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), specifically the National Center for Complementary and Integrative Health (NCCIH), has announced a forthcoming funding opportunity titled "Assessing the Feasibility of Incorporating Mechanisms in Multisite Clinical Trials of Mind and Body Interventions on Whole Person Health Restoration." This Notice of Funding Opportunity (NOFO), currently forecasted, is designed to advance research exploring how mind and body interventions can influence whole person health restoration, focusing particularly on emotional well-being (EWB) mechanisms. The primary objective of this NOFO is to support multisite feasibility studies that will inform future large-scale efficacy and effectiveness trials. These studies must include mind and body interventions such as meditation, yoga, acupuncture, music, or multicomponent approaches, and they must be conducted across at least two geographically distinct locations. This multisite design is intended to ensure generalizability and reproducibility of findings. Central to the initiative is the requirement to investigate the mechanisms by which these interventions affect whole person health and EWB, thereby laying a rigorous groundwork for future mechanistic clinical trials. The funding initiative will prioritize research that can demonstrate several critical elements: fidelity in intervention delivery across multiple sites, reproducibility in engaging targeted EWB mechanisms, and the feasibility of participant recruitment, retention, and randomization. Additionally, applicants must assess the practicality of collecting comprehensive clinical and mechanistic data and explore the relationships between mechanistic changes and clinical outcomes across all sites. Importantly, all applicants are required to use the Whole Person Health Index as a clinical outcome measure and may supplement it with other clinically relevant outcome tools. The NCCIH emphasizes interdisciplinary collaboration in response to this funding opportunity, encouraging applications from teams with expertise in complementary and integrative health, clinical trial methodology, and mechanistic research. The proposed mechanism for funding will use the R33 Clinical Trial Required activity code, and the announcement is intended to provide sufficient lead time for developing robust, collaborative project designs. According to the forecast, the estimated post date is May 26, 2026, with an expected application due date of October 15, 2026. Awards are anticipated to be made by July 13, 2027, with project start dates expected by July 20, 2027. This opportunity is not currently accepting applications, and further details will be provided upon the official publication of the NOFO. No cost sharing or matching funds are required for this program. Contact for this funding opportunity is Dr. Jennifer N. Baumgartner at the NCCIH, who can be reached at [email protected] or 301-402-4084. While no PDF guidelines have been linked at this stage, updates and the full NOFO are anticipated closer to the post date. This initiative complements another NCCIH opportunity (PAR-25-449), focusing on feasibility testing in real-world settings as a prerequisite to clinical mechanistic trials.