A Randomized Controlled Trial of A Digital, Self-Guided, Avatar Assisted- Cognitive Behavioral Therapy Platform to Treat Addiction: Digital RITch®CBT vs. Standard CBT

项目摘要 物质使用者障碍(SODS)和亲密伴侣暴力(IPV)对家庭和社会都是毁灭性的 (CT案例，2015)每年用于肥皂水的医疗支出为7000亿美元，每年为126亿美元 IPV的成本。药物使用和IPV的发生率很高(IPV；CT病例，2015)。肥皂率 在新冠肺炎大流行期间(Dubey等人，2020年)，在获得护理的时间段，IPV增加 由于没有远程健康或数字治疗平台，被打乱了。令人震惊的高肥皂率 大流行期间的IPV强调了对设备和数字设备进行更多临床研究试验的必要性 技术发展(DTX)。CBT是一种循证疗法，已被证明是有效的 改善一些行为健康障碍的治疗结果(杜特拉等人，2008年)，包括 个体化(1：1)CBT疗法治疗男性罪犯药物滥用和IPV的初步疗效 情态(Easton等人，2017年)。最近的元分析评论报告显示，CBT的数字化版本正在显示 治疗一系列适应不良行为的有效性(Spek等人，2007年)以及肥胖症(Carroll和 同事，2014；卡罗尔等人，2008)，但有限的数字版本缺乏个性化和相关性 内容向患者自述症状苦恼。到目前为止，数字化平台还没有用于治疗 进入药物滥用治疗的患者中的SUDS和IPV。研究人员呼吁使用更多的随机对照试验 CBT的DTX作为在SUD-IPV客户中改变健康行为的载体(Nesset和同事， 2019年)。考虑到我们之前成功使用CBT在12周的1：1治疗中同时治疗肥皂水和IPV，我们 将我们的综合CBT疗法扩展到DTX平台。DTX平台具有优势，因为它们 易于传播、经济高效，可提高客户参与度并最大限度地遵守 练习练习。今天存在的技术是现代化的，以允许个性化的治疗内容 与报告的症状苦恼有关。我们开发了一个为期12周的数字、阿凡达辅助的互动平台， Ritch®CBT，作为患者自我指导的干预平台，供患者在家中练习 在他们方便的时候进行应对技能练习。为响应美国国立卫生研究院的标准杆21-183，我们建议进行第一阶段 和II研究：UG3(第一阶段)和UH3(第二阶段)，与FDA合作，关于持续反馈和 监管流程。在第一阶段，我们提出了一项可行性研究，即随机对照试验，以测试疗效 在接受成瘾治疗的SUD-IPV患者中，Ritch®CBT的比例为1：1。如果 有效，将在第二阶段(UH3)进行有效性研究，以改善治疗结果 在患有肥皂泡和IPV共病的个人和他们的家人中，一种常见的共生 全美家庭内部的问题。

Project Summary Substance User Disorders (SUDS) and Intimate partner violence (IPV) are devastating to families and society (CT CASE, 2015) costing $700 billion annually in healthcare expenditures for SUDS and $12.6 billion in annual costs for IPV. There is a high co-occurrence of substance use and IPV (IPV; CT CASE, 2015). Rates of SUDS and IPV increased during the Covid-19 pandemic (Dubey et al., 2020) at a time period when access to care was disrupted in the absence of Telehealth or Digital Therapy Platforms. The alarmingly higher rates of SUDS and IPV during the pandemic underscored the need for more clinical research trials for device and digital technology developments (DTx). CBT is an evidence based therapy vehicle that has been shown to be effective in improving treatment outcomes across a number of behavioral health disorders (Dutra et al., 2008) including initial efficacy in treating substance abuse and IPV among male offenders in an individual (1:1) CBT therapy modality (Easton et al., 2017). Recent meta-analytic reviews report that digitized versions of CBT are showing effectiveness in treating a range of maladaptive behaviors (Spek et al., 2007) as well as SUDS (Carroll and colleagues, 2014; Carroll et al., 2008) but are limited digital versions that lack personalization and relevant content to patients self-reported symptom distress. To date, digitized platforms have not been used to treat SUDS and IPV among clients entering substance abuse treatment. Researchers are calling for more RCTs using DTx’s of CBT as a vehicle for healthy behavior change among SUD - IPV clients (Nesset and colleagues, 2019). Given our prior success with CBT to treat both SUDS and IPV across 12 weeks of 1:1 treatment, we extended our integrated CBT therapy to a DTx platform. DTx platforms are advantageous because they are easy to disseminate, cost-effective, lead to increases in clients’ engagement and maximize compliance with practice exercises. The technology that exists today is modernized to allow for personalized therapy content to be linked to reported symptom distress. We developed a 12- week digital, Avatar Assisted, interactive platform, RITch®CBT, as an intervention platform self -guided by patients and for patients to use “at home” to practice coping skill exercises at their convenience. In response to NIH’s PAR 21-183, we propose to conduct a Phase I and II Study: UG3 (Phase I) and UH3 (Phase II) in collaboration with the FDA regarding ongoing feedback and regulatory processes. In Phase I, we propose a feasibility study, a randomized controlled trial to test the efficacy of RITch®CBT among SUD-IPV clients entering addiction treatment comparing it to face to face 1:1 CBT. If efficacy is achieved, an effectiveness study will be performed in Phase II (UH3) to improve treatment outcomes among individuals and their families suffering from co-occurring SUDS and IPV, a common co-occurring problem within families across the U.S.