protocolSection identificationModule nctId: NCT06294353, orgStudyIdInfo id: WCTP-ED-B-01, briefTitle: Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-29, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: WELT corp, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Eating Disorders, conditions: Binge Eating, conditions: Binge-Eating Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 134, type: ESTIMATED, armsInterventionsModule interventions name: WELT-ED (CBT based DTx), interventions name: Standard Treatment, outcomesModule primaryOutcomes measure: Binge Eating Frequency, secondaryOutcomes measure: Eating Disorder Examination Questionnaire (EDE-Q), secondaryOutcomes measure: Clinical Impairment Assessment (CIA), secondaryOutcomes measure: Patient health questionnaire-9 (PHQ-9), secondaryOutcomes measure: Generalized anxiety disorder 7-item scale (GAD-7), secondaryOutcomes measure: The EuroQol Visual Analogue Scale (EQ-VAS), secondaryOutcomes measure: Clinical Global Impression of Improvement (CGI-I), secondaryOutcomes measure: Clinical Global Impression of Severity (CGI-S), otherOutcomes measure: Adherence (Compliance) to WELT-ED (applicable only to WELT-ED Group), otherOutcomes measure: BMI (Body Mass Index), otherOutcomes measure: WELT-ED App Usage Satisfaction (applicable only to WELT-ED Group), otherOutcomes measure: App-Based Lifestyle and Eating Data (applicable only to WELT-ED Group), otherOutcomes measure: Change in Regular Meal Frequency (applicable only to WELT-ED Group), eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, status: RECRUITING, city: Seoul, zip: 03080, country: Korea, Republic of, contacts name: soohee Choi, role: CONTACT, phone: 0215885700, email: soohchoi@snu.ac.kr, geoPoint lat: 37.566, lon: 126.9784, locations facility: Severance Hospital, status: RECRUITING, city: Seoul, zip: 03722, country: Korea, Republic of, contacts name: Young Chul Jung, MD, role: CONTACT, phone: 82-2-2228-1622, email: eugenejung@yuhs.ac, geoPoint lat: 37.566, lon: 126.9784, hasResults: False