Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required)

The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), has issued a Notice of Funding Opportunity (NOFO) titled “Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required).” This reissue of PAR-24-084, now listed as PAR-25-274, supports feasibility clinical trials aimed at informing the planning of future full-scale clinical trials within the NCCIH’s mission. It emphasizes the development of complementary and integrative health approaches with physical or psychological therapeutic inputs—collectively referred to as mind and body interventions. The purpose of this funding opportunity is to generate essential feasibility data for the design and conduct of subsequent efficacy, effectiveness, pragmatic, or implementation clinical trials. It supports activities such as refining interventions, testing recruitment and retention methods, tailoring content for specific populations or settings, assessing the feasibility of control conditions, and evaluating the acceptability and adherence to interventions. Applications should explicitly demonstrate the scientific necessity of the proposed research and its relevance to a future trial. The NOFO provides up to $450,000 in direct costs over a maximum three-year project period, with no more than $225,000 in direct costs in any one year. Only applications proposing randomized controlled trials with an intervention and comparator arm will be accepted; waitlist controls are not permitted. The opportunity is open to a broad range of eligible applicants, including higher education institutions, nonprofits, for-profit organizations, local governments, and tribal entities. Applications must be submitted electronically through NIH’s ASSIST system, Grants.gov Workspace, or institutional system-to-system solutions. Required registration includes SAM, eRA Commons, and Grants.gov. Letters of support from key collaborators, justification for sample sizes, and detailed data and safety monitoring plans are mandatory. Specific attention must be given to adherence to NIH guidelines on human subjects research, vulnerable populations, and data management and sharing policies. Applications are due multiple times annually through October 2026. The next available deadline is June 20, 2025, with reviews in November 2025 and funding start dates beginning in April 2026. Proposed studies must align with NCCIH’s priorities, such as enhancing health behaviors, managing chronic conditions (e.g., anxiety, depression, pain), or improving whole person health. Preference is given to projects that address underserved populations or integrate interventions into real-world settings like healthcare systems or community organizations. Evaluation criteria for this NOFO focus on the significance and innovation of the research, rigor and feasibility of the approach, qualifications of the investigators, and adequacy of institutional resources. The proposed feasibility study should not duplicate prior research and must provide strong rationale for its necessity. Data and safety monitoring requirements, potential FDA regulatory oversight, and ethical protections for participants are strictly enforced, ensuring the scientific integrity and safety of the studies funded under this opportunity.