NCT03630718

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

Randomized Controlled Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With Primary Biliary Cholangitis in Women (CBP-HOPE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis, Biliary

Interventions

Type	Name	Description
BEHAVIORAL	Psychoeducational 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.
BEHAVIORAL	Hypnosis intervention	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.

Timeline

• Start date: 2019-05-27
• Primary completion: 2023-05-17
• Completion: 2023-05-22
• First posted: 2018-08-15
• Last updated: 2025-06-25

Locations

1 site across 1 country: France