An interventional study of Psychoeducational Intervention and Hypnosis intervention in Liver Cirrhosis, Biliary, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Supportive care
Fatigue is a clinical symptom that has been described as the most disturbing by around 50% of patients with PBC. It has an important impact on patients' quality of life and is associated with an increased mortality risk. To treat fatigue in PBC, only medical treatments have been tested with limited efficacy or serious sides' effects. In other diseases, mostly cancer, psychological interventions showed efficacy on fatigue decrease. Most interventions consist in psychoeducation with: education about fatigue, development of self-care or coping techniques, activity management and learning to balance between activities and rest. Hypnosis, which consists in a body work for psycho-therapeutic use (e.g., through imagination), has also shown promising results. Moreover, psychological intervention efficacy seems to be influenced by patients' characteristics, such as personality. Therefore, the first aim of the present single-center randomized controlled phase 2 trial is to assess the efficacy of a psycho educational intervention and a hypnosis intervention on PBC patients' fatigue to demonstrate that both psychoeducational and hypnosis interventions decrease patient fatigue.
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
This study's enrollment of 55 is close to the median of 60 across 151 interventional studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients assigned to no intervention
Patients assigned to psychoeducational intervention
Behavioral: Psychoeducational Intervention
Patients assigned to hypnosis intervention
Behavioral: Hypnosis intervention
The psychoeducational intervention will be a structured education programme and will consist of informing patients about fatigue dimensions, aetiology and treatments, by helping them to develop strategies to cope with fatigue better and by teaching them to manage the balance between activities and rest. The construction of the contents of the sessions of this intervention will aim to reduce fatigue via the programme developed by Reif et al. in cancer patients and is composed of 6 sessions of 90 minutes, one session per week. It is a group intervention for 8 patients. For this project, the investigators have reorganised the sessions and their content to fit with an individual format adapted to PBC. This format is more appropriate to take into account the specificity of the manifestation of fatigue for each patient.
Also known as: EG-EDU
The hypnosis intervention will consist of decreasing fatigue and the related distress, and increasing feelings of energy and well-being. Therefore, each hypnosis exercise will be audiotaped and given to the patient at the end of the session. Patients will be asked to use these recordings as much as they want to help them to manage fatigue. The techniques used are inspired by those used in chronic pain management and fatigue.
Also known as: EG-HYP
PBC-40 questionaire
Time frame: At month 3
Short Form Health Survey (SF36) (1)
Time frame: At Day 0
Short Form Health Survey (SF36) (2)
Time frame: At week 5
Short Form Health Survey (SF36) (3)
Time frame: At month 3
Short Form Health Survey (SF36) (4)
Time frame: At month 6
Multidimensional fatigue inventory (MFI) (1)
Time frame: At Day 0
Multidimensional fatigue inventory (MFI) (2)
Time frame: At week 5
Multidimensional fatigue inventory (MFI) (3)
Time frame: At month 3
Multidimensional fatigue inventory (MFI) (4)
Time frame: At month 6
PBC-40 questionaire (1)
Time frame: At Day 0
PBC-40 questionaire (2)
Time frame: At week 5
PBC-40 questionaire (3)
Time frame: At month 6
Pittsburg Sleep Quality Inventory (PSQI) (1)
Time frame: At Day 0
Pittsburg Sleep Quality Inventory (PSQI) (2)
Time frame: At week 5
Pittsburg Sleep Quality Inventory (PSQI) (3)
Time frame: At month 3
Pittsburg Sleep Quality Inventory (PSQI) (4)
Time frame: At month 6
Epworth Sleeping Scale (ESS) (1)
Time frame: At Day 0
Epworth Sleeping Scale (ESS) (2)
Time frame: At week 5
Epworth Sleeping Scale (ESS) (3)
Time frame: At month 3
Epworth Sleeping Scale (ESS) (4)
Time frame: At month 6
Hospital Anxiety and Depression Scale (HADS) (1)
Time frame: At Day 0
Hospital Anxiety and Depression Scale (HADS) (2)
Time frame: At week 5
Hospital Anxiety and Depression Scale (HADS) (3)
Time frame: At month 3
Hospital Anxiety and Depression Scale (HADS) (4)
Time frame: At month 6
Plan to share: No
Ran from May 2019 to primary completion in May 2023, 47 months.
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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