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

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ClinicalTrials.gov Identifier: NCT03630718
Recruitment Status : Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
University of Paris 5 - Rene Descartes
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis, Biliary Behavioral: Psychoeducational Intervention Behavioral: Hypnosis intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With Primary Biliary Cholangitis in Women (CBP-HOPE)
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019


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 Name: 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 Name: EG-HYP




Primary Outcome Measures :
  1. Multidimensional fatigue inventory (MFI) (1) [ Time Frame: At Day 0 ]
  2. Multidimensional fatigue inventory (MFI) (2) [ Time Frame: At week 5 ]
  3. Multidimensional fatigue inventory (MFI) (3) [ Time Frame: At month 3 ]
  4. Multidimensional fatigue inventory (MFI) (4) [ Time Frame: At month 6 ]

Secondary Outcome Measures :
  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. PBC-40 questionaire (1) [ Time Frame: At Day 0 ]
  6. PBC-40 questionaire (2) [ Time Frame: At week 5 ]
  7. PBC-40 questionaire (3) [ Time Frame: At month 3 ]
  8. PBC-40 questionaire (4) [ Time Frame: At month 6 ]
  9. Pittsburg Sleep Quality Inventory (PSQI) (1) [ Time Frame: At Day 0 ]
  10. Pittsburg Sleep Quality Inventory (PSQI) (2) [ Time Frame: At week 5 ]
  11. Pittsburg Sleep Quality Inventory (PSQI) (3) [ Time Frame: At month 3 ]
  12. Pittsburg Sleep Quality Inventory (PSQI) (4) [ Time Frame: At month 6 ]
  13. Epworth Sleeping Scale (ESS) (1) [ Time Frame: At Day 0 ]
  14. Epworth Sleeping Scale (ESS) (2) [ Time Frame: At week 5 ]
  15. Epworth Sleeping Scale (ESS) (3) [ Time Frame: At month 3 ]
  16. Epworth Sleeping Scale (ESS) (4) [ Time Frame: At month 6 ]
  17. Hospital Anxiety and Depression Scale (HADS) (1) [ Time Frame: At Day 0 ]
  18. Hospital Anxiety and Depression Scale (HADS) (2) [ Time Frame: At week 5 ]
  19. Hospital Anxiety and Depression Scale (HADS) (3) [ Time Frame: At month 3 ]
  20. Hospital Anxiety and Depression Scale (HADS) (4) [ Time Frame: At month 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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> 40),
  • 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 based on histological arguments (elastometry> 16 kPa), or on signs of portal hypertension based on echographic, endoscopic or biological (platelets <150000) approaches,
  • Presence of disabling pruritus (permanent, or EVA> 5/10, or objectivable scratching skin lesions),
  • Patient on liver transplantation waiting list or total bilirubin> 50 μmol / L (3 mg / dL), or MELD score ≥ 15 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630718


Contacts
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Contact: Christophe CORPECHOT, MD +33 1 49 28 28 36 christophe.corpechot@aphp.fr
Contact: Aurélie UNTAS, PhD +33 1 76 53 30 50 aurelie.untas@parisdescartes.fr

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

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03630718     History of Changes
Other Study ID Numbers: K180401J
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Liver Cirrhosis, Biliary
Female
Cholangitis
Hypnosis
Psychological treatment
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Cirrhosis, Biliary
Biliary Tract Diseases
Fatigue
Fibrosis
Signs and Symptoms
Pathologic Processes
Liver Diseases
Digestive System Diseases
Bile Duct Diseases
Cholestasis, Intrahepatic
Cholestasis