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

Ceiling: $350,000
Applications Due: Closed
Federal
US Department of Health & Human Services (National Institutes of Health)

This funding opportunity supports researchers conducting multi-site clinical trials to evaluate complementary and integrative health approaches that combine physical and psychological therapies, aiming to gather essential data for future larger-scale studies.

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.

Eligibility

States
All
Regions
All
Eligible Entities
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 organizations, Public housing authorities, Native American tribal organizations, Nonprofits

Funding

Program Funding
Award Ceiling
$350,000
Award Floor
Award Count

Timing

Posted Date
December 20, 2023
App Status
No Longer Accepting Applications
Pre-app Deadline
Application Deadline
November 21, 2024

Funder

Funding Source
Source Type
Federal
Contact Name
Contact Email
Contact Phone
--

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