Liver Transplantation (LT)mHOPENCT07734142
Mental Health Outcomes and Psychological Evaluation After Liver Transplantation
An observational study of Liver Transplantation (LT), run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation (LT)
- What is being tested?
- questionnaires and Individual semi-structured interview
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Daniel Eyraud contact
About this study
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.
Read more
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)
- Being tested
- questionnaires, Individual semi-structured interview
- Keywords
- Liver Transplantation, Depression, Anxiety, Alcohol-Related Liver Disease
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Subjects included in the study will answer questionnaires
Individual semi-structured interviewOther
A 45-minute individual semi-structured interview with a psychologist will be conducted in a purposive sample of 20 participants.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplantation (LT)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734142
- Sponsor's protocol ID
- APHP251964
- Other IDs
- 2026-A01468-43
- Acronym
- mHOPE
- Status last verified
- Jun 2026
- First submitted
- 15 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided