Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women (CBP-HOPE)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Liver Cirrhosis, Biliary

Treatments: Behavioral: Psychoeducational Intervention; Behavioral: Hypnosis intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03630718

K180401J

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 3 patient groups

Control Group (CG)

No Intervention group

Description:

Patients assigned to no intervention

Psychoeducational Intervention Group (EG-EDU)

Active Comparator group

Description:

Patients assigned to psychoeducational intervention

Treatment:

Behavioral: Psychoeducational Intervention

Hypnosis intervention Group (EG-HYP)

Active Comparator group

Description:

Patients assigned to hypnosis intervention

Treatment:

Behavioral: Hypnosis intervention