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

Primary Purpose

Liver Cirrhosis, Biliary

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Psychoeducational Intervention

Hypnosis intervention

About this trial

This is an interventional supportive care trial for Liver Cirrhosis, Biliary focused on measuring Liver Cirrhosis, Biliary, Female, Cholangitis, Hypnosis, Psychological treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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> 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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group (CG)

Psychoeducational Intervention Group (EG-EDU)

Hypnosis intervention Group (EG-HYP)

Arm Description

Patients assigned to no intervention

Patients assigned to psychoeducational intervention

Patients assigned to hypnosis intervention

Outcomes

Primary Outcome Measures

Multidimensional fatigue inventory (MFI) (1)

Multidimensional fatigue inventory (MFI) (2)

Multidimensional fatigue inventory (MFI) (3)

Multidimensional fatigue inventory (MFI) (4)

Secondary Outcome Measures

Short Form Health Survey (SF36) (1)

Short Form Health Survey (SF36) (2)

Short Form Health Survey (SF36) (3)

Short Form Health Survey (SF36) (4)

PBC-40 questionaire (1)

PBC-40 questionaire (2)

PBC-40 questionaire (3)

PBC-40 questionaire (4)

Pittsburg Sleep Quality Inventory (PSQI) (1)

Pittsburg Sleep Quality Inventory (PSQI) (2)

Pittsburg Sleep Quality Inventory (PSQI) (3)

Pittsburg Sleep Quality Inventory (PSQI) (4)

Epworth Sleeping Scale (ESS) (1)

Epworth Sleeping Scale (ESS) (2)

Epworth Sleeping Scale (ESS) (3)

Epworth Sleeping Scale (ESS) (4)

Hospital Anxiety and Depression Scale (HADS) (1)

Hospital Anxiety and Depression Scale (HADS) (2)

Hospital Anxiety and Depression Scale (HADS) (3)

Hospital Anxiety and Depression Scale (HADS) (4)

Full Information

NCT ID

NCT03630718

First Posted

June 15, 2018

Last Updated

August 10, 2018

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

University of Paris 5 - Rene Descartes

1. Study Identification

Unique Protocol Identification Number

NCT03630718

Brief Title

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

Acronym

CBP-HOPE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 2018 (Anticipated)

Primary Completion Date

July 2019 (Anticipated)

Study Completion Date

November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

University of Paris 5 - Rene Descartes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cirrhosis, Biliary

Keywords

Liver Cirrhosis, Biliary, Female, Cholangitis, Hypnosis, Psychological treatment

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group (CG)

Arm Type

No Intervention

Arm Description

Patients assigned to no intervention

Arm Title

Psychoeducational Intervention Group (EG-EDU)

Arm Type

Active Comparator

Arm Description

Patients assigned to psychoeducational intervention

Arm Title

Hypnosis intervention Group (EG-HYP)

Arm Type

Active Comparator

Arm Description

Patients assigned to hypnosis intervention

Intervention Type

Behavioral

Intervention Name(s)

Psychoeducational Intervention

Other Intervention Name(s)

EG-EDU

Intervention Description

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

Intervention Name(s)

Hypnosis intervention

Other Intervention Name(s)

EG-HYP

Intervention Description

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.

Primary Outcome Measure Information:

Title

Multidimensional fatigue inventory (MFI) (1)

Time Frame

At Day 0

Title

Multidimensional fatigue inventory (MFI) (2)

Time Frame

At week 5

Title

Multidimensional fatigue inventory (MFI) (3)

Time Frame

At month 3

Title

Multidimensional fatigue inventory (MFI) (4)

Time Frame

At month 6

Secondary Outcome Measure Information:

Title

Short Form Health Survey (SF36) (1)

Time Frame

At Day 0

Title

Short Form Health Survey (SF36) (2)

Time Frame

At week 5

Title

Short Form Health Survey (SF36) (3)

Time Frame

At month 3

Title

Short Form Health Survey (SF36) (4)

Time Frame

At month 6

Title

PBC-40 questionaire (1)

Time Frame

At Day 0

Title

PBC-40 questionaire (2)

Time Frame

At week 5

Title

PBC-40 questionaire (3)

Time Frame

At month 3

Title

PBC-40 questionaire (4)

Time Frame

At month 6

Title

Pittsburg Sleep Quality Inventory (PSQI) (1)

Time Frame

At Day 0

Title

Pittsburg Sleep Quality Inventory (PSQI) (2)

Time Frame

At week 5

Title

Pittsburg Sleep Quality Inventory (PSQI) (3)

Time Frame

At month 3

Title

Pittsburg Sleep Quality Inventory (PSQI) (4)

Time Frame

At month 6

Title

Epworth Sleeping Scale (ESS) (1)

Time Frame

At Day 0

Title

Epworth Sleeping Scale (ESS) (2)

Time Frame

At week 5

Title

Epworth Sleeping Scale (ESS) (3)

Time Frame

At month 3

Title

Epworth Sleeping Scale (ESS) (4)

Time Frame

At month 6

Title

Hospital Anxiety and Depression Scale (HADS) (1)

Time Frame

At Day 0

Title

Hospital Anxiety and Depression Scale (HADS) (2)

Time Frame

At week 5

Title

Hospital Anxiety and Depression Scale (HADS) (3)

Time Frame

At month 3

Title

Hospital Anxiety and Depression Scale (HADS) (4)

Time Frame

At month 6

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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> 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christophe CORPECHOT, MD

Phone

+33 1 49 28 28 36

christophe.corpechot@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Aurélie UNTAS, PhD

Phone

+33 1 76 53 30 50

aurelie.untas@parisdescartes.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christophe CORPECHOT, MD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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