Transforming mental health care via science-based, personalizable and scalable digital therapeutics - Project Summary_Abstract Mental health problems are increasing worldwide; however, the vast majority of people struggling with mental health challenges do not receive any treatment and the mental health workforce is woefully insufficient to meet our population-level needs. Digital Therapeutics (DTx) are optimally positioned to tackle these challenges and transform mental health care. DTx are clinical-grade software used to prevent, treat, or manage a medical disorder or disease. DTx can have a major impact on health costs, health behavior, and health outcomes. For example, DTx can effectively treat depression, anxiety, ADHD, panic disorder and eating disorders, among many other mental health conditions. And, they are associated with marked reductions in ED visits, inpatient utilization, and net costs, and increases in medication adherence. Despite their impressive clinical value, several challenges persist in fully realizing the potential of DTx to improve people’s lives globally. First, the pace at which DTx are developed, tested, and commercialized is slow. Second, many development activities are redundant across projects. Third, due to budget, time and capacity constraints, many scientists develop prototypes of DTx that can be used in research but which are not built to scale for large numbers of users. Finally, most DTx cannot be readily modified for various populations critical for advancing digital health equity (adapted to culture, language, race, ethnicity, sexual orientation). Based on over two decades of NIH-supported work developing, evaluating and commercializing DTx, we have developed a unique DTx platform (Laddr) which integrates science-based, therapeutic processes to address a wide range of behavioral problems within a single digital platform. This platform offers the potential to revolutionize digital health - as it provides a scalable model for delivering DTx to treat any disorder with a behavioral component. We now plan to make an editable version of Laddr (called Cogito) commercially available to developers of DTx. Cogito will provide a turnkey solution for rapidly developing, evaluating, deploying, and scaling DTx for the prevention, treatment and/or management of any disease or disorder - via a drag and drop interface with no programming necessary. In this Phase 1 SBIR application, we will finalize several features of the Cogito platform to increase its commercial potential as a turnkey platform for developing and hosting DTx. And we will assess the feasibility, technical merit, and commercial potential of the Cogito DTx platform via usability testing with clinical researchers. We will focus on the usability of Cogito with researchers in the mental health field in this initial phase and then expand to a broad clinical research community focused on the prevention, treatment, or management of various health conditions in future iterations of this work. to markedly accelerate the pace and impact of science based DTx. Overall, Cogito offers great promise
