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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| BMI (Body Mass Index) |
Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujin Lee | Contact | 82-2-6439-0707 | info@weltcorp.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D002032 | Bulimia |
| D056912 | Binge-Eating Disorder |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| 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. |
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| 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 |
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 |
| 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 |
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
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| D006963 | Hyperphagia |