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

WELT corp

Status: Enrolling

Conditions: Binge-Eating Disorder; Eating Disorders; Binge Eating

Treatments: Device: WELT-ED (CBT based DTx); Behavioral: Standard Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT06294353

WCTP-ED-B-01

Details and patient eligibility

About

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.

Enrollment: 134 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

WELT-ED (CBT based DTx)

Experimental group

Description:

Participants in this group will receive a shortened version of the standard treatment plus access to the DTx app for 8 weeks. The DTx app is designed to provide therapeutic interventions based on CBT principles, aiming to help participants manage and reduce their eating disorder symptoms. Participants are expected to engage with the app, completing tasks such as self-monitoring food diaries. The app will collect data on adherence, including diary completion rates and app login frequency. Additional Support: Aside from app usage, participants will receive counseling and support therapy during visits at baseline, the 4-week mark, and the 8-week mark. They will continue any pre-existing medication for eating disorders.

Treatment:

Device: WELT-ED (CBT based DTx)

Standard Treatment

Other group

Description:

Participants will receive the standard treatment protocol for eating disorders, which includes regular counseling and support therapy at all scheduled visits. This treatment is comprehensive and follows the conventional approach to managing eating disorders, without the use of the DTx app. Participants will continue any pre-existing medication for eating disorders.

Treatment:

Behavioral: Standard Treatment