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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Binge-Eating Disorder; Binge Eating; Eating Disorders
• Intervention / Treatment: Device: WELT-ED (CBT based DTx); Behavioral: Standard Treatment

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yujin Lee; Phone Number: 82-2-6439-0707; Email: info@weltcorp.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: soohee Choi; Phone Number: 0215885700; Email: soohchoi@snu.ac.kr
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital
    • Contact: Young Chul Jung, MD; Phone Number: 82-2-2228-1622; Email: eugenejung@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WELT-ED (CBT based DTx); 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); 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.
Other: Standard Treatment; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Disorder Examination Questionnaire (EDE-Q)	28 items divided into four subscales: dietary restraint, concern with eating, concern with body shape, and concern with weight. Excluding frequency questions, it assesses symptoms over the past 4 weeks on a 7-point scale from 0 to 6, where higher scores indicate more problematic eating behaviors and attitudes.	8 weeks
Clinical Impairment Assessment (CIA)	Purpose: Evaluates the secondary impairment in three main areas (personal, social, and cognitive) related to eating disorders. Format: A brief self-report tool consisting of 16 items, scored on a 4-point scale from 0 (no impairment) to 3 (high impairment). Interpretation: Total score ranges from 0 to 48, higher scores indicate greater personal, social, and cognitive impairment due to eating disorders.	8 weeks
Patient health questionnaire-9 (PHQ-9)	Purpose: Assesses symptoms of depression based on the diagnostic criteria for major depressive disorder in DSM-IV, focusing on the past two weeks. Format: Comprises 9 questions related to mood, sleep changes, fatigue, appetite change, guilt, worthlessness, concentration difficulty, restlessness, and suicidal thoughts, scored from 0 (not at all) to 3 (nearly every day). Interpretation: Higher scores indicate more severe symptoms of depression.	8 weeks
Generalized anxiety disorder 7-item scale (GAD-7)	Purpose: A screening tool developed to identify symptoms of generalized anxiety disorder, evaluating the severity of related anxiety or worry. Format: Contains 7 items, with responses ranging from 0 (not at all) to 3 (nearly every day). Interpretation: Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms and greater functional impairment.	8 weeks
The EuroQol Visual Analogue Scale (EQ-VAS)	Purpose: Measures the participant's overall health status as part of a quality of life questionnaire. Format: A visual analogue scale from 0 to 100. Interpretation: Higher scores represent better overall health status.	8 weeks
Clinical Global Impression of Improvement (CGI-I)	Purpose: Assesses the degree of improvement or worsening in a participant's overall health status at 4 weeks (Visit 3) and 8 weeks (Visit 5). Format: Rated on a 7-point scale, with lower scores indicating greater improvement. Interpretation: Designed to provide a description of change over time, emphasizing the clinician's perspective on patient progress.	8 weeks
Clinical Global Impression of Severity (CGI-S)	Purpose: Evaluates the overall severity of the participant's condition at baseline, 4 weeks (Visit 3), and 8 weeks (Visit 5). Format: A 7-point scale is used, with higher scores indicating greater disease severity. Interpretation: Aims to quantify the severity of the condition from a clinical standpoint, offering insight into the disorder's impact on the patient's life.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI (Body Mass Index)	The change in BMI from baseline (pre-use) to after 8 weeks of using the medical device (Visit 5) is assessed. BMI = weight (kg) / height (m)^2.	8weeks
Adherence (Compliance) to WELT-ED (applicable only to WELT-ED Group)	Adherence at the 8-week mark (Visit 5) is evaluated based on the completion rate of self-monitoring food diaries and the number of logins to the app (applicable only to the experimental group).	8weeks
WELT-ED App Usage Satisfaction (applicable only to WELT-ED Group)	App usage satisfaction is assessed through a questionnaire at the 8-week mark (Visit 5) (applicable only to the experimental group).	8 weeks
App-Based Lifestyle and Eating Data (applicable only to WELT-ED Group)	The participants' lifestyle habits (Activity data is evaluated as change of number of steps) and eating data are evaluated through self-monitoring food diaries collected via the app.	8weeks
Change in Regular Meal Frequency (applicable only to WELT-ED Group)	Changes in the frequency of meals are assessed through self-monitoring food diaries collected via the app	8 weeks

Collaborators and Investigators

• Sponsor: WELT corp

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Digital Therapeutics; App Based Intervention; Digital Cognitive Behaviorial Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: WCTP-ED-B-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No