Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required)

This funding opportunity from the National Institutes of Health (NIH), specifically through the National Center for Complementary and Integrative Health (NCCIH), supports investigator-initiated, multisite clinical trials focusing on mind and body interventions. These clinical trials will explore the efficacy and effectiveness of complementary health approaches, such as psychological, physical, and multicomponent interventions, in treating or managing various health conditions. The funding is structured to encourage rigorous, Phase III-level trials that can inform broader health care practices. Applicants must submit two cooperative agreements in tandem: one for a Clinical Coordinating Center (CCC) and another for a Data Coordinating Center (DCC). The CCC will oversee participant recruitment, clinical trial implementation, and scientific conduct, while the DCC will handle data analysis, management, and administrative support. This dual structure is intended to ensure independence and data integrity across multiple sites. The purpose of this funding is to assess the safety, efficacy, and real-world applicability of mind and body therapies, with specific attention to underrepresented health areas prioritized by NCCIH. The trials may utilize various study designs, such as adaptive, explanatory, and pragmatic trials, with strong justification required for any approach chosen. Proposals must also meet NCCIH’s research goals in areas like health behavior, emotional well-being, symptom management, and minority health disparities. Projects with applications in integrated care settings, community organizations, or health systems are encouraged to foster real-world relevance. The inclusion of a Plan for Enhancing Diverse Perspectives (PEDP) is mandatory, aligning with NIH’s goal of promoting inclusivity in research teams and participant populations. Funding is flexible but must reflect the trial’s actual needs, with budgets that may exceed $500,000 in direct costs. The grant follows a phased approach: a one-year UG3 phase supports trial preparation, followed by the UH3 phase, which funds trial execution for up to four years. Milestones include development of study protocols, participant accrual plans, and establishing a Data and Safety Monitoring Board (DSMB). Continuation to the UH3 phase depends on meeting UG3 milestones, with NIH reviewing progress at each stage to ensure compliance and feasibility. CCC applications must articulate clear, achievable milestones, and contingency plans for the UH3 phase. Eligible applicants include higher education institutions, nonprofits, local governments, for-profit organizations, and specific community organizations. The CCC and DCC applications must include documentation demonstrating the team’s past success with similar trials, including data fidelity across sites, recruitment effectiveness, and participant retention. Additionally, applicants must prove that preliminary data supports both the proposed intervention’s feasibility and the relevance of the study’s outcome measures. Teams with experience conducting multisite trials in similar populations are favored, and applicants must ensure that all relevant FDA or regulatory approvals, such as IND or IDE requirements, are addressed before an award. Applications must include comprehensive plans for trial management, including coordination across sites and a commitment to high-quality data collection. They must also submit detailed recruitment and retention strategies, especially for diverse populations. Budget justifications must support all requested costs, including those for the PEDP, participant translation services, and site-specific recruitment. A milestone plan for both the UG3 and UH3 phases is required, detailing timelines for key events like recruitment completion, data analysis, and publication of findings. Review criteria include significance, innovation, rigor, and feasibility. Applications will be assessed on their potential impact on clinical practice, the robustness of the study design, recruitment and retention plans, and the qualifications of the research team. Reviews will evaluate the project’s alignment with NCCIH priorities and its potential to advance complementary and integrative health research. NIH will not consider applications that do not involve multisite trials, lack a mind-body intervention, or use a waitlist control. Applicants are encouraged to contact NCCIH scientific staff to discuss scope and relevance prior to submission. Applications open on January 20, 2025, with deadlines through June 22, 2026. Letters of intent are encouraged 30 days before the submission date, and applications must follow NIH’s electronic submission guidelines through ASSIST or Grants.gov.