Opportunity Information: Apply for PAR 25 449
The National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH), is offering a grant opportunity to fund mechanistic clinical trial research that tests how mind and body interventions improve health by changing emotional well-being (EWB). The overall idea is to move beyond simply asking whether an intervention "works" and instead focus on how it works, specifically through emotional well-being mechanisms that may help restore or improve whole person health (WPH). The opportunity is titled "Mind and Body Interventions to Restore Whole Person Health via Emotional Well-Being Mechanisms (R61/R33 Clinical Trial Required)" and is listed as PAR-25-449 under CFDA 93.213.
The studies supported under this program are expected to evaluate interventions that act through psychological and/or physical inputs. Examples mentioned include mindfulness meditation, yoga, acupuncture, massage, and other brain-based or body-based approaches that are commonly considered mind-body or integrative health interventions. A key requirement is that the proposed research must be a mechanistic clinical trial, meaning it should be designed to identify and test specific mechanisms, not just measure broad clinical outcomes. In this NOFO, the primary outcome should be an innovative mechanism of emotional well-being, and the research should also examine how those EWB changes relate to whole person health using the Whole Person Health Index (WPHI) as a secondary outcome.
NCCIH is emphasizing rigor, power, and strong preparatory evidence. Applications need to be supported by strong preliminary data, with expectations comparable to what reviewers would normally look for in an R01-level application. In practice, that means applicants should already have convincing prior findings showing feasibility, intervention acceptability, likely effect sizes, measurement performance for mechanistic outcomes, and a clear rationale linking the intervention to the proposed EWB mechanisms and downstream whole person health associations.
The funding uses a two-phase cooperative style award structure: R61 followed by R33. The R61 phase is essentially a supported launch period where the research team must meet predefined feasibility and performance benchmarks before proceeding. These milestones typically involve demonstrating that recruitment and retention are achievable, the intervention can be delivered with fidelity, mechanistic measures can be collected as planned, adherence targets can be met, and data quality and safety monitoring processes are functioning well. Only if the R61 milestones are successfully completed does the project transition into the R33 phase, which funds the full-scale mechanistic clinical trial. This staged approach is meant to reduce risk and improve efficiency by ensuring the larger, more expensive trial proceeds only after feasibility is clearly demonstrated.
A wide range of domestic applicants are eligible. Eligible organizations include 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 tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses. The NOFO also explicitly highlights several categories of institutions and community-connected entities as eligible, including 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, eligible federal agencies, and U.S. territories or possessions.
There are also clear restrictions related to foreign involvement. Non-U.S. (foreign) organizations are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as NIH defines them in its Grants Policy Statement) are not allowed. In other words, applications must be fully domestic in terms of organizational eligibility and project components.
Administratively, this is a discretionary NIH grant opportunity with an original closing date listed as June 7, 2028, which suggests multiple receipt cycles may occur up to that date depending on the NIH schedule for this PAR. The award ceiling is not specified in the provided excerpt, and the expected number of awards is also not listed here, so applicants would typically need to consult the full NOFO text for budget guidance, project period limits, and any institute-specific caps or expectations.
In summary, this opportunity is designed for teams ready to run a high-quality, well-powered mechanistic clinical trial of a mind-body intervention, with emotional well-being mechanisms as the primary endpoint and whole person health (via the WPHI) as a key secondary endpoint. It is particularly aimed at projects that already have strong preliminary evidence and can use the R61/R33 milestone-driven structure to prove feasibility first and then complete a definitive mechanistic trial.Apply for PAR 25 449
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Mind and Body Interventions to Restore Whole Person Health via Emotional Well-Being Mechanisms (R61/R33 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 2025-09-26.
- Applicants must submit their applications by 2028-06-07.
- 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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Frequently Asked Questions (FAQs)
What is this grant opportunity?
This is a National Institutes of Health (NIH) funding opportunity from the National Center for Complementary and Integrative Health (NCCIH) titled "Mind and Body Interventions to Restore Whole Person Health via Emotional Well-Being Mechanisms (R61/R33 Clinical Trial Required)." It is listed as PAR-25-449 under CFDA 93.213.
What is the main purpose of PAR-25-449?
The purpose is to support mechanistic clinical trial research that tests how mind and body interventions improve health by changing emotional well-being (EWB). The focus is on understanding how an intervention works (mechanisms), not only whether it works (clinical outcomes alone).
What kinds of interventions does NCCIH expect to be studied?
The program is intended for interventions with psychological and/or physical inputs that are commonly considered mind-body or integrative health approaches. Examples mentioned include mindfulness meditation, yoga, acupuncture, massage, and other brain-based or body-based approaches.
What does "mechanistic clinical trial" mean in this NOFO?
In this opportunity, a mechanistic clinical trial is designed to identify and test specific mechanisms of action. The trial should be built to rigorously measure and evaluate the proposed mechanism(s), rather than focusing primarily on broad clinical endpoints without testing how the intervention produces effects.
