Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT00247234
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2005-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}, {'id': 'D010554', 'term': 'Personality Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081843', 'term': 'Schema Therapy'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-20', 'studyFirstSubmitDate': '2005-10-31', 'studyFirstSubmitQcDate': '2005-10-31', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of life', 'timeFrame': '5 years', 'description': 'Self-report measures'}, {'measure': 'depression', 'timeFrame': '5 years', 'description': 'Self-report measures'}, {'measure': 'anxiety', 'timeFrame': '5 years', 'description': 'Self-report measures'}, {'measure': 'suicidal ideation', 'timeFrame': '5 years', 'description': 'Self-report measures'}], 'secondaryOutcomes': [{'measure': 'Use of psychotropic medication', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Personality Disorder, Borderline', 'Avoidant Personality Disorder']}, 'descriptionModule': {'briefSummary': 'This study intends to compare the effectiveness of schema therapy with standard psychiatric outpatient care for patients with borderline or avoidant personality disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Avoidant or Borderline personality disorders\n\nExclusion Criteria:\n\n* Do not speak Scandinavian languages\n* Antisocial personality disorder\n* Narcissistic personality disorder\n* Affective bipolar disorder I\n* Schizophrenia\n* Mental impairment/organic brain disorder\n* Substance dependence\n* Planned pregnancy\n* Serious somatic illness\n* Anorexia Nervosa'}, 'identificationModule': {'nctId': 'NCT00247234', 'briefTitle': 'Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Effectiveness of Group Based Schema Therapy in the Treatment of Borderline Personality Disorder and Avoidant Personality Disorder', 'orgStudyIdInfo': {'id': 'ursula.falkmer+AEA-stolav.no'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'schema therapy', 'interventionNames': ['Behavioral: Schema Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard care', 'description': 'standard psychiatric out-patient care', 'interventionNames': ['Behavioral: standard care']}], 'interventions': [{'name': 'Schema Therapy', 'type': 'BEHAVIORAL', 'description': 'group based schema therapy', 'armGroupLabels': ['schema therapy']}, {'name': 'standard care', 'type': 'BEHAVIORAL', 'description': 'standard psychiatric out-patient care', 'armGroupLabels': ['standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7030', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Are Holen, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Neuroscience, NTNU - Faculty of Medicine, MTFS, NO-7489 Trondheim, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}