Socializing a Science-based Digital Therapeutic for Substance Use Disorders

社会化基于科学的药物使用障碍数字疗法

• 批准号: 10323186
• 负责人: Michael John Grabinski
• 金额: $ 83.66万
• 依托单位: SQUARE2 SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10323186
• 关键词: Address; Adult; Behavior; Behavior Therapy; Behavioral; Benchmarking; Binge Eating; Capital; Car Phone; Caring; Communities; Computer software; Coping Skills; Data Reporting; Disease; Disease Management; Dropout; Education; Exercise; Family member; Feedback; Friends; Funding; Future; Goals; Health; Healthcare; Healthcare Systems; Incentives; Individual; International; Intervention; Medical; Medicine; Mental Depression; Modeling; Motivation; Outcome; Outpatients; Participant; Patient Self-Report; Patients; Persons; Phase; Population; Prize; Problem Solving; Problem behavior; Process; Psychological reinforcement; Randomized; Randomized Controlled Trials; Recovery; Research; Rewards; Science; Small Business Innovation Research Grant; Smoking; Social Development; Social Functioning; Social support; Socialization; Structure; Substance Use Disorder; System; Technology; Therapeutic; Time; Toxicology; Transcend; Treatment outcome; United States Food and Drug Administration; United States National Institutes of Health; Urine; Visual; Work; analog; base; behavior change; behavioral health; chronic pain; data sharing; digital; digital delivery; digital intervention; digital treatment; effectiveness evaluation; experience; follow up assessment; improved; medical specialties; mobile computing; non-drug; novel; post intervention; prevent; programs; social; social communication; standard care; substance use; success; support network; tool; treatment site; usability; virtual

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.

项目概要/摘要 数字疗法正在重新定义医学的未来。数字疗法是指用于 预防、治疗或控制医疗障碍或疾病。数字疗法包装了整个护理模式 – 可以按照最先进的科学最佳实践忠实地交付 – 成为一个统一的、 无缝数字交付系统。这些工具可实现随时随地的医疗保健。 第 2 阶段 SBIR 提案的申请团队开发了治疗教育系统 (TES)， 这成为美国第一个获得美国食品和药物管理局（FDA）授权的“处方数字治疗” 美国的 TES 可以说是最有经验支持的药物使用障碍 (SUD) 数字干预措施 治疗。我们的团队还领导了 NIH 资助的二十多年的数字化开发和评估工作 针对多种人群的治疗方法 - 包括患有慢性疼痛、抑郁症、大量吸烟的人， 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 包含了 TES 背后的科学，但该平台提供了一个可扩展的模型 提供数字疗法来治疗任何具有行为成分的疾病。 在这个 SBIR 项目中，我们建议通过扩展 Laddr 以允许其用户与 Laddr 一起“走向社交” 在行为改变之旅中加入他们选择的非吸毒支持网络。干预措施 利用社会支持可以帮助个人继续参与治疗，巩固他们的成功，并且 帮助他们解决挑战。然而，先前尝试将社会支持纳入 SUD 治疗 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，并且 (3) 不提供结构或 支持人员提供有效支持的流程。 Laddr 将通过允许 个人可以实时分享 Laddr 的有关他们的成功和挑战的数据，他们的支持者可以 随时随地提供社交支持。社会支持将嵌入一个强有力的以科学为基础的 数字治疗过程——从而为支持人员提供一个清晰的框架来提供支持。 我们将在这个项目中重点关注 Laddr 的基于 TES 的 SUD 组件，并且稍后可以扩展这个社交 Laddr 内其他健康领域的功能。在该项目的第一阶段，我们开发并演示了 包含新颖社交支持功能的 Laddr 版本的技术优点和可行性。同相 2、我们建议根据第一阶段的反馈完成Laddr社交版的开发 并评估 Laddr 社交版在改善 SUD 治疗结果方面的有效性。致我们的 知识，该项目将是第一个将基于科学的数字疗法社会化的项目。