Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (R01 Clinical Trial Required) | PAR 25 207

Opportunity Information: Apply for PAR 25 207

The National Institute of Mental Health (NIMH), within the National Institutes of Health (NIH), is offering an R01 grant opportunity (PAR-25-207) to fund large, well-powered clinical effectiveness trials focused on the post-acute phase of mental health care. The central idea is to test what works after an initial or acute episode of treatment, when people often still face residual symptoms, functional impairment, relapse risk, and challenges staying engaged with care. The goal is to generate strong, real-world evidence about interventions and service approaches that help youth, adults, and older adults maintain gains, recover functioning, and achieve better longer-term outcomes.

This funding opportunity specifically targets post-acute interventions and services that are matched to the stage of illness. In practical terms, that means the intervention should make sense for what typically comes next after someone has completed an initial treatment or stabilized from an acute episode. Examples of the kinds of post-acute goals NIMH highlights include consolidating and maintaining improvements from the initial phase of care, managing ongoing or residual symptoms and impairments, preventing relapse or recurrence, promoting medication or therapy adherence when relevant, and improving appropriate service use (for instance, supporting follow-up care, stepped care, coordinated care, or continued monitoring). The NOFO also emphasizes that the intensity and burden of the post-acute approach should be appropriate, meaning applicants should consider whether the intervention is realistically scalable and tolerable for patients and service systems over the longer term.

The required project type is an effectiveness trial under the R01 mechanism, and the NOFO is explicit that studies should be statistically powered to deliver a definitive answer about whether the intervention is effective. That points to pragmatic, real-world testing in typical care settings and with populations that reflect who actually receives services, rather than small exploratory studies designed mainly to see if something might work. Alongside the main effectiveness question, NIMH is encouraging applicants to test well-justified hypotheses about how and for whom the intervention works. This includes examining moderators (which subgroups benefit most or least, such as differences by age, baseline severity, comorbidity, setting, or social determinants), mediators (the intermediate processes that explain changes in outcomes), and mechanisms of action (the underlying pathways through which the intervention produces effects). In other words, the agency is looking for trials that not only answer "does it work?" but also provide insight into why it works and under what conditions, in ways that can improve future intervention design and implementation.

This NOFO is not positioned as a pilot or early feasibility opportunity. If a team needs support to establish feasibility, acceptability, tolerability, safety, or preliminary signals of benefit for a post-acute approach, NIMH points applicants to a companion R34 program (noted as TEMP-24814) intended for pilot effectiveness trials. The R01 here is meant for interventions that are ready for a definitive, adequately powered effectiveness test.

Eligibility is broad and includes many types of applicants across government, education, nonprofit, and private sectors. Eligible applicants listed 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; Native American tribal organizations (other than federally recognized tribal governments); 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. The announcement also explicitly calls out additional eligible applicant categories 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, non-U.S. entities (foreign organizations), Indian/Native American tribal governments (other than federally recognized), and U.S. territories or possessions. This wide eligibility aligns with the focus on real-world service delivery and the likelihood that effective post-acute care models will require partnerships across health systems, community organizations, and diverse settings.

From an administrative standpoint, the opportunity is a discretionary NIH grant in the health funding category, associated with CFDA number 93.242. The opportunity was created on 2024-10-31, and the original closing date listed is 2028-01-07, indicating multiple application cycles may be available across several years depending on NIH receipt dates and the NOFO schedule. The award ceiling and expected number of awards are not specified in the provided source information, which is common for some NIH announcements where budgets depend on the scope, justification, and availability of funds.

Overall, this NOFO is aimed at advancing the evidence base for what should happen after the acute phase of mental health treatment, with a strong emphasis on practical effectiveness, longer-term outcomes, and understanding the drivers of sustained recovery. The projects that fit best will be those that can test a clearly defined post-acute intervention or service strategy at sufficient scale, in realistic settings, with rigorous methods capable of producing a clear and actionable answer about effectiveness and about the key factors that influence outcomes over time.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "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 25 207

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