NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required)

The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), has announced a funding opportunity for multisite feasibility clinical trials investigating mind and body interventions. This funding opportunity aims to support investigator-initiated research that examines complementary and integrative health approaches. These interventions, including practices such as yoga, meditation, acupuncture, and guided imagery, are increasingly recognized as nonpharmacologic methods for managing symptoms like chronic pain, anxiety, and mild depression. The trials supported under this initiative are expected to address the feasibility of conducting full-scale, multisite efficacy or effectiveness studies by assessing recruitment, adherence, intervention fidelity, and data collection across diverse populations and multiple sites. The purpose of this funding is to generate data critical to the design and execution of future rigorous clinical trials that evaluate the efficacy or effectiveness of mind and body interventions. Investigators must demonstrate the scientific necessity for the proposed feasibility study through preliminary data from single-site trials or relevant published literature. The studies should test recruitment, randomization, and retention strategies; ensure intervention delivery fidelity; and assess methods for consistent outcome measurement across sites. While mechanistic measures can be included to establish data collection feasibility, the primary focus is not to assess the efficacy of interventions but to build the foundation for subsequent large-scale trials. Funding under this program is not limited but generally should not exceed $350,000 in direct costs per year or a total project period of three years, though projects up to five years are permissible with strong justification. Eligible applicants include higher education institutions, nonprofits, for-profit entities, and government organizations, among others. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) to foster inclusivity and diverse collaboration. Applications must follow detailed instructions provided in the NIH guide, and incomplete applications, including those missing a PEDP, will not be reviewed. Key application deadlines include February 20, June 20, and October 20 annually, starting in 2025, with funding decisions anticipated approximately 8-10 months later. Applicants are encouraged to contact NCCIH program staff early to discuss the alignment of their proposed study with the objectives of this funding opportunity. All applications must demonstrate that the intervention is well-tolerated and feasible based on prior studies and that the research team has the necessary experience to conduct and manage multisite trials effectively. Applications must propose a randomized controlled trial design with at least one intervention and one comparator arm. Detailed descriptions of the intervention, study population, and recruitment strategies are required. The trial design must ensure geographic diversity and include a plan for participant recruitment and retention. Importantly, applications that propose waitlist comparators, entirely remote trials, or feasibility trials that do not involve multisite designs will not be considered responsive to this funding opportunity. This program aligns with NCCIH’s priorities to advance complementary health research and address public health issues, including health disparities, chronic pain, mental health conditions, and emotional well-being. By supporting these feasibility studies, NCCIH aims to facilitate the generation of high-quality evidence that can inform clinical practices and contribute to whole-person health care strategies.