Effectiveness of CBT-based digital therapeutic device for substance use disorder: study protocol for a randomized controlled trial (Preprint)

BACKGROUND In South Korea, the spread of illicit drug use is rapidly increasing, particularly among individuals in their 20s, with a worsening cycle of misuse among young adults experiencing mental health problems. However, there are very few inpatient treatment hospitals nationwide; even in the Seoul metropolitan area, treatment capacity remains limited and the de-designation of previously designated hospitals has hindered patient management. Community-based addiction service organizations are also scarce, and there are no concrete plans to expand treatment programs. To address these gaps, our team developed a cognitive behavioral therapy (CBT)–based digital therapeutic (DTx) called D-STOP, conceptually modeled after the U.S.-developed digital therapeutic reset-O, and we plan to evaluate it in patients with substance use disorders (SUD). Background In South Korea, the spread of illicit drug use is rapidly increasing, particularly among individuals in their 20s, with a worsening cycle of misuse among young adults experiencing mental health problems. However, there are very few inpatient treatment hospitals nationwide; even in the Seoul metropolitan area, treatment capacity remains limited and the de-designation of previously designated hospitals has hindered patient management. Community-based addiction service organizations are also scarce, and there are no concrete plans to expand treatment programs. To address these gaps, our team developed a cognitive behavioral therapy (CBT)–based digital therapeutic (DTx) called D-STOP, conceptually modeled after the U.S.-developed digital therapeutic reSET-O, and we plan to evaluate it in patients with substance use disorders (SUD). OBJECTIVE This clinical study aims to verify the efficacy of D-STOP, a CBT-based digital therapeutic developed by our team. The primary endpoint is the abstinence success rate during weeks 9–12 of treatment. METHODS Following an initial screening assessment, we will enroll 118 patients who meet criteria for SUD. Participants will be recruited from psychiatry departments at medical institutions designated for addiction treatment and clinical care in Korea, located in Chuncheon, Seoul, Daegu, and Yangsan. Over 12 weeks, participants will receive CBT and motivational enhancement modules via D-STOP; during study visits, they will receive therapeutic feedback from psychiatrists or study staff. Efficacy will be tested by comparing the control group (treatment as usual; TAU) with the experimental group (TAU + D-STOP) on the primary endpoint (abstinence success rate), using logistic regression to estimate the treatment effect and test superiority against a pre-specified margin. RESULTS As the trial is ongoing, we hypothesize that the experimental group will demonstrate an abstinence success rate exceeding that of the control group by at least the superiority margin, supporting the efficacy of D-STOP. The study protocol received IRB approval on April 14, 2025, and participant recruitment is currently in progress. CONCLUSIONS Digital therapeutics have the potential to improve access to care in resource-constrained settings and yield socioeconomic benefits. Through this study, we aim to validate D-STOP as a useful and accessible tool for patients with SUD.