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

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 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 multi-site trial. The need for multi-site feasibility trials are 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 randomized clinical trials to determine efficacy or effectiveness. The data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive fully powered multi-site clinical trial that has the potential to make a significant impact on public health Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this FOA..

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 allowed.