Study of Psychological Defense Mechanisms Used by Liver Transplant Patients

Liver Diseases Clinical Trial

— GHEPA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458756
• Other study ID #: 2006_0623
• Secondary ID: DGS 2006/0393
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: October 24, 2016
• Start date: December 2006
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Diseases

Locations

Country	Name	City	State
France	University Hospital, Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Bond Defense Style Questionnaire 88	Change in psychological defense mechanisms measured by the Defense Style Questionnaire 88, prior and after liver transplantation	baseline and 6 months and 1 year and 5 years	No
Secondary	personality disorders evaluation by SCID II personality scale	structure of personality using the SCID II personality scale	baseline and 6 months and 1 year and 5 years	No
Secondary	Minimal International Neuropsychiatric Interview MINI results	presence of psychopathological disorders evaluated by MINI six months, one year and five years after liver transplantation	6 months and 1 year and 5 years	No
Secondary	Alcohol Use Disorders Identification Test AUDIT score	consumption, misuse and alcohol dependence measured by AUDIT score	baseline and 6 months and 1 year and 5 years	No
Secondary	Change in mental health level by General Health Questionnaire GHQ 28	Change in mental health levl measured by the General Health Questionnaire GHQ 28, prior and after liver transplantation	baseline and 6 months and 1 year and 5 years	No
Secondary	social evolution	change in professional, family , financial states	baseline and 6 months and 1 year and 5 years	No