Study of Psychological Defense Mechanisms Used by Liver Transplant Patients (GHEPA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University Hospital, Lille
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01458756
First received: October 24, 2011
Last updated: April 16, 2012
Last verified: March 2012
  Purpose

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.

Before 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.

The 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.


Condition
Liver Diseases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Psychological Defense Mechanisms Used by Liver Transplant Patients on Their Somatic Psychological and Social Outcome. Research for Protective or Vulnerability Factors.

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • change in Bond Defense Style Questionnaire 88 [ Time Frame: baseline and 6 months and 1 year and 5 years ] [ Designated as safety issue: No ]
    Change in psychological defense mechanisms measured by the Defense Style Questionnaire 88, prior and after liver transplantation


Secondary Outcome Measures:
  • personality disorders evaluation by SCID II personality scale [ Time Frame: baseline and 6 months and 1 year and 5 years ] [ Designated as safety issue: No ]
    structure of personality using the SCID II personality scale

  • Minimal International Neuropsychiatric Interview MINI results [ Time Frame: 6 months and 1 year and 5 years ] [ Designated as safety issue: No ]
    presence of psychopathological disorders evaluated by MINI six months, one year and five years after liver transplantation

  • Alcohol Use Disorders Identification Test AUDIT score [ Time Frame: baseline and 6 months and 1 year and 5 years ] [ Designated as safety issue: No ]
    consumption, misuse and alcohol dependence measured by AUDIT score

  • Change in mental health level by General Health Questionnaire GHQ 28 [ Time Frame: baseline and 6 months and 1 year and 5 years ] [ Designated as safety issue: No ]
    Change in mental health levl measured by the General Health Questionnaire GHQ 28, prior and after liver transplantation

  • social evolution [ Time Frame: baseline and 6 months and 1 year and 5 years ] [ Designated as safety issue: No ]
    change in professionnal, family , financial states


Estimated Enrollment: 120
Study Start Date: December 2006
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
liver transplant patients
Population of adult patients awaiting liver transplant, status on the waiting list in the transplant center of University Hospital of Lille.

Detailed Description:

The objective is to measure the influence of variations of psychological defense mechanisms.

The 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)

The 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).

The 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients awaiting liver transplantation and registered on the waiting list in the transplant center of University Hospital of Lille

Criteria

Inclusion Criteria:

  • adult patients between 18 and 65 years old
  • liver disease requiring a liver transplantation
  • registered on the waiting transplant list in the University Hospital of Lille

Exclusion Criteria:

  • fulminant hepatitis
  • mental incapacity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458756

Contacts
Contact: Olivier COTTENCIN +33 3 20 44 58 38 olivier.cottencin@chru-lille.fr
Contact: Anne-Laure DEMARTY anne-laure.demarty@chru-lille.fr

Locations
France
University Hospital, Lille Recruiting
Lille, France, 59037
Contact: Olivier COTTENCIN    +33 3 20 44 58 38    olivier.cottencin@chru-lille.fr   
Sub-Investigator: Nicole DECLERCK         
Sub-Investigator: Philippe MATHURIN         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Olivier COTTENCIN University Hospital, Lille
  More Information

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01458756     History of Changes
Other Study ID Numbers: CP 06/64, 2006/0623, DGS 2006/0393
Study First Received: October 24, 2011
Last Updated: April 16, 2012
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Lille:
liver transplant patients
hepatic transplantation

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 29, 2014