Notice of Intent to Publish a Notice of Funding Opportunity for NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required)

Key Dates

• June 14, 2021 - NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required). See NOFO PAR-21-241.    

National Center for Complementary and Integrative Health (NCCIH)

The National Center for Complementary and Integrative Health (NCCIH) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required). 

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.  

The NOFO is expected to be published in December 2023 with an expected application due date in Winter 2024. 

This NOFO will utilize the R01 activity code. Details of the planned NOFO are provided below. 

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 multi-site 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 NCCIH’s mission. The 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: 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 multicomponent interventions, and/or demonstrating feasibility of data collection across sites in preparation for a future fully-powered, multi-site efficacy/ effectiveness trial. The need for multi-site 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 multi-site clinical trial that has the potential to make a significant impact on public health.  

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Pete Murray, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-496-4054
Email: peter.murray@nih.gov