Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-01 @ 6:59 AM
Study NCT ID:
NCT01832792
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2013-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guided Self-help for Binge Eating
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052018', 'term': 'Bulimia Nervosa'}, {'id': 'D056912', 'term': 'Binge-Eating Disorder'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2013-04-09', 'studyFirstSubmitQcDate': '2013-04-15', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Therapist Time', 'timeFrame': 'After every contact with the patient (approx. weekly), including weekly sessions during treatment (12 weeks)', 'description': 'Therapists are asked to indicate (to the nearest 5 minutes) how much time they spend doing clinical / administrative tasks for each patient (patient name not included). Although there are no formal guidelines for how therapists report their time, it should accurately record all contact with patients, and thus is suggested to be completed approximately weekly.'}], 'primaryOutcomes': [{'measure': 'EDE-Q', 'timeFrame': 'Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up', 'description': 'The EDE-Q is given as a measure of eating disorder symptoms in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient\'s first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up. Binge eating is the primary outcome measure, with other eating disorder symptoms as secondary measures. Change in these symptoms will be assessed over the course of treatment.'}], 'secondaryOutcomes': [{'measure': 'CORE-OM', 'timeFrame': 'Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up', 'description': 'The CORE-OM is given as a measure of psychological distress in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient\'s first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up.'}, {'measure': 'RSES', 'timeFrame': 'Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up', 'description': 'The RSES is given as a measure of self-esteem in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient\'s first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up.'}, {'measure': 'CIA', 'timeFrame': 'Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up', 'description': 'The CIA is given as a measure of psychological functioning (quality of life) in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient\'s first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up.'}, {'measure': 'HAq-II', 'timeFrame': 'End of Session 3 of treatment (3 weeks into treatment)', 'description': 'The Helping Alliance Questionnaire is given as a measure of therapeutic alliance after Session 3 of treatment (after 3 weeks from start of treatment) and again at end-of-treatment.'}, {'measure': 'Healthcare Use', 'timeFrame': 'Change in healthcare use between Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up', 'description': 'A measure of healthcare use was developed for the study and is given at Start-of-treatment, End-of-treatment, and 6-month follow-up. Start-of-treatment will proceed as soon as possible after assessment; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bulimia Nervosa', 'Eating Disorder Not Otherwise Specified', 'Binge Eating Disorder']}, 'referencesModule': {'references': [{'pmid': '24886555', 'type': 'DERIVED', 'citation': 'Jenkins PE, Luck A, Burrows A, Boughton N. Comparison of face-to-face versus email guided self-help for binge eating: study protocol for a randomised controlled trial. Trials. 2014 May 22;15:181. doi: 10.1186/1745-6215-15-181.'}]}, 'descriptionModule': {'briefSummary': 'Guided self-help (GSH) is a recommended first-step treatment for bulimia nervosa, binge eating disorder, and atypical variants of these disorders. The current study proposes to investigate the effectiveness of providing GSH either face-to-face or via e-mail, also using a delayed treatment control condition. Symptom outcomes will be assessed, and an estimate of cost-effectiveness made. Results are proposed to be disseminated locally and internationally (through submission to conferences and peer-reviewed journals), and will hopefully inform local service provision.\n\nPlease note that we are only able to offer the intervention to individuals who are currently registered with a General Practitioner that is covered by Oxford Health NHS Foundation Trust - this is typically restricted to practices in Oxfordshire, Buckinghamshire, and parts of Wiltshire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Registration with a General Practitioner covered by Oxford Health NHS Foundation Trust (typically: Oxfordshire, Buckinghamshire, parts of Wiltshire)\n* Primary diagnosis of an eating disorder with recurrent binge eating (BN, EDNOS \\[BN-type\\] or BED)\n* Age above 17.5 years (box below requires whole numbers)\n\nExclusion Criteria:\n\n* A severe eating disorder (e.g., one complicated by medical issues that would not be best managed by a self-help intervention)\n* BMI \\<18.5\n* Rapid weight loss (regardless of BMI)\n* current excessive drug use\n* active and untreated psychosis (the latter two are usually exclusion criteria to the EDS)'}, 'identificationModule': {'nctId': 'NCT01832792', 'briefTitle': 'Guided Self-help for Binge Eating', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Oxford Health NHS Foundation Trust'}, 'officialTitle': 'Guided Self-help for Binge Eating', 'orgStudyIdInfo': {'id': 'OxGSH1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-help', 'description': 'In this condition, participants complete a self-help intervention with the support of a therapist. This lasts 12 weeks.', 'interventionNames': ['Other: Face-to-face self-help', 'Other: E-mail self-help']}, {'type': 'OTHER', 'label': 'Waiting List', 'description': 'One third of participants will be allocated to a treatment waiting list, after which they will be randomised to one of the other two arms.', 'interventionNames': ['Other: Waiting List']}], 'interventions': [{'name': 'Face-to-face self-help', 'type': 'OTHER', 'description': 'Participants in this arm will receive face-to-face self-help; that is, self-help with the support of a therapist, attending the clinic in person.', 'armGroupLabels': ['Self-help']}, {'name': 'E-mail self-help', 'type': 'OTHER', 'description': 'Participants in this arm will receive e-mail self-help; that is, self-help with the support of a therapist, provided via e-mail.', 'armGroupLabels': ['Self-help']}, {'name': 'Waiting List', 'type': 'OTHER', 'description': 'Waiting list condition - participants assigned to a waiting list (no intervention) condition', 'armGroupLabels': ['Waiting List']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7JX', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Oxford Health NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Paul E Jenkins, DClinPsychol', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford Health NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford Health NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}