Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 Clinical Trial Required)

The Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (PAR-25-178), issued by the National Institutes of Health (NIH), supports pilot studies to evaluate the effectiveness and implementation of mental health interventions in community settings. This funding opportunity is designed to optimize preventive and therapeutic interventions with demonstrated efficacy for broader populations or community practice settings and to develop and preliminarily test innovative service delivery interventions. Eligible applicants include state and local governments, public and private higher education institutions, nonprofits, small businesses, for-profit organizations, Native American tribal entities, and community-based organizations. Additional eligible entities include Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), and international organizations. The funding supports pilot trials consistent with the NIMH’s experimental therapeutics approach, which requires projects to evaluate whether interventions engage their proposed mechanisms of action. Applicants must investigate how interventions lead to changes in clinical or functional outcomes, provider behavior, or service access and continuity. Studies should focus on preliminary testing and development of interventions before conducting larger-scale efficacy trials. No specific funding ceiling or floor is provided, and cost-sharing is not required. Applications will be accepted on a rolling basis through October 15, 2027. Proposals should include clear objectives, hypotheses supported by prior data, and a plan for measuring intervention mechanisms and effectiveness. This program is part of the NIH's commitment to advancing mental health care by bridging the gap between research and community-based practice. For full details, including submission requirements, applicants can review the NOFO or contact NIH Grants Information at grantsinfo@nih.gov.