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).
Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 - Clinical Trial Required)
National Institutes of Health lists this opportunity for nonprofit applicant type listed. Review the coded eligibility, award range, source synopsis, and official notice before deciding whether to apply.
Deadline
October 15, 2027
359 days remaining
Award range
—
official range may be incomplete
Applicant signal
Nonprofit applicant type listed
the official notice controls eligibility
- 00 — State governments
- 01 — County governments
- 02 — City or township governments
- 04 — Special district governments
- 05 — Independent school districts
- 06 — Public and state-controlled institutions of higher education
- 07 — Federally recognized Native American tribal governments
- 08 — Public housing authorities and Indian housing authorities
- 11 — Native American tribal organizations other than federally recognized tribal governments
- 12 — 501(c)(3) nonprofits other than institutions of higher education
- 13 — Nonprofits without 501(c)(3) status other than institutions of higher education
- 20 — Private institutions of higher education
- 22 — For-profit organizations other than small businesses
- 23 — Small businesses
- 25 — Other applicants; see the official eligibility clarification
These are high-level Grants.gov codes. Additional eligibility text, geographic restrictions, and program-specific rules in the official notice can narrow them.
- Confirm entity eligibility in the full Notice of Funding Opportunity.
- Check SAM.gov and Grants.gov registration requirements and timing.
- Read every attachment for matching, cost-share, geography, and award conditions.
- Verify the exact deadline time and any agency-specific submission portal.
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Source: Grants.gov daily XML extract, 2026-10-21 extract. This page reproduces selected public listing fields for research convenience. The official Notice of Funding Opportunity and agency instructions control. This product uses the Grants.gov API but is not endorsed or certified by the U.S. Department of Health and Human Services.