Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-29 @ 11:20 PM
Study NCT ID:
NCT01208259
Status:
COMPLETED
Last Update Posted:
2010-09-28
First Post:
2010-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Psychological Treatment of Overweight Binge Eaters Minority Supplement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D002032', 'term': 'Bulimia'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '1999-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-24', 'studyFirstSubmitDate': '2010-08-31', 'studyFirstSubmitQcDate': '2010-09-22', 'lastUpdatePostDateStruct': {'date': '2010-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short and long-term efficacy of two treatments for binge eating among the overweight: Group Cognitive-Behavior (CBT) and Group Interpersonal Therapy (IPT).', 'description': 'Assessments of binge eating and associated eating disorder psychopathology, general psychological functioning, and weight occurred before treatment, at post treatment, and at 4-month intervals up to 12 months following treatment.'}]}, 'conditionsModule': {'keywords': ['Body Mass Index', 'Bulimia/therapy', 'Comorbidity', 'Interpersonal Relations', 'Psychotherapy/methods'], 'conditions': ['Binge Eating Disorder', 'Cognitive Therapy/Methods', 'Mental Disorders/Epidemiology', 'Obesity/Epidemiology', 'Obesity/Therapy']}, 'referencesModule': {'references': [{'pmid': '12150647', 'type': 'RESULT', 'citation': 'Wilfley DE, Welch RR, Stein RI, Spurrell EB, Cohen LR, Saelens BE, Dounchis JZ, Frank MA, Wiseman CV, Matt GE. A randomized comparison of group cognitive-behavioral therapy and group interpersonal psychotherapy for the treatment of overweight individuals with binge-eating disorder. Arch Gen Psychiatry. 2002 Aug;59(8):713-21. doi: 10.1001/archpsyc.59.8.713.'}]}, 'descriptionModule': {'briefSummary': 'Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but its long-term impact and time course on other BED-related symptoms remain largely unknown. This study compares the effects of group CBT and group IPT across BED-related symptoms among overweight individuals with BED.', 'detailedDescription': "Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but its long-term impact and time course on other BED-related symptoms remain largely unknown. This study compares the effects of group CBT and group IPT across BED-related symptoms among overweight individuals with BED. METHODS: One hundred sixty-two overweight patients meeting DSM-IV criteria for BED were randomly assigned to 20 weekly sessions of either group CBT or group IPT. Assessments of binge eating and associated eating disorder psychopathology, general psychological functioning, and weight occurred before treatment, at posttreatment, and at 4-month intervals up to 12 months following treatment. RESULTS: Binge-eating recovery rates were equivalent for CBT and IPT at posttreatment (64 \\[79%\\] of 81 vs 59 \\[73%\\] of 81) and at 1-year follow-up (48 \\[59%\\] of 81 vs 50 \\[62%\\] of 81). Binge eating increased slightly through follow-up but remained significantly below pretreatment levels. Across treatments, patients had similar significant reductions in associated eating disorders and psychiatric symptoms and maintenance of gains through follow-up. Dietary restraint decreased more quickly in CBT but IPT had equivalent levels by later follow-ups. Patients' relative weight decreased significantly but only slightly, with the greatest reduction among patients sustaining recovery from binge eating from posttreatment to 1-year follow-up. CONCLUSIONS: Group IPT is a viable alternative to group CBT for the treatment of overweight patients with BED. Although lacking a nonspecific control condition limits conclusions about treatment specificity, both treatments showed initial and long-term efficacy for the core and related symptoms of BED."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* DSM-IV research criteria for binge-eating disorder\n* Average of greater than or equal to 2 days of binge eating per week for at least 6 months' duration\n* Marked stress regarding binge eating\n* At least 3 to 5 associated behavioral features (e.g. eating when not physically hungry) Other study criteria\n* 18-65 years old\n* Body mass index, 27-48 kg/m squared\n\nExclusion Criteria:\n\n* Pregnant or planning to become pregnant\n* Taking weight-affecting or psychotropic medications\n* Psychiatric conditions warranting immediate treatment\n* Current enrollment in psychotherapy or a weight loss program"}, 'identificationModule': {'nctId': 'NCT01208259', 'briefTitle': 'The Psychological Treatment of Overweight Binge Eaters Minority Supplement', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Randomized Comparison of Group-Behavioral Therapy and Group Interpersonal Psychotherapy for the Treatment of Overweight Individuals With Binge-Eating Disorder Minority Supplement', 'orgStudyIdInfo': {'id': 'R29MH138403'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Binge Eating Disorder/Therapy', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy (CBT)', 'Behavioral: Interpersonal Therapy (IPT)']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy (CBT)', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Binge Eating Disorder/Therapy']}, {'name': 'Interpersonal Therapy (IPT)', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Binge Eating Disorder/Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511-3516', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Denise E Wilfley, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Denise E. Wilfley, Ph.D.', 'oldOrganization': 'San Diego State University'}}}}