Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required) | PAR 21 134

Opportunity Information: Apply for PAR 21 134

The National Institute of Mental Health (NIMH), under the National Institutes of Health (NIH), is offering a discretionary grant opportunity titled "Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required)" (Funding Opportunity Number: PAR 21-134; CFDA: 93.242). This funding announcement is a reissue of an earlier solicitation (RFA-MH-18-705) and sits within NIMH's clinical trials pipeline, meaning it is specifically meant to move promising psychosocial ideas into real-world testing through a required clinical trial component. The overall focus is on advancing new or improved psychosocial interventions, as well as sharpening and validating the intervention targets those programs are designed to affect, with the goal of improving prevention or treatment outcomes for mental disorders.

A central theme of this opportunity is NIMH's "experimental therapeutics" approach. In practical terms, applicants are expected to do more than show that an intervention helps people feel better; the project should identify a clear, theoretically grounded target (for example, a cognitive, affective, behavioral, or neuropsychological process that the intervention is designed to change) and then demonstrate that the intervention actually engages that target. The grant supports work that takes findings from basic and translational science areas such as behavioral science, cognitive science, affective science, and neuropsychology and turns them into intervention strategies that can be tested in humans. The intent is to shorten the time between discoveries about mechanisms of behavior and emotion and the creation of interventions that reliably prevent or reduce symptoms and impairment.

This R33 mechanism is structured to support pilot-stage clinical trial research for up to three years. The funded work is expected to replicate target engagement shown in prior studies (so, confirming that the intervention reliably changes the intended mechanism) and to test whether the degree of target engagement is associated with changes in clinical outcomes. In other words, the project should help answer questions like: Did the intervention change the specific process it was designed to change, and did that change track with meaningful improvements in symptoms, functioning, or other clinically important endpoints? This emphasis is meant to help the field distinguish between interventions that merely correlate with improvement and interventions that work through a measurable, changeable mechanism that can be optimized and scaled.

Eligibility is broad and includes many types of U.S. organizations and governmental units, such as state, county, and municipal governments; special district governments; independent school districts; federally recognized tribal governments; public housing authorities; public and state-controlled institutions of higher education; private colleges and universities; nonprofit organizations (both with and without 501(c)(3) status); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and certain tribal governments that are not federally recognized. Notably, the eligibility list also includes non-U.S. entities (foreign organizations), signaling that international applicants may apply when consistent with NIH policies and the goals of the program.

Key administrative details in the posted source information include an original closing date of 2024-10-15 and a creation date of 2021-03-02. While an award ceiling and expected number of awards are not specified in the excerpt provided, the core programmatic message is clear: NIMH is looking for carefully designed pilot clinical trials of psychosocial preventive or therapeutic interventions that can demonstrate target engagement and link that engagement to clinical change, thereby strengthening the mechanistic foundation for future intervention refinement, larger trials, and eventual implementation.

• 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 2021-03-02.
• Applicants must submit their applications by 2024-10-15. (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 PAR 21 134

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