Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 Clinical Trial Required) | PAR 25 178

Opportunity Information: Apply for PAR 25 178

The National Institutes of Health, through the National Institute of Mental Health (NIMH), is offering an R01 grant opportunity titled "Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 Clinical Trial Required)" (Funding Opportunity Number PAR 25-178; CFDA 93.242). This program supports early-stage, real-world clinical trials that sit at the intersection of effectiveness research (does an intervention work in routine practice settings and diverse populations?) and implementation research (how can it be delivered well, consistently, and at scale in those settings?). The focus is on pilot-level hybrid trials, meaning projects are expected to generate practical evidence about both outcomes and delivery, while still being appropriately scoped as pilots rather than full-scale definitive effectiveness trials.

The scientific purpose centers on advancing NIMH's clinical trials "pipeline" by funding studies that either (1) improve and adapt preventive or therapeutic interventions that have already shown efficacy, so they can perform well with broader populations or in community practice environments, or (2) develop and conduct preliminary testing of innovative mental health services interventions. In practice, this means applicants can propose work such as adapting an evidence-based therapy to better fit primary care, schools, community clinics, or other routine service settings; testing strategies to improve reach, engagement, continuity, or quality of care; or piloting new service delivery models that address access, coordination, or provider behavior in mental health systems.

A key requirement is alignment with NIMH's experimental therapeutics approach. Projects are expected to go beyond asking whether an intervention helps; they must also explicitly test whether the intervention engages its intended target(s) or mechanism(s) that are presumed to drive meaningful change. Those targets might include clinical or functional mechanisms (for example, measurable changes in symptoms, functioning, cognition, emotion regulation, or related processes), as well as service and implementation mechanisms (for example, changes in provider behavior, fidelity to care processes, patient engagement, improved access, better continuity, or other measurable system-level pathways). In other words, the trial design should be built to evaluate both outcomes and whether the hypothesized mechanism was actually affected, so that results can inform future optimization and scaling decisions.

This opportunity is categorized as discretionary funding and uses the NIH grant mechanism (R01). It is explicitly a clinical trial required announcement, so proposed projects must meet NIH's definition of a clinical trial and include appropriate trial methods and protections (for example, clear intervention and comparison conditions, outcomes, and a plan for human subjects oversight consistent with NIH expectations). While the announcement emphasizes pilot studies, the intent is that results will be strong enough to justify next-step research, such as a larger effectiveness trial, a more advanced hybrid effectiveness-implementation study, or a broader implementation effort.

Eligibility is broad and includes many types of U.S. organizations and governmental entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized); public housing authorities and Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The notice 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) entities.

The opportunity was created on 2024-11-26 and lists an original closing date of 2027-10-15. Some award details such as an explicit award ceiling and the expected number of awards are not specified in the provided source text, which typically means applicants should consult the full NOFO for budget expectations, allowed project periods, and any institute-specific caps or guidance. Overall, the program is designed for teams that can run a rigorous, mechanism-focused pilot clinical trial in real-world settings, with an eye toward producing actionable findings about both mental health outcomes and the practical conditions needed for successful delivery.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (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 2024-11-26.
• Applicants must submit their applications by 2027-10-15.
• 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 25 178

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