Socializing a Science-based Digital Therapeutic for Substance Use Disorders

项目摘要/摘要 数字疗法正在重新定义医学的未来。数字治疗指的是用于 预防、治疗或管理医学紊乱或疾病。数字治疗将一整套护理模式打包在一起 -可以根据最先进的科学最佳实践，以保真度交付到统一的、 无缝数字传输系统。这些工具可实现随时随地的医疗保健。 该第二阶段SBIR提案的申请团队开发了治疗教育系统(TES)， 它成为美国食品和药物管理局(FDA)授权的第一个 美国TES可以说是最有经验支持的、针对物质使用障碍(SUD)的数字干预 治疗。我们的团队还领导了NIH资助的20多年的数字开发和评估工作 为多种人群提供治疗--包括患有慢性疼痛、抑郁症、重度吸烟、 和/或暴饮暴食问题。我们开发了一个独特的移动平台(Laddr®)，它集成了 以科学为基础的治疗过程，以解决广泛的行为问题 单一移动平台。Laddr包含TES背后的科学知识，但该平台为 提供数字疗法来治疗任何带有行为成分的障碍。 在这个SBIR项目中，我们建议通过扩展laddr使其用户能够 在他们的行为改变之旅中加入他们选择的非药物使用支持网络。干预措施 利用社会支持可以帮助个人参与治疗，加强他们的成功，以及 帮助他们解决难题。然而，先前将社会支持落实到SUD治疗中的尝试 已受到以下挑战：(1)要求支持人员亲自来到SUD治疗地点，(2)不 及时与支持人员分享可采取行动的信息，以及(3)没有提供结构或 支持人员提供有效支持的流程。Laddr将通过允许 个人从LADR实时分享关于他们的成功和挑战的数据，他们的支持者可以 提供随时随地的社交支持。社会支持将嵌入以强烈的科学为基础的 数字化治疗流程--从而为支持人员提供提供支持的明确框架。 在这个项目中，我们将重点放在基于TES的Laddr的SUD组件上，稍后可以扩展这个社会 功能扩展到LADDR中的其他健康域。在该项目的第一阶段，我们开发并演示了 包含新的社会支持功能的LADDR版本的技术优势和可行性。同相 2、我们建议根据第一阶段的反馈完成Laddr社交版本的开发 并评估社会版LADR在改善SUD治疗结果方面的有效性。致我们的 知识，这个项目将是第一个将基于科学的数字疗法社会化的项目。

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.