Efficacy of Cognitive Behavioral Therapy-Based Digital Therapeutics for Substance Use Disorder: Protocol for a Randomized Controlled Trial
Abstract
Background: Illicit drug use has been rapidly increasing in South Korea, particularly among individuals in their 20s, contributing to a growing burden of substance use disorder (SUD). However, treatment infrastructure remains limited. Nationwide, only a small number of inpatient treatment hospitals are available, and treatment capacity in the Seoul metropolitan area is insufficient to meet growing demand. In addition, community-based addiction services are scarce, creating barriers to continuous care. Digital therapeutics (DTx) have emerged as a promising approach to improve treatment accessibility and continuity of care. In particular, cognitive behavioral therapy (CBT)-based DTx such as RESET-O, developed in the United States and authorized by the US Food and Drug Administration, have demonstrated clinical benefits in supporting addiction recovery. Building on this concept, our team developed D-STOP, a CBT-based DTx intervention designed to support individuals with SUD in the Korean clinical context.
Objective: This study aims to evaluate the efficacy of D-STOP as an adjunctive DTx intervention for patients with SUD.
Methods: This study is a randomized controlled clinical trial designed to evaluate the efficacy of D-STOP in individuals diagnosed with SUD. Following an initial screening assessment, 118 participants meeting the diagnostic criteria will be enrolled. Participants will be recruited from psychiatry departments at addiction treatment and clinical care…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 118 participants or records.
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