Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-03-05 @ 4:54 PM
Study NCT ID:
NCT01611220
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2012-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dissonance Inpatient Relapse Prevention Program for 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2012-05-25', 'studyFirstSubmitQcDate': '2012-05-30', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': '1 year', 'description': 'The main outcome is to assess the number of patients with good BMI outcome (BMI ≥ 18.5) at 12-month follow-up end in the two arm conditions.'}], 'secondaryOutcomes': [{'measure': 'Eating disorder Examination (EDE)', 'timeFrame': '1 year', 'description': 'Number of patients with "full remission" defined as having a global EDE score below 1SD above the community mean (1.74) and a BMI ≥ 18.5.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anorexia Nervosa', 'Relapse prevention', 'Cognitive Dissonance', 'Inpatient treatment', 'Cognitive behavior therapy'], 'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'references': [{'pmid': '18377128', 'type': 'BACKGROUND', 'citation': 'Stice E, Marti CN, Spoor S, Presnell K, Shaw H. Dissonance and healthy weight eating disorder prevention programs: long-term effects from a randomized efficacy trial. J Consult Clin Psychol. 2008 Apr;76(2):329-40. doi: 10.1037/0022-006X.76.2.329.'}]}, 'descriptionModule': {'briefSummary': 'Anorexia Nervosa inpatient treatment has often a short-term success as weight is restored to a healthy level, but high percentage of patients relapse during the first year following the discharge. The development of strategies to overcome this problem represents a priority for clinicians. Aim of this trial is to evaluate the effects of a relapse prevention program based on cognitive dissonance theory developed for hospitalized patients.', 'detailedDescription': 'Inpatient treatment for anorexia nervosa is often successful in restoring body weight, but a high percentage of patients relapse following discharge. The aim of the study was to assess the effect of a relapse prevention program during the last phase of inpatient treatment. Patients, when they achieve a BMI of 18.5, are randomly allocated to complete the standard cognitive behavior inpatient treatment (CBT-I) or to complete the standard CBT-I plus eight relapse prevention groups based on the cognitive dissonance. The intervention has been derived by the selective and indicated prevention programs using a dissonance-based approach. This intervention showed to be effective in reducing the risk for eating pathology onset. The primary outcome of the study is to assess the number of patients allocated to the two condition with a BMI equal or greater than 18.5 at 12-months after discharge.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Body Mass Index ≥ 18.5\n* Anorexia Nervosa patients admitted to inpatient treatment\n* Written informed consent\n\nExclusion Criteria:\n\n* Male\n* Schizophrenia or other psychiatric disorders\n* Substance abuse\n* Medical complication that may hamper the interpretation of results (medical condition that causes weight changes)\n* Absence of medical treatment (drugs) that may hamper the interpretation of results\n* Pregnancy or plan to get pregnant'}, 'identificationModule': {'nctId': 'NCT01611220', 'acronym': 'RePAN', 'briefTitle': 'Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Villa Garda Hospital'}, 'officialTitle': 'Dissonance Inpatient Relapse Prevention Program for Anorexia Nervosa: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'USL22#03/12-CEP329'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard cognitive behavior inpatient treatment'}, {'type': 'EXPERIMENTAL', 'label': 'RePAN', 'description': 'Standard cognitive behavior inpatient treatment plus 8 dissonance relapse prevention groups', 'interventionNames': ['Behavioral: RePAN']}], 'interventions': [{'name': 'RePAN', 'type': 'BEHAVIORAL', 'otherNames': ['Dissonance relapse prevention'], 'description': 'The dissonance relapse prevention intervention consists of eight groups conducted by a psychologist who involves participants in interactive activities aimed to prevent relapse after discharge from the inpatient treatment', 'armGroupLabels': ['RePAN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37016', 'city': 'Garda', 'state': 'Verona', 'country': 'Italy', 'facility': 'Villa Garda Hospital', 'geoPoint': {'lat': 45.57889, 'lon': 10.71763}}], 'overallOfficials': [{'name': 'Riccardo Dalle Grave, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Eating and Weight Disorders, Villa Garda Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Villa Garda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Eating and Weight Disorders', 'investigatorFullName': 'Riccardo Dalle Grave', 'investigatorAffiliation': 'Villa Garda Hospital'}}}}