Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required) | PAR 24 084

Opportunity Information: Apply for PAR 24 084

The NIH National Center for Complementary and Integrative Health (NCCIH) is offering an R34 grant opportunity (PAR-24-084) to fund feasibility clinical trials of complementary and integrative health approaches that use physical and/or psychological therapeutic inputs, often referred to as mind and body interventions. The focus is on conditions and topics that NCCIH has already identified as high-priority research areas. The central purpose is not to run a full-scale efficacy or effectiveness trial yet, but to generate the practical and scientific groundwork needed to design a strong, competitive, subsequent larger clinical trial that fits within NCCIHs mission and could ultimately have meaningful public health impact.

This NOFO is specifically aimed at feasibility trials that answer the kinds of questions that commonly make or break a later large trial. Applicants are expected to clearly describe the future clinical trial they intend to pursue after the R34, and to make a convincing case that the feasibility work proposed here is scientifically necessary for that next step. In other words, the R34 project should be built around closing specific knowledge gaps that currently prevent a well-justified, well-designed full-scale study. NCCIH is looking for applications where the feasibility aims are tightly linked to clear design decisions for the later trial, rather than general pilot work that is not clearly connected to a next-stage protocol.

Examples of the kinds of feasibility issues this opportunity is meant to support include determining whether an intervention is acceptable and workable when there is little or no prior published feasibility data, and tailoring or adapting an intervention so it fits a particular population, delivery modality, or real-world setting. It also includes refining the content and structure of the intervention, such as identifying an appropriate session frequency, intensity, or duration that participants can realistically follow. The NOFO highlights operational questions too, including whether recruitment strategies will succeed, whether retention is likely to be adequate, and whether data collection procedures are realistic and produce usable data. It also supports work to refine and test the feasibility of protocolized multi-component interventions (where multiple elements need to be delivered in a standardized way), and to examine whether proposed control conditions are acceptable and whether participants will adhere to them, since weak control adherence can undermine a later full-scale trial.

Because this is an R34 clinical trial mechanism, the funding is explicitly for clinical trial activity at the feasibility stage, with the expectation that the results will directly inform a subsequent clinical efficacy or effectiveness study, a pragmatic trial, or a dissemination and implementation trial. The later full-scale trial is expected to be designed in a way that could plausibly produce findings with significant public health relevance, not just small or narrowly applicable results. NCCIH also encourages applicants to contact the appropriate NCCIH scientific or research program staff before submitting, which can help ensure the proposed topic aligns with NCCIH priorities and that the feasibility aims are appropriate for this mechanism.

A required element of the application is a Plan for Enhancing Diverse Perspectives (PEDP), reflecting NIH and NCCIH emphasis on bringing a broader range of viewpoints and participation into the research enterprise. While the specific content of the PEDP will depend on the project, applicants should plan for how they will incorporate diverse perspectives in ways that strengthen the science and improve relevance to the populations affected by the targeted conditions.

Eligibility for this opportunity is broad and includes many types of domestic organizations such as state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities. The NOFO also explicitly notes additional eligible applicant types such as faith-based and community-based organizations and a range of minority-serving institutions, including HBCUs, Hispanic-serving institutions, AANAPISISs, Tribal Colleges and Universities, and Alaska Native and Native Hawaiian Serving Institutions. Foreign organizations are not eligible to apply directly, and non-U.S. components of U.S. organizations are not eligible to apply, but foreign components (as defined by NIH policy) are allowed, meaning certain elements of the work can be conducted abroad under NIH rules if appropriately justified and structured.

Key administrative details include that this is a discretionary grant program within the health funding activity category (CFDA 93.213) administered by NIH, with an award ceiling listed as $450,000. The original closing date shown is 2026-11-13. Overall, the opportunity is best suited for teams that already have a credible concept for a later full-scale NCCIH-relevant clinical trial, but need targeted feasibility data to finalize the intervention approach, participant procedures, controls, and operational methods required to run that definitive study successfully.

• 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 2023-12-20.
• Applicants must submit their applications by 2026-11-13. (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 $450,000.00 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.

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