OpportunityTitle: Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01- Clinical Trial Required)
AdditionalInformationOnEligibility: 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.
Description: 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 &quot;go/no-go&quot; decisions about further development, effectiveness testing, or dissemination of the intervention. Interventions to be studied include, but are not limited to behavioral, cognitive, interpersonal, and device-based (both invasive/surgically implanted as well as noninvasive/transcranial) 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&apos;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&apos;s potential for significant clinical benefit.
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GrantorContactText: NIH OER Webmaster &lt;br/&gt;FBOWebmaster@OD.NIH.GOV