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

NACompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

May 27, 2019

Primary Completion Date

May 17, 2023

Study Completion Date

May 22, 2023

Conditions
Liver Cirrhosis, Biliary
Interventions
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."

Trial Locations (1)

75012

Service hépatologie Hôpital Saint-Antoine, Paris

All Listed Sponsors
collaborator

University of Paris 5 - Rene Descartes

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT03630718 - Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women | Biotech Hunter | Biotech Hunter