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Mental Health Outcomes and Psychological Evaluation After Liver Transplantation

Mental Health Outcomes and Psychological Evaluation After Liver Transplantation

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07734142
Acronym
mHOPE
Enrollment
250
Registered
2026-07-29
Start date
2026-10-01
Completion date
2028-10-01
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation (LT)

Keywords

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

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.

Interventions

OTHERquestionnaires

Subjects included in the study will answer questionnaires

OTHERIndividual semi-structured interview

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To determine the prevalence of moderate-to-severe depressive symptoms: Patient Health Questionnaire-9 (PHQ-9)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.Moderate to severe depressive symptoms will be defined as a PHQ-9 score ≥ 10

Secondary

MeasureTime frameDescription
To identify predictors associated with moderate-to-severe depressive symptomsThe 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..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).
To compare anxiety symptoms according to the presence of moderate-to-severe depressive symptomsThese 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.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).
To compare sleep quality according to the presence of moderate-to-severe depressive symptomsThese 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.]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.
To compare alcohol consumption according to the presence of moderate-to-severe depressive symptomsThese 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.]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).
To evaluate the impact of moderate-to-severe depressive symptoms on health-related quality of life assessed using the EQ-5D-5LA 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.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
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)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.]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.

Contacts

CONTACTMarie-Virginie Oré
marie-virginie.ore@aphp.fr+33 142 17 75 32
CONTACTDaniel Eyraud
daniel.eyraud@aphp.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026