SBIR-STTR Award

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.

Project Terms:
Achievement; addiction; Address; Adult; alcohol use disorder; approach behavior; base; Behavior; behavior change; Behavior Therapy; Behavioral; behavioral economics; Binge Eating; Buprenorphine; Car Phone; Caring; chronic pain; Clinical Treatment; Clinical Trials Network; Cognition; Communities; Decision Making; digital; Disease; Disease Management; drug abstinence; Drug abuse; Drug usage; Education; Family member; feeding; Friends; Funding; Future; Goals; Gold; Health; Healthcare; Healthcare Systems; improved; improved outcome; Incentives; Individual; International; Intervention; Medicine; member; Mental Depression; Methadone; mobile computing; Modeling; Motivation; Names; National Institute of Drug Abuse; Online Systems; Opiate Addiction; Outcome; Patient Recruitments; Pattern; Persons; Pharmaceutical Preparations; Phase; Population; Prize; Problem behavior; Problem Solving; Process; Psychological reinforcement; randomized trial; Recovery; Relapse; Research; Rewards; Sampling; Science; sharing data; Small Business Innovation Research Grant; social communication; Social Functioning; Social support; Socialization; Structure; Substance Use Disorder; success; support network; System; Techniques; Technology; Testing; Therapeutic; Time; tool; Transcend; Treatment outcome; treatment site; United States Food and Drug Administration; United States National Institutes of Health; usability; virtual; Work;

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>