NCT01458756

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

9.8 years

First QC Date

October 24, 2011

Last Update Submit

October 24, 2016

Conditions

Keywords

liver transplant patientshepatic transplantation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • personality disorders evaluation by SCID II personality scale

    baseline and 6 months and 1 year and 5 years

  • Minimal International Neuropsychiatric Interview MINI results

    6 months and 1 year and 5 years

  • Alcohol Use Disorders Identification Test AUDIT score

    baseline and 6 months and 1 year and 5 years

  • Change in mental health level by General Health Questionnaire GHQ 28

    baseline and 6 months and 1 year and 5 years

  • social evolution

    baseline and 6 months and 1 year and 5 years

Study Arms (1)

liver transplant patients

Population of adult patients awaiting liver transplant, status on the waiting list in the transplant center of University Hospital of Lille.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • fulminant hepatitis
  • mental incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Olivier COTTENCIN

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2011

First Posted

October 25, 2011

Study Start

December 1, 2006

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations