NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required)

Open Posted

Opportunity number
PAR-25-267
Agency
Applications due
Award size
Up to $350,000

Opportunity facts

Funding instrument
Grant
Category
  • Health
Eligible applicants
  • Higher Education Inst. (Public)
  • Non-501(c)(3) Nonprofits
  • County Governments
  • Special District Governments
  • Tribal Governments (Federally Recognized)
  • Public or Indian Housing Auth.
  • City/Township Governments
  • Tribal Organizations (Not Federally Recognized)
  • For Profit Organizations
  • State Governments
  • Independent School Districts
  • Higher Education Inst. (Private)
  • 501(c)(3) Nonprofits
  • Small Businesses
  • Other
Points of contact
Full announcement

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The National Institutes of Health National Center for Complementary and Integrative Health (NCCIH) is soliciting applications for investigator-initiated multisite feasibility clinical trials of mind and body interventions, with applications due November 17, 2026. This R01 award requires applicants to propose a multisite feasibility trial designed to generate data necessary for planning and conducting a subsequent fully powered efficacy, effectiveness, or implementation trial.

Eligible applicants include higher education institutions (public and private), 501(c)(3) and non-501(c)(3) nonprofits, for-profit organizations, small businesses, state and local governments, tribal governments and organizations, tribal colleges, faith-based and community-based organizations, HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, and AANAPISIs. Non-domestic organizations and foreign components as defined in the NIH Grants Policy Statement are ineligible; however, foreign components within U.S. organizations are permitted.

Applicants must justify the need for multisite feasibility trials through sufficient preliminary data from single-site feasibility or acceptability trials or published literature. The proposed research should fill scientific knowledge gaps by addressing intervention fidelity delivery across sites, feasibility of recruitment and randomization, participant adherence and retention, feasibility of protocolized multimodal interventions, and data collection processes necessary to support a future fully powered multisite clinical trial with significant public health impact.

Applications undergo two-stage peer review evaluated on scientific merit, innovation and significance, technical adequacy of design, investigator competency, adequacy of facilities and resources, budget necessity, relevance to program objectives, and adequacy of human or animal subject protections. The program operates under Assistance Listing 93.213 (Research and Training in Complementary and Integrative Health). Award timelines average 6 to 10 months from application to notice of award.

Synopsis

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.

Eligibility

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; 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 allowed.

Files

File Type Posted
PKG00288878.pdf PDF

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