An observational study in Liver Transplantation (LT), sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's planned enrollment of 250 is above the median of 160 across 1,084 observational studies indexed under Depression.
Browse Depression studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Subjects included in the study will answer questionnaires
A 45-minute individual semi-structured interview with a psychologist will be conducted in a purposive sample of 20 participants.
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.
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..
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.
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.]
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.]
To evaluate the impact of moderate-to-severe depressive symptoms on health-related quality of life assessed using the EQ-5D-5L
Health-related quality of life will be assessed using the EQ-5D-5L descriptive system, which evaluates five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each scored on a five-level scale
Time frame: A 45-minute semi-structured interview conducted on the same day as the routine post-liver transplantation follow-up visit at the hospital, 5-10 years after liver transplantation.
To evaluate the impact of moderate-to-severe depressive symptoms on health-related quality of life assessed using the EQ Visual Analogue Scale (EQ-VAS)
Health-related quality of life will be assessed using the EQ Visual Analogue Scale (EQ-VAS), a 0-100 visual analogue scale on which participants rate their current overall health status, with 0 representing the worst imaginable health state and 100 the best imaginable health state.
Time frame: A 45-minute semi-structured interview conducted on the same day as the routine post-liver transplantation follow-up visit at the hospital, 5-10 years after liver transplantation.]
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris