NCCIH Mind and Body Clinical Trial Cooperative Agreement (U01) | PAR 17 215

Opportunity Information: Apply for PAR 17 215

The NCCIH Mind and Body Clinical Trial Cooperative Agreement (U01) (Funding Opportunity Number PAR-17-215) is a National Institutes of Health discretionary funding opportunity from the National Center for Complementary and Integrative Health (NCCIH) that supports investigator-initiated clinical trials focused on mind and body interventions in NCCIH-designated high-priority research areas. The award mechanism is a cooperative agreement (U01), which generally means the funded project is still led by the investigators, but with substantial NIH programmatic involvement compared to a typical research grant. The overall intent is to move promising mind-body approaches toward stronger, trial-ready evidence by refining interventions, testing key components, and generating the practical data needed to design a later, larger study.

This FOA is aimed at clinical trials that are developmental and optimization-focused rather than definitive, large-scale efficacy or effectiveness trials. Applicants are expected to propose trials that do one or more of the following: develop and test adaptive interventions (for example, approaches where aspects of the intervention can be adjusted based on participant response); optimize an intervention by identifying which components of a multi-part or complex intervention are actually driving changes in outcomes; evaluate whether the intervention can be delivered consistently and with fidelity across different sites as preparation for a future multi-site trial; or collect additional preliminary information needed to finalize the design of a later multi-site study, such as determining the appropriate dose, frequency, or duration of the intervention. In other words, the emphasis is on strengthening the intervention and the trial procedures so that a subsequent larger trial is well-justified and well-designed.

A key expectation is that applicants already have a meaningful base of preliminary data. NCCIH signals that it is not looking for projects starting from scratch; instead, the application should be grounded in evidence showing the study can realistically be executed and that the intervention has credible potential benefit. Specifically, the preliminary foundation should include demonstrated feasibility for recruiting and accruing participants, evidence that participants can adhere to the intervention, and evidence of retention through study completion and final data collection. NCCIH also emphasizes the importance of completing final data collection from any related studies and showing that the intervention is promising clinically, which helps justify investing additional federal resources in optimization and trial-readiness work.

The FOA also draws clear boundaries around what it will not support. It is explicitly not intended to fund multi-site efficacy or effectiveness trials, which are usually larger, more definitive studies designed to provide conclusive evidence of clinical benefit under tightly controlled (efficacy) or real-world (effectiveness) conditions. In addition, it will not support trials that test mind and body interventions for the treatment or prevention of cancer, meaning cancer-focused mind-body clinical trials fall outside the scope of this announcement.

Eligibility is broad and includes many types of domestic organizations and certain non-U.S. entities. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other organizations. The FOA also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This broad eligibility reflects an interest in supporting a wide range of capable research teams and settings, including community-based and minority-serving institutions.

Administratively, the opportunity falls under the health activity category and is associated with CFDA number 93.213. The FOA record indicates a creation date of March 10, 2017, and an original closing date of January 24, 2018. The source information provided does not specify an award ceiling or expected number of awards, so those specifics would typically need to be confirmed in the full FOA text or related NIH documentation. Overall, the program is best understood as a pathway funding mechanism for mind-body clinical trials that are ready to be optimized, standardized, and positioned for a later, more definitive multi-site study, while avoiding both large confirmatory trials and oncology-focused intervention testing under this particular announcement.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NCCIH Mind and Body Clinical Trial Cooperative Agreement (U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213.
• This funding opportunity was created on 2017-03-10.
• Applicants must submit their applications by 2018-01-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 17 215

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