Wednesday, February 5, 2025
2/5/2025
Digital therapeutics are redefining the future of medicine. Digital therapeutics refer to the use of mobile technology to provide personalized, digital health interventions to treat diseases. These tools enable anytime and anywhere healthcare. Given that there are more mobile phones in the world than there are people in the world, digital therapeutics offer the potential to be transformative. The applicant team of this SBIR proposal developed the Therapeutic Education System (TES), which became the very first digital therapeutic approved by the U.S. Food and Drug Administration (under a rebranded name in 09/17). TES is the most empirically-supported, digital intervention for substance use disorder (SUD) treatment. Our team has also been engaged in over two decades of NIH-funded work developing and evaluating digital therapeutics for many populations (e.g., persons with chronic pain, depression, alcohol use disorders). We have developed a unique mobile platform (Laddr®) which integrates science-based, digital therapeutics for multiple health domains. Laddr includes the content of TES. However, Laddr employs validated, science-based techniques to address a wide range of behavioral problems in the context of a single mobile platform. This platform offers the potential to revolutionize digital health -- as it provides a scalable model for delivering digital therapeutics to treat any disease with a behavioral component. And, it allows for the concurrent treatment of more than one disease within a given individual. Despite the strong empirical support for Laddr in impacting SUDs and other health domains, it does not enable end users to engage a social support network to help them as they use Laddr. Interventions that leverage social support networks can help keep individuals engaged in treatment, reinforce their successes, and help them troubleshoot challenges. Research has shown that engaging a support network of non- substance users (e.g., family members, friends) in one’s SUD treatment can greatly enhance treatment outcomes. 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/process for support persons to provide effective support. In this SBIR application, we propose to expand Laddr to allow its users to engage a support network of their choosing in their journey of behavior change. Individuals can in real-time share data from Laddr about their successes and challenges, and their support network 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. To our knowledge, this project will be the first to socialize science-based digital therapeutics.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).