Assessing the Feasibility of Incorporating Mechanisms in Multisite Clinical Trials of Mind and Body Interventions on Whole Person Health Restoration

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.