Mental Health Outcomes and Psychological Evaluation After Liver Transplantation

Overview

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.

Interventions

• Other questionnaires
  Subjects included in the study will answer questionnaires
• Other Individual semi-structured interview
  A 45-minute individual semi-structured interview with a psychologist will be conducted in a purposive sample of 20 participants.

Primary outcome measures

• To determine the prevalence of moderate-to-severe depressive symptoms: Patient Health Questionnaire-9 (PHQ-9) [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 outcome measures (6)

• To identify predictors associated with moderate-to-severe depressive symptoms [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 [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 [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 [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 [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) [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.]]

Eligibility criteria

Inclusion criteria

• 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
• Able to write and physically capable of completing written questionnaires

Exclusion criteria

• 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
• Refusal to participate in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07734142 · APHP251964 · 2026-A01468-43

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