Study Comparing Digital Avatar-Assisted CBT and Standard Face-to-Face CBT for Treating Addiction and Intimate Partner Violence in Men Aged 18 to 65

What this Trial Is About

Researchers are evaluating a digital, interactive platform called RITchCBT designed to treat Substance Use Disorders SUD and co-occurring Intimate Partner Violence IPV in men entering addiction treatment. This Phase I and II study involves a randomized controlled trial to compare the digital RITchCBT with standard one-on-one face-to-face Cognitive Behavioral Therapy CBT. The study aims to explore the feasibility and effectiveness of this digital therapy approach in reducing both addiction and IPV behaviors among a diverse male population. The study will enroll 40 male participants diagnosed with substance dependence and recent IPV behaviors, randomly assigned to either digital RITchCBT or standard CBT groups. Each therapy consists of weekly 60-minute sessions over 12 weeks. The digital RITchCBT uses an avatar-assisted interactive approach allowing participants to engage conveniently from home with practice exercises outside sessions. The standard CBT involves manualized, human-administered treatment. If Phase I shows positive results, a larger Phase II trial with 160 participants will follow to further test effectiveness. Participants will undergo multiple assessments including self-reported cravings, days abstinent from substance use and aggression, breath and urine tests to confirm abstinence, and reports from collateral sources. Primary outcomes are measured weekly during treatment and at follow-ups 3, 6, and 9 months post-treatment. Secondary outcomes include impulsivity and distress tolerance scales, while additional data involve regulatory feedback and submissions. The total participant involvement spans screening, 12 weeks of treatment, and extended follow-ups to monitor progress and safety.

A Randomized Controlled Trial of Digital CBT to Treat Addiction: Digital RITch®CBT vs. Standard CBT