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Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 - Clinical Trial Required)

National Institutes of Health · Opportunity PAR-25-177

Deadline October 15, 2027 401 days left
Award range Not stated
Total program funding
PostedNovember 26, 2024

Who can apply

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

About this opportunity

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).

Award history — this exact opportunity

NIH RePORTER lists 2 funded awards under PAR-25-177 across 2 organizations.

Awards by fiscal year 2026: 2
Award size (min / median / max) $974k / $1.1M / $1.2M

Total award obligations, not per-year amounts.

Recent awardees include: FLORIDA INTERNATIONAL UNIVERSITY, UNIVERSITY OF LOUISVILLE.

Source: NIH RePORTER, matched on the exact opportunity number. NIH publishes success rates by institute and activity code — source.

Portfolio context — this listing covers more than this opportunity

This opportunity is funded under Assistance Listing 93.242 (“Mental Health Research Grants”), a broad federal program that made about 863 new awards per year over the last five fiscal years (median award $552k). Those figures describe that whole portfolio — not this specific solicitation, so we don't show them as if they were this opportunity's track record.

Applicant counts per solicitation are not published by any federal agency — no one can honestly sell you that number. NIH publishes success rates by institute and activity code — source.

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