The Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 Clinical Trial Required), funded by the National Institutes of Health (NIH), supports clinical trials testing the effectiveness of mental health treatments, preventive interventions, and service delivery strategies in community and practice settings. The program emphasizes interventions that improve access, quality, equity, and value of mental health services and seeks to identify mechanisms driving intervention outcomes, mediators, and moderators of effects.

Eligible applicants include a wide range of entities such as nonprofits with or without 501(c)(3) status, for-profit organizations, small businesses, public and private higher education institutions, state and local governments, tribal governments and organizations, Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, and other community-based organizations. Foreign organizations are also eligible to apply.

Projects must address significant mental health challenges with the potential to inform clinical and public health practices. Applications should propose adequately powered trials with clear, well-justified hypotheses supported by pilot data. Trials must incorporate the NIMH experimental therapeutics approach, testing whether interventions engage the mechanisms presumed to underlie their effects. The funding opportunity also supports multisite trials when necessary to increase sample size, diversity, or recruitment efficiency.

While there is no specified ceiling or floor for awards, the program supports projects of varying scope and duration based on merit and relevance. Cost-sharing or matching is not required. Applications are accepted on a rolling basis, with the closing date set for October 15, 2027.

This opportunity provides critical support for advancing mental health interventions and improving service delivery systems. For further details, including application instructions and contacts, visit the full NOFO or email grantsinfo@nih.gov.