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 new interventions, confirmatory efficacy trials, through to effectiveness trials. 

This NOFO seeks to support well-powered clinical trials consistent with NIMH's priorities for: 1) 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 optimized interventions in accessible settings. Applications responsive to this NOFO are hybrid effectiveness implementation trials that examine the effectiveness and clinical impact of interventions to prevent or treat mental illness, implementation challenges and strategies within the intervention setting, and at least one mechanism of action associated with an intervention and/or implementation strategy. The research covered under this announcement addresses practice-relevant questions and must be conducted within accessible intervention settings where the typical consumer can be identified as in need of care and be readily connected to an intervention.