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NCT Number: NCT01458756

Study of Psychological Defense Mechanisms Used by Liver Transplant Patients

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.

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Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Lille

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. change in Bond Defense Style Questionnaire 88

    Time frame: baseline and 6 months and 1 year and 5 years

    Change in psychological defense mechanisms measured by the Defense Style Questionnaire 88, prior and after liver transplantation

Secondary outcomes

  1. personality disorders evaluation by SCID II personality scale

    Time frame: baseline and 6 months and 1 year and 5 years

    structure of personality using the SCID II personality scale

  2. Minimal International Neuropsychiatric Interview MINI results

    Time frame: 6 months and 1 year and 5 years

    presence of psychopathological disorders evaluated by MINI six months, one year and five years after liver transplantation

  3. Alcohol Use Disorders Identification Test AUDIT score

    Time frame: baseline and 6 months and 1 year and 5 years

    consumption, misuse and alcohol dependence measured by AUDIT score

  4. Change in mental health level by General Health Questionnaire GHQ 28

    Time frame: baseline and 6 months and 1 year and 5 years

    Change in mental health levl measured by the General Health Questionnaire GHQ 28, prior and after liver transplantation

  5. social evolution

    Time frame: baseline and 6 months and 1 year and 5 years

    change in professional, family , financial states

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Evaluation of Psychological Defense Mechanisms Used by Liver Transplant Patients on Their Somatic Psychological and Social Outcome. Research for Protective or Vulnerability Factors.

Acronym: GHEPA

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Oct 25, 2011
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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