The National Institute of Mental Health (NIMH), part of NIH, is accepting R01 applications under PAR-25-177, Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions. The program supports definitive hybrid trials that simultaneously evaluate the clinical impact of evidence-supported mental health interventions, implementation factors or strategies affecting access, engagement, quality, fidelity or sustainability, and at least one hypothesized mechanism of action.
Next application deadline: October 15, 2026 at 5:00 PM local time of the applicant organization. The NOFO remains open for additional cycles through October 15, 2027.
Funding: Application budgets are not limited but must reflect the actual needs of the proposed project. The maximum project period is five years. Cost sharing is not required.
Eligibility: Eligible applicants include public and private institutions of higher education, nonprofits, small businesses and other for-profit organizations, state and local governments, independent school districts, tribal entities, faith- or community-based organizations, and other listed organization types. Required applicant registrations must be active before submission.
Program requirements: Applications must propose a clinical trial, be supported by pilot data, be statistically powered to provide a definitive answer regarding intervention effectiveness, evaluate implementation factors or strategies, and assess at least one mechanism of action. NIMH encourages use of existing infrastructure such as practice-based research networks, electronic medical records, registries and routinely collected school data. Technology may be used to increase intervention reach, efficiency, effectiveness or scalability, and the NOFO specifically recognizes consumer-facing technology, provider-facing technology and digital approaches as potential implementation supports.
Submission and compliance: Applications may be prepared through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. The application must address the required Research Strategy and PHS Human Subjects and Clinical Trials information, data management and sharing, and applicable NIMH data and safety monitoring requirements. NIH expects timely ClinicalTrials.gov registration and results reporting for funded trials. IRB/IEC review is required, and FDA IND/IDE requirements apply when a regulated investigational use requires them. Applicable HHS health-IT standards also apply when award funds implement, acquire, or upgrade covered health IT.
Agency contacts and notices: NIMH identifies Joel Sherrill, Ph.D. (301-443-2477) for studies involving therapeutic and preventive interventions and Michael Freed, Ph.D. (301-443-3747) for studies involving services interventions. The NOFO was updated March 31, 2025 to align with agency priorities, and NIH directs applicants to reread the full announcement before submission. Related notices also include the effectiveness/services trials pre-application webinar notice and NIH-wide application/data-sharing notices.
Atlas fit: Strong Arkansas implementation-science opportunity, with a conditional technology role. The Nonagon N9+ may be relevant where an applicant-led mental health intervention legitimately requires guided remote physical examination, vitals or other objective clinical data collection, technology-enabled service delivery, or scalable remote workflow support. N9+ should not be positioned as the mental health intervention itself. Dr. Miltie is within an eligible for-profit organizational class, but a direct application should not advance without independently verified qualifying pilot data, mental-health clinical-trial leadership, implementation-science capability, practice-setting access and human-subjects infrastructure. A partner-led technology-subcontract pathway with an experienced Arkansas academic or clinical research team is more realistic.