NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required)
This grant supports multi-site feasibility clinical trials of mind and body interventions to gather necessary data for future large-scale trials in high-priority health areas.
Funder: National Institutes of Health
Due Dates: June 20, 2025 (New/Renewal/Resubmission/Revision) | July 15, 2025 (AIDS) | October 20, 2025 (New/Renewal/Resubmission/Revision) | November 18, 2025 (AIDS) | February 20, 2026 (New/Renewal/Resubmission/Revision) | March 17, 2026 (AIDS) | June 22, 2026 (New/Renewal/Resubmission/Revision) | July 14, 2026 (AIDS) | October 20, 2026 (New/Renewal/Resubmission/Revision) | November 17, 2026 (AIDS)
Funding Amounts: Recommended maximum: $350,000 direct costs/year (typically up to 3 years; max 5 years if well justified)
Summary: Supports multi-site feasibility clinical trials of mind and body interventions to generate data needed for future large-scale efficacy or effectiveness studies in high-priority health areas.
Key Information: Preliminary single-site feasibility data are required; applications must justify the need for a multi-site trial and cannot propose fully powered efficacy studies.
Description
This opportunity, offered by the National Center for Complementary and Integrative Health (NCCIH) at NIH, funds investigator-initiated, multi-site feasibility clinical trials of mind and body interventions. The goal is to collect critical data necessary for planning and conducting future, fully powered, multi-site efficacy, effectiveness, pragmatic, or dissemination/implementation trials in areas of high research priority for NCCIH.
Mind and body interventions may include physical (e.g., yoga, tai chi, acupuncture, massage), psychological (e.g., mindfulness, meditation, hypnosis, guided imagery), or multi-component/integrative approaches (e.g., traditional Chinese medicine, naturopathic medicine, or combinations of complementary and conventional care).
Applicants must propose a multi-site feasibility trial (at least two geographically distinct sites) to address key scientific gaps such as:
- Delivering the intervention with fidelity across sites
- Feasibility of recruitment, accrual, and randomization
- Participant adherence and retention
- Feasibility of protocolized, multi-modal interventions
- Feasibility of data collection across sites
The need for a multi-site feasibility trial must be justified by sufficient preliminary data from prior single-site feasibility or acceptability studies.
