Clinical trial No longer in our active list Interventional Ages 19 to 65

Digital therapy for treating eating disorders

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

Run by WELT corp · NCT06294353 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

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

Study typeInterventional
Ages19 Years to 65 Years
SexAll
Enrollment134 (estimated)
SponsorWELT corp
Industry-sponsored
Locations2 sites (Seoul and 1 other locations)
Trial IDNCT06294353 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 19 to 65 diagnosed with an eating disorder and experiencing frequent binge eating.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in using digital therapeutics for mental health conditions, suggesting potential success for this approach.

Who can join: the full rules

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 it's running

  • Seoul National University Hospital
    Seoul, Korea, Republic of
    Recruiting
  • Severance Hospital
    Seoul, Korea, Republic of
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.