Assessing the Feasibility of Incorporating Mechanisms in Multi-site Clinical Trials of Mind and Body Interventions on Whole Person Health Restoration (R33 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-28-091
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Up to $500,000
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- Other
- Higher Education Inst. (Private)
- Tribal Governments (Federally Recognized)
- Small Businesses
- State Governments
- Special District Governments
- Higher Education Inst. (Public)
- For Profit Organizations
- Independent School Districts
- County Governments
- Tribal Organizations (Not Federally Recognized)
- Public or Indian Housing Auth.
- 501(c)(3) Nonprofits
- City/Township Governments
- Non-501(c)(3) Nonprofits
- Points of contact
-
- nccihderfunding@nih.gov
- Jennifer N. Baumgartner jennifer.baumgartner@nih.gov (301) 402-4084
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Center for Complementary and Integrative Health (NCCIH) is soliciting applications for multi-site feasibility clinical trials of mind and body interventions on whole person health restoration, with an application due date of November 16, 2029. This R33 funding opportunity is open to higher education institutions (public and private), nonprofits with and without 501(c)(3) status, for-profit organizations, state and local governments, tribal governments and organizations, and other entity types; foreign organizations and non-U.S. components of U.S. organizations are ineligible. Cost sharing is not required.
Award budgets are strongly encouraged not to exceed $500,000 in direct costs per year for no more than three years, though four years are allowable with strong justification; typical awards range from $300,000 to $1.2 million for three- to five-year periods. The period of performance extends across multiple application cycles with due dates on February 16, June 16, and October 16 of each year through 2029.
Studies must assess feasibility and reproducibility of mind and body interventions including meditation, yoga, acupuncture, music, or multicomponent approaches across at least two geographically distinct sites. All applications must use the Whole Person Health Index as the primary clinical outcome measure and include validated mechanisms of emotional well-being measurement. Studies must employ randomized controlled trial designs with at least one intervention arm and one active comparator (excluding waitlist controls). Preliminary data demonstrating measurable impacts on target emotional well-being mechanisms, absence of frequent adverse events, and pilot feasibility in comparable populations are required. Applications require clinical trial experience tables, data and safety monitoring plans with independent committee oversight, recruitment and retention plans with accrual benchmarks, FDA regulatory correspondence if applicable, letters of support from all participating sites, and Data Management and Sharing Plans.
Evaluation criteria assess scientific merit, innovation, rigor, feasibility, investigator expertise, institutional resources, human subjects protections, and alignment with NIH Gold Standard Science principles. The opportunity is assigned to Assistance Listings 93.213 (Research and Training in Complementary and Integrative Health) and 93.473 (Complementary and Integrative Health – Research Projects).
Synopsis
The National Center for Complementary and Integrative Health (NCCIH) announces this Notice of Funding Opportunity (NOFO) to solicit applications for multi-site feasibility trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) to reproduce and translate mechanisms of emotional well-being (EWB) into large-scale clinical trials that advance our understanding of whole person health. These early-phase multi-site trials are essential for 1) demonstrating that the mind and body intervention can be delivered with fidelity across sites; 2) demonstrating reproducibility and rigor in engaging targeted mechanisms of EWB by the mind and body intervention across sites; 3) assessing feasibility of participant recruitment and retention, as well as randomization; 4) assessing feasibility of collecting comprehensive clinical (whole person health restoration) and mechanistic (EWB) data across sites; and 5) exploring correlations between changes in mechanistic targets and clinical outcome measurements pooled across sites. By laying this groundwork, studies supported under this NOFO will advance the science of whole person health and prepare the field for rigorous clinical trials and mechanistic mediation analysis with the potential to improve the health and well-being of all Americans.
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations: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.
Files
| File | Type | Posted |
|---|---|---|
| PKG00294403.pdf | ||
| PAR-28-091-Full-Announcement.html | HTML file |
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