Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 - Clinical Trial Required)
This grant funds clinical trials testing mental health treatment and services interventions in community settings to improve access and quality.
Funder: National Institutes of Health
Due Dates: June 17, 2025 (New/Renewal/Resubmission/Revision) | October 15, 2025 | February 13, 2026 | June 15, 2026 | October 15, 2026 | February 17, 2027 | June 15, 2027 | October 15, 2027
Funding Amounts: No budget cap; project period up to 5 years; $27M total across this and companion NOFOs in FY26.
Summary: Funds large-scale, multisite clinical trials of mental health interventions in real-world settings to improve access, quality, and outcomes.
Key Information: Clinical trial required; hybrid effectiveness-implementation design mandatory; foreign and domestic applicants eligible.
Description
This opportunity supports full-scale, hybrid effectiveness-implementation clinical trials of mental health interventions. The focus is on testing optimized therapeutic, preventive, or services interventions in community, practice, or online settings, with the goal of improving access, continuity, quality, equity, and value of mental health services. Trials must be adequately powered, address significant practice-relevant questions, and include an explicit evaluation of mechanisms of action underlying intervention effects. The program is a key part of the National Institute of Mental Health (NIMH) clinical trials pipeline, emphasizing real-world impact and scalability.
