Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 - Clinical Trial Required)

This funding opportunity supports clinical trials to test the effectiveness of treatment, preventive, and services interventions for mental health. The program has two main components: (1) clinical trials to test the effectiveness of optimized therapeutic and preventive interventions for use in community and practice settings; and (2) clinical trials to evaluate the effectiveness of patient-, provider-, organizational-, or systems-level services interventions to improve access, continuity, quality, equity, and/or value of mental health services. The NOFO is intended to support trials that address significant problems with potential to inform practice, are adequately powered to definitively answer primary research questions with well-justified hypotheses supported by pilot data, and examine questions regarding mediators and moderators of effects. Consistent with the NIMH experimental therapeutics approach, effectiveness trials must explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects. The collaborative R01 mechanism provides support for multisite trials when two or more sites are necessary for completion of the trial.