Assessing the Feasibility of Incorporating Mechanisms in Multisite Clinical Trials of Mind and Body Interventions on Whole Person Health Restoration
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The National Center for Complementary and Integrative Health (NCCIH) plans to release a Notice of Funding Opportunity focused on supporting multi-site feasibility studies that evaluate mind and body interventions such as meditation, yoga, acupuncture, music, or multicomponent approaches aimed at restoring whole person health. These studies are intended to establish foundational data to guide future large-scale clinical efficacy and effectiveness trials, as well as to explore how these interventions may mediate emotional well-being through well-characterized mechanisms. Required to be conducted across at least two geographically distinct sites, the studies must demonstrate intervention fidelity, reproducibility, participant recruitment and retention feasibility, as well as the capability for comprehensive clinical and mechanistic data collection. Applicants will be required to use the Whole Person Health Index as the clinical outcome measure, with allowance for additional clinically relevant outcomes. This initiative complements another NCCIH funding opportunity by emphasizing feasibility testing in multisite real-world settings before advancing to larger mechanistic trials. The opportunity encourages multidisciplinary teams experienced in complementary health, clinical trials, and mechanistic research to prepare collaborative proposals. Although applications are not yet being solicited, prospective applicants are given advance notice to develop rigorous project plans. The funding will utilize the R33 Clinical Trial Required activity code, with further details forthcoming.
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The National Center for Complementary and Integrative Health (NCCIH) intends to publish a Notice of Funding Opportunity (NOFO) to support multi-site feasibility studies of mind and body interventions (e.g., meditation, yoga, acupuncture, music, or multicomponent interventions) on whole person health restoration. The goal of this NOFO is to establish foundational work necessary to inform and enable future large-scale clinical efficacy and effectiveness trials of mind and body interventions on whole person health restoration, as well as investigation of the potential mediating effects of mind and body interventions on whole person health restoration by established or well-studied mechanisms underlying emotional well-being (EWB). Studies proposed under this NOFO must be conducted across at least two geographically distinct sites to enhance generalizability and reproducibility. Key expectations to achieve the NOFO goal include: 1) demonstrating that the mind and body intervention can be delivered with fidelity across sites; 2) demonstrating reproducibility and rigor in engaging targeted mechanisms of EWB by the mind and body intervention across sites; 3) assessing feasibility of participant recruitment and retention, as well as randomization; 4) assessing feasibility of collecting comprehensive clinical (whole person health restoration) and mechanistic (EWB) data across sites; and 5) exploring correlations between changes in mechanistic targets and clinical outcome measurements pulled across sites. Applicants are required to use the Whole Person Health Index and may also use one or more of its individual components as the clinical outcome measure of whole person health restoration. Additional clinical outcome measures are allowable based on clinical relevance. This NOFO will complement a different NCCIH funding opportunity (PAR-25-449) supporting mechanistic clinical trials by emphasizing the critical step of feasibility testing in real-world and multisite settings. Multidisciplinary teams with experience in complementary and integrative health, clinical trial design, and mechanistic research are particularly encouraged to consider applying. Applications are not being solicited at this time. This Notice is being issued to provide potential applicants ample time to develop strong, collaborative, and responsive project plans. This anticipated NOFO will utilize the R33 Clinical Trial Required activity code. Further details will be provided in the forthcoming announcement.