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

Launched by WELT CORP · Feb 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new digital tool called WELT-ED, which is designed to help people with eating disorders, particularly those who struggle with binge eating. The goal is to see if WELT-ED is as effective and safe as traditional treatments like therapy. During the study, participants will either use the WELT-ED app or receive standard treatment for eight weeks. Researchers will check in with them to assess their eating disorder symptoms and any side effects they might experience.

To be eligible for the trial, participants need to be adults aged 19 to 65 who have been diagnosed with an eating disorder, specifically those who binge eat at least four times in the past month. They should be comfortable using a smartphone app and willing to give their written consent after learning about the study. However, certain individuals, such as those with specific psychiatric disorders, recent surgical procedures, or significant medical issues, will not be able to join. This study is currently recruiting participants, and it aims to contribute valuable information about new ways to treat eating disorders.

Gender

ALL

Eligibility 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.