Assessing the Feasibility of Incorporating Mechanisms in Multisite Clinical Trials of Mind and Body Interventions on Whole Person Health Restoration (R01 Clinical Trial Required)

The National Institutes of Health (NIH), through its National Center for Complementary and Integrative Health (NCCIH), has issued a forecasted Notice of Funding Opportunity (NOFO) titled "Assessing the Feasibility of Incorporating Mechanisms in Multisite Clinical Trials of Mind and Body Interventions on Whole Person Health Restoration." This opportunity is expected to open in December 2025 under funding opportunity number FOR-AT-25-007. It will support R01-level clinical trials and requires inclusion of a clinical trial as part of the application. The NIH, a part of the U.S. Department of Health and Human Services, is the primary federal agency conducting and supporting medical research, and NCCIH leads in exploring integrative health approaches. This grant aims to establish foundational feasibility studies of mind and body interventions—such as yoga, acupuncture, meditation, music therapy, or combined methods—specifically focused on whole person health restoration. The emphasis is on designing multisite clinical trials capable of examining both clinical outcomes and emotional well-being (EWB) mechanisms. These feasibility studies are intended to inform future large-scale clinical trials by testing not only the implementation logistics but also the reproducibility of targeted mechanisms. The scope of the funding includes projects that must take place across at least two geographically distinct sites to ensure broader generalizability. Applicants are required to demonstrate fidelity in intervention delivery across locations, robust recruitment and retention strategies, randomization feasibility, comprehensive clinical and mechanistic data collection, and correlation analyses between mechanistic and clinical outcomes. Use of the Whole Person Health Index as the clinical outcome measurement tool is mandatory, though additional clinically relevant measures are permitted. Eligible applicants span a wide array of public and private entities, including state and local governments, small and large businesses, public and private higher education institutions, independent school districts, public housing authorities, and both federally recognized and other Native American tribal entities. Nonprofits with 501(c)(3) status (excluding institutions of higher education) are also eligible. The funding opportunity does not require matching contributions from awardees. Applications are expected to open on December 5, 2025, with a submission deadline of February 5, 2026. The estimated award date is July 1, 2026, with funded projects also starting on that date. As this is a forecasted opportunity, applications are not being accepted at this time, but the advance notice allows applicants to prepare competitive and collaborative proposals. The NIH highlights the importance of multidisciplinary teams with expertise in complementary and integrative health, clinical trial design, and mechanistic research. For more information or inquiries, potential applicants are encouraged to contact Dr. Jennifer N. Baumgartner at the NCCIH. She can be reached via email at jennifer.baumgartner@nih.gov or by phone at 301-402-4084. Full application and program details will be provided in the formal announcement when it is published later in 2025.