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

The goal of this funding opportunity is to support early phase clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) for conditions that have been identified by NCCIH as high priority research topics. This funding opportunity is intended to support feasibility clinical trials, which will provide data that are critical for the planning and design of a subsequent controlled cohort study, clinical efficacy or effectiveness study, or a pragmatic trial. The data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial, including, but not limited to the following: examining feasibility and acceptability of interventions lacking published data; adapting an intervention to a specific population; refining the intervention to determine the most appropriate frequency or duration; determining feasibility of recruitment, retention and data collection procedures; refining and assessing the feasibility of protocolized multimodal interventions; or examining acceptability and adherence of control conditions. This FOA will not support randomized clinical trials to test or determine efficacy or effectiveness; nor will this FOA support repetition of feasibility or acceptability research that has been previously conducted in the same or similar patient population with the same or similar intervention. Applications that propose solely to write a protocol or manual of operations or to develop infrastructure for a clinical trial are not appropriate for this announcement. The subsequent larger trial should have the potential to make a significant impact on public health.