Pilot Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (R01 Clinical Trial Required) | PAR 25 206

Opportunity Information: Apply for PAR 25 206

The National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), is soliciting applications for PAR 25-206, an R01 funding opportunity that requires a clinical trial. The focus is on pilot effectiveness trials for post-acute interventions and services aimed at improving longer-term outcomes for people with mental health conditions after they have completed an initial, acute phase of treatment. In practical terms, this program is about what happens next: how to consolidate early gains, manage lingering symptoms or functional impairment, prevent relapse, support adherence, and help people use services appropriately once the most intensive stage of care has ended.

The core emphasis is on developing and testing interventions that are matched to the stage of illness in both purpose and intensity. NIMH is looking for approaches that make sense for the post-acute phase, meaning they should be designed to maintain or extend benefits from prior treatment without imposing unnecessary burden. Examples of the kinds of post-acute goals highlighted include maintaining improvement achieved in acute treatment, addressing residual symptoms or day-to-day functioning problems that remain, reducing risk of relapse or recurrence, supporting continued engagement with care when appropriate, and improving how individuals navigate and use services over time.

This NOFO is specifically for pilot-phase effectiveness research, not fully powered definitive trials. Applicants are expected to run a clinical trial that can answer early, practical questions about whether the intervention is workable in real-world settings and for the intended population. The trial design should generate evidence on feasibility (can the study and intervention actually be delivered as intended), tolerability (is the burden manageable), acceptability (do participants and settings find it usable and worthwhile), and safety. In addition, it should provide preliminary signals of effectiveness, meaning early outcome patterns that suggest the intervention could improve post-acute outcomes enough to justify a larger, more definitive study.

A key expectation is that the pilot trial does more than just measure outcomes; it should also test whether the intervention engages the target(s) or mechanism(s) that are presumed to drive its effects. In other words, NIMH wants applicants to articulate what the intervention is supposed to change (a clinical, behavioral, service-use, or other mechanism) and then collect data that show whether that change is actually happening. The point is to reduce uncertainty before scaling up: the pilot should yield the kind of information needed to plan a larger comparative effectiveness study or practical trial, including estimates and operational details that inform design decisions.

This funding opportunity is positioned as a stepping stone to a later, fully powered effectiveness trial. NIMH explicitly notes that support for definitive, fully powered effectiveness studies focused on post-acute phase interventions is provided through a separate R01 mechanism identified as TEMP-24813. That separation matters because it signals how reviewers will likely judge applications: success here is not defined by definitive proof of effectiveness, but by a strong pilot trial that demonstrates the intervention can be implemented, is acceptable and safe, engages its intended targets, and produces preliminary outcome data that justify and shape the next-stage trial.

In terms of logistics and eligibility, this is a discretionary grant (R01) under the NIH umbrella, in the health funding activity category, associated with CFDA number 93.242. The opportunity was created on October 31, 2024, with an original closing date listed as January 7, 2028. A wide range of applicant organizations are eligible, including state, county, city/township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations that are not federally recognized governments; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible groups 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), eligible federal agencies, faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations).

Overall, PAR 25-206 is aimed at advancing the post-acute phase of mental health care by funding pilot clinical trials that are pragmatic enough to reflect real service settings while still being rigorous about what the intervention is targeting and how it might work. The deliverable is not a final answer about effectiveness, but a well-justified, well-executed pilot trial that de-risks a future definitive effectiveness study and strengthens the field of post-acute mental health intervention research.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pilot Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (R01 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 2024-10-31.
• Applicants must submit their applications by 2028-01-07.
• 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 25 206

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