Mental Health Outcomes and Psychological Evaluation After Liver Transplantation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Receiving a liver transplant is a major life event that can be physically and emotionally challenging. During the first five years after transplantation, more than one in two liver transplant recipients experience a mental health disorder. These disorders may reduce adherence to treatment, increase the risk of graft rejection, impair quality of life, and, in some cases, increase the risk of death. Depression is the most common mental health disorder, affecting approximately one in four liver transplant recipients.

Survival after liver transplantation has improved considerably over recent decades. However, little is known about the long-term mental health of liver transplant recipients. Routine follow-up visits after transplantation play an important role by strengthening the relationship between patients and the healthcare team and by providing regular opportunities to assess mental well-being in addition to standard transplant follow-up, such as monitoring liver health, screening for cancer and cardiovascular disease, and managing treatment-related complications. These visits also help identify the need for additional support, such as addiction specialists, dietitians, or other healthcare professionals, and provide an opportunity to detect symptoms of depression, particularly in patients experiencing personal or family difficulties.

Beyond routine medical follow-up, there is a growing need to better understand mental health many years after liver transplantation. Learning from patients' experiences may help improve the early detection, prevention, and management of depression and other mental health disorders.

The primary objective of this study is to determine the prevalence of moderate-to-severe depressive symptoms among adult liver transplant recipients who underwent transplantation more than five years ago.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥18 years of age)

Having undergone a single liver transplantation during adulthood at Pitié-Salpêtrière Hospital

Attending a post-transplant follow-up consultation at Pitié-Salpêtrière Hospital 5 to 10 years after liver transplantation

Proficiency in the French language, required to complete the questionnaires

Disqualifiers

Patients who have undergone a second liver transplantation (re-transplantation)

Patients who have received a combined organ transplant

Adults under legal guardianship or curatorship

Patients deprived of their liberty by judicial or administrative decision

Trial population

All patients who underwent a first liver transplantation at Pitié-Salpêtrière Hospital, Paris, and who present for a routine follow-up visit 5 to 10 years after transplantation

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • questionnaires

    Other intervention

    Subjects included in the study will answer questionnaires

  • Individual semi-structured interview

    Other intervention

    A 45-minute individual semi-structured interview with a psychologist will be conducted in a purposive sample of 20 participants.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

To determine the prevalence of moderate-to-severe depressive symptoms: Patient Health Questionnaire-9 (PHQ-9)

Moderate to severe depressive symptoms will be defined as a PHQ-9 score ≥ 10

Time frame
The assessment will be performed once using a self-administered paper questionnaire completed by participants during a routine post-liver transplantation follow-up visit at the hospital, 5-10 years after liver transplantation.

Secondary outcomes

1

To identify predictors associated with moderate-to-severe depressive symptoms

Candidate predictors were selected based on previous studies and include : age; sex; educational level; employment status; marital status; history of psychiatric disorders; receipt of psychotherapy; use of pharmacological treatment for anxiety, depression, or sleep disorders; substance use disorders (alcohol, tobacco, cannabis, and other illicit drugs).

Time frame
The assessment will be performed once using a self-administered paper questionnaire completed by participants during a routine post-liver transplantation follow-up visit at the hospital, 5-10 years after liver transplantation..
2

To compare anxiety symptoms according to the presence of moderate-to-severe depressive symptoms

Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Anxiety severity will be classified according to the GAD-7 score as follows: none (0), minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).

Time frame
These assessments will be performed once using self-administered paper questionnaires completed during a routine post-liver transplantation follow-up visit at the hospital, 5-10 years after liver transplantation.
3

To compare sleep quality according to the presence of moderate-to-severe depressive symptoms

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global PSQI score ranges from 0 to 21, with a score greater than 5 indicating poor sleep quality.

Time frame
These assessments will be performed once using self-administered paper questionnaires completed during a routine post-liver transplantation follow-up visit at the hospital, 5-10 years after liver transplantation.]
4

To compare alcohol consumption according to the presence of moderate-to-severe depressive symptoms

Alcohol consumption will be assessed using the Alcohol Use Disorders Identification Test (AUDIT). Total AUDIT scores (0-40) will be categorized as follows: no alcohol use disorder (0), low-risk alcohol use (1-7), hazardous or harmful alcohol use (8-14), and probable alcohol dependence (≥15).

Time frame
These assessments will be performed once using self-administered paper questionnaires completed during a routine post-liver transplantation follow-up visit at the hospital, 5-10 years after liver transplantation.]

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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