Laboratories to Optimize Digital Health (R01 Clinical Trial Required)

The National Institute of Mental Health (NIMH) is reissuing the "Laboratories to Optimize Digital Health" Funding Opportunity Announcement (FOA) to support research on digital mental health interventions aimed at increasing reach, efficiency, and effectiveness. This opportunity, designated as R01 (PAR-23-096), seeks applications for developing digital health "test beds"—infrastructures that use established digital mental health platforms to refine and optimize existing digital interventions for definitive trials, particularly focusing on populations experiencing health disparities or vulnerability. Eligible projects should engage well-established digital mental health platforms, which are already evidence-based and have a substantial user base, to facilitate large-scale, cost-effective trials that provide clear answers on intervention effectiveness. The FOA prioritizes research partnerships between technology developers and academic researchers, leveraging infrastructure to conduct secondary data analysis, exploratory studies, and pragmatic effectiveness trials. These studies should focus on refining intervention components and improving user engagement strategies. Key areas of interest include adaptive interventions, just-in-time adaptive interventions based on real-time data, and intervention enhancements for high-risk periods or care transitions. Proposals must align with the NIMH’s Experimental Therapeutics model, targeting specific mechanisms hypothesized to influence mental health outcomes and including assessments of intervention effects on these mechanisms. Eligibility for this grant is broad, encompassing higher education institutions, nonprofits, for-profits, local and state governments, and foreign entities, provided they meet NIH’s registration requirements. Non-U.S. institutions may apply if they meet NIH standards for foreign entities. Applications should adhere to NIH’s SF424 (R&R) Application Guide and must use electronic submission systems like ASSIST or Grants.gov. Budgets are flexible, based on the project's needs, and the maximum award period is four years. Applications will be reviewed based on scientific merit, relevance, and feasibility, with attention to the project’s potential for real-world scalability and utility. Projects that address challenges with technology uptake, adherence, privacy, and safety will receive favorable consideration. The FOA emphasizes innovation, particularly in leveraging mobile health and health information technologies such as smartphones, sensors, and electronic health records, to integrate biological, social, and behavioral data. Submission deadlines are based on NIH's standard due dates, with applications due by February 5, June 5, and October 5 annually until the FOA expires on January 8, 2025. Researchers interested in applying are encouraged to submit a letter of intent 30 days before the deadline, although it is not mandatory. For full compliance, applicants should carefully review the FOA-specific requirements and NIH policies, as noncompliance may delay or disqualify applications.