Mental Health Outcomes and Psychological Evaluation After Liver Transplantation

NCT07734142 | Not Yet Recruiting

• 2 other identifiers: APHP2519642026-A01468-43
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Transplantation (LT)

Keywords

Liver Transplantation; Depression; Anxiety; Alcohol-Related Liver Disease

Outcome Measures

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

  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 (6)

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

  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

  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

  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

  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

  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.

Interventions

questionnaires OTHER

Subjects included in the study will answer questionnaires

Individual semi-structured interview OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Marie-Virginie Oré

CONTACT

+33 142 17 75 32; marie-virginie.ore@aphp.fr

Daniel Eyraud

CONTACT

daniel.eyraud@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-06