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

National Institutes of Health

This Funding Opportunity Announcement (FOA) invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority. Applications submitted under this FOA are expected to propose a multi-site feasibility clinical trial to assess whether the intervention can be delivered with fidelity across sites; demonstrate feasibility of recruitment, accrual, and randomization of participants across sites; demonstrate participant adherence to the intervention, as well as retention of participants throughout the study across sites; and/or demonstrate feasibility of data collection across sites in preparation for a future fully powered, multi-site efficacy/ effectiveness trial. The need for multi-site feasibility trials is expected to be justified by sufficient preliminary data from previous single site feasibility or acceptability trial(s) or the published literature. This FOA will not support clinical trials that determine efficacy or effectiveness. The data collected should be used to fill gaps in scientific knowledge and be necessary to develop a competitive fully powered multi-site clinical trial that has the potential to make a significant impact on public health

Prior to submitting to this FOA, applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact person for the science area of the planned application.

Deadlines:

Application Due Dates: Feb. 20, 2024; June 20, 2024; Oct 21, 2024; Feb 20, 2025; June 20, 2025; Oct 20, 2025; Feb 20, 2026; June 22, 2026; Oct 20, 2026
AIDS Application Due Dates: March 11, 2024; July 15, 2024; Nov 13, 2024; March 10, 2025; July 15, 2025; Nov 18, 2025; March 17, 2026; July 14, 2026; Nov 17, 2026

PAR-24-083 Expiration Date November 18, 2026

Specialties

Medical

Medical - Clinical Science

Medical - Basic Science

Eligibility Requirements

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Sponsor Type:

Address: National Institutes of Health; 31 Center Drive; MSC 2220; Bethesda; MD 20892-2220; USA

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