NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required) | PAR 25 267

Opportunity Information: Apply for PAR 25 267

The National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH), is soliciting applications under funding opportunity PAR-25-267 for investigator-initiated, multi-site feasibility clinical trials of complementary and integrative health approaches that have physical and/or psychological therapeutic components, commonly referred to as mind and body interventions. The grant mechanism is an R01, and a clinical trial is required, meaning the proposed work must involve prospective assignment of human participants to an intervention and evaluation of health-related outcomes in a way that meets NIH's definition of a clinical trial. The core purpose of this program is not to run a definitive, fully powered efficacy or effectiveness trial right away, but to generate the specific, practical evidence needed to design and successfully launch a later full-scale multi-site trial that fits within NCCIH's mission and high-priority research areas.

The emphasis is on feasibility, and the application is expected to make a clear, credible case that a larger subsequent trial is planned and that the proposed feasibility study is scientifically necessary to prepare for it. In other words, applicants should describe what the future full-scale study will look like (for example, an efficacy or effectiveness trial, a pragmatic trial, or a dissemination and implementation study), then explain exactly which uncertainties or operational gaps must be resolved first and how the proposed R01 feasibility trial will resolve them. NCCIH is signaling that it wants feasibility trials that do real "de-risking" work for a later, more expensive and complex study, rather than pilot projects that are only loosely connected to a clear next step.

Examples of the kinds of feasibility questions NCCIH expects this R01 to address include whether the mind and body intervention can be delivered consistently and with fidelity across multiple sites, which often requires standardized training, manuals, quality assurance processes, and cross-site monitoring. The NOFO also highlights the importance of showing that multi-site recruitment, accrual, and randomization procedures will work in practice, including whether sites can enroll the right participants at the needed pace and whether participants are willing to be randomized. It also prioritizes evidence about participant adherence to the intervention and retention over time, because even a promising intervention can fail in a larger trial if people do not attend sessions, do not complete home practice, or drop out. For interventions that are multimodal or protocolized (for example, combining movement, breathing, and behavioral components), applicants may use this feasibility trial to refine the protocol and test whether the full package can be delivered as intended in different real-world settings. Another major focus is cross-site data collection feasibility, such as whether outcome assessments can be standardized, whether measures are acceptable to participants, whether data systems work reliably across locations, and whether staff can implement the assessment schedule without excessive missingness.

Because this is specifically a multi-site feasibility program, applicants are expected to justify why multiple sites are needed at the feasibility stage rather than waiting until the later definitive trial. NCCIH indicates that this justification should be grounded in sufficient preliminary evidence, such as prior single-site feasibility or acceptability trials or strong published literature supporting the intervention and its rationale. The expectation is that the feasibility trial will fill remaining knowledge gaps that cannot be adequately addressed in a single site context, such as variability in delivery across settings, differences in participant populations, or the operational realities of coordinating recruitment and intervention delivery in more than one location.

Key administrative details from the opportunity include an award ceiling of $350,000 and an original closing date of 2026-11-17. The program is listed under CFDA 93.213. Eligible applicants are broad and include many types of U.S.-based organizations and government entities, such as state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses, as well as federally recognized Native American tribal governments and other tribal organizations. The NOFO also explicitly calls out eligibility for a range of community- and minority-serving institutions and organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American and Native American Pacific Islander Serving Institutions (AANAPISISs), along with faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Restrictions related to foreign involvement are specific. Non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as NIH defines them in the NIH Grants Policy Statement, are allowed, which generally means limited, well-justified parts of the research may occur outside the U.S. under an eligible U.S. applicant organization, provided NIH policy requirements are met and the foreign component is necessary and well explained.

Overall, this opportunity is designed for teams that already have enough early evidence to believe a mind and body intervention is promising and worth scaling up, but who still need multi-site operational proof and protocol refinement before committing to a large, expensive, fully powered trial. The strongest applications will tightly connect feasibility aims to a clearly articulated future definitive study, show why a multi-site feasibility design is essential now, and focus data collection on the practical, decision-making information that will directly strengthen a later, competitive full-scale NCCIH-aligned clinical trial with meaningful public health relevance.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body 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): 93.213.
• This funding opportunity was created on 2024-11-21.
• Applicants must submit their applications by 2026-11-17. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $350,000.00 in funding.
• 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 25 267

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