Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for researchers and academic institutions seeking to develop and test psychosocial therapeutic and preventive interventions for mental disorders through a two-stage clinical trial mechanism (R61/R33). Eligible applicants include academic medical centers, research universities, medical schools, and research institutions with the capacity to design, conduct, and evaluate rigorous clinical trials. The program supports both basic/translational research (R61 phase) and efficacy testing in clinical populations (R33 phase). NIH expects applications to propose innovative interventions addressing significant mental health treatment gaps, with potential for future clinical impact. The grant operates nationally and is not geographically restricted. Applicants must demonstrate institutional commitment, access to relevant clinical populations, and experience with clinical trial methodology.
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Program description
Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/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 two years of support for evaluation of target engagement and establishment of intervention parameters, and 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
- 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
How to apply
Application links
Required documents
- NIH Form SF-424 (R&R) and associated cover letter
- Project narrative (research strategy) with specific aims, significance, innovation, approach, and expected outcomes
- Detailed budget and budget narrative for both R61 and R33 phases
- Biosketch (CV) for all key personnel (NIH format)
- Research plan including preliminary data, intervention development details, clinical trial protocol, and statistical analysis plan
- Recruitment and retention plan with evidence of access to participant populations
- Letters of support from clinical sites, partner institutions, and collaborators
- Institutional commitment documentation (e.g., letter from department chair or institutional official)
- Data and safety monitoring plan (for clinical trial component)
- Human subjects protection documentation (IRB approval or reliance agreements)
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
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$78,262,050
-
$75,056,208
-
$74,756,329
-
$64,705,159
-
$63,991,707
-
$54,214,022
-
$48,653,752
-
$38,895,082
-
$38,475,557
-
$35,940,675
Top States by Funding
- CA 15 awards $408.1M
- MA 9 awards $230.5M
- NY 6 awards $184.2M
- CT 4 awards $183.5M
- WA 4 awards $174.9M
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 R61/R33 grant?
Eligibility includes U.S. and foreign for-profit and nonprofit organizations, public and private institutions such as universities, colleges, hospitals, laboratories, and other research institutions. Federal agencies and state/local government entities may also apply. Applicants must have the capacity to conduct rigorous clinical trials.
What is the two-stage R61/R33 mechanism?
The R61 phase (typically 2 years) supports development and preliminary testing of the intervention in laboratory or pilot settings. The R33 phase (typically 3 years) supports a full clinical trial to test efficacy in a patient population. Continuation to R33 is contingent on meeting R61 milestones.
What types of psychosocial interventions are supported?
The program supports therapeutic and preventive interventions for mental disorders, which may include behavioral therapies, psychotherapy modalities, cognitive interventions, social support programs, and other psychosocial approaches with evidence of potential benefit.
How competitive are these applications?
R61/R33 awards are highly competitive. Success typically requires innovative, well-designed interventions with clear mechanistic understanding, preliminary evidence of efficacy, and feasible clinical trial plans with realistic recruitment and retention strategies.
What is the typical funding level and timeline?
Funding varies but typically ranges from $200,000 to $500,000+ per year (combined R61 and R33 phases). R61 phase is usually 2 years; R33 phase typically 3 years, with a total project period of 5 years.
💡 Tips for applicants
- Invest time upfront in identifying a mental disorder with a clear treatment gap and a psychosocial intervention strategy with mechanistic plausibility. Reviewers prioritize innovation and clinical significance over incremental improvements.
- Develop a rigorous and feasible clinical trial design for the R33 phase during the R61 application, including detailed recruitment, enrollment, and retention plans. Unrealistic enrollment projections are a frequent source of reviewer concern.
- Build partnerships with relevant clinical sites and populations early. Letters of support from clinicians, patient advocates, and recruitment sites strengthen applications and demonstrate institutional commitment.
- Clearly articulate the transition from R61 (development/preliminary testing) to R33 (efficacy trial). Specify measurable milestones and go/no-go decision criteria for moving to the R33 phase.
- Address potential threats to validity: describe your approach to blinding, fidelity monitoring, comparator/control conditions, and management of confounding variables. NIH reviewers scrutinize methodological rigor carefully.
⚠️ Common mistakes
Applications frequently fail due to insufficient preliminary data supporting the intervention's mechanism or promising early efficacy signals. Reviewers expect evidence beyond theoretical rationale. Additionally, many applications underestimate recruitment challenges and propose unrealistic enrollment timelines for the R33 clinical trial phase, or lack detailed fidelity and quality assurance protocols for a psychosocial intervention that will be delivered across multiple sites.
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