Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for investigator-initiated clinical trials of mind and body interventions in complementary and integrative health. Eligible applicants include research institutions, HBCUs, tribal colleges, faith-based organizations, and other organizations. The project must be a multi-site feasibility clinical trial that supports planning for a larger clinical trial.
Strong preliminary data from single-site feasibility studies are expected. The application must clearly justify why a multi-site feasibility trial is scientifically necessary before moving to a full-scale efficacy trial.
Non-U.S. organizations are ineligible. However, foreign components of U.S. organizations are allowed. Applicants must have capacity to conduct rigorous multi-site clinical research.
Not the right fit? Find grants for your organization in 5 questions →
Program description
This notice of funding opportunity (NOFO) invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority. Applications submitted under this NOFO are expected to propose a multisite feasibility clinical trial that will provide new information that is scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial within NCCIHs mission. NCCIH expects that applications to this NOFO will describe the planned future clinical trial and in so doing demonstrate that the proposed (R01) research is scientifically necessary to design or plan the subsequent fully powered, full-scale clinical trial. Under this R01, the data collected should be used to fill gaps in scientific knowledge, including, but not limited to the following: assessing whether the intervention can be delivered with fidelity across sites; demonstrating feasibility of recruitment, accrual, and randomization of participants across sites; demonstrating participant adherence to the intervention, as well as retention of participants throughout the study across sites; refining and assessing the feasibility of protocolized multimodal interventions, and/or demonstrating feasibility of data collection across sites in preparation for a future fully powered, multisite efficacy or effectiveness trial. The need for multisite feasibility trials is expected to be justified by sufficient preliminary data from previous single site feasibility or acceptability trial(s) or the published literature. The data collected should be used to fill gaps in scientific knowledge and be necessary to develop a competitive fully powered multisite clinical trial that has the potential to make a significant impact on public health.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- County Government
- Faith-based Organization
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
How to apply
Application links
Key dates & requirements
Required documents
- R01 Application Form (SF-424)
- Project Narrative (Research Strategy section)
- Preliminary Data
- Budget and Justification
- NIH Biosketch for Key Personnel
- Letters of Institutional Support from All Sites
- Protocol or Protocol Summary
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
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
- CA 13 awards $83.5M
- MA 13 awards $80.2M
- WA 8 awards $69.9M
- NC 7 awards $53.8M
- 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
Who can apply for this grant?
Universities, research institutions, HBCUs, tribal colleges, faith-based organizations, and other eligible organizations can apply. Foreign organizations cannot apply, but U.S. organizations with foreign components are permitted.
What type of research does this grant support?
Multi-site feasibility clinical trials of mind and body interventions in complementary health. The trial must generate data needed to design a future full-scale efficacy or effectiveness trial.
What is the deadline and funding amount?
The deadline is November 17, 2026. Awards typically reach $350,000, though amounts vary by project.
What preliminary data do I need to show?
You must provide strong preliminary evidence from single-site feasibility or acceptability trials, or published literature justifying why a multi-site feasibility study is necessary.
What should the feasibility trial accomplish?
Demonstrate intervention fidelity across sites, recruitment and randomization feasibility, participant adherence, protocol refinement, and data collection feasibility for future larger trials.
💡 Tips for applicants
- Start with your strongest preliminary data from single-site work to justify multi-site expansion clearly.
- Explain exactly what gaps the feasibility trial will fill for your planned efficacy trial.
- Detail your recruitment strategy and participant retention plans for each site upfront.
- Show the NIH how your feasibility results will directly inform the design of your next, larger trial.
- Demonstrate that your team has experience managing multi-site clinical trials successfully.
⚠️ Common mistakes
Applicants propose full efficacy trials instead of focused feasibility studies. Applications lack strong preliminary data or don't justify the transition from single-site to multi-site work. Teams underestimate coordination challenges and site-to-site variability in protocol implementation.
Similar grants
- OPEN Assessing the Feasibility of Incorporating Mechanisms in Multisite Clinical Trials of Mind and Body Interventions on Whole Person Health Restoration — National Institutes of Health
- CLOSED Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required) — National Institutes of Health
- OPEN Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required) — National Institutes of Health
- OPEN Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required) — National Institutes of Health
- OPEN Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 – Clinical Trial Required) — National Institutes of Health