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