Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required)

This Notice of Funding Opportunity (NOFO) invites applications for research projects that are centered on clinical trials for complementary and integrative health interventions. These trials should focus on areas of high research priority as designated by the NCCIH and must be conducted completely remotely with no in-person interaction between the research team and participants. The use of mobile health tools and technologies is permitted.

Applicants are expected to propose a clinical trial which is fully powered and conducted entirely remotely. They must provide a strong rationale supporting why a remotely delivered approach is fitting, as well as preliminary data validating the feasibility and safety of this approach. The proposal should also include evidence that the intervention being tested holds the promise of potential clinical benefits.

Furthermore, an important requirement for all applicants is to formulate a Plan for Enhancing Diverse Perspectives (PEDP). This plan will be reviewed during the scientific and technical peer-evaluation process, and applications without this plan will be deemed incomplete and hence withdrawn.

It is highly recommended that applicants consult with appropriate NCCIH Scientific/Research contacts to discuss details of their proposed study prior to application submission. Prospective applicants should also ensure they thoroughly understand the NOFO instructions and the guidelines available for the PEDP.