CompletedNot Applicable

Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women

France55 participantsStarted 2019-05-27

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women from 18 to 75 years old, * Diagnosis of primary biliary cholangitis (PBC) according to recognized criteria (EASL 2017), * Medically stable under treatment with UDCA initiated for at least 6 months, ie medically stable on the basis of liver biological parameters (no increase of more than 20% in bilirubin, ALP and transaminases) and absence of disabling pruritus (permanent and EVA\> 6/10 or scratching lesions), * Presenting a significant level of fatigue (fatigue score on PBC-40\>= 33), * Understanding the French language, * Availability and ability of the patient to access an internet network terminal to answer the online questionnaires of the study, * Signed consent form. Exclusion Criteria: * Presence of cirrhosis with a Child-Pugh B or C, * Presence of disabling pruritus (permanent, or EVA\>= 7/10 in the last 3 weeks, or objectivable scratching skin lesions), * Patient on liver transplantation waiting list or total bilirubin\> 50 μmol / L (3 mg / dL), or recent complication (\<6 months) of cirrhosis (ascites, hepatic encephalopathy, rupture bleeding) of esophageal varices), * Untreated depressive disorder, * Any comorbidity not medically controlled (i.e. all dosage changes \<3 months due to a control of the associated pathology deemed insufficient by the referring physician) or life-threatening in the medium term (within 2 years). * Psychiatric disorder modifying the relationship to the reality

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PBC-40 questionaire

Timeframe: At month 3

Trial details

NCT IDNCT03630718

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-17

View on ClinicalTrials.gov More Liver Cirrhosis, Biliary trials