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

The National Center for Complementary and Integrative Health (NCCIH) has presented a grant opportunity, known as the Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required). This grant seeks applications for researcher-led clinical trials in areas of high research priority defined by NCCIH.

The trials should investigate health approaches that utilize physical and/or psychological treatments, commonly known as mind and body interventions. Applicants are expected to propose a feasibility study that includes multiple research sites. Information gathered from these studies should fill the gap in scientific knowledge and help plan and conduct subsequent larger-scale trials.

The main aim of these R01 studies is to establish the necessary groundwork for future full-scale clinical trials. This includes demonstrating the ability to maintain treatment fidelity across sites, showing the capability of recruiting, enrolling, and randomizing participants across all locations, verifying participant adherence to the intervention and retention throughout the study, refining multimodal interventions, and proving the feasibility of data collection across all sites.

Considerable preliminary data should justify the need for multi-site feasibility trials. This could come from previous single-site trials or evidence published in academic literature. Furthermore, the data gathered through this grant should be crucial in formulating a large-scale multi-site clinical trial that could have a significant impact on public health.