Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT06703502
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2024-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Pilot Online Binge Eating Disorder Group (BEG) in Under 18s.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-31', 'size': 302672, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-18T08:19', 'hasProtocol': True}, {'date': '2023-02-08', 'size': 118899, 'label': 'Informed Consent Form: Service User', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-18T08:20', 'hasProtocol': False}, {'date': '2023-02-08', 'size': 118443, 'label': 'Informed Consent Form: Parent Carer version', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-18T08:21', 'hasProtocol': False}, {'date': '2023-03-31', 'size': 118315, 'label': 'Informed Consent Form: 16+ Service User', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-18T08:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eating Disorder Examination Questionnaire', 'timeFrame': '23rd May 2023-26th September 2023', 'description': 'The questionnaire is designed to assess the range, frequency and severity of behaviours associated with a diagnosis of an eating disorder.'}], 'secondaryOutcomes': [{'measure': "Revised Children's Anxiety and Depression Scale (RCADS) Child", 'timeFrame': '23rd May 2023-26th September 2023', 'description': "The Revised Children's Anxiety and Depression Scale (RCADS) measures the reported frequency of various symptoms of anxiety and low mood."}, {'measure': "Revised Children's Anxiety and Depression Scale (RCADS) Parent/Carer", 'timeFrame': '23rd May 2023-26th September 2023', 'description': "The Revised Children's Anxiety and Depression Scale (RCADS) measures the reported frequency of various symptoms of anxiety and low mood."}, {'measure': 'Feedback form', 'timeFrame': '23rd August 2023', 'description': 'Feedback form asking questions about experience of the group and any recommendations for future groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['group', 'adolescent'], 'conditions': ['Binge Eating Disorder']}, 'descriptionModule': {'briefSummary': 'The National Institute for Clinical Excellence recommends a cognitive behavioural therapy (CBT) group intervention for binge eating disorder in under-18s. However, there is limited current research in this population. The present study sought to evaluate a CBT group intervention for binge eating disorder in under-18s.', 'detailedDescription': "Background and study aims: The National Institute for Clinical Excellence recommends a cognitive behavioural therapy (CBT) group intervention for binge eating disorder in under-18s. However, there is limited current research in this population. The present study sought to evaluate a CBT group intervention for binge eating disorder in under-18s.\n\nWho can participate? Participants were recruited from the Coventry Warwickshire Partnership Trust's Children and Young People Eating Disorders Team (n=2).\n\nWhat does the study involve: Participating in a group intervention and completing questionnaires (Eating Disorder Examination - Questionnaire (EDE-Q), Revised Children's Anxiety and Depression Scale (RCADS) Child and RCADS Parent) before the group, at the end of the group and a follow-up appointment, as well as a feedback form at the end of the group intervention.\n\nWhat are the possible benefits and risks of participating:\n\n* Benefits: Working towards recovering from binge eating disorder\n* Risks: As with all therapy, there is a risk of distress due to the topics discussed. There is no more risk than any other group online therapy.\n\nWhere is the study run from: Online intervention for participants who are eligible and who are under the care of the RISE Eating Disorders Team within Coventry and Warwickshire NHS Partnership Trust.\n\nWhen is the study starting and how long is it expected to run for: The study commenced on on 23rd May 2023. The group intervention ran from 20th June 2023 to 26th September 2023."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population for study were young people (under 18) that are receiving support from the RISE Eating Disorder Team in the Coventry and Warwickshire Partnership Trust with a diagnosis of binge eating disorder.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Binge Eating Disorder\n* Under 18 prior to the group commencing\n* Spoke English fluently\n\nExclusion Criteria:\n\n* If they were underweight. This was measured by percentage median body mass index (%mBMI) as recommended by the Medical Emergencies in Eating Disorders guidelines (Royal College of Psychiatrists, 2022) for under 18s. As such, individuals were excluded if %mBMI was less than 95%\n* If they had any physical illness serious enough to prevent the participant from engaging fully in the group and completing the in-between session work\n* If they were pregnant\n* If they had an eating disorder-induced physical health state requiring regular medical intervention by the nursing team\n* If they presented a mental health state requiring stabilisation prior to participating in the group intervention according the assessment team\n* If they regularly used alcohol and/or drugs\n* If they repeatedly self-harmed to the point of requiring additional interventions\n* If they had a living situation not conducive to the start of an intervention (ongoing or upcoming changes).'}, 'identificationModule': {'nctId': 'NCT06703502', 'briefTitle': 'Evaluation of Pilot Online Binge Eating Disorder Group (BEG) in Under 18s.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Coventry and Warwickshire Partnership NHS Trust'}, 'officialTitle': 'Investigating the Efficacy of an Online Binge Eating Disorder Group Intervention for Under 18s', 'orgStudyIdInfo': {'id': '320293'}}, 'contactsLocationsModule': {'locations': [{'zip': 'CV2 1XA', 'city': 'Coventry', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Wood End Health Centre', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to the small population size, it does not feel appropriate to share the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coventry and Warwickshire Partnership NHS Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Birmingham Newman University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}