NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required)

US Dept. of Health & Human Services: National Institutes of Health (NIH)

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Next deadline: Jun 20, 2024

Later deadlines: Jul 15, 2024, Oct 21, 2024, Nov 13, 2024, Feb 20, 2025, Mar 10, 2025, Jun 20, 2025, Jul 15, 2025, Oct 20, 2025, Nov 18, 2025, Feb 20, 2026, Mar 17, 2026, Jun 22, 2026, Jul 14, 2026, Oct 20, 2026, Nov 17, 2026

Grant amount: Up to US $1,050,000

Fields of work: Integrative & Alternative Health

Applicant type: Nonprofit, Government Entity, Indigenous Group, For-Profit Business

Funding uses: Research

Location of project: United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico Show all

Location of residency: United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico Show all

Overview:

NOTE: The following deadlines apply to standard grant applications (due by 5:00 pm  local time of applicant organization):

  • February 20, 2024
  • June 20, 2024
  • October 21, 2024
  • February 20, 2025
  • June 20, 2025
  • October 20, 2025
  • February 20, 2026
  • June 22, 2026
  • October 20, 2026

The following deadlines apply to AIDS-related grant applications (due by 5:00 pm local time of applicant organization):
  • March 11, 2024
  • July 15, 2024
  • November 13, 2024
  • March 10, 2025
  • July 15, 2025
  • November 18, 2025
  • March 17, 2026
  • July 14, 2026
  • November 17, 2026
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.

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US Dept. of Health & Human Services: National Institutes of Health (NIH)
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This page was last reviewed December 28, 2023 and last updated December 28, 2023