Laboratories to Optimize Digital Health (R01 Clinical Trial Required)
Funding Agency:
- National Institutes of Health
This FOA uses the R01 mechanism and is intended promote partnerships between software developers and academic researchers and leverage existing digital mental health platform infrastructure. It is expected that the proposed digital mental health platforms will be well established, provide evidence-based interventions and have a substantial existing user base. It is also expected that these partnerships will enable applicants to conduct research both to rapidly test ideas and conduct exploratory research as well secondary data analyses and large cost-effective pragmatic effectiveness trials. While this FOA will support testing of evidence-based digital health intervention approaches, it is not intended to support the translation of existing face-to-face treatments into technology-based applications.
Investigators are strongly encouraged to review NOT-MH-18-031 for guidance concerning the NIMH high priority topics in digital mental health. For this FOA, NIMH requires investigators to develop and leverage partnerships with digital health developers and existing well-established digital health delivery platforms, so that the research follows a deployment-focused model of services design and testing. Deployment-focused studies take into account the perspective of relevant stakeholders and key characteristics of settings intended to implement optimized digital mental health interventions. Potential stakeholders include, but are not limited to, federal agencies (e.g., Centers for Medicare and Medicaid Services, Substance Abuse and Mental Health Services Administration, Health Resources and Services Administration, Department of Defense, Department of Veterans Affairs); commercial health insurers/funders; public and commercial disability insurers; employers and other payers; delivery systems; professional/trade associations; accrediting and licensing organizations; medical education and other training programs; clinicians; vendors of information technology and other relevant products/services; service users; family members; and community organizations. The applicant should identify key stakeholders based on the characteristics of the proposed intervention and how the intervention will be deployed within service systems. Such communication and collaboration will ensure findings are relevant and practical, create opportunities for research that is not otherwise feasible, and enable stakeholders to anticipate relevant research initiatives in their planning and activities. Where appropriate, it is strongly encouraged that applicants seek consultation from the Food and Drug Administration for guidance related to regulatory approval/certification of the digital mental health interventions that are being tested.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
June 05, 2022; October 05, 2022
Adam Haim, Ph.D., National Institute of Mental Health (NIMH), Telephone: 301-435-3593; Email: Haima@mail.nih.gov