Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-05 @ 8:58 PM
Study NCT ID:
NCT02745067
Status:
COMPLETED
Last Update Posted:
2025-03-26
First Post:
2016-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2016-04-13', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eating Disorder Examination Questionnaire (EDE-Q), score', 'timeFrame': '1 year'}, {'measure': 'BMI', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'references': [{'pmid': '35123583', 'type': 'RESULT', 'citation': 'Kessler U, Kleppe MM, Rekkedal GA, Ro O, Danielsen Y. Experiences when implementing enhanced cognitive behavioral therapy as a standard treatment for anorexia nervosa in outpatients at a public specialized eating-disorder treatment unit. J Eat Disord. 2022 Feb 5;10(1):15. doi: 10.1186/s40337-022-00536-7.'}, {'pmid': '37194104', 'type': 'DERIVED', 'citation': 'Kleppe MM, Kessler U, Rekkedal GA, Skjakodegard HF, Danielsen YS. Differences in sleep patterns between patients with anorexia nervosa and healthy controls: a cross-sectional study. J Eat Disord. 2023 May 16;11(1):76. doi: 10.1186/s40337-023-00799-8.'}, {'pmid': '35040160', 'type': 'DERIVED', 'citation': 'Kleppe MM, Bronstad I, Lied GA, Danielsen Y, Rekkedal GA, Kessler U. Intestinal barrier integrity in anorexia nervosa (a pilot study). Int J Eat Disord. 2022 May;55(5):703-708. doi: 10.1002/eat.23678. Epub 2022 Jan 17.'}, {'pmid': '32040232', 'type': 'DERIVED', 'citation': 'Kessler U, Rekkedal GA, Ro O, Berentsen B, Steinsvik EK, Lied GA, Danielsen Y. Association between gastrointestinal complaints and psychopathology in patients with anorexia nervosa. Int J Eat Disord. 2020 May;53(5):532-536. doi: 10.1002/eat.23243. Epub 2020 Feb 10.'}, {'pmid': '27716162', 'type': 'DERIVED', 'citation': 'Danielsen YS, Ardal Rekkedal G, Frostad S, Kessler U. Effectiveness of enhanced cognitive behavioral therapy (CBT-E) in the treatment of anorexia nervosa: a prospective multidisciplinary study. BMC Psychiatry. 2016 Oct 5;16(1):342. doi: 10.1186/s12888-016-1056-6.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to gain knowledge about the effectiveness of enhanced cognitive behavioral therapy (CBT-E) for anorexia nervosa (AN).', 'detailedDescription': 'The study will assess the potency of outpatient CBT-E in a sample of patients suffering from AN who are admitted to the Section for Eating Disorders at the Department for Psychosomatic Medicine, Haukeland University Hospital in Bergen, Norway.\n\nSecondary objectives are to (1) prospectively identify baseline predictors of treatment outcome and dropout, (2) determine variables related to the treatment process and patient engagement as predictors of the outcome and/or treatment dropout, and (3) in a multidisciplinary approach, focus on selected pathophysiological mechanisms including changes in the gut microbiota as well as immunological measures in patients with severe AN in different stages of the disease, and determine to what extent they are related to treatment outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged \\>16 years\n* suffering from AN, as diagnosed based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) and confirmed with a clinical examination.\n* either at least one unsuccessful treatment attempt in a secondary health-care service unit or severe AN that is evaluated as not manageable in a secondary health-care service unit.\n\nExclusion Criteria:\n\n* deemed unsafe to manage on an outpatient basis\n* psychiatric comorbidity that precludes a focused eating-disorder treatment, such as psychosis or drug abuse.\n* not available to participate during the requested treatment period\n* for the analysis of the gut microbiota: patients suffering from inflammatory bowel disease, acute or chronic diarrhea or other bowel disease, treatment with antibiotics during the previous 3 months before stool sampling, or laxative abuse;'}, 'identificationModule': {'nctId': 'NCT02745067', 'briefTitle': 'Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa: a Prospective Multidisciplinary Study', 'orgStudyIdInfo': {'id': '2015/2328'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Enhanced cognitive behavioral therapy', 'description': 'Enhanced cognitive behavioral therapy (CBT-E) for eating disorders', 'interventionNames': ['Behavioral: enhanced cognitive behavioral therapy']}], 'interventions': [{'name': 'enhanced cognitive behavioral therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Enhanced cognitive behavioral therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Ute Kessler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haukeland University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}