Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required) | PAR 25 274

Opportunity Information: Apply for PAR 25 274

The National Institutes of Health, through the National Center for Complementary and Integrative Health (NCCIH), is offering the PAR-25-274 funding opportunity to support feasibility clinical trials of complementary and integrative health approaches that use physical and/or psychological therapeutic inputs, commonly referred to as mind and body interventions. The purpose is not to fund a full-scale efficacy or effectiveness trial right away, but to generate the specific early clinical evidence needed to properly design and justify a later, larger and more definitive study that fits within NCCIH priorities. In practical terms, this mechanism is meant to reduce uncertainty before investing in a major clinical trial by funding the kind of groundwork that makes a subsequent trial more rigorous, credible, and likely to succeed.

This Notice of Funding Opportunity focuses on conditions that NCCIH has identified as high-priority research topics. Applicants are expected to be explicit about what the eventual follow-on clinical trial will be (for example, an efficacy trial, effectiveness study, pragmatic trial, or dissemination and implementation trial) and to show why the proposed R34 feasibility work is scientifically necessary to plan that next step. Reviewers will be looking for a clear line connecting the feasibility trial to the future full-scale trial, including what design decisions the R34 data will support and how those decisions matter for public health impact. NCCIH emphasizes that the subsequent larger trial should have a realistic chance to meaningfully affect health outcomes at a population level, not just produce incremental or highly localized insights.

The R34 feasibility trial can be used to address several common problems that prevent a larger study from being ready. Examples named in the announcement include testing feasibility and acceptability when an intervention has little or no published clinical trial data, tailoring or adapting an intervention's content or structure for a particular population or setting, and refining key intervention parameters such as frequency, dose, intensity, or duration. It also supports practical trial-planning questions like whether recruitment strategies will work, whether retention will be adequate, whether outcome and data-collection procedures are workable, and whether multi-component or protocolized interventions can be delivered consistently across staff or sites. Another emphasized area is control group design, including whether control conditions are acceptable to participants and whether adherence and engagement are realistic, since weak control conditions can undermine the interpretability of later trials.

A notable feature of this NOFO is the requirement for a Plan for Enhancing Diverse Perspectives (PEDP). While the specific contents will follow NIH guidance, the intent is to ensure the research team, participant populations, study settings, and/or conceptual approaches reflect diversity in ways that strengthen the science and improve relevance and generalizability. NCCIH also encourages applicants to contact the appropriate NCCIH Scientific/Research contact before submission, which signals that early alignment with NCCIH priorities and expectations is important and may help applicants avoid proposing studies that do not fit the institute's mission or the intent of this mechanism.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities, such as state, county, city, 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; tribal organizations that are not federally recognized; public housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The NOFO also explicitly highlights additional eligible categories such as Historically Black Colleges and Universities, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions, as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Foreign organizations are not eligible to apply as applicants, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components are allowed as defined by the NIH Grants Policy Statement, meaning a U.S. applicant may be able to include certain justified international elements (for example, specific expertise, resources, or populations) if they meet NIH rules and are well supported scientifically and administratively. The opportunity is categorized as a discretionary grant in the health area, associated with CFDA number 93.213. The funding opportunity was created on 2024-11-21, and the listed original closing date is 2026-11-17. The announcement does not provide an award ceiling or expected number of awards in the provided text, so applicants would need to consult the full NOFO for budget limits, project period constraints, and any institute-specific caps or expectations.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 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 2024-11-21.
• Applicants must submit their applications by 2026-11-17. (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 25 274

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