RCT of Woebot for Substance Use Disorders

项目摘要/摘要 药物滥用占美国人口的5%-6%，但只有20%的吸毒者 障碍(SUD)利用治疗服务，因为存在显著的治疗途径障碍(例如，耻辱； 经济、时间和运输方面的限制；无法接触到合格的供应商；导航面临挑战 复杂的处理系统；感知的效用较低)。消费者应用程序(应用程序)和自动化 对话代理(CA)可以减少或消除传统SoD的常见但显著的障碍 治疗。CA可以提供类似教练或赞助商的体验，但不需要人工实施 为即时治疗提供帮助。因此，它们的规模潜力是不受限制的、立竿见影的； CA瞬间吸引了数百万用户。不以人为本也能减少被认为的耻辱。这个 基于文本的对话界面增加了参与度，这是非关系型应用程序未能实现的一项壮举 始终如一。Woebot是一个CA，一周7天，每天24小时都可以即时联系到 用户。使用对话的语气，它鼓励情绪跟踪，并提供一般心理教育 作为量身定制的同理心、基于认知行为疗法(CBT)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 提供肥皂水治疗；它在患者的高峰期提供即时的、基于证据的量身定制支持 渴望。一项随机对照试验表明，Woebot在统计和临床上显著降低了抑郁症的发病率。 与对照组相比，以及同类中最好的应用参与率(平均值=14个应用中的12个互动 天数)。Woebot目前没有提供SUDS计划，尽管63%的当前用户表示有兴趣 所述内容。Woebot目前作为一款消费者应用程序的触角很大，初步数据表明它的用户很高 参与加上治疗心理疾病的功效，使其成为专注于肥皂泡的理想平台， 量身定做的、可立即扩展的数字治疗。因此，本申请提出：(1)开发和试点 一种基于证据的药物滥用内容，专用于Woebot提供的个人数字治疗 患有亚症和全证物质使用障碍(Woebot-SuDS；I期)；(2)与FDA接触 关于W-SUDS获得FDA批准的可能性以及(3)研究W-SUDS与SCC的疗效比较 在适当动力的随机对照试验(第二阶段)中。

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).