Digital therapy for treating eating disorders
A Randomized, Multicenter, Treatment-as-usual Controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Eating Disorder
This study is testing a new app for treating eating disorders to see if it works as well as regular therapy over eight weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | WELT corp Industry-sponsored |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06294353 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of WELT-ED, a digital therapeutic device based on Cognitive Behavioral Therapy (CBT), for individuals with eating disorders. Participants will either use the WELT-ED app or receive standard treatment over an 8-week period. The study aims to determine if WELT-ED is as effective as traditional treatments in reducing eating disorder symptoms and to assess its safety. Participants will undergo assessments to monitor their health status and symptom changes throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 65 diagnosed with an eating disorder and experiencing frequent binge eating.
Not a fit: Patients who have previously received Cognitive Behavioral Therapy for their eating disorder or have a history of bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this digital therapeutic approach could provide a convenient and effective treatment option for individuals struggling with eating disorders.
How similar studies have performed: Other studies have shown promise in using digital therapeutics for mental health conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged between 19 and 65 years * Diagnosed with an eating disorder according to ICD-10. F50.0 Anorexia nervosa F50.1 Atypical anorexia nervosa F50.2 Bulimia nervosa F50.3 Atypical bulimia nervosa F50.4 Overeating associated with other psychological disturbances F50.5 Vomiting associated with other psychological disturbances F50.8 Other eating disorders F50.9 Eating disorder, unspecified) * Have a binge eating frequency (as per item 14 of the EDE-Q) of 4 or more times over the past 4 weeks (28 days) at the time of screening. * Able to use a mobile application (app) on a smartphone without difficulty. * After receiving and understanding sufficient information about this clinical trial, voluntarily decides to participate and provides written consent. Exclusion Criteria: * Previously received Cognitive Behavioral Therapy for the treatment of an eating disorder. * Have a history of bariatric surgery (e.g., adjustable gastric band, sleeve gastrectomy, biliopancreatic diversion, Roux-en-Y gastric bypass). * Have a BMI less than 17 kg/m\^2 or more than 40 kg/m\^2 at the time of screening. * Diagnosed with a major psychiatric disorder according to the MINI. * Have a past or current diagnosis of schizophrenia or bipolar disorder. * At risk of suicide (C-SSRS score of 4 or higher) or have attempted suicide in the past 2 weeks. * Have active and progressive physical illnesses (e.g., congestive heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorders (e.g., cerebrovascular disease), neurodegenerative diseases (e.g., dementia, multiple sclerosis), unstable medical conditions, or a life expectancy of less than 6 months. * Pregnant or planning to become pregnant during the trial period. * Participated in another clinical trial within 4 weeks prior to screening. * Have a history of alcohol or substance abuse. * Considered by the investigator to be unsuitable for participation in this clinical trial for any other reason.
Where this trial is running
Seoul and 1 other locations
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Severance Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Yujin Lee
- Email: info@weltcorp.com
- Phone: 82-2-6439-0707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.