NCT06294353

Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01)

A Randomized, Multicenter, Treatment-as-usual Controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Eating Disorder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: WELT corp · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders. The main questions it aims to answer are: * Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders? * Is the WELT-ED safe for use in the target population without causing adverse effects? Participants will: * Undergo assessments to determine their baseline health status and severity of eating disorder symptoms. * Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks). * Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects.

Conditions

• Eating Disorders
• Binge Eating
• Binge-Eating Disorder

Interventions

Type	Name	Description
DEVICE	WELT-ED (CBT based DTx)	The product delivers Cognitive Behavioral Therapy for Eating Disorders (CBT-ED) through a software interface (iOS and Android), designed to engage patients in a structured and interactive manner. It operates by analyzing patterns in the patient's lifestyle and eating data, identifying problematic behaviors associated with their eating disorder. Based on this analysis, the software sets daily learning objectives aimed at fostering positive cognitive and behavioral habits. By providing tailored guidance and support, the product seeks to assist patients in making sustainable changes, ultimately contributing to the improvement of eating disorder symptoms. This approach combines the principles of CBT-ED with the convenience and accessibility of digital technology, offering a personalized therapeutic experience to support patients in their recovery.
BEHAVIORAL	Standard Treatment	In the control group, from screening/baseline (Visit 1) to 8 weeks (Visit 5), counseling and support therapy will be conducted at all visits. Participants can continue taking SSRI medications and other antipsychotic drugs that they were already taking for the treatment of eating disorders during the trial period. However, the intake of any additional antipsychotic drugs, other than those already being taken (including SSRIs), is prohibited during the trial period.

Timeline

• Start date: 2023-03-29
• Primary completion: 2024-06-30
• Completion: 2024-08-30
• First posted: 2024-03-05
• Last updated: 2024-03-06

Locations

2 sites across 1 country: South Korea