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

NCT ID: NCT03630718

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-27
• Study Completion Date: 2023-05-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group (CG)

Patients assigned to no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Psychoeducational Intervention Group (EG-EDU)

Patients assigned to psychoeducational intervention

Group Type: ACTIVE_COMPARATOR

Psychoeducational Intervention

Intervention Type: BEHAVIORAL

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.

Hypnosis intervention Group (EG-HYP)

Patients assigned to hypnosis intervention

Group Type: ACTIVE_COMPARATOR

Hypnosis intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

EG-EDU; EG-HYP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Paris 5 - Rene Descartes

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe CORPECHOT, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service hépatologie Hôpital Saint-Antoine

Paris, , France

Countries

France

References

Untas A, Goffette C, Flahault C, Vioulac C, Chazouilleres O, Soret PA, Ben Belkacem K, Gaouar F, Bernard N, Rousseau A, Corpechot C. PBC-HOPE: A Randomized Controlled Trial of Hypnosis and Psychoeducation in Women With Primary Biliary Cholangitis and Fatigue. Am J Gastroenterol. 2025 Jul 14. doi: 10.14309/ajg.0000000000003639. Online ahead of print.

Reference Type: DERIVED

PMID: 40658125 (View on PubMed)

Other Identifiers

K180401J

Identifier Type: -

Identifier Source: org_study_id