Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required)

Background
The National Institute of Mental Health (NIMH) is part of the Department of Health and Human Services and aims to transform the understanding and treatment of mental illnesses through basic and clinical research.

The purpose of this funding opportunity is to encourage pilot research that develops and tests innovative psychosocial interventions for mental disorders, aligning with NIMH's experimental therapeutics approach. This NOFO supports the translation of emerging research into preventative or therapeutic interventions, focusing on the early phases of intervention development.

Grant Details
This NOFO invites applications for R33 Exploratory/Developmental Grants Phase II, specifically targeting the development and testing of novel psychosocial interventions.

The studies should confirm target engagement from prior research and assess the relationship between target engagement and clinical outcomes. Eligible interventions may include in-person or technology-assisted delivery methods. The R33 grant supports projects that replicate target engagement, test whether engaging the intervention target mediates changes in clinical outcomes, and provide evidence for further development or confirmatory efficacy trials.

Studies must demonstrate how combined therapies positively synergize or fill gaps left by monotherapies, with a clear hypothesis about how modifications can lead to clinical benefits.

Eligibility Requirements
Eligible applicants include higher education institutions (both public and private), nonprofits, for-profit organizations (including small businesses), local governments, state governments, county governments, city or township governments, Indian/Native American tribal governments (both federally recognized and others), federal agencies, foreign organizations, and faith-based organizations. Individuals from diverse backgrounds are encouraged to apply.

Period of Performance
The project period may not exceed three years.

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