The National Institute of Mental Health (NIMH), a component of the National Institutes of Health (NIH) under the Department of Health and Human Services (HHS), has announced a funding opportunity titled "Laboratories to Optimize Digital Health (R01 Clinical Trial Required)." This grant, issued under Funding Opportunity Number (FON) PAR-25-136, aims to support research projects that test strategies to enhance the reach, efficiency, effectiveness, and quality of digital mental health interventions. These interventions should be designed to improve mental health outcomes, including suicide prevention and treatment for serious mental illness, particularly among populations that experience health disparities.

The grant intends to establish digital health test beds leveraging well-established digital health platforms and infrastructure to refine and optimize existing evidence-based digital mental health interventions. The goal is to conduct clinical research that is statistically powered to provide conclusive evidence of intervention effectiveness. This funding opportunity is aligned with NIMH’s mission to transform the understanding and treatment of mental illnesses through basic and clinical research, with an ultimate focus on prevention, recovery, and cure.

The grant will support partnerships between software developers and academic researchers to utilize digital mental health platforms that already have a substantial user base. It is required that digital health interventions proposed for this funding opportunity be based on empirical evidence and that studies include a well-defined intervention mechanism and hypothesis-driven outcome assessment. The research scope covers a wide range of digital mental health intervention strategies, including adaptive and just-in-time interventions, real-time data collection and analytics, and optimization of engagement strategies for digital mental health tools.

The funding mechanism is an R01 Research Project Grant, which requires applicants to propose and conduct clinical trials. The application budget is not limited, but it must reflect the actual needs of the proposed project. The maximum project period is four years. The number of awards depends on NIH appropriations and the number of meritorious applications received. Eligibility for this grant includes institutions of higher education (both public and private), nonprofits, small businesses, for-profit organizations, local governments, tribal entities, public housing authorities, and foreign organizations.

The application process requires compliance with NIH submission procedures through Grants.gov, NIH ASSIST, or an institutional system-to-system solution. The earliest submission date is January 5, 2025, with multiple application due dates occurring three times annually until the expiration date of January 8, 2028. Applicants are encouraged to submit letters of intent at least 30 days before each application due date. Applications are reviewed by NIH’s peer review system based on scientific merit, feasibility, significance, and innovation.

Applicants must adhere to all NIH grant policies, including data management and sharing requirements. The research is expected to contribute data to the NIMH Data Archive (NDA), facilitating broad access to digital mental health research data. Prospective applicants are encouraged to contact program officials at NIMH for guidance on aligning their proposals with the funding opportunity’s goals and priorities.