RCT of Woebot for Substance Use Disorders

项目总结/摘要 物质滥用占美国人口的5-6%，但只有20%的人使用物质 疾病（SUD）利用考虑到显著的治疗获得障碍的治疗服务（例如，耻辱; 经济、时间和交通限制;缺乏合格的供应商;导航挑战 复杂的处理系统;低感知效用）。消费者应用程序（应用程序）和自动化 会话代理（CA）可以减少或消除传统SUD的常见但重要的障碍 治疗CA可以提供类似教练或教练的体验，但不需要人工实现 协助进行即时治疗。因此，它们的规模潜力是不受约束和直接的; CA可以瞬间吸引数百万用户。不以人为本也会减少人们所感受到的耻辱。的 基于文本的对话式界面增加了参与度，这是非关系型应用程序未能实现的壮举 始终如一Woebot是一个每周7天，每天24小时即时可用的CA， 用户.使用对话的语气，它鼓励情绪跟踪，并提供一般的心理教育以及 作为定制的同理心，认知行为疗法（CBT）为基础的行为改变工具，和行为模式 洞察力. Woebot基于应用程序的平台和以用户为中心的设计理念使其成为 SUD治疗交付;它在患者的高峰时刻提供即时的，基于证据的定制支持。 渴望一项随机对照试验表明，Woebot在统计学和临床上显著降低了抑郁症 与对照组相比，沿着最佳应用参与率（平均值= 14次互动中有12次互动 天）。Woebot目前没有提供SUD程序，尽管63%的现有用户表示有兴趣 内容说。Woebot目前作为一款消费者应用程序的覆盖面很大，初步数据显示其用户数量很高。 参与加上治疗心理疾病的功效，将其定位为关注SUDS的理想平台， 量身定制的可立即升级的数字治疗。因此，本申请提出：（1）开发和试点 一个基于证据的，物质滥用的内容，具体为一个Woebot交付的数字治疗的个人 与亚综合征和完全综合征物质使用障碍（Woebot-SUDs; I期）;（2）与FDA合作 关于W-SUD获得FDA批准的可能性，以及（3）研究W-SUD与SCC相比的疗效 在一项适当把握度的RCT中（II期）。

Project Summary/Abstract Substance abuse accounts for 5-6% of the US population yet only 20% of individuals with substance use disorders (SUDs) utilize treatment services given the significant treatment access barriers (e.g., stigma; economic, time, and transportation constraints; lack of access to qualified providers; challenges navigating complex treatment systems; low perceived utility). Consumer applications (apps) and automated conversational agents (CAs) may reduce or eliminate common yet significant barriers to traditional SUDs treatment. CAs can deliver a coach or sponsor-like experience and yet do not require human implementation assistance for in-the-moment treatment delivery. Thus, their scale potential is unconstrained and immediate; CAs engage millions of users instantaneously. Being non-human-based also reduces perceived stigma. The conversational, text-based interface increases engagement, a feat non-relational apps have failed to achieve consistently. Woebot, a CA instantaneously available 24 hours per day, 7 days per week, ‘checks in’ with users. Using conversational tones, it encourages mood tracking and delivers general psychoeducation as well as tailored empathy, cognitive behavior therapy (CBT)-based behavior change tools, and behavioral pattern insight. Woebot’s app-based platform and user-centered design philosophy makes it an optimal modality for SUDs treatment delivery; it offers immediate, evidence-based tailored support in the patient’s peak moment of craving. An RCT demonstrated that Woebot had statistically and clinically significant reductions in depression compared to a control group, along with best in class app-engagement rates (mean=12 interactions in 14 days). Woebot does not currently offer a SUDs program, although 63% of current users expressed interest in said content. Woebot’s current, substantial reach as a consumer app, preliminary data indicating its high user engagement plus efficacy to treat a psychological condition, posies it as an ideal platform for a SUDs-focused, tailored, and immediately scalable digital therapeutic. Thus, this application proposes to: (1) develop and pilot an evidence-based, substance abuse content specific for a Woebot-delivered digital therapeutic for individuals with sub- and full syndrome substance use disorders (Woebot-SUDs; phase I); (2) engage with the FDA regarding W-SUDs potential for FDA approval as well as (3) investigate W-SUDs efficacy compared to a SCC in an appropriately powered RCT (phase II).