Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 Clinical Trial Required)
This grant funds pilot trials to improve mental health interventions' effectiveness, aiming to expand target populations and test new service delivery methods.
Funder: National Institutes of Health
Due Dates: June 17, 2025 (Renewal/Resubmission/Revision) | October 15, 2025 (Renewal/Resubmission/Revision) | February 13, 2026 (New) | June 15, 2026 (Renewal/Resubmission/Revision) | October 15, 2026 (Renewal/Resubmission/Revision) | February 17, 2027 (New) | June 15, 2027 (Renewal/Resubmission/Revision) | October 15, 2027 (Renewal/Resubmission/Revision)
Funding Amounts: Up to $750,000 direct costs over 3 years; no more than $250,000 direct costs per year; project period up to 3 years.
Summary: Funds pilot hybrid effectiveness-implementation clinical trials to optimize and preliminarily test mental health interventions and implementation strategies in real-world settings.
Key Information: Clinical trial required; foreign and domestic applicants eligible; strong emphasis on mechanism evaluation and community/practice setting relevance.
Description
This opportunity from the National Institute of Mental Health (NIMH) supports pilot hybrid effectiveness-implementation clinical trials for mental health interventions. The goal is to generate preliminary data on the effectiveness and implementation of preventive or therapeutic interventions, or innovative service delivery strategies, in routine care, community, school, or online settings. Projects must explicitly evaluate whether the intervention engages the hypothesized mechanism(s) of action and address feasibility, acceptability, and fit for broader or under-resourced populations.
The program is designed for studies that:
- Optimize and test interventions with prior efficacy for broader or more diverse populations or new settings.
- Develop and pilot innovative service delivery or implementation strategies.
- Simultaneously assess clinical outcomes, implementation factors, and at least one mechanism of action.
Applications must use a hybrid trial design and incorporate community/practice partner perspectives. Projects should address mental health disparities and may leverage existing infrastructure (e.g., practice-based research networks, electronic health records, school data).
