Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT02829658
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2016-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Care Services by Patients With Borderline Personality Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011581', 'term': 'Psychological Tests'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2016-07-04', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare data among BPD Patients and general population', 'timeFrame': 'during five years previously to the inclusion', 'description': 'Utilization of mental health care'}], 'secondaryOutcomes': [{'measure': 'Hospitalizations', 'timeFrame': 'During five years previously to the inclusion', 'description': 'Compare hospitalizations between BPD patients and general population'}, {'measure': 'Demographics data', 'timeFrame': 'Inclusion', 'description': 'Compare demographic data between BPD patient and general population'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Borderline Personality Disorder']}, 'referencesModule': {'references': [{'pmid': '25526809', 'type': 'RESULT', 'citation': 'Cailhol L, Thalamas C, Garrido C, Birmes P, Lapeyre-Mestre M. [Mental health service utilization among borderline personality disorder patients inpatient]. Encephale. 2015 Apr;41(2):115-22. doi: 10.1016/j.encep.2014.10.008. Epub 2014 Dec 17. French.'}]}, 'descriptionModule': {'briefSummary': 'Borderline personality disorder (BPD) is characterized by a pervasive pattern of instability and impulsivity. Several North American prospective studies support the high level of mental health care utilization in this population. There is little data in other systems of health organization, such as France. Furthermore, little is known on the variables associated with the mental health service utilization among BPD patients.\n\nThe main objective was to compare the utilization of mental health care among BPD patients, to the general population and patients with another personality disorder (PD) and to describe the demographic and clinical factors associated with the group of patients who use the most health care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'First, four groups were composed: BPD, other PD, control groups for PD and other PD. The first two groups were recruited from a screening of inpatients including a self-administered questionnaire (Personality Disorder Questionnaire 4+). Matched controls (age, sex) composed the 3rd and 4th group (BPD control and other PD control). They were randomly chosen in the health database insurance previously used.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Affiliated with the health insurance\n* Inpatient Psychiatry\n\nExclusion Criteria:\n\n* Patient in forced hospitalization\n* chronic psychotic disorder, mania or hypomania state, known mental retardation.\n* Patient does not speak or read French'}, 'identificationModule': {'nctId': 'NCT02829658', 'acronym': 'EpiB', 'briefTitle': 'Use of Care Services by Patients With Borderline Personality Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Use of Care Services by Patients With Borderline Personality Disorder', 'orgStudyIdInfo': {'id': '08 120 03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Psychiatric patients group', 'description': 'Patient groups were composed with: BPD, other PD and assessed Psychologic test', 'interventionNames': ['Behavioral: Psychologic test']}, {'label': 'Control group', 'description': 'Matched controls (age, sex) composed the 3rd and 4th group (BPD control and other PD control). They were randomly chosen in the health database insurance previously used. They had no intervention.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'Psychologic test', 'type': 'BEHAVIORAL', 'description': 'Assessment by a psychologist including the Structured Interview for Diagnostic and Statistical Manual (DSM)-IV Personality Disorders (SIDP-IV) was given straight to those who had a score above 28. This questionnaire allowed us to distinguish one group of subjects with BPD and a group with other PD (without BPD). Clinical evaluation included Axis I (MINI), Axis II (SIDP-IV), psychopathological features (YSQ-I, Defense Style Questionnaire (DSQ-40), demographic variables and therapeutic alliance (Haq-II).', 'armGroupLabels': ['Psychiatric patients group']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'CAILHOL Lionel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}