OpportunityTitle: Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34  Clinical Trial Required)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:  Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.  Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.  Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Description: 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.
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