The National Institute of Mental Health (NIMH) has announced an exciting R01 funding opportunity designed to propel evidence-based mental health solutions into practical, accessible settings. This initiative, PAR-25-178, focuses on optimizing therapeutic and preventive interventions, paving the way for larger clinical trials.
Scope
This Notice of Funding Opportunity (NOFO) solicits pilot hybrid effectiveness-implementation research. The primary objectives are twofold: refining interventions with previously demonstrated efficacy for broader populations (such as in routine care, schools, or online communities) and testing implementation strategies that support sustainable delivery in these accessible settings. Research should generate the preliminary data needed for a fully-powered clinical trial, encompassing feasibility, acceptability, safety, and fit, while also exploring outcomes and hypothesized mechanisms of action.
Eligibility
The program is widely accessible to diverse organizations. Eligible entities include higher education institutions, nonprofits (with or without 501(c)(3) status), small businesses, for-profit organizations, and local, state, or tribal governments. Non-domestic (foreign) entities are also eligible to apply.
Partnership
While specific academic-industry partnerships are not strictly mandated, the NOFO allows for multi-site trial designs to increase sample sizes, speed up recruitment, and enhance participant diversity. Applicants can establish subcontractual agreements to support enrollment and coordinate expertise across various institutional contexts.
Deadlines: Upcoming standard R01 application due dates include October 15, 2026; February 17, 2027; June 15, 2027; and October 15, 2027. Letters of Intent are requested 30 days prior to the application due date.
Key Requirements:
- Proposals must focus on pilot effectiveness studies, optimizing previously validated preventive or therapeutic interventions.
- Studies must explicitly address whether the intervention engages the mechanism(s) presumed to drive clinical outcomes or behavior changes.
- Applicants must propose research designs that adequately explore feasibility, safety, and acceptability in community or practical settings.
More info : https://grants.nih.gov/grants/guide/pa-files/PAR-25-178.html
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