Effectiveness Trials to Test Mental Health System Interventions (R61/R33 Clinical Trial Required)
Can you apply?
This grant is for researchers testing mental health system interventions through effectiveness trials. Eligible applicants include academic institutions, government agencies, nonprofits, and small businesses with research capacity. Projects must use the NIH R61/R33 two-phase structure with clinical trial requirements. Geographic scope is nationwide. Funded activities include trial design, implementation, evaluation, and dissemination of mental health system improvements.
This grant is for researchers testing mental health system interventions through effectiveness trials. Eligible applicants include academic institutions, government agencies, nonprofits, and small businesses with research capacity. Projects must use the NIH R61/R33 two-phase structure with clinical trial requirements. Geographic scope is nationwide. Funded activities include trial design, implementation, evaluation, and dissemination of mental health system improvements.
Program description
This R61/R33 concept complements NIMHs suite of clinical trial NOFOs by supporting feasibility and infrastructure development (R61) followed by well-powered clinical trials (R33) to test the effectiveness of system interventions and strategies for improving the organization, delivery, coordination, and clinical and functional outcomes of mental health services. System interventions – which may span, for example, structural, policy, organizational, and interpersonal domains – attend to issues about the access, equity, engagement/utilization, value (cost/financing), management, or quality and safety of mental health services, with the goal of improved care processes and clinical and functional outcomes. Accordingly, the focus of system interventions may include a variety of care settings, such as health systems and organizations, mental health and community clinics, schools, and child welfare or juvenile justice systems
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
Details
This grant is for researchers testing mental health system interventions through effectiveness trials. Eligible applicants include academic institutions, government agencies, nonprofits, and small businesses with research capacity. Projects must use the NIH R61/R33 two-phase structure with clinical trial requirements. Geographic scope is nationwide. Funded activities include trial design, implementation, evaluation, and dissemination of mental health system improvements.
How to apply
Application links
Required documents
- SF-424 (R&R) Application
- Project Narrative (specific aims, background, methods, evaluation plan)
- Research Strategy (innovation and significance)
- Budget and Budget Narrative
- Biographical Sketches (key personnel)
- Facilities and Resources
- Letters of Support from partner sites
- Protection of Human Subjects documentation
- Data Management Plan
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 can apply for this grant?
Academic institutions, government agencies, nonprofits, and small businesses with demonstrated research capability can apply. Your organization must have infrastructure to conduct clinical trials.
What types of projects are funded?
Effectiveness trials testing mental health system interventions. Projects must include rigorous evaluation and implementation science approaches.
What is the R61/R33 structure?
Phase 1 (R61) tests feasibility and refines your intervention. Phase 2 (R33) conducts the full-scale effectiveness trial.
How competitive is this grant?
Very competitive. NIH research grants typically fund 10-20% of applications. Strong preliminary data and experienced teams are essential.
What is the funding range?
Funding varies by phase and scope, but typical NIH R-series grants range from $300K-$1M+ annually depending on project complexity.
💡 Tips for applicants
- Show strong preliminary evidence that your intervention works before applying. NIH reviewers expect proof of concept.
- Include a detailed implementation plan showing how your intervention fits real-world mental health settings.
- Emphasize rigorous evaluation methods with clear outcome measures and realistic timelines.
- Highlight your team's expertise in clinical trials, mental health research, and systems implementation.
- Address potential barriers to implementation and explain your dissemination strategy for scaling successful results.
⚠️ Common mistakes
Weak preliminary data or insufficient evidence your intervention is ready for testing. Unclear timeline or unrealistic scope for a two-phase trial. Vague evaluation plans lacking specific, measurable outcomes.
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