Jul 27, 2025, 16:53

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

The National Institute of Mental Health (NIMH) invites R01 applications for well-powered hybrid effectiveness–implementation trials that simultaneously evaluate (1) clinical impact of evidence-supported mental health interventions in routine care or community settings, (2) implementation strategies affecting uptake and sustainability, and (3) at least one underlying mechanism of action .

Eligibility Criteria:

U.S. and foreign organizations, including higher-education institutions, nonprofits (501(c)(3) and others), for-profit entities (small businesses and others), local/state/federal government units, tribal organizations, and other community-based groups .
Applicant institutions must complete SAM (or NCAGE), obtain a UEI, register in eRA Commons (PD/PI and SO accounts), and Grants.gov before submission.
PD(s)/PI(s) must hold separate eRA Commons accounts for each role.
Applications must propose an NIH-defined clinical trial with a hybrid design evaluating intervention effectiveness, implementation factors, and at least one mechanism of action.

Funding Details:

NIMH intends to commit $27 million in FY 2026 across this NOFO and companions.
Budgets are uncapped but should reflect actual project needs; maximum project period is 5 years.
Funds may support personnel, intervention delivery, implementation strategies, mechanism assessment, data collection, and related costs.
Clinical trial registration, data and safety monitoring, and compliance with NIMH clinical trial policies are required .

Deadline:

All applications are due by 5:00 PM local time on the following dates:

February 14, 2025 (New, Renewal, Resubmission)
June 17, 2025
October 15, 2025
February 13, 2026
June 15, 2026
October 15, 2026
February 17, 2027
June 15, 2027
October 15, 2027

(Expiration: October 16, 2027)

Where to Go for Further Information:

Apply via NIH ASSIST, Grants.gov Workspace, or institutional S2S (search Funding Opportunity Number PAR-25-177).
For scientific questions and LOI submissions (30 days before due dates): [email protected]
For application guidance: [email protected]
For Grants.gov technical support: [email protected]

clinical trial community settings deployment-focused effectiveness research hybrid trial Implementation Science mechanism of action mental health mental illness NIH NIMH PAR-25-177 R01 translational research

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