Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (R01 Clinical Trial Required)

The National Institute of Mental Health (NIMH) is offering a funding opportunity titled "Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes," with a focus on supporting clinical trials to evaluate therapeutic and service delivery interventions for post-acute mental health care across diverse age groups. This funding aims to establish the effectiveness of interventions designed for the period following acute mental health treatment, particularly in managing residual symptoms, preventing relapse, and promoting continued adherence to treatments. Studies should be geared toward improving long-term outcomes and must include assessments of mechanisms of action, as well as predictors and moderators, to ensure interventions match the specific phase of illness and patient needs. Applicants must propose a clinical trial with a robust design that is sufficiently powered to definitively determine the intervention's effectiveness. Projects may include interventions designed to bridge transitions from intensive treatment to lower-intensity follow-up care, such as digital health applications, care management strategies, and approaches for relapse prevention or managing medication adherence. This funding opportunity encourages applications from research that focus on reducing health disparities in mental health outcomes for underserved populations, including racial and ethnic minorities, rural communities, and other marginalized groups. Examples of relevant research include continuation therapies to support gains made during initial treatment, novel methods for integrating mental health care into non-traditional settings (e.g., schools or primary care), and technology-assisted self-monitoring tools for early detection of clinical deterioration. Applicants should also consider studies that examine how community-based intervention delivery can meet the needs of diverse populations or mitigate known barriers in accessing sustained mental health support. NIMH emphasizes the importance of a deployment-focused model, encouraging interventions that are feasible, scalable, and suitable for real-world practice settings, with input from stakeholders such as patients, clinicians, and administrators. Applications should address how the proposed intervention may be implemented in practical settings, including provisions for monitoring implementation fidelity and maintaining scalability. Hybrid effectiveness-implementation trials are also encouraged to evaluate both the effectiveness of an intervention and the feasibility of its adoption in clinical settings. Eligibility is open to a wide range of U.S. and foreign institutions, including higher education institutions, nonprofits, for-profit organizations, and government entities. The funding program accepts new, renewal, and resubmission applications, and there is no specific budget cap; however, project budgets must realistically reflect the proposed study's needs. Awards may last up to five years, though most are expected to be three to four years. Applicants seeking $500,000 or more in direct costs annually must consult with a scientific contact at least six weeks before submission. Key deadlines include an open date for applications on January 5, 2025, and the earliest due date on February 5, 2025, with standard NIH submission deadlines through 2028. Successful applicants must comply with NIH policies, including requirements for data management and sharing, as well as the use of validated outcome measures. Additionally, all trials involving human subjects must adhere to NIH standards for participant protection, with specific guidelines on data safety, informed consent, and monitoring plans.