Advancing Learning Health Care Research in Outpatient Mental Health Treatment Settings (R34 Clinical Trial Optional)

The National Institute of Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA) invite applications for exploratory/developmental research within the learning healthcare framework to improve outpatient mental health and substance use treatment systems. This opportunity supports adoption, implementation, sustainability, and continuous improvement of evidence-based practices (EBPs), focusing on Certified Community Behavioral Health Clinics (CCBHCs) or similar organizations meeting federal certification criteria. Active collaboration between researchers and community behavioral health partners is essential, emphasizing co-designed studies addressing health disparities, workforce development, measurement-based care, hybrid effectiveness-implementation trials, and 988 crisis response services. The initiative aims to transform mental health and substance use treatment by generating actionable knowledge and tools to advance EBPs. Priorities include understanding patient subgroups, reducing disparities, streamlining interventions for specific populations, enhancing crisis care, integrating primary and mental health care, and testing innovative training, supervision, or payment strategies to sustain EBPs. Research is encouraged to employ state-of-the-art methods like hybrid trial designs, comparative effectiveness studies, or health services research to test scalable and equitable approaches for real-world implementation. Eligible applicants include higher education institutions, nonprofits, for-profit entities, and local and state governments within the U.S. Collaboration with clinical practice partners, such as behavioral health practitioners, service user advocates, or policymakers, is mandatory. These partners must be included as key personnel or advisory board members. The research team must use a co-development approach, utilizing team-building methodologies like Plan-Do-Study-Act cycles or interactive design teams. Funding supports pilot research to test feasibility, refine protocols, and collect preliminary data for R01-level studies. Applications may include clinical trials following NIMH’s experimental therapeutics approach, ensuring studies explore mechanisms of therapeutic change. Proposals must justify intervention adaptations, targeting factors linked to poor response, engagement, or relapse. Non-responsive proposals include those lacking clinical partner collaboration or deviating from specified EBP focus areas. Direct costs are limited to $450,000 over three years, with a maximum of $225,000 in any single year. Applications must be submitted electronically, with a due date for new submissions starting February 16, 2025. Letters of intent are encouraged but not mandatory. Proposals should incorporate a robust data management and sharing plan, including adherence to NIMH’s data-sharing requirements via the National Institute of Mental Health Data Archive (NDA). Review criteria include the significance of the research, innovation, feasibility, and investigator expertise. Applications should demonstrate the capacity to advance learning healthcare in community settings, produce generalizable knowledge, and support rapid implementation of findings. Proposals are evaluated for scientific rigor, collaboration with practice partners, alignment with program priorities, and potential for scalability and sustainability. This funding opportunity seeks to address systemic barriers in mental health and substance use care by fostering research that bridges the gap between scientific discovery and practical application, promoting equitable and effective healthcare solutions across diverse populations and settings.