Wednesday, February 5, 2025
2/5/2025
Project Summary/Abstract Digital therapeutics are redefining the future of medicine. Digital therapeutics refer to software used to prevent, treat, or manage a medical disorder or disease. Digital therapeutics package an entire model of care – that can be delivered with fidelity and in accordance with state-of-the-science best practices – into a unified, seamless digital delivery system. These tools enable anytime and anywhere healthcare. The applicant team of this Phase 2 SBIR proposal developed the Therapeutic Education System (TES), which became the very first Food and Drug Administration (FDA)-authorized “prescription digital therapeutic” in the U.S. TES is arguably the most empirically-supported, digital intervention for substance use disorder (SUD) treatment. Our team has also led over two decades of NIH-funded work developing and evaluating digital therapeutics for multiple populations - including persons living with chronic pain, depression, heavy smoking, and/or binge eating problems. We have developed a unique mobile platform (Laddr®) which integrates science-based, therapeutic processes to address a wide range of behavioral problems in the context of a single mobile platform. Laddr includes the science behind TES, but this platform provides a scalable model for delivering digital therapeutics to treat any disorder with a behavioral component. In this SBIR project, we propose to “go social” with Laddr by expanding Laddr to allow its users to engage a non drug-using support network of their choosing in their journey of behavior change. Interventions that leverage social support can help keep individuals engaged in treatment, reinforce their successes, and help them troubleshoot challenges. However, prior attempts to implement social support into SUD treatment have been challenged by: (1) requiring support persons to come to SUD treatment sites in person, (2) not sharing actionable information with support persons in a timely manner and (3) not providing a structure or process for support persons to provide effective support. Laddr will address all of these challenges by allowing individuals to share data from Laddr in real time about their successes and challenges, and their supporter can offer anytime/anywhere social support. Social support will be embedded within a strongly science-based digital therapeutic process – thus providing support persons with a clear framework in which to offer support. We will focus on the TES-based SUD component of Laddr in this project and can later expand this social functionality to other health domains within Laddr. In Phase I of this project, we developed and demonstrated the technical merit and feasibility of a version of Laddr that includes novel social support functionality. In Phase 2, we propose to complete the development of the social version of Laddr based on feedback from Phase 1 and evaluate the effectiveness of the social version of Laddr in improving SUD treatment outcomes. To our knowledge, this project will be the first to socialize science-based digital therapeutics.
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