NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required) | PAR 21 241

Opportunity Information: Apply for PAR 21 241

The NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions funding opportunity (PAR-21-241) is a National Institutes of Health (NIH) R01 grant designed to support investigator-initiated, multi-site feasibility clinical trials focused on complementary and integrative health approaches that use physical and/or psychological therapeutic inputs, commonly referred to as mind and body interventions. The central purpose is not to prove that an intervention works in the definitive sense, but to determine whether a larger, fully powered multi-site trial is practical and can be executed rigorously across multiple locations. NCCIH is looking for projects aligned with its designated areas of high research priority, and it expects applicants to build a strong justification for why a multi-site feasibility study is needed at this point in the intervention development pipeline.

A key expectation under this FOA is that proposed studies will directly test the operational readiness of a future large-scale trial across more than one site. That includes showing that the intervention can be delivered with fidelity across sites, meaning the intervention is implemented consistently and according to protocol despite differences in personnel, setting, and participant populations. Applicants are also expected to demonstrate feasibility of recruitment, accrual, and randomization across sites, along with participant adherence to the intervention and retention through follow-up. In addition, the FOA emphasizes the importance of demonstrating the feasibility of data collection across sites, which often includes testing common data elements, harmonized procedures, and the reliability of outcomes assessment across different teams and locations. The overall deliverable is a clear, evidence-based path toward a later, fully powered multi-site trial by identifying and addressing logistical, methodological, and implementation barriers early.

This opportunity is explicitly not intended to support randomized clinical trials aimed at determining efficacy or effectiveness. In other words, even if randomization is used as part of feasibility testing, the study should not be framed or powered as a definitive test of clinical benefit. Instead, the data collected should fill specific gaps that would otherwise prevent a competitive, well-designed future trial. Examples of the kinds of gaps this FOA is meant to address include uncertainties about recruitment rates in different settings, the acceptability of randomization, adherence challenges, site-to-site variability in intervention delivery, missing data patterns, outcome measurement performance, and the practicality of standardizing training and quality assurance across sites. The expectation is that the feasibility outcomes will directly inform the design choices, resource needs, and risk mitigation strategies for a later trial with stronger public health impact potential.

NCCIH also signals that applications should be grounded in sufficient preliminary evidence to justify moving from single-site exploration to multi-site feasibility. That preliminary justification can come from earlier single-site feasibility or acceptability studies or from a strong published literature base indicating that the intervention is promising enough to warrant the added complexity and cost of a multi-site effort. In practical terms, applicants should be prepared to explain why single-site data are no longer enough, what uncertainties remain that only a multi-site feasibility study can resolve, and how the proposed work will reduce the likelihood of failure in a subsequent large trial.

The FOA encourages prospective applicants to communicate with the relevant NCCIH Scientific/Research contact before submitting. This is a practical cue that NCCIH expects alignment with its priority areas and prefers that applicants clarify fit, scope, and feasibility-trial expectations early. These pre-submission conversations can help ensure that the application is framed around feasibility milestones rather than definitive clinical outcomes, and that the proposed intervention and study design match NCCIH programmatic interests.

In terms of eligibility, the program is broadly open to many U.S.-based organization types typically eligible for NIH grants, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; tribal governments (federally recognized); tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible agencies of the federal government, and U.S. territories or possessions. At the same time, non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible. However, foreign components, as defined under NIH policy, are allowed, which generally means discrete elements of the project may be conducted outside the U.S. when they provide special expertise, resources, populations, or conditions not readily available domestically, consistent with NIH rules.

Administratively, this is a discretionary grant mechanism under the NIH, categorized under health (CFDA 93.213). The FOA was created on June 14, 2021, and the source information provided lists an original closing date of December 21, 2023. The listed award ceiling is $350,000, indicating an upper bound reflected in the posting (applicants would still need to follow the FOA-specific budgeting instructions and NIH cost principles). The instrument type is a grant and the activity code is R01, which generally supports discrete, specified, and circumscribed research projects, but here it is specifically tailored to multi-site feasibility clinical trials with required clinical trial features.

Overall, the opportunity is aimed at teams ready to take a promising mind and body intervention from earlier groundwork into a more realistic, real-world test of whether a multi-site trial can be done well. The strongest applications will keep the focus on feasibility metrics, cross-site standardization, quality control, recruitment and retention performance, adherence and fidelity monitoring, and data collection infrastructure, all tied to a clear plan for how the results will de-risk and strengthen a later, fully powered trial that could meaningfully affect public health.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required)" 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 2021-06-14.
• Applicants must submit their applications by 2023-12-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $350,000.00 in funding.
• 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 21 241

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