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Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 Clinical Trial Required) - PAR-25-178

Funder
National Institutes of Health
LOI Deadline
LOI Required
Recommended, but not required
Application Deadline
Maximum Project Duration
3 years
Research Focus Areas
Mental Health Implementation Science
Mental Health Treatments/Interventions
Delivery and Utilization of Care
Research Methods
Randomized Control Trials (RCT)
Description
NIMH solicits clinical trial applications through a series of notice of funding opportunities (NOFOs) that cover the intervention development pipeline, from first-in-human, early testing of interventions, confirmatory efficacy trials, through to effectiveness trials. This NOFO seeks pilot hybrid effectiveness implementation research consistent with NIMH's priorities for: 1) refining and optimizing preventive and therapeutic interventions with previously demonstrated efficacy for use with broader target populations or for delivery routine care, school, community, or online settings, and 2) research on implementation strategies that support the delivery and sustainability of evidence supported interventions in accessible settings. This NOFO supports pilot research designed to generate the preliminary data needed as a prerequisite to a well powered clinical trial. This includes research designed to assess the feasibility, acceptability, safety, and fit of approach, and explore the impact of the approach on both the outcomes of interest and at least one hypothesized mechanism of action.