Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01)

 

The purpose of this Funding Opportunity Announcement (FOA) is to support confirmatory efficacy testing of non-pharmacological therapeutic and preventive interventions for mental disorders in adults and children through an experimental therapeutics approach. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support "go/no-go" decisions about further development, effectiveness testing, or dissemination of the intervention. Intervention studies include, but are not limited to behavioral, cognitive, interpersonal, and device-based approaches, or a combination thereof. Interventions appropriate for efficacy testing must be based on a compelling scientific rationale, previous demonstration that the intervention engages and alters the hypothesized mechanism of action, a preliminary efficacy signal, and must address an unmet therapeutic need. Support will be provided for a trial of the intervention's efficacy that includes measurement of the hypothesized mechanism of action and the relationship between change in the mechanism and change in functional or clinical effects. Ultimately, this FOA is intended to support a sufficiently- powered efficacy trial to determine the intervention's potential for significant clinical benefit.

Active RFA-MH-16-425 Agency: Department of Health and Human Services
Office: National Institutes of Health Grant 4 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. 10/14/2016 This program does not have cost sharing or matching requirements. NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV
http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-16-425.html FBOWebmaster@OD.NIH.GOV $4,000,000.00