Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required) | PAR 21 240

Opportunity Information: Apply for PAR 21 240

The NIH, through the National Center for Complementary and Integrative Health (NCCIH), is offering a discretionary grant opportunity (PAR-21-240) to fund early-phase, 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 central purpose is not to prove that an intervention works, but to generate the practical, real-world evidence needed to responsibly design a later, larger-scale study such as a controlled cohort study, a clinical efficacy or effectiveness trial, or a pragmatic clinical trial. In other words, this program is meant to help research teams answer the "Can we do this well, and how should we do it?" questions that must be settled before launching an expensive, definitive trial.

Projects supported under this announcement are expected to focus on conditions that NCCIH has already identified as high priority research topics. The feasibility work should directly address gaps in knowledge that would otherwise weaken a future full-scale clinical trial application. Examples of the kinds of questions NCCIH expects investigators to tackle include whether a specific mind and body intervention is feasible and acceptable in a target population when little or no prior published data exist, whether an existing intervention needs to be adapted for a particular group, and how to refine the intervention parameters (such as the most appropriate session frequency, intensity, or duration). The FOA also highlights operational feasibility, such as whether recruitment strategies are realistic, whether retention is likely to be strong enough to support a larger trial, and whether data collection procedures are workable and acceptable for participants and study sites. It can also support refining and testing the feasibility of protocolized multimodal interventions (interventions with more than one coordinated component) and evaluating whether proposed control conditions are acceptable and whether participants are likely to adhere to them, which is often a major stumbling block in mind and body research.

At the same time, the announcement draws clear boundaries around what it will not fund. It will not support randomized clinical trials designed to test, demonstrate, or determine efficacy or effectiveness. It also will not fund repetitive feasibility or acceptability studies that have essentially already been done, meaning applicants need to show that their proposed feasibility questions are still genuinely unanswered for the intervention and population they intend to study. Additionally, applications that primarily aim to write a protocol, produce a manual of operations, or build general trial infrastructure without conducting the kind of feasibility clinical trial work described are considered nonresponsive to the opportunity. The expectation is that the feasibility trial will produce actionable results that inform a subsequent larger trial with credible potential to matter for public health.

This opportunity uses the R34 funding mechanism and is categorized under health research (CFDA 93.213). The listed award ceiling is $225,000. It is open to a wide range of U.S.-based applicants, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The FOA also explicitly includes categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, and eligible federal agencies, as well as U.S. territories or possessions. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible. Foreign components, as defined by NIH policy, are not allowed.

Key administrative details include that the sponsoring agency is the National Institutes of Health, the opportunity was created on June 14, 2021, and the original closing date listed is December 21, 2023. Overall, the program is best viewed as a structured on-ramp to a later definitive trial: it supports the careful testing of trial readiness (intervention delivery, participant engagement, recruitment logistics, measurement procedures, and control condition practicality) so that the next-stage study is both scientifically compelling and operationally realistic.

• 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 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 $225,000.00 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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