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 complements NIMH’s suite of clinical trial funding opportunities by supporting milestone-driven feasibility and infrastructure development (R61) research followed by well-powered clinical trials (R33) to test the effectiveness of system interventions or strategies that improve the organization, delivery, coordination, and outcomes of mental health care for priority populations.  System interventions - which may span, for example, structural, policy, and organizational domains - attend to issues about the access, engagement/utilization, value (cost/financing), management, or quality and safety of mental health services, with the goal of improved care processes and clinical, functional, or population level outcomes.  Accordingly, the focus of system interventions may include multiple factors/levels related to care delivered within or across a variety of care settings, such as health systems and organizations, mental health and community clinics, schools, and social welfare or justice systems. Projects may test the impact of policies and practices, interventions to facilitate care transitions and continuity across settings, and interventions to improve linkages/coordination across systems.

Researchers will have up to two years in the R61 phase to demonstrate feasibility and adequate infrastructure to justify conducting the main trial (R33).  Applicants pursuing other stages of intervention development and testing should refer to companion NOFOs listed at Support for Clinical Trials at NIMH.