Assessing the Feasibility of Incorporating Mechanisms in Multisite Clinical Trials of Mind and Body Interventions on Whole Person Health Restoration
Can you apply?
This grant is for research institutions and organizations conducting multisite clinical trials of mind-body interventions. Eligible applicants typically include academic medical centers, universities, research hospitals, and nonprofit research organizations with capacity to manage clinical trials across at least two geographically distinct sites. The grant supports feasibility studies examining mind and body interventions (meditation, yoga, acupuncture, music, etc.) on whole person health restoration. Studies must demonstrate intervention fidelity across sites, assess recruitment and retention feasibility, and measure both clinical and mechanistic outcomes related to emotional well-being. No cost-sharing is required.
Key dates
- Jul 8, 2025 Applications open
- Oct 15, 2026 Application deadline in 136 days
- Jul 13, 2027 Award announced
- Jul 20, 2027 Project start
This grant is for research institutions and organizations conducting multisite clinical trials of mind-body interventions. Eligible applicants typically include academic medical centers, universities, research hospitals, and nonprofit research organizations with capacity to manage clinical trials across at least two geographically distinct sites. The grant supports feasibility studies examining mind and body interventions (meditation, yoga, acupuncture, music, etc.) on whole person health restoration. Studies must demonstrate intervention fidelity across sites, assess recruitment and retention feasibility, and measure both clinical and mechanistic outcomes related to emotional well-being. No cost-sharing is required.
Program description
The National Center for Complementary and Integrative Health (NCCIH) intends to publish a Notice of Funding Opportunity (NOFO) to support multi-site feasibility studies of mind and body interventions (e.g., meditation, yoga, acupuncture, music, or multicomponent interventions) on whole person health restoration. The goal of this NOFO is to establish foundational work necessary to inform and enable future large-scale clinical efficacy and effectiveness trials of mind and body interventions on whole person health restoration, as well as investigation of the potential mediating effects of mind and body interventions on whole person health restoration by established or well-studied mechanisms underlying emotional well-being (EWB). Studies proposed under this NOFO must be conducted across at least two geographically distinct sites to enhance generalizability and reproducibility. Key expectations to achieve the NOFO goal include: 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 pulled across sites. Applicants are required to use the Whole Person Health Index and may also use one or more of its individual components as the clinical outcome measure of whole person health restoration. Additional clinical outcome measures are allowable based on clinical relevance. This NOFO will complement a different NCCIH funding opportunity (PAR-25-449) supporting mechanistic clinical trials by emphasizing the critical step of feasibility testing in real-world and multisite settings. Multidisciplinary teams with experience in complementary and integrative health, clinical trial design, and mechanistic research are particularly encouraged to consider applying. Applications are not being solicited at this time. This Notice is being issued to provide potential applicants ample time to develop strong, collaborative, and responsive project plans. This anticipated NOFO will utilize the R33 Clinical Trial Required activity code. Further details will be provided in the forthcoming announcement.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- Colleges (all higher ed)
- County Government
- Hospital
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for research institutions and organizations conducting multisite clinical trials of mind-body interventions. Eligible applicants typically include academic medical centers, universities, research hospitals, and nonprofit research organizations with capacity to manage clinical trials across at least two geographically distinct sites. The grant supports feasibility studies examining mind and body interventions (meditation, yoga, acupuncture, music, etc.) on whole person health restoration. Studies must demonstrate intervention fidelity across sites, assess recruitment and retention feasibility, and measure both clinical and mechanistic outcomes related to emotional well-being. No cost-sharing is required.
How to apply
Application links
Key dates & requirements
Required documents
- R33 Application (PHS 398 form)
- Project Narrative/Research Plan
- Budget and Budget Justification
- Curriculum Vitae (key personnel)
- Letters of Support (from collaborating sites)
- Human Subjects Protection documentation
- Data Management Plan
- Detailed Site Coordination Plan
Program contact
- 👤 Jennifer N. Baumgartner, Ph.D. National Center for Complementary and Integrative Health (NCCIH)
- 📧 jennifer.baumgartner@nih.gov
- 📞 301-402-4084
Funding track record
Recent awards under CFDA 93.213 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$22,367,527
-
$21,646,919
-
$19,236,131
-
$17,730,528
-
$15,036,701
-
$14,473,882
-
$12,748,932
-
$11,956,053
-
$11,225,697
-
$10,919,780
Top States by Funding
- MA 13 awards $80.2M
- CA 12 awards $79.7M
- WA 8 awards $69.9M
- NC 7 awards $52.3M
- NY 6 awards $40.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.213). How funding has trended year over year.
| 2024 | $240,178,154 | |
| 2025 | $232,899,116 | |
| 2026 est. | $2,655,626 |
FAQ
What types of institutions can apply?
Academic medical centers, universities, research hospitals, and nonprofit research organizations experienced in clinical trial management are eligible. Multidisciplinary teams with complementary and integrative health expertise are encouraged.
What is the key requirement for study design?
Studies must be conducted across at least two geographically distinct sites. This requirement enhances generalizability and reproducibility of findings.
What outcomes must be measured?
The Whole Person Health Index is required as the clinical outcome measure. Mechanistic outcomes targeting emotional well-being mechanisms are also required.
When is the official NOFO opening?
This is a pre-announcement notice. The formal NOFO has not yet been published. Applications are not being solicited at this time.
What is the funding mechanism?
This NOFO will use the R33 Clinical Trial Required activity code, which typically supports feasibility and efficacy testing phases.
💡 Tips for applicants
- Build your team now. Identify strong collaborators across at least two sites with complementary expertise in clinical trials and mind-body intervention delivery.
- Start planning your study design early. Document how you will demonstrate intervention fidelity, reproducibility, and feasibility of recruitment, retention, and randomization.
- Familiarize yourself with the Whole Person Health Index. This is a required outcome measure, so understand its components and implementation before application.
- Develop preliminary data on your target population. Show evidence of recruitment feasibility and demand for your intervention at both proposed sites.
- Review the complementary mechanistic trials NOFO (PAR-25-449). Understanding how your feasibility work will inform larger efficacy trials strengthens your application narrative.
⚠️ Common mistakes
Proposing single-site studies instead of multisite designs. Failing to demonstrate clear mechanisms linking the intervention to emotional well-being outcomes. Underestimating feasibility challenges in participant recruitment, retention, or intervention fidelity across diverse sites.
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