The NCCIH is offering this grant to support multi-site feasibility clinical trials of complementary and integrative mind and body interventions. This grant is for researchers to collect essential data, scientifically necessary for planning subsequent large-scale clinical efficacy, effectiveness, pragmatic, or dissemination and implementation studies. Applicants must demonstrate the feasibility trial’s necessity, addressing aspects such as intervention fidelity, recruitment, participant adherence and retention, protocol refinement, and data collection across multiple sites. Preliminary data justifying the multi-site approach is required. The program aims to foster the development of competitive, fully powered clinical trials with the potential to significantly impact public health within NCCIH’s mission.
Opportunity ID: 357301
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-267 |
| Funding Opportunity Title: | NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 21, 2024 |
| Last Updated Date: | Nov 21, 2024 |
| Original Closing Date for Applications: | Nov 17, 2026 |
| Current Closing Date for Applications: | Nov 17, 2026 |
| Archive Date: | Dec 23, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $350,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) For profit organizations other than small businesses State governments Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Special district governments Public and State controlled institutions of higher education Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts City or township governments Public housing authorities/Indian housing authorities Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This notice of funding opportunity (NOFO) invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority. Applications submitted under this NOFO are expected to propose a multisite feasibility clinical trial that will provide new information that is scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial within NCCIHs mission. NCCIH expects that applications to this NOFO will describe the planned future clinical trial and in so doing demonstrate that the proposed (R01) research is scientifically necessary to design or plan the subsequent fully powered, full-scale clinical trial. Under this R01, the data collected should be used to fill gaps in scientific knowledge, including, but not limited to the following: assessing whether the intervention can be delivered with fidelity across sites; demonstrating feasibility of recruitment, accrual, and randomization of participants across sites; demonstrating participant adherence to the intervention, as well as retention of participants throughout the study across sites; refining and assessing the feasibility of protocolized multimodal interventions, and/or demonstrating feasibility of data collection across sites in preparation for a future fully powered, multisite efficacy or effectiveness trial. The need for multisite feasibility trials is expected to be justified by sufficient preliminary data from previous single site feasibility or acceptability trial(s) or the published literature. The data collected should be used to fill gaps in scientific knowledge and be necessary to develop a competitive fully powered multisite clinical trial that has the potential to make a significant impact on public health. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-267.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00288878 | Jan 20, 2025 | Nov 17, 2026 | View |
Package 1
Mandatory forms
357301 RR_SF424_5_0-5.0.pdf
357301 PHS398_CoverPageSupplement_5_0-5.0.pdf
357301 RR_OtherProjectInfo_1_4-1.4.pdf
357301 PerformanceSite_4_0-4.0.pdf
357301 RR_KeyPersonExpanded_4_0-4.0.pdf
357301 PHS398_ResearchPlan_5_0-5.0.pdf
357301 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357301 RR_Budget_3_0-3.0.pdf
357301 RR_SubawardBudget30_3_0-3.0.pdf
357301 PHS398_ModularBudget_1_2-1.2.pdf
357301 PHS_AssignmentRequestForm_4_0-4.0.pdf
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