Liver DiseasesGHEPANCT01458756
Study of Psychological Defense Mechanisms Used by Liver Transplant Patients
An observational study of Liver Diseases, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Diseases
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2006to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients awaiting liver transplantation and registered on the waiting list in the transplant center of University Hospital of Lille
Who may be able to join
- 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
Who cannot join
- fulminant hepatitis
- mental incapacity
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Liver Diseases
- Keywords
- liver transplant patients, hepatic transplantation
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| liver transplant patients | Population of adult patients awaiting liver transplant, status on the waiting list in the transplant center of University Hospital of Lille. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Bond Defense Style Questionnaire 88
Change in psychological defense mechanisms measured by the Defense Style Questionnaire 88, prior and after liver transplantation
Measured: baseline and 6 months and 1 year and 5 years
Secondary outcomes (5)
personality disorders evaluation by SCID II personality scale
structure of personality using the SCID II personality scale
Measured: baseline and 6 months and 1 year and 5 years
Minimal International Neuropsychiatric Interview MINI results
presence of psychopathological disorders evaluated by MINI six months, one year and five years after liver transplantation
Measured: 6 months and 1 year and 5 years
Alcohol Use Disorders Identification Test AUDIT score
consumption, misuse and alcohol dependence measured by AUDIT score
Measured: baseline and 6 months and 1 year and 5 years
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
Measured: baseline and 6 months and 1 year and 5 years
social evolution
change in professional, family , financial states
Measured: baseline and 6 months and 1 year and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startDec 2006
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier COTTENCIN, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458756
- Sponsor's protocol ID
- 2006_0623
- Other IDs
- DGS 2006/0393
- Acronym
- GHEPA
- Status last verified
- Oct 2016
- First submitted
- 24 Oct 2011
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01458756
- Acronym / sponsor ID
- GHEPA / 2006_0623
- Conditions
- Liver Diseases
- Keywords
- liver transplant patients, hepatic transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver transplant patients | – | –Population of adult patients awaiting liver transplant, status on the waiting list in the transplant center of University Hospital of Lille. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients awaiting liver transplantation and registered on the waiting list in the transplant center of University Hospital of Lille
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- fulminant hepatitis
- mental incapacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
personality disorders evaluation by SCID II personality scale
Time frame: baseline and 6 months and 1 year and 5 years
Minimal International Neuropsychiatric Interview MINI results
Time frame: 6 months and 1 year and 5 years
Alcohol Use Disorders Identification Test AUDIT score
Time frame: baseline and 6 months and 1 year and 5 years
Change in mental health level by General Health Questionnaire GHQ 28
Time frame: baseline and 6 months and 1 year and 5 years
social evolution
Time frame: baseline and 6 months and 1 year and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier COTTENCIN principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Bond Defense Style Questionnaire 88 (time frame: baseline and 6 months and 1 year and 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.