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

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis, Biliary
• Intervention / Treatment: Behavioral: Psychoeducational Intervention; Behavioral: Hypnosis intervention

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe CORPECHOT, MD; Phone Number: +33 1 49 28 28 36; Email: christophe.corpechot@aphp.fr
• Study Contact Backup: Name: Aurélie UNTAS, PhD; Phone Number: +33 1 76 53 30 50; Email: aurelie.untas@parisdescartes.fr

Study Locations

• France
  • Paris, France, 75012
    • Service hépatologie Hôpital Saint-Antoine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group (CG); Patients assigned to no intervention
Active Comparator: Psychoeducational Intervention Group (EG-EDU); Patients assigned to psychoeducational intervention	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.; Other Names: EG-EDU
Active Comparator: Hypnosis intervention Group (EG-HYP); Patients assigned to hypnosis intervention	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.; Other Names: EG-HYP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Multidimensional fatigue inventory (MFI) (1)	At Day 0
Multidimensional fatigue inventory (MFI) (2)	At week 5
Multidimensional fatigue inventory (MFI) (3)	At month 3
Multidimensional fatigue inventory (MFI) (4)	At month 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Short Form Health Survey (SF36) (1)	At Day 0
Short Form Health Survey (SF36) (2)	At week 5
Short Form Health Survey (SF36) (3)	At month 3
Short Form Health Survey (SF36) (4)	At month 6
PBC-40 questionaire (1)	At Day 0
PBC-40 questionaire (2)	At week 5
PBC-40 questionaire (3)	At month 3
PBC-40 questionaire (4)	At month 6
Pittsburg Sleep Quality Inventory (PSQI) (1)	At Day 0
Pittsburg Sleep Quality Inventory (PSQI) (2)	At week 5
Pittsburg Sleep Quality Inventory (PSQI) (3)	At month 3
Pittsburg Sleep Quality Inventory (PSQI) (4)	At month 6
Epworth Sleeping Scale (ESS) (1)	At Day 0
Epworth Sleeping Scale (ESS) (2)	At week 5
Epworth Sleeping Scale (ESS) (3)	At month 3
Epworth Sleeping Scale (ESS) (4)	At month 6
Hospital Anxiety and Depression Scale (HADS) (1)	At Day 0
Hospital Anxiety and Depression Scale (HADS) (2)	At week 5
Hospital Anxiety and Depression Scale (HADS) (3)	At month 3
Hospital Anxiety and Depression Scale (HADS) (4)	At month 6

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: University of Paris 5 - Rene Descartes
• Investigators: Principal Investigator: Christophe CORPECHOT, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2019
• Primary Completion (Actual): May 17, 2023
• Study Completion (Actual): May 22, 2023

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hypnosis; Female; Psychological treatment; Cholangitis; Liver Cirrhosis, Biliary
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Fibrosis; Liver Cirrhosis; Liver Cirrhosis, Biliary
• Other Study ID Numbers: K180401J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No