Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (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 and organizations testing the effectiveness of mental health interventions through clinical trials. Eligible applicants include universities (public and private), medical centers, nonprofits, faith-based organizations, tribal governments, and federal agencies. The grant supports full-scale effectiveness trials in community and practice settings, testing therapeutic, preventive, and services interventions. All applicants must be capable of conducting rigorous clinical trials with adequate statistical power and must have preliminary pilot data supporting their research questions.
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Program description
Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required). This NOFO is a key element of NIMHs set of NOFOs to support clinical trials research across the intervention development and testing pipeline. The NOFO supports (1) clinical trials to test the effectiveness of optimized therapeutic and preventive interventions for use in community and practice settings; and (2) clinical trials to evaluate the effectiveness of patient-, provider-, organizational-, or systems-level services interventions to improve access, continuity, quality, equity, and/or value of mental health services. This NOFO is intended to support trials that: address a significant problem, such that the findings have potential to inform practice; are adequately powered to definitively answer the primary research question(s), with well-justified hypotheses supported by pilot data; and are designed to examine questions regarding mediators and moderators of effects. Consistent with the NIMH experimental therapeutics approach, this NOFO is intended to support effectiveness trials that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism(s) that accounts for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, etc.). The collaborative R01 mechanism provides support for multisite trials when two or more sites are necessary for completion of the trial (e.g., to increase sample size, accelerate recruitment, or increase sample diversity and representation).
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Faith-based Organization
- Hospital
- 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
Key dates & requirements
Required documents
- SF-424 (R&R) Application Form
- Project Narrative (research strategy and specific aims)
- Biographical Sketch(es)
- Budget and Budget Justification
- Facilities and Resources
- Letters of Support (for multisite trials)
- Preliminary Data/Pilot Study Results
- Appendix (including recruitment materials if applicable)
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
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$75,056,208
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$74,756,329
-
$64,705,159
-
$63,991,707
-
$54,214,022
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$48,653,752
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$38,895,082
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$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 can apply for this grant?
Research institutions, nonprofits, academic medical centers, faith-based organizations, tribal governments, and eligible federal agencies. Applicants must be capable of conducting rigorous clinical trials.
What types of interventions does this grant fund?
Therapeutic, preventive, and services-level mental health interventions tested through effectiveness trials in community and practice settings.
Is pilot data required?
Yes. Hypotheses must be well-justified and supported by preliminary pilot data before submitting the full application.
What is the trial design requirement?
Trials must be adequately powered, examine mediators and moderators of effects, and assess whether interventions engage their presumed mechanisms.
Can multisite trials receive funding?
Yes. The collaborative R01 mechanism specifically supports multisite trials when multiple sites are needed for sample size, recruitment, or diversity.
💡 Tips for applicants
- Ground your research question in a significant clinical problem with evidence that findings will inform real-world practice and policy.
- Include strong pilot data demonstrating feasibility and preliminary effect sizes; reviewers will scrutinize underdeveloped hypotheses.
- Design trials to be adequately powered for your primary outcomes and to measure the mechanisms through which your intervention works.
- Address equity and diversity in recruitment and implementation across sites; NIMH emphasizes representation in clinical trials.
- If proposing a multisite trial, clearly justify why multiple sites are essential and describe coordination and management structures.
⚠️ Common mistakes
Submitting without adequate pilot data or with weak preliminary evidence. Proposing a trial that is underpowered or lacking clear mechanistic hypotheses aligned with NIMH experimental therapeutics approach. Insufficient attention to equity, diversity, and representation in trial design and participant recruitment.
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