NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required) | PAR 24 083

Opportunity Information: Apply for PAR 24 083

The National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH), is offering an R01 grant opportunity (PAR-24-083) to support investigator-initiated, multi-site feasibility clinical trials of complementary and integrative health approaches that use physical and/or psychological therapeutic inputs, often referred to as mind and body interventions. The core purpose is not to run a definitive, fully powered efficacy or effectiveness trial right away, but to generate the specific, practical, and scientifically necessary evidence needed to confidently design and launch a later, larger clinical trial that fits within NCCIHs mission. In other words, applicants are expected to use this R01 to de-risk a future full-scale study by showing that the intervention and trial methods can actually work across multiple locations and populations.

A key expectation is that the application clearly lays out the planned future clinical trial (for example, a fully powered multi-site efficacy trial, effectiveness study, pragmatic trial, or dissemination and implementation trial) and explains why the feasibility work proposed in this R01 is essential to that next step. NCCIH is looking for feasibility data that fill real knowledge gaps and directly inform the design choices of the subsequent trial. The feasibility outcomes can include, but are not limited to, whether the intervention can be delivered with fidelity across different sites (meaning it is implemented consistently and as intended), whether participants can be recruited and enrolled at the needed pace across sites, and whether randomization procedures function smoothly in a multi-site environment. The NOFO also emphasizes demonstrating participant adherence to the intervention and retaining participants through follow-up, since both are common failure points when scaling from single-site studies to multi-site trials.

This opportunity also supports feasibility work for more complex, protocolized multimodal interventions, where multiple components must be delivered in a standardized way. Applicants can use the feasibility trial to refine the intervention protocol, training procedures, quality assurance methods, and cross-site coordination processes so that the later trial is realistically executable. Another major focus is confirming the feasibility of data collection across sites, including the ability to gather comparable measures in consistent ways, maintain data quality, and ensure the study operations are robust enough to support a full-scale multi-site trial later. Overall, NCCIH wants applicants to treat the feasibility trial as a targeted tool: collect the exact information needed to make the later pivotal study competitive, credible, and likely to succeed, rather than simply repeating early-stage pilot work.

Because multi-site feasibility studies are resource-intensive, the NOFO indicates that the need for a multi-site approach should be justified by sufficient preliminary evidence, such as data from earlier single-site feasibility or acceptability studies or strong support from the published literature. The expectation is that applicants are not starting from zero; they should already have reason to believe the intervention is plausible and acceptable, and now need to show it can be standardized and implemented across multiple settings. The end goal is to position a subsequent fully powered multi-site clinical trial that could meaningfully affect public health if successful.

In terms of eligibility, the opportunity is broadly open across many organization types, including state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; and a wide range of nonprofit and for-profit organizations (including small businesses, but excluding the small business-specific mechanisms). The NOFO also explicitly highlights eligibility for organizations such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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, and U.S. territories or possessions. However, non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed, which can matter for specific collaborations or research elements that legitimately require work outside the U.S. while remaining anchored in a U.S.-based applicant organization.

Administrative details from the listing include that it is a discretionary grant program in the health area (CFDA 93.213) administered by NIH, with an original closing date shown as 2026-11-17. The award ceiling is listed as $350,000. (The listing does not specify the number of expected awards.) Taken together, this NOFO is best understood as an NCCIH-supported on-ramp to a larger, high-impact multi-site trial: applicants propose a rigorously designed feasibility clinical trial, justify why multi-site testing is necessary at this stage, and produce concrete evidence that the intervention delivery, recruitment and retention processes, and data collection systems are ready to scale into a definitive, full-scale study.

• 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 2023-12-20.
• 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.

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