Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 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 research institutions, universities, and nonprofits with research capacity seeking to conduct rigorous clinical trials testing the effectiveness of mental health interventions. Applicants must be able to conduct NIH-compliant research with institutional review board (IRB) oversight and human subjects protections. The program supports both non-pharmacological approaches (e.g., psychotherapy, behavioral interventions, digital therapeutics) and pharmacological treatments for mental disorders across the lifespan. A clinical trial component is required. Funding is available to institutions located in the United States and its territories that meet NIH eligibility standards.
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Program description
Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required). As part of NIMH’s clinical trials pipeline NOFOs, this announcement supports confirmatory efficacy testing of non pharmacological therapeutic and preventive interventions for mental disorders in adults and children that address unmet therapeutic needs, and are consistent with the NIMH emphasis on the experimental therapeutics approach. In this approach, clinical trials should be designed to increase knowledge of the relationship between underlying disease processes and the mechanisms of action through which any intervention produces therapeutic change.
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
How to apply
Application links
Required documents
- NIH R01 application form (SF-424 R&R and associated forms)
- Project narrative (limited to specified page count, typically 12-15 pages)
- Specific Aims page (1 page)
- Research Strategy including Background, Significance, Innovation, and Approach
- Research Plan with detailed Clinical Trial Design section
- Statistical analysis and power analysis documentation
- Letters of support from participating clinical sites (if applicable)
- IRB approval or certification of planned human subjects protections
- Biographical sketches of senior/key personnel (NIH format)
- Current and Pending Support documentation
- Budget narrative and justification
- Data management and sharing plan
- Appendix materials (preliminary data figures, protocols, instruments, etc.)
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
-
$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 grant?
Research institutions, universities, teaching hospitals, nonprofit research organizations, and other research entities with IRB approval capabilities and demonstrated research infrastructure can apply. Applicants must have the capacity to conduct NIH-compliant clinical trials with human subjects.
Is a clinical trial required?
Yes, this R01 mechanism requires a confirmatory efficacy clinical trial as the primary research component. Studies must be designed to test intervention effectiveness in defined populations with mental health conditions.
What types of interventions are supported?
The program supports both non-pharmacological interventions (psychotherapy, behavioral therapy, digital health tools, etc.) and pharmacological treatments for mental disorders. Interventions must have preliminary evidence of promise.
How competitive is this program?
NIH R01 grants are highly competitive. Success rates typically range from 15-25%. Applications must demonstrate scientific rigor, methodological excellence, experienced research teams, and clear clinical significance.
What is the typical funding range?
R01 awards from NIH typically range from $250,000 to $500,000+ per year, depending on project scope, duration, and institute. Actual amounts vary and should be discussed with your NIH program officer during pre-submission.
💡 Tips for applicants
- Contact your assigned NIH program officer before submitting your application. They can clarify expectations, provide feedback on your research design, and help align your proposal with program priorities.
- Build a strong multidisciplinary team that includes experienced clinical researchers, biostatisticians, and clinicians with expertise in your target disorder and intervention type.
- Demonstrate preliminary data showing that your intervention shows promise and that your clinical trial design is rigorous and feasible. Include power calculations, realistic enrollment projections, and retention strategies.
- Address health disparities and recruitment/retention of underrepresented populations in your study design. NIH increasingly expects inclusive science practices.
- Pay careful attention to the specific clinical trial requirements (phase of trial, control conditions, outcome measures) outlined in the program announcement to ensure your design meets all mandates.
⚠️ Common mistakes
Applications often fail when they lack sufficient preliminary data demonstrating the intervention's promise or when the clinical trial design is not sufficiently rigorous (inadequate sample size justification, weak control conditions, vague outcomes). Another common pitfall is underestimating the complexity of recruitment and retention in mental health research or failing to address feasibility in the proposed timeline and budget. Finally, insufficient detail on how the research team has managed multi-site trials or large-scale clinical research previously can reduce competitiveness.
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