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Completed

NCT Number: NCT03630718

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

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.

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Key information

Conditions

Liver Cirrhosis, Biliary Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service hépatologie Hôpital Saint-Antoine

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducational intervention

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.

Other names: EG-EDU

Hypnosis intervention

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.

Other names: EG-HYP

Primary outcomes

  1. PBC-40 questionaire

    Time frame: At month 3

Secondary outcomes

  1. Short Form Health Survey (SF36) (1)

    Time frame: At Day 0

  2. Short Form Health Survey (SF36) (2)

    Time frame: At week 5

  3. Short Form Health Survey (SF36) (3)

    Time frame: At month 3

  4. Short Form Health Survey (SF36) (4)

    Time frame: At month 6

  5. Multidimensional fatigue inventory (MFI) (1)

    Time frame: At Day 0

  6. Multidimensional fatigue inventory (MFI) (2)

    Time frame: At week 5

  7. Multidimensional fatigue inventory (MFI) (3)

    Time frame: At month 3

  8. Multidimensional fatigue inventory (MFI) (4)

    Time frame: At month 6

  9. PBC-40 questionaire (1)

    Time frame: At Day 0

  10. PBC-40 questionaire (2)

    Time frame: At week 5

  11. PBC-40 questionaire (3)

    Time frame: At month 6

  12. Pittsburg Sleep Quality Inventory (PSQI) (1)

    Time frame: At Day 0

  13. Pittsburg Sleep Quality Inventory (PSQI) (2)

    Time frame: At week 5

  14. Pittsburg Sleep Quality Inventory (PSQI) (3)

    Time frame: At month 3

  15. Pittsburg Sleep Quality Inventory (PSQI) (4)

    Time frame: At month 6

  16. Epworth Sleeping Scale (ESS) (1)

    Time frame: At Day 0

  17. Epworth Sleeping Scale (ESS) (2)

    Time frame: At week 5

  18. Epworth Sleeping Scale (ESS) (3)

    Time frame: At month 3

  19. Epworth Sleeping Scale (ESS) (4)

    Time frame: At month 6

  20. Hospital Anxiety and Depression Scale (HADS) (1)

    Time frame: At Day 0

  21. Hospital Anxiety and Depression Scale (HADS) (2)

    Time frame: At week 5

  22. Hospital Anxiety and Depression Scale (HADS) (3)

    Time frame: At month 3

  23. Hospital Anxiety and Depression Scale (HADS) (4)

    Time frame: At month 6

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • University of Paris 5 - Rene Descartes

Registry information

Official study title

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

Acronym: CBP-HOPE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 15, 2018
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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