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 药物用户障碍（SUD）和亲密的伴侣暴力（IPV）对家庭和社会造成了破坏 （CT案，2015年）每年的SUDS医疗支出为7000亿美元，年度为126亿美元 IPV的成本。物质使用和IPV的同时存在很高（IPV； CT案例，2015年）。泡沫的速度 在访问护理的时期，IPV在Covid-19-19大流行期间增加（Dubey等，2020） 在没有远程医疗或数字疗法平台的情况下被破坏了。 SUD的更高速度令人震惊 大流行期间的IPV强调了对设备和数字的更多临床研究试验的需求 技术发展（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时（Dutra等，2008） 男性犯罪者（1：1）CBT治疗中男性罪犯治疗药物滥用和IPV的初步效率 模态（Easton等，2017）。最近显示的CBT的数字化版本的荟萃分析评论报告 在治疗一系列不良适应行为方面的有效性（Spek等，2007）以及泡沫（Carroll和Carroll和 同事，2014年； Carroll等，2008），但是缺乏个性化和相关性的数字版本有限 满足于自我报告的症状困扰的患者。迄今为止，数字化平台尚未用于治疗 客户之间的SUD和IPV进入药物滥用治疗。研究人员呼吁使用更多的RCT使用 DTX的CBT是SUD -IPV客户（Nesset及其同事， 2019）。鉴于我们先前在CBT上成功治疗SUD和IPV在1：1治疗中都可以治疗SUD和IPV，我们 将我们集成的CBT疗法扩展到DTX平台。 DTX平台是有利的，因为它们是 易于传播，具有成本效益，导致客户参与度增加并最大化遵守 练习练习。如今存在的技术现代化，以允许个性化的治疗内容 与报道的症状困扰有关。我们开发了一个为期12周的数字化头像辅助，交互式平台， Ritch®CBT作为一种干预平台，由患者自我指导，患者使用“在家”练习 在方便的情况下应对技能练习。为了响应NIH的21-183杆，我们建议进行I期 和II研究：UG3（I阶段）和UH3（II阶段）与FDA关于正在进行的反馈和 监管过程。在第一阶段，我们提出了一项可行性研究，这是一项随机对照试验以测试效率 进入成瘾治疗的SUD-IPV客户中的Ritch®CBT将其与面对面对1：1 CBT进行了比较。如果 实现了有效性，将在第二阶段（UH3）中进行有效性研究以改善治疗结果 在个人及其家人中，患有同时发生的SUDS和IPV，这是一个共同的同时发生 美国家庭中的问题