Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT01458756
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2011-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Psychological Defense Mechanisms Used by Liver Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2011-10-24', 'studyFirstSubmitQcDate': '2011-10-24', 'lastUpdatePostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in Bond Defense Style Questionnaire 88', 'timeFrame': 'baseline and 6 months and 1 year and 5 years', 'description': 'Change in psychological defense mechanisms measured by the Defense Style Questionnaire 88, prior and after liver transplantation'}], 'secondaryOutcomes': [{'measure': 'personality disorders evaluation by SCID II personality scale', 'timeFrame': 'baseline and 6 months and 1 year and 5 years', 'description': 'structure of personality using the SCID II personality scale'}, {'measure': 'Minimal International Neuropsychiatric Interview MINI results', 'timeFrame': '6 months and 1 year and 5 years', 'description': 'presence of psychopathological disorders evaluated by MINI six months, one year and five years after liver transplantation'}, {'measure': 'Alcohol Use Disorders Identification Test AUDIT score', 'timeFrame': 'baseline and 6 months and 1 year and 5 years', 'description': 'consumption, misuse and alcohol dependence measured by AUDIT score'}, {'measure': 'Change in mental health level by General Health Questionnaire GHQ 28', 'timeFrame': 'baseline and 6 months and 1 year and 5 years', 'description': 'Change in mental health levl measured by the General Health Questionnaire GHQ 28, prior and after liver transplantation'}, {'measure': 'social evolution', 'timeFrame': 'baseline and 6 months and 1 year and 5 years', 'description': 'change in professional, family , financial states'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver transplant patients', 'hepatic transplantation'], 'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'Organ transplantation has a special place in the medical field. It symbolizes a medicine whose limits always seem to be repelled. Because transplantation is unusual, it places people in front of outstanding issues which he has to cope with his personality and history. Factors involved in the psychology of patient presenting with graft are past and present psychic functioning, object relations, experience of transplantation itself and quality of social environment.\n\nBefore or after graft defense mechanisms can be so intense that they can make the patient unable to overcome the graft. Yet as a pathological mechanism that denial was considered beneficial provided it is short.\n\nThe aim of this study is to evaluate on psychopathological influence of psychological defense mechanisms used by liver transplant patients on their somatic psychological and social outcome.', 'detailedDescription': "The objective is to measure the influence of variations of psychological defense mechanisms.\n\nThe investigators want to measure the influence of personal history of patients, causal disease pre-existing, conditions of graft's realization, structure of patient's social environment (family or institutional); and wish to identify which of those elements can be protective or vulnerability factors with a view to allow adequate support (especially for patients who had multiple poor prognostic factors)\n\nThe investigators will study pre-transplant psychological defense mechanisms of the subjects using the Bond Defense Style Questionnaire and structure of personality using the SCID II personality scale. They will evaluate post-transplant patient outcomes on clinical and social developments with DSQ 88 and General Health Questionnaire (GHQ 28) to six months, twelve months and five years after transplantation. Meanwhile, they will address each time you visit the data on consumption, misuse and alcohol dependence using the AUDIT questionnaire (Alcohol Use Disorders Identification Test).\n\nThe hypothesis is that the defense mechanisms, their variations and personality of the patients are both vulnerability factors as protective factors in different phases of the graft. Identification should allow to optimize care and improve overall health. Results of this research could make it possible to determine the factors used in liaison psychiatry in the long term to ensure an adequate medical and psychiatric support to transplant patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients awaiting liver transplantation and registered on the waiting list in the transplant center of University Hospital of Lille', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients between 18 and 65 years old\n* liver disease requiring a liver transplantation\n* registered on the waiting transplant list in the University Hospital of Lille\n\nExclusion Criteria:\n\n* fulminant hepatitis\n* mental incapacity'}, 'identificationModule': {'nctId': 'NCT01458756', 'acronym': 'GHEPA', 'briefTitle': 'Study of Psychological Defense Mechanisms Used by Liver Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Evaluation of Psychological Defense Mechanisms Used by Liver Transplant Patients on Their Somatic Psychological and Social Outcome. Research for Protective or Vulnerability Factors.', 'orgStudyIdInfo': {'id': '2006_0623'}, 'secondaryIdInfos': [{'id': 'DGS 2006/0393', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'liver transplant patients', 'description': 'Population of adult patients awaiting liver transplant, status on the waiting list in the transplant center of University Hospital of Lille.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'University Hospital, Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Olivier COTTENCIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}