What outcome is expected to be the primary outcome?
The primary outcome is expected to be an innovative emotional well-being (EWB) mechanism. The study should be designed so that the main endpoint directly evaluates the proposed EWB mechanism(s).
What is expected to be a secondary outcome?
Whole person health is expected to be assessed as a secondary outcome using the Whole Person Health Index (WPHI). The research should also examine how changes in EWB relate to whole person health as measured by the WPHI.
How does NCCIH define the relationship between emotional well-being and whole person health in this program?
Based on the information provided, NCCIH is specifically interested in whether mind and body interventions restore or improve whole person health by changing emotional well-being, and in quantifying how EWB changes are associated with whole person health outcomes (with WPHI as the specified measure).
What type of award mechanism is used (R61/R33)?
This opportunity uses a two-phase, milestone-driven structure: an R61 phase followed by an R33 phase. The R61 phase is a supported launch period to demonstrate feasibility and meet predefined benchmarks. If those benchmarks are met, the project transitions to the R33 phase to support the full-scale mechanistic clinical trial.
What is the purpose of the R61 phase?
The R61 phase is meant to reduce risk before a larger trial begins. During R61, teams are expected to meet feasibility and performance milestones (for example, showing recruitment and retention are achievable and that mechanistic measurements can be collected as planned) before moving to R33.
What kinds of milestones are typically expected in the R61 phase?
Milestones typically include demonstrating that recruitment and retention are achievable, the intervention can be delivered with fidelity, mechanistic measures can be collected as planned, adherence targets can be met, and data quality and safety monitoring processes are functioning effectively.
Does a project automatically move from R61 to R33?
No. Transition from R61 to R33 depends on successfully completing the predefined R61 feasibility and performance milestones. Only then does the project proceed to the R33 phase.
What is funded in the R33 phase?
The R33 phase supports the full-scale mechanistic clinical trial, after feasibility and performance have been demonstrated during the R61 phase.
How strong does the preliminary evidence need to be?
NCCIH emphasizes rigor, power, and strong preparatory evidence. Applications are expected to be supported by strong preliminary data, with expectations comparable to what reviewers would look for in an R01-level application.
What kinds of preliminary data are implied as important for competitiveness?
The provided description indicates that applicants should already have convincing prior findings showing feasibility, intervention acceptability, likely effect sizes, measurement performance for mechanistic outcomes, and a clear rationale linking the intervention to the proposed EWB mechanisms and downstream associations with whole person health.
Is the trial required?
Yes. The title explicitly states "Clinical Trial Required," and the description emphasizes that the research must be a mechanistic clinical trial.
Who is eligible to apply?
A wide range of domestic applicants are eligible, including many types of government entities, higher education institutions (public and private), tribal governments and tribal organizations, public housing authorities, nonprofit organizations (with or without 501(c)(3) status in the categories described), for-profit organizations other than small businesses, and small businesses.
Are community-based organizations eligible?
Yes. The NOFO explicitly highlights faith-based or community-based organizations and regional organizations among eligible entities (as described in the provided information).
Are minority-serving institutions eligible?
Yes. The NOFO explicitly highlights Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities among eligible entities.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly highlighted as eligible in the provided information.
Are federal agencies eligible to apply?
Eligible federal agencies are explicitly highlighted as eligible applicants in the provided information.
Can a non-U.S. (foreign) organization apply?
No. Non-U.S. (foreign) organizations are not eligible to apply under this opportunity.
Can a U.S. organization include a non-U.S. component?
No. Non-U.S. components of U.S. organizations are not eligible, and foreign components (as NIH defines them in its Grants Policy Statement) are not allowed. The project must be fully domestic in terms of organizational eligibility and project components.
What is the listed closing date for this opportunity?
The original closing date listed is June 7, 2028. This suggests there may be multiple receipt cycles up to that date depending on the NIH schedule for this PAR.
Is the award budget ceiling provided here?
No. The award ceiling is not specified in the provided excerpt. Applicants would typically need to consult the full NOFO text for budget guidance.
Is the expected number of awards provided here?
No. The expected number of awards is not listed in the provided excerpt.
What does NCCIH mean by moving beyond whether an intervention "works"?
In this program, NCCIH is prioritizing studies that can explain how a mind and body intervention produces effects, specifically by testing emotional well-being mechanisms as the central focus, rather than relying mainly on broad clinical outcome changes without mechanistic testing.
What is the central theme of the supported projects?
Projects should be ready to run a high-quality, well-powered mechanistic clinical trial of a mind-body intervention, with emotional well-being mechanisms as the primary endpoint and whole person health measured using the WPHI as a key secondary endpoint, supported by strong preliminary evidence and a milestone-driven R61/R33 plan.
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