Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required) | PAR 25 182

Opportunity Information: Apply for PAR 25 182

Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required) is a National Institute of Mental Health (NIMH), National Institutes of Health (NIH) funding opportunity (PAR 25-182; CFDA 93.242) that supports early-stage, but clinically grounded, work to create and refine new psychosocial interventions and prevention strategies for mental disorders. The central idea is to move promising findings from basic and translational research in behavioral, cognitive, affective, and neuropsychological sciences into interventions that can be tested in humans through a structured clinical trials pipeline. This opportunity is positioned for teams that are not only proposing a new therapy or preventive program, but also clearly specifying the intervention "target" (the process or mechanism the intervention is designed to change) and showing, with data, that the intervention can engage that target in ways that matter.

The program is built around NIMH's experimental therapeutics approach, meaning success is not defined only by whether symptoms improve. Instead, applicants are expected to define measurable targets and demonstrate target engagement, then connect that engagement to downstream clinical outcomes. In practice, this steers projects toward careful measurement and hypothesis-driven testing of how and why an intervention works, rather than treating the intervention as a black box. The goal is to accelerate translation by requiring strong links between mechanistic science (what changes in behavior, cognition, emotion regulation, learning, stress responsivity, social processing, etc.) and clinically meaningful outcomes.

The funding mechanism is a two-phase R61/R33 award that supports a progression from pilot development work to a more confirmatory stage, with both phases involving clinical trial activity (the notice explicitly requires a clinical trial). The R61 phase can provide up to two years of support and is intended for evaluation of target engagement and for establishing key intervention parameters. This is typically where a team refines the intervention content and delivery, determines feasibility and acceptability in the intended population, optimizes dosing or intensity (for example number of sessions, duration, modality, level of support), and demonstrates that the intervention measurably engages the proposed target. The R33 phase can provide up to three additional years of support and is meant to replicate target engagement findings from earlier work and to test whether changes in the target are associated with changes in clinical outcomes. In other words, it pushes projects beyond initial promise by asking for replication and for evidence that the target engagement is meaningfully tied to symptom change, functioning, or other clinical endpoints, depending on the disorder and population.

Eligibility is broad and includes many types of institutions and organizations that could develop and test psychosocial interventions. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations other than small businesses; small businesses; and other entities. The opportunity also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This wide eligibility reflects the reality that intervention development often benefits from partnerships across universities, healthcare systems, community providers, schools, and culturally specific organizations.

Administratively, this is a discretionary grant opportunity from NIH/NIMH. The listing provides an original closing date of 2027-10-15 and a creation date of 2024-11-26. Specific award ceiling and expected number of awards are not stated in the provided source data, so applicants would typically rely on the full NOFO and NIH budget guidance to understand anticipated budgets, allowable costs, and any institute-specific expectations.

Overall, this NOFO is aimed at research teams ready to run a phased, target-focused clinical trial program for a psychosocial intervention or preventive approach, with strong emphasis on (1) clearly defined and measurable intervention targets, (2) evidence of target engagement, (3) careful parameter setting and optimization early on, and (4) replication plus a direct test of whether target engagement relates to improvement in clinical outcomes in the later phase.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2024-11-26.
• Applicants must submit their applications by 2027-10-15.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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