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

数字化、自我引导、阿凡达辅助认知行为治疗平台治疗成瘾的随机对照试验：数字 RITch® CBT 与标准 CBT

• 批准号: 10710167
• 负责人: Caroline J. Easton
• 金额: $ 52.17万
• 依托单位: ROCHESTER INSTITUTE OF TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10710167
• 关键词: Adverse effects; Aftercare; Aggressive behavior; Alcohols; Back; Breath Tests; COVID-19 pandemic; Caring; Child; Client; Clinical Data; Clinical Research; Cognitive Therapy; Collaborations; Computers; Conflict (Psychology); Coping Skills; DSM-V; Development; Devices; Disease; Distress; Effectiveness; Epidemic; Exercise; Face; Family; Feasibility Studies; Feedback; HIV; Health Expenditures; Health Services Accessibility; Home; Impulsivity; Individual; Injury; Intervention; Lead; Link; Measures; Mental Depression; Methods; Modality; Modeling; Modernization; National Institute of Drug Abuse; Outcome; Outcome Measure; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Phase; Post-Traumatic Stress Disorders; Process; Protocols documentation; Questionnaires; Randomized; Randomized, Controlled Trials; Recording of previous events; Regulatory Pathway; Reporting; Research; Research Personnel; Sampling; Sexually Transmitted Diseases; Societies; Standardization; Substance Addiction; Substance Use Disorder; Substance abuse problem; Symptoms; Technology; Time; Toxicology; Treatment outcome; United States; United States National Institutes of Health; Urine; Validation; Visit; addiction; behavior change; behavioral health; chronic pain; cost; cost effective; craving; digital; digital platform; digital technology; digital treatment; distress tolerance; effectiveness study; effectiveness testing; efficacy testing; ethnic diversity; evidence base; gastrointestinal; improved; intimate partner violence; maladaptive behavior; male; men; offender; pandemic disease; personalized medicine; primary outcome; randomized trial; randomized, controlled study; reduced substance use; response; secondary outcome; substance abuse treatment; substance use; substance user; success; technology development; telehealth; timeline; trait; treatment comparison; trial design; user-friendly; web app

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.

项目摘要 物质使用者障碍（SUDS）和亲密伴侣暴力（IPV）对家庭和社会具有破坏性 (CT CASE，2015年）每年花费7000亿美元用于SUDS的医疗保健支出， IPV的成本。物质使用和IPV的共同发生率很高（IPV; CT CASE，2015）。SUDS价格 和IPV在Covid-19大流行期间增加（Dubey et al.，到2020年，在获得护理的时间段内， 由于缺乏远程医疗或数字治疗平台而中断。令人震惊的高SUDS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 技术开发（DTx）。CBT是一种基于证据的治疗工具，已被证明是有效的 在改善许多行为健康障碍的治疗结果方面（Dutra等，2008年），包括 个体（1：1）CBT治疗男性罪犯中药物滥用和IPV的初始疗效 模态（伊斯顿等人，2017年）。最近的荟萃分析评论报告说，CBT的数字化版本显示， 治疗一系列适应不良行为的有效性（Spek等人，2007）以及SUDS（卡罗尔和 同事，2014;卡罗尔等人，2008年），但数字版本有限，缺乏个性化和相关性 患者自我报告的症状困扰的内容。迄今为止，数字化平台尚未用于治疗 进入药物滥用治疗的客户中的SUDS和IPV。研究人员呼吁更多的随机对照试验， CBT作为SUD-IPV客户健康行为改变的工具的DTx（Nesset及其同事， 2019年）。鉴于我们之前成功地用CBT在12周的1：1治疗中治疗了SUDS和IPV，我们 将我们的综合CBT疗法扩展到DTx平台。DTx平台的优势在于， 易于传播，具有成本效益，提高客户参与度，最大限度地遵守 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， 与报告的症状困扰有关。我们开发了一个为期12周的数字化，阿凡达辅助，互动平台， RITch®CBT，作为患者自我指导的干预平台，供患者“在家”练习使用 在他们方便的时候练习应对技巧。为了响应NIH的PAR 21-183，我们建议进行I期研究。 和II期研究：UG 3（I期）和UH 3（II期）与FDA合作进行持续反馈， 监管程序。在第一阶段，我们提出了一个可行性研究，一个随机对照试验，以测试疗效 RITch®CBT在接受成瘾治疗的SUD-IPV客户中的比例，将其与面对面1：1 CBT进行比较。如果 达到疗效后，将在II期（UH 3）进行有效性研究，以改善治疗结局 在患有共同发生的SUDS和IPV的个人及其家庭中， 美国家庭的问题。