A Randomized, Multicenter, Treatment-as-usual Controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Eating Disorders in South Korea: Study Protocol

Abstract Background Eating disorders, including anorexia nervosa, bulimia nervosa, and binge eating disorder, present significant challenges to both physical health and psychosocial functioning. Despite cognitive behavioral therapy (CBT) being an effective treatment for binge eating, accessibility issues limit its reach, underscoring the need for innovative treatment solutions. The digital cognitive behavioral therapy (dCBT) application "WELT-ED" presents a promising alternative, aiming to bridge this gap by offering accessible, scalable, and cost-effective treatment. Methods This study is a two-center, two-arm randomized controlled trial comparing the efficacy and safety of "WELT-ED" against standard care for individuals with eating disorders in South Korea. A total of 134 participants will be enrolled, randomly divided into either the dCBT intervention group (n = 67) or a control group receiving standard care (n = 67). Assessments at baseline, midpoint, and post-intervention will evaluate primary outcomes such as binge eating frequency, and secondary outcomes including psychosocial impairment. Safety, compliance, and satisfaction within the intervention group will also be analyzed to provide a comprehensive evaluation of the dCBT's impact. Discussion This research aims to investigate the possibility of "WELT-ED," a dCBT app, addressing the treatment gap for eating disorders in South Korea. By evaluating its efficacy, safety, and user satisfaction, the results could support incorporating digital interventions into standard care. This may transform how eating disorders are managed by improving access to evidence-based therapies. Trial registration This study was approved by the Institutional Review Board of Yonsei Severance Hospital (No. 2022-2865-002) and Seoul National University Hospital (No. D-2212-043-1385). It has been registered on ClinicalTrials.gov (27 February 2025, identifier: NCT06294353).