Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33- Clinical Trial Required) | RFA MH 18 705

Opportunity Information: Apply for RFA MH 18 705

The National Institutes of Health is offering this discretionary grant opportunity (RFA MH 18 705; CFDA 93.242) to fund R33 projects that pilot test new psychosocial therapeutic and preventive interventions for mental disorders in both adults and children. The central idea is to move beyond simply asking whether an intervention "works" and instead use an experimental therapeutics approach, meaning the study must directly test whether the intervention engages a clearly defined, measurable target or mechanism and whether changes in that target are linked to meaningful clinical benefit. The program is built to generate rigorous, decision-ready evidence, so the resulting data should clearly support a go/no-go determination about whether the intervention is worth further development or larger-scale testing, even if the findings are negative.

This FOA is specifically aimed at innovation in either the intervention target, the intervention strategy, or both. Targets can include potentially modifiable behavioral, cognitive, affective, or interpersonal factors and processes, as well as neural circuits, patterns of neural activity tied to specific behaviors or cognitive functions, and other neurobiological mechanisms that relate to risk for, causation of, or maintenance of a mental disorder. On the intervention side, NIH is open to in-person or technology-assisted approaches (for example, digitally delivered or hybrid models), as long as the approach is novel in the sense intended by the FOA. The intervention can be tested as a standalone treatment/prevention method (monotherapy) or as an augmentation layered on top of an existing standard treatment, which allows applicants to explore whether a new mechanism-focused component improves outcomes beyond usual care.

Because this is an R33 clinical trial required mechanism, applicants need to propose a clinical trial that is structured to produce high scientific utility. In practice, that means strong design features such as clear operationalization of the proposed target, credible and sensitive measures of target engagement, and an analytic plan that explicitly connects target change to clinical outcomes. The FOA also emphasizes replication of prior target engagement findings, implying that proposals should generally be grounded in some earlier evidence suggesting the target can be engaged, with the R33 stage used to confirm that engagement reliably and to evaluate whether the engaged mechanism translates into symptom reduction, functional improvement, or prevention-related benefit in at-risk groups.

The funding period is up to three years, reflecting the pilot nature of the work and the expectation that projects will be efficient and tightly focused on mechanism-confirming tests rather than broad, multi-aim effectiveness programs. The broader goal is translation: speeding the movement of basic science discoveries about mechanisms and processes underlying mental disorders into practical interventions that can be tested quickly and credibly for their potential to reduce symptoms, restore function, or prevent disorder onset.

Eligibility is broad and includes many public and private entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and additional categories highlighted by NIH such as Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations. The original closing date listed for this opportunity was February 18, 2021, and the FOA was initially created on November 14, 2017.

• 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 (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 2017-11-14.
• Applicants must submit their applications by 2021-02-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

Apply for RFA MH 18 705

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