An interventional study of WELT-ED (CBT based DTx) and Standard Treatment in Eating Disorders, Binge Eating and Binge-Eating Disorder, sponsored by WELT corp. Recruiting at 2 sites in Korea, Republic of. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by WELT corp · Not applicable, Interventional, and Treatment
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:
Participants will:
233 studies on the registry are indexed under Binge-Eating Disorder; 53 are open to participants now.
This study's planned enrollment of 134 is above the median of 77 across 190 interventional studies indexed under Binge-Eating Disorder.
Browse Binge-Eating Disorder studies →WELT corp is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Compared within Binge-Eating Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Feeding and Eating Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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.
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.
Binge Eating Frequency
Change of Binge Eating Frequency (item 14 of the Eating Disorder Examination Questionnaire, EDE-Q)
Time frame: from baseline (pre-use) to the 8-week point.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
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).
Time frame: 8weeks
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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Jun 2024, 15 months after the start.
Of 89 interventional studies with no phase under Binge-Eating Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
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