should test whether the degree of target engagement is associated with changes in clinical outcomes. Put simply, it should help answer: did the intervention change the process it was designed to change, and did that change track with meaningful clinical improvement?
16) Why is NIMH emphasizing target engagement and mechanistic links?
This emphasis is meant to help distinguish interventions that merely correlate with improvement from interventions that work through a measurable, changeable mechanism that can be optimized and scaled.
17) What kinds of interventions are within scope?
Based on the description, the scope includes psychosocial therapeutic interventions and psychosocial preventive interventions for mental disorders, particularly those that can demonstrate target engagement and connect that engagement to clinical change in a pilot clinical trial.
18) Is eligibility limited to universities?
No. Eligibility is described as broad and includes many U.S. organization types and governmental units as well as other categories described in the announcement.
19) What U.S. governmental organizations are listed as eligible?
The eligible categories listed include:
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Federally recognized tribal governments
- Public housing authorities/Indian housing authorities
20) What higher education institutions are listed as eligible?
The eligible categories listed include:
- Public and state-controlled institutions of higher education
- Private institutions of higher education (private colleges and universities)
21) Are nonprofits eligible to apply?
Yes. The announcement lists nonprofit organizations with 501(c)(3) status and nonprofits without 501(c)(3) status as eligible.
22) Are for-profit organizations eligible?
Yes. The eligibility list includes for-profit organizations other than small businesses, and it also includes small businesses.
23) Are faith-based or community-based organizations eligible?
Yes. The announcement specifically highlights faith-based or community-based organizations among additional eligible applicant categories.
24) Are minority-serving institutions specifically called out as eligible?
Yes. The announcement highlights additional eligible categories including:
- Historically Black Colleges and Universities (HBCUs)
- Hispanic-serving Institutions
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISISs)
25) Are U.S. territories or possessions included in eligibility?
Yes. The announcement includes U.S. territories or possessions and also mentions regional organizations.
26) Are tribal governments that are not federally recognized eligible?
Yes. The announcement notes eligibility for certain tribal governments that are not federally recognized.
27) Can non-U.S. (foreign) organizations apply?
Yes. The eligibility list includes non-U.S. entities (foreign organizations), indicating that international applicants may apply when consistent with NIH policies and the goals of the program.
28) What is the posted original closing date in the provided information?
The posted information includes an original closing date of 2024-10-15.
29) What is the creation date shown in the provided information?
The posted information includes a creation date of 2021-03-02.
30) Is there an award ceiling or expected number of awards provided in the excerpt?
No. The excerpt provided states that an award ceiling and the expected number of awards are not specified in the information shared.
31) What is the core programmatic message of the opportunity?
NIMH is looking for carefully designed pilot clinical trials of psychosocial preventive or therapeutic interventions that can (1) demonstrate target engagement and (2) link that engagement to clinical change, strengthening the mechanistic foundation for future refinement, larger trials, and eventual implementation.
32) How does this opportunity fit within NIMH's broader research pathway?
The description states that it sits within NIMH's clinical trials pipeline and is meant to help move promising psychosocial ideas into real-world testing through a required clinical trial component.
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Applicants also applied for:
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| Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed) Apply for PAR 21 122 Funding Number: PAR 21 122 Agency: National Institutes of Health Category: Health Funding Amount: $499,000 |
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| Development of Animal Models and Related Biological Materials for Research (R21 Clinical Trial Not Allowed) Apply for PAR 21 167 Funding Number: PAR 21 167 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| High-Priority Behavioral and Social Research Networks in Alzheimers Disease and Alzheimers Disease-Related Dementias (R24 Clinical Trial Optional) Apply for RFA AG 22 012 Funding Number: RFA AG 22 012 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
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