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

NCT06294353 | Recruiting

• 1 other identifier: WCTP-ED-B-01
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Digital Therapeutics; Digital Cognitive Behaviorial Therapy; App Based Intervention

Outcome Measures

Primary Outcomes (1)

• Binge Eating Frequency

  Change of Binge Eating Frequency (item 14 of the Eating Disorder Examination Questionnaire, EDE-Q)

  from baseline (pre-use) to the 8-week point.

Secondary Outcomes (7)

• Eating Disorder Examination Questionnaire (EDE-Q)

  8 weeks

• Clinical Impairment Assessment (CIA)

  8 weeks

• Patient health questionnaire-9 (PHQ-9)

  8 weeks

• Generalized anxiety disorder 7-item scale (GAD-7)

  8 weeks

• The EuroQol Visual Analogue Scale (EQ-VAS)

  8 weeks

Other Outcomes (5)

• Adherence (Compliance) to WELT-ED (applicable only to WELT-ED Group)

  8weeks

• BMI (Body Mass Index)

  8weeks

• WELT-ED App Usage Satisfaction (applicable only to WELT-ED Group)

  8 weeks

Study Arms (2)

WELT-ED (CBT based DTx)

EXPERIMENTAL

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.

Device: WELT-ED (CBT based DTx)

Standard Treatment

OTHER

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.

Behavioral: Standard Treatment

Interventions

WELT-ED (CBT based DTx) DEVICE

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.

WELT-ED (CBT based DTx)

Standard Treatment BEHAVIORAL

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.

Standard Treatment

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• WELT corp: lead

Study Sites (2)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders; Bulimia; Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperphagia

Central Study Contacts

Yujin Lee

CONTACT

82-2-6439-0707; info@weltcorp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: March 29, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)