Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required)
Can you apply?
This grant is for researchers and research institutions developing psychosocial therapeutic and preventive interventions for mental disorders. Eligible applicants include universities, research institutions, nonprofit organizations, and other entities capable of conducting NIH-funded clinical research. The R33 phase requires demonstrated feasibility from prior R21 funding or equivalent preliminary data, and must include a clinical trial component. Applicants must have appropriate institutional infrastructure, IRB approval capabilities, and access to study populations. Geographic scope is nationwide; international collaborators may participate but the lead institution must be U.S.-based. Activities supported include intervention development, refinement, feasibility testing, and clinical trial implementation for mental health conditions.
This grant is for researchers and research institutions developing psychosocial therapeutic and preventive interventions for mental disorders. Eligible applicants include universities, research institutions, nonprofit organizations, and other entities capable of conducting NIH-funded clinical research. The R33 phase requires demonstrated feasibility from prior R21 funding or equivalent preliminary data, and must include a clinical trial component. Applicants must have appropriate institutional infrastructure, IRB approval capabilities, and access to study populations. Geographic scope is nationwide; international collaborators may participate but the lead institution must be U.S.-based. Activities supported include intervention development, refinement, feasibility testing, and clinical trial implementation for mental health conditions.
Program description
Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required). As part of NIMH’s clinical trials pipeline, this NOFO encourages pilot research developing and testing novel psychosocial interventions and/or targets. Consistent with NIMH’s emphasis on the experimental therapeutics approach to intervention development, it intends to speed the translation of emergent research in basic, behavioral, cognitive, affect, and neuropsychological science into preventative or therapeutic interventions. This RFA will provide up to three years of support to replicate target engagement from prior studies and to test the association between target engagement and change in clinical outcome(s).
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Community Health Center
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
Details
This grant is for researchers and research institutions developing psychosocial therapeutic and preventive interventions for mental disorders. Eligible applicants include universities, research institutions, nonprofit organizations, and other entities capable of conducting NIH-funded clinical research. The R33 phase requires demonstrated feasibility from prior R21 funding or equivalent preliminary data, and must include a clinical trial component. Applicants must have appropriate institutional infrastructure, IRB approval capabilities, and access to study populations. Geographic scope is nationwide; international collaborators may participate but the lead institution must be U.S.-based. Activities supported include intervention development, refinement, feasibility testing, and clinical trial implementation for mental health conditions.
How to apply
Application links
Required documents
- SF-424 (Application for Federal Assistance) and SF-424 (R&R) forms
- Project Narrative (specific aims, background, significance, innovation, approach, timeline)
- Research Strategy section detailing clinical trial design and methods
- Budget and Budget Justification
- NIH Biographical Sketch (for key personnel)
- Facilities and Resources documentation
- Letters of Support from clinical sites or partner institutions
- IRB approval or evidence of IRB review plan
- Prior R21 progress report (if applicable) or preliminary data documentation
- Data Management and Sharing Plan (per NIH policy)
- Authentication of Key Personnel commitment
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.242 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$75,056,208
-
$74,756,329
-
$72,845,834
-
$64,705,159
-
$63,991,707
-
$54,214,022
-
$38,895,082
-
$38,475,557
-
$34,635,977
-
$34,475,710
Top States by Funding
- CA 15 awards $408.1M
- MA 9 awards $230.3M
- NY 6 awards $184.2M
- WA 4 awards $174.9M
- CT 3 awards $138.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.242). How funding has trended year over year.
| 2024 | $1,722,300,004 | |
| 2025 | $1,726,864,191 | |
| 2026 est. | $99,221,272 |
FAQ
Who is eligible to apply for this R33 grant?
Universities, research hospitals, nonprofit organizations, state and local governments, small businesses, and other institutions with research capacity can apply. Individuals must be affiliated with a research institution. For R33, you typically need prior R21 funding or equivalent preliminary data demonstrating feasibility.
What is the R33 phase and how does it differ from R21?
The R21 is an exploratory phase for preliminary research. The R33 is the follow-on "scale-up" phase that requires demonstrated feasibility and mandates a clinical trial component. You typically need R21 data or equivalent to move to R33.
What must the clinical trial component include?
The clinical trial must be a rigorous test of the intervention's efficacy or effectiveness in a real-world or controlled setting with appropriate sample size, outcome measures, and study design. It should demonstrate that your intervention can be delivered and evaluated at scale.
What is the typical funding amount and project period?
R33 grants typically fund for 2-3 years with budgets ranging from $150,000 to $400,000+ in direct costs, depending on scope and study population size. Exact amounts vary by institute and complexity of the trial.
When is the application deadline and what is the review timeline?
The deadline for this cycle is October 15, 2027. Standard NIH review takes approximately 4-6 months after submission, with funding decisions typically made 6-9 months after deadline.
💡 Tips for applicants
- Leverage preliminary data from prior R21 funding or pilot work to demonstrate feasibility; reviewers expect solid evidence that your intervention is ready for clinical testing. Show clear progress from development to trial-ready status.
- Design a rigorous clinical trial with appropriate statistical power, clearly specified primary/secondary outcomes, and appropriate control or comparison conditions. Be specific about recruitment, retention, and fidelity monitoring strategies.
- Address implementation science principles: explain how the intervention will be delivered in real-world settings, what training providers need, and how you'll measure both efficacy and feasibility of implementation.
- Build a strong multidisciplinary team including the intervention developer(s), experienced clinical trial methodologist, statistician, and if relevant, community partners or stakeholders who can advise on relevance and uptake.
- Use the specific NIH format pages and follow CFDA 93.242 requirements carefully; common rejections occur when applications are unclear about clinical trial components, lack adequate preliminary data, or have unrealistic timelines for the proposed scope.
⚠️ Common mistakes
Applications for this grant often fail when the clinical trial component is underdeveloped or lacks sufficient methodological rigor—reviewers expect a fully powered, well-designed trial that can yield publication-quality results. Another frequent issue is insufficient preliminary data: moving from R21 to R33 requires clear evidence of feasibility; applications without solid prior data or a compelling justification for skipping the R21 phase rarely succeed. Additionally, many applicants underestimate the complexity of delivering psychosocial interventions in clinical settings and fail to adequately address implementation barriers, training protocols, and fidelity monitoring.
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