Phase II year
2021
(last award dollars: 2022)
Phase II Amount
$1,519,197
Digital therapeutics are redefining the future of medicine. Digital therapeutics refer to software used toprevent, 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" inthe 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 digitaltherapeutics 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 integratesscience-based, therapeutic processes to address a wide range of behavioral problems in the context of asingle mobile platform. Laddr includes the science behind TES, but this platform provides a scalable model fordelivering 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 toengage a non drug-using support network of their choosing in their journey of behavior change. Interventionsthat leverage social support can help keep individuals engaged in treatment, reinforce their successes, andhelp them troubleshoot challenges. However, prior attempts to implement social support into SUD treatmenthave been challenged by: (1) requiring support persons to come to SUD treatment sites in person, (2) notsharing actionable information with support persons in a timely manner and (3) not providing a structure orprocess for support persons to provide effective support. Laddr will address all of these challenges by allowingindividuals to share data from Laddr in real time about their successes and challenges, and their supporter canoffer anytime/anywhere social support. Social support will be embedded within a strongly science-baseddigital 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 socialfunctionality to other health domains within Laddr. In Phase I of this project, we developed and demonstratedthe technical merit and feasibility of a version of Laddr that includes novel social support functionality. In Phase2, we propose to complete the development of the social version of Laddr based on feedback from Phase 1and evaluate the effectiveness of the social version of Laddr in improving SUD treatment outcomes. To ourknowledge, this project will be the first to socialize science-based digital therapeutics.
Public Health Relevance Statement: Project Narrative
To our knowledge, this project will be the first to "go social" with science-based digital therapeutics. In a world
that has used digital technology to create unprecedented models of social communication across the globe,
this project is distinct in that it uses digital technology to support science-based, social communications to help
treat disease. Laddr® can provide scalable, science-based solutions for substance use disorder care and
may also inform generalizable and scalable solutions to the treatment of disease that transcend specific
diseases, populations, and contexts.
Project Terms: <21+ years old>