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Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions

Updated: Jun 21, 2022

Letter of Intent Due Date: 30 days before application due date

Application Due Date: October 14, 2022 (and others); 5pm local time

Funding Opportunity Purpose from NIH

"NIMH solicits clinical trial applications through a series of Funding Opportunity Announcements (FOAs) that cover the intervention development pipeline, from first-inhuman, early testing of new interventions, confirmatory efficacy trials, through to effectiveness trials. The purpose of this FOA is to encourage pilot research consistent with NIMH's priorities for: 1) effectiveness research on preventive and therapeutic interventions with previously demonstrated efficacy, for use with broader target populations or for use in community practice settings, and 2) research on the development and preliminary testing of innovative services interventions.

Consistent with the NIMH experimental therapeutics approach, this FOA is intended to support pilot studies of intervention effectiveness or service delivery approaches that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism(s) that accounts for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, etc.). In this pilot effectiveness phase of research, NIMH places highest priority on intervention and service delivery approaches that can be justified in terms of their potential to substantially impact practice and public health.

This FOA supports pilot studies and provides resources for evaluating the feasibility, tolerability, acceptability and safety and preliminary effectiveness of approaches to improve mental health/functional outcomes, to modify risk factors, or to improve service delivery, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., comparative effectiveness study, pragmatic trial). Support for fully-powered effectiveness studies is provided through separate FOAs that utilize the R01 mechanism for single-site effectiveness trials (PAR-21-130; "Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01).") and collaborative R01 mechanism for multi-site effectiveness trials (PAR-21-129;"Clinical Trials to Test the Effectiveness of Treatment, Prevention, and Services Interventions (Collaborative R01 Clinical Trial Required)"). Applicants pursuing other stages of the clinical trial pipeline should consider one of the companion FOAs listed above."

You can find the complete grant overview here.

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