Mind and Body Interventions to Restore Whole Person Health via Emotional Well-Being Mechanisms (R61/R33 Clinical Trial Required)

Background
The National Center for Complementary and Integrative Health (NCCIH) announces this Notice of Funding Opportunity (NOFO) to solicit applications for research on mind and body interventions that impact emotional well-being (EWB) and their associations with whole person health (WPH). This initiative aligns with the NIH's mission to address the health needs of the American people and improve their well-being.

The NOFO supports rigorous mechanistic research studies that examine the effects of various interventions such as mindfulness meditation, yoga, acupuncture, and massage on EWB mechanisms, which are crucial for understanding health restoration.

Grant Details
The NOFO will support well-powered mechanistic clinical trials using a two-phased award funding mechanism (R61/R33). The R61 phase focuses on establishing feasibility benchmarks for proposed trials, while the R33 phase will complete full-scale trials contingent upon successful completion of R61 milestones. Applications must provide preliminary data comparable to R01 proposals.

Studies should investigate innovative mechanisms of EWB as primary outcomes and their relationship with the Whole Person Health Index (WPHI) as secondary outcomes. Key objectives include:
1) Demonstrating feasibility in recruitment and retention of participants;
2) Establishing a well-powered randomized controlled trial design;
3) Including multidisciplinary collaborations;
4) Providing strong preliminary data linking interventions to EWB mechanisms.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, tribal governments, and other entities. Foreign organizations are not eligible to apply. Applicants must have the necessary skills and resources to carry out the proposed research.

Period of Performance
The maximum period for the combined R61 and R33 phases is 5 years, with up to 2 years allocated for the R61 phase and up to 4 years for the R33 phase.

Grant Value
NCCIH intends to commit $2,000,000 in FY 2026 to fund three awards. Each application budget may not exceed $475,000 per year in direct costs.