Clinical trial NCT03630718: Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women
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
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis, Biliary
Keywords: Liver Cirrhosis, Biliary
Female
Cholangitis
Hypnosis
Psychological treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: University of Paris 5 - Rene Descartes
First posted: 2018-08-15
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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\>= 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

Primary outcomes:
measure: Multidimensional fatigue inventory (MFI) (1)
timeFrame: At Day 0
measure: Multidimensional fatigue inventory (MFI) (2)
timeFrame: At week 5
measure: Multidimensional fatigue inventory (MFI) (3)
timeFrame: At month 3
measure: Multidimensional fatigue inventory (MFI) (4)
timeFrame: At month 6
Secondary outcomes:
measure: Short Form Health Survey (SF36) (1)
timeFrame: At Day 0
measure: Short Form Health Survey (SF36) (2)
timeFrame: At week 5
measure: Short Form Health Survey (SF36) (3)
timeFrame: At month 3
measure: Short Form Health Survey (SF36) (4)
timeFrame: At month 6
measure: PBC-40 questionaire (1)
timeFrame: At Day 0
measure: PBC-40 questionaire (2)
timeFrame: At week 5
measure: PBC-40 questionaire (3)
timeFrame: At month 3
measure: PBC-40 questionaire (4)
timeFrame: At month 6
measure: Pittsburg Sleep Quality Inventory (PSQI) (1)
timeFrame: At Day 0
measure: Pittsburg Sleep Quality Inventory (PSQI) (2)
timeFrame: At week 5
measure: Pittsburg Sleep Quality Inventory (PSQI) (3)
timeFrame: At month 3
measure: Pittsburg Sleep Quality Inventory (PSQI) (4)
timeFrame: At month 6
measure: Epworth Sleeping Scale (ESS) (1)
timeFrame: At Day 0
measure: Epworth Sleeping Scale (ESS) (2)
timeFrame: At week 5
measure: Epworth Sleeping Scale (ESS) (3)
timeFrame: At month 3
measure: Epworth Sleeping Scale (ESS) (4)
timeFrame: At month 6
measure: Hospital Anxiety and Depression Scale (HADS) (1)
timeFrame: At Day 0
measure: Hospital Anxiety and Depression Scale (HADS) (2)
timeFrame: At week 5
measure: Hospital Anxiety and Depression Scale (HADS) (3)
timeFrame: At month 3
measure: Hospital Anxiety and Depression Scale (HADS) (4)
timeFrame: At month 6
Other outcomes:
Locations:
city: Paris
country: France
facility: Service hépatologie Hôpital Saint-Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Christophe CORPECHOT, MD
role: PRINCIPAL_INVESTIGATOR
References: