Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33) | RFA MH 17 604

Opportunity Information: Apply for RFA MH 17 604

The Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33) funding opportunity (RFA-MH-17-604) is an NIH grant program designed to accelerate the early testing and refinement of brand-new psychosocial interventions aimed at treating or preventing mental disorders in both adults and children. Its core goal is to move promising ideas from basic science into interventions that can be tested efficiently, with studies structured to produce clear, decision-ready evidence about whether an approach is worth advancing. A defining feature of this announcement is its emphasis on an experimental therapeutics approach, meaning applicants are expected to focus not only on whether symptoms improve, but also on whether the intervention actually engages and changes a specified, scientifically grounded target mechanism that is believed to drive risk for, onset of, or maintenance of a mental disorder.

The FOA prioritizes innovation in either the intervention target, the intervention strategy, or both. Targets can be behavioral, cognitive, affective, or interpersonal processes that are potentially modifiable and plausibly connected to mental disorder outcomes. Targets may also include more biologically oriented mechanisms, such as neural circuits, patterns of neural activity supporting specific behaviors or cognitive functions, or other neurobiological processes implicated in vulnerability, causation, or symptom persistence. On the intervention side, the program is open to a wide range of psychosocial strategies, including traditional in-person approaches as well as technology-assisted delivery (for example, digital platforms or other tech-enabled modalities), as long as what is being tested is genuinely novel in target and/or strategy rather than a minor variation of an existing treatment package. The intervention can be evaluated as a standalone treatment (monotherapy) or as an add-on intended to augment standard care.

This opportunity uses a two-phase, milestone-driven structure intended to support fast but rigorous development. The first phase, the R61 (up to two years), funds preliminary testing focused on demonstrating that the intervention impacts the proposed target, often described as target engagement. During this phase, the research plan is expected to include clear, pre-specified go/no-go milestones so that outcomes will meaningfully guide next steps rather than leaving results ambiguous. If the R61 milestones are met, projects can transition to the second phase, the R33 (up to three additional years). The R33 supports replication of target engagement and, importantly, tests whether changes in the targeted mechanism are related to meaningful clinical benefit, such as symptom reduction, functional improvement, or prevention of disorder onset in at-risk populations. The overall structure is meant to ensure that even negative findings are scientifically useful by clarifying whether the underlying mechanism was engaged and what that implies about the intervention concept.

In practical terms, the FOA is pushing applicants to design trials where the outcome will inform development decisions quickly and credibly. That means specifying a mechanistic target tied to the disorder or risk state, selecting measures capable of detecting target engagement, and designing a study that can answer whether the intervention changed the mechanism and whether that change tracks with clinical outcomes. The expectation is that studies will be informative regardless of whether the intervention ultimately shows benefit, because the design should reveal whether the theory about the mechanism and the intervention was supported.

The grant is classified as a discretionary NIH grant in the health funding category (CFDA 93.242). Eligible applicants are broad and include state, county, and local governments; public and state-controlled and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The FOA explicitly highlights additional eligible applicant types 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, regional organizations, eligible federal agencies, non-domestic (non-U.S.) entities, tribal governments that are not federally recognized, and U.S. territories or possessions. This breadth signals an interest in drawing innovation from many settings, including community-based and culturally specific institutions, not only traditional academic medical centers.

Key administrative details from the source listing include the originating agency (National Institutes of Health), the funding opportunity number (RFA-MH-17-604), the original closing date (2017-11-14), and the creation date (2016-12-13). While the listing does not specify an award ceiling or expected number of awards, the central value of the announcement lies in its staged R61/R33 design and its requirement that mechanistic, target-focused evidence drive progression decisions. Overall, this FOA is geared toward developing the next generation of psychosocial interventions by insisting on strong alignment between mechanism, intervention design, and measurable target engagement, with the long-term aim of restoring functioning, reducing symptoms, and preventing mental disorders in people at elevated risk.

• 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)" 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 2016-12-13.
• Applicants must submit their applications by 2017-11-14. (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.

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