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

Background
The National Institute of Mental Health (NIMH) is issuing this Notice of Funding Opportunity (NOFO) to support clinical trials research aimed at testing the effectiveness of mental health interventions. The goal is to transform the understanding and treatment of mental illnesses through basic and clinical research, ultimately paving the way for prevention, recovery, and cure. This NOFO specifically seeks to fund full-scale hybrid effectiveness-implementation trials that address significant mental health problems and have the potential to inform practice.

Grant Details
This NOFO supports clinical trials that:
1) test the effectiveness of optimized therapeutic and preventive interventions in community and practice settings;
2) evaluate services interventions aimed at improving access, continuity, quality, equity, or value of mental health services;
3) are adequately powered to answer primary research questions with well-justified hypotheses supported by pilot data;
4) examine mediators and moderators of effects;
5) include a hybrid trial design that evaluates both clinical impact and implementation factors;
6) incorporate technology for intervention delivery and support; and
7) address disparities in mental health outcomes. Applications must specify at least one hypothesized mechanism of action for the intervention or implementation strategy.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local/state governments, tribal governments, foreign organizations, and other entities. Special encouragement is given to institutions serving underrepresented groups such as Hispanic-serving Institutions and Historically Black Colleges and Universities (HBCUs). Individuals from diverse backgrounds are also encouraged to apply.

Period of Performance
The maximum project period is five years. Applicants are encouraged to consider shorter durations where feasible.

Grant Value
NIMH intends to commit a total of $27 million for FY 2026 for this NOFO and its companion opportunities. Application budgets are not limited but must reflect the actual needs of the proposed project.

Place of Performance
The grant will be performed in accessible intervention settings where typical consumers can be readily connected to an intervention.