Effectiveness Trials to Test Mental Health System Interventions (R61/R33 Clinical Trial Required)
Research to test the effectiveness of mental health system interventions for better care outcomes, from feasibility and infrastructure development to powered clinical trials.
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 (R61: max 2 years, R33: max 4 years); $27M total NIMH commitment in FY26 for this and companion NOFOs.
Summary: Supports milestone-driven feasibility (R61) and well-powered effectiveness trials (R33) of system-level interventions to improve mental health care delivery and outcomes.
Key Information: Clinical trial required; only system-level interventions (not individual-level) are eligible; foreign and domestic applicants allowed.
Description
This opportunity from the National Institute of Mental Health (NIMH) supports a two-phase (R61/R33) clinical trial mechanism to rigorously test the effectiveness of system-level interventions designed to improve the organization, delivery, coordination, and outcomes of mental health care. The R61 phase funds feasibility and infrastructure development, while the R33 phase supports a fully powered effectiveness trial contingent on successful completion of R61 milestones.
System interventions may address structural, policy, organizational, or multi-level factors within or across care settings (e.g., health systems, community clinics, schools, child welfare, or justice systems). The focus is on interventions that can improve access, equity, engagement, value, management, or quality and safety of mental health services, with the ultimate goal of better clinical and functional outcomes for priority populations.
Projects must use a clinical trial design and explicitly test how, why, for whom, and in which settings the system intervention is effective. The program encourages research that addresses disparities and incorporates deployment-focused, practice-relevant questions, with stakeholder engagement and data sharing as key components.
