Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-31 @ 9:33 AM
Study NCT ID:
NCT07094503
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adolescent Chatbot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098322', 'term': 'Disordered Eating Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ED risk factors; Weight Concerns Scale', 'timeFrame': '6 - months', 'description': 'Weight concerns scale as found in the Stanford Washington Eating Disorder (SWED) screen is a 5-item validated self-report questionnaire which measures concern with weight and dieting. Each item is scored on a 5-100 scale, then an average is computed across all 5 items for a 0-100 score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adolescents', 'Disordered Eating Behaviors', 'Eating Disorder Symptoms', 'Eating Pathology', 'Eating disorder Prevention', 'Body Image', 'Body Image Disturbance', 'Digital Mental Health', 'Chatbot'], 'conditions': ['Body Image Disturbance', 'Disordered Eating Behaviors', 'Eating Disorder Prevention']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://washu.qualtrics.com/jfe/form/SV_0PX2BXw3bYrT1rM?Source=ClinTrials', 'label': 'Prescreen to the Study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test an eating disorders prevention digital chatbot program in a diverse group of adolescents.', 'detailedDescription': "Eating disorders (EDs) are impacting youth at extreme rates, with up to 22% of adolescents reporting ED symptoms, and are associated with very high psychiatric comorbidity. Since adolescence is a critical period for the onset of eating disorders, prevention during this stage is essential to reducing lifetime prevalence. Interventions have been developed to prevent the onset of these devastating disorders, but these programs are generally not publicly available and rarely offer support for addressing comorbidity or the unique needs of vulnerable subpopulations (e.g., low-income populations, sexual and gender minorities, racial/ethnic minorities, those from rural areas), who are even less likely to have access to high-quality care. One scalable, engaging, easy-to use, and convenient approach to increasing access to evidence-based EDs prevention for underserved groups involves using a chatbot. This project will adapt our team's existing EDs prevention chatbot for use with adolescents, including those from diverse backgrounds, and evaluate its effectiveness. Our deep industry and non-profit partnerships will ensure scalability and ultimate real-world impact."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. 13 - 17 years old\n2. Owns a smartphone\n3. Speaks English\n4. US resident\n5. Screens as at-risk for an eating disorder\n6. Not currently in treatment for an eating disorder\n\nExclusion Criteria:\n\n1. Below 13 or older than 17 years of age\n2. Does not own a smartphone\n3. Does not speak English\n4. Lives outside the US\n5. Screens as:\n\n 1. Having a subclinical or clinical ED\n 2. Not at risk for an ED\n 3. In treatment for an ED'}, 'identificationModule': {'nctId': 'NCT07094503', 'acronym': 'EMBody', 'briefTitle': 'Adolescent Chatbot', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Improving Access to Services, Preventing Eating Disorders, and Addressing Comorbid Depression and Anxiety in Diverse Adolescents', 'orgStudyIdInfo': {'id': '202501059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chatbot Intervention Condition', 'description': 'Participants receive access to the digital chatbot program featuring 5 CBT based modules for 3 months. Modules include psychoeducation and CBT-based exercises on regular eating and improving body image.', 'interventionNames': ['Behavioral: Wysa Digital Chatbot Program']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control', 'description': 'Participants receive access to the digital chatbot program after 6 months and completion of the study.'}], 'interventions': [{'name': 'Wysa Digital Chatbot Program', 'type': 'BEHAVIORAL', 'description': 'Wysa is a digital rules-based chatbot program platform offering cognitive-behavioral therapy-based guided self-help modules, including five modules for eating and body image developed by our team. Participants in this arm will engage with the digital chatbot program daily for three months to complete all five modules.', 'armGroupLabels': ['Chatbot Intervention Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nathalie A Gullo, B.S./B.A.', 'role': 'CONTACT', 'email': 'Gullo@wustl.edu', 'phone': '314-935-5843'}, {'name': 'Marianna Horton, B.S./B.A.', 'role': 'CONTACT', 'email': 'M.horton@wustl.edu', 'phone': '314-935-5843'}, {'name': 'Ellen E Fitzsimmons-Craft, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Nathalie A Gullo, B.S/B.A.', 'role': 'CONTACT', 'email': 'Gullo@wustl.edu', 'phone': '314-935-5843'}, {'name': 'Marianna Horton, B.S./B.A.', 'role': 'CONTACT', 'email': 'M.horton@wustl.edu', 'phone': '314-935-5843'}], 'overallOfficials': [{'name': 'Ellen Fitzsimmons-Craft, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study is not federally funded.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychological & Brain Sciences', 'investigatorFullName': 'Ellen E. Fitzsimmons-Craft', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}