The National Center for Complementary and Integrative Health (NCCIH) announces this Notice of Funding Opportunity (NOFO) to solicit applications for research on how mind and body interventions through psychological and/or physical inputs (e.g., mindfulness meditation, yoga, acupuncture, massage, and other brain and/or body based interventions) impact mechanisms of emotional well-being (EWB) and their associations with whole person health (WPH), consistent with the NIH priority to address the health needs of the American people and improve their well-being.
Donor Name: National Center for Complementary and Integrative Health (NCCIH)
State: All States
County: All Counties
Type of Grant: Grant
Deadline: 06/07/2028
Size of the Grant: $100,000 to $500,000
Grant Duration: 5 Years
Details:
The NOFO will support rigorous and well-powered human mechanistic research studies that are supported by strong preliminary data. The studies should examine the effects of mind and body interventions on innovative mechanisms of EWB (as the primary outcome), as well as the associated relationship with the Whole Person Health Index (WPHI, as a secondary outcome). To enhance research safety, rigor, and efficiency of NIH-funded mechanistic clinical trials, this initiative will use a two-phased award funding mechanism (R61/R33). The funding will support an initial phase (R61) to establish feasibility benchmarks for a subsequent proposed second phase (R33) mechanistic clinical trial, which will be contingent upon successful achievement of R61 benchmarks (“Go/No-Go Criteria”). Applications should provide preliminary data that are comparable in quality and quantity to those expected for an R01 application.
The National Center for Complementary and Integrative Health (NCCIH) provides funding for research into complementary and integrative health approaches. Eligible entities (including, but not limited to: research and academic institutions, private companies) may submit research grant applications using the Grants.gov website. All applications undergo a rigorous two-stage peer review system, and funding decisions are made based on the review of applications that are most meritorious and responsive to the mission of NCCIH.
The NOFO will address the fundamental knowledge gaps by supporting rigorous, well-powered, and innovative mechanistic clinical trials with strong preliminary data to understand the impact of mind and body interventions on innovative mechanisms of EWB (primary outcome) as well as their associations with the Whole Person Health Index (secondary outcome).
The scientific priority of this NOFO is placed on the level of innovation for the proposed EWB mechanisms in the context of the proposed mind and body intervention. Examples of potentially innovative EWB-related mechanisms include, but are not limited to:
- Neural circuitry
- Microbiome
- Inflammation
- Interoception
- Epigenetics, gene expression, and DNA repair
R61 Phase: Feasibility Phase (1–2 years)
The goal of the R61 phase is to demonstrate the feasibility of conducting the proposed hypothesis-driven mechanistic clinical trial. Key benchmarks for a successful demonstration of feasibility must include both recruitment and retention goals. NCCIH may, as appropriate, negotiate “Go/No-Go” transition criteria prior to award. There will be no negotiations regarding benchmarks or milestones prior to the submission of applications for this NOFO. All applications are expected to clearly articulate the transition feasibility criteria. Applicants must provide justification of the chosen feasibility criteria. Unblinding and data analysis are not permitted at the end of the R61 phase.
R33 Phase: Mechanistic Study (2–4 years, maximum total award period of 5 years)
Funding for the R33 phase is contingent on demonstrating the ability to successfully recruit and retain participants, and collect the proposed mechanistic measure according to the proposed study design. The R33 phase will continue participant recruitment, conduct, and assessment to complete the mechanistic clinical trial. No changes to the interventions or design are permitted in the R33 phase. A clear study timeline for completion of the proposed mechanistic trial during the R33 phase must be included.
R61/R33 Transition Process
R33 transition requests will undergo an administrative review by NCCIH to determine whether the Go/No-Go Criteria for the feasibility criteria have been met before an R33 award is made. Funding for, and transition to, the R33 phase is contingent on the following:
- Submission of an “R33 Transition Request Application” 2 months prior to the end of the R61
- Meeting the Go/No-Go Criteria articulated in the R61 phase
- The availability of funds
Funding Information
- NCCIH intends to commit $2,000,000 in FY 2026 to fund three awards.
- Application budgets may not exceed $475,000 per year in direct costs.
Project Period
The scope of the project should determine the project period for each phase. The maximum period of the combined R61 and R33 phases is 5 years, with up to 2 years for the R61 phase and up to 4 years for the R33 phase.
Eligibility Criteria
Higher Education Institutions – Includes all types
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized).
Federal Governments
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
Foreign Organizations
- Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 not allowed.
For more information, visit Grants.gov.
