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

This funding opportunity, issued by the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH), supports investigator-initiated, fully remote clinical trials assessing the efficacy or effectiveness of complementary and integrative health interventions. The interventions must be delivered entirely remotely, utilizing mobile health (mHealth) tools or other digital technologies, with no in-person contact between research staff and study participants. Applications are expected to present preliminary data demonstrating the safety, feasibility, and promise of clinical benefit of the intervention under investigation, as well as robust preliminary experience by the research team in conducting remote trials. The purpose of this Notice of Funding Opportunity (NOFO) is to support fully powered clinical trials across a spectrum of research from explanatory to pragmatic, focused on complementary and integrative health approaches such as mind and body practices (e.g., mindfulness, yoga, tai chi, guided imagery) and natural products (e.g., botanicals, probiotics, dietary supplements). These interventions are frequently used by the public and hold potential for addressing symptoms such as pain, anxiety, stress, and sleep disturbances, among others. The NOFO particularly emphasizes applications aligned with NCCIH strategic priorities, including promoting whole-person health, health behavior promotion, emotional well-being, and reducing health disparities. Funding is provided through the R01 Research Project Grant mechanism, with no budget cap, though applications must reflect actual project needs. The maximum project duration is five years. The program encourages the study of interventions integrated into real-world settings and delivered to geographically diverse populations through remote technologies. It excludes studies with any in-person contact, waitlist control designs, interventions involving DEA-regulated substances, and research conducted outside the U.S. or Canada. Eligible applicants include a wide range of entities such as higher education institutions, nonprofits, small businesses, state and local governments, and tribal organizations. Foreign organizations and non-domestic components of U.S. organizations are not eligible to apply. Applicants must register with multiple federal systems, including SAM, eRA Commons, and Grants.gov, to be eligible. Applications must include a detailed research strategy and milestone plan, justification for remote design, power calculations with at least 90 percent power, and a strong recruitment and retention plan. Specific attention is given to the quality and relevance of preliminary data, the track record of the research team in remote trial execution, and compliance with regulatory requirements if natural products or regulated devices are used. Proposals undergo rigorous scientific review based on their significance, innovation, approach, investigator experience, and environment. The next application due date is February 20, 2025, with subsequent cycles occurring three times per year until the expiration date of November 18, 2026. All submissions must be received by 5:00 PM local time of the applicant organization. An independent Data and Safety Monitoring Board (DSMB) is required to oversee participant safety and study integrity.