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Liver Cirrhosis, BiliaryCBP-HOPENCT03630718

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

A study testing Psychoeducational Intervention and Hypnosis intervention in people with Liver Cirrhosis, Biliary, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Liver Cirrhosis, Biliary
What is being tested?
Psychoeducational Intervention and Hypnosis intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteFrance
Study dates
27 May 2019to 22 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service hépatologie Hôpital Saint-Antoine

    Paris, 75012

Other trials in France

About this study

Official title: 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.

Being tested
Psychoeducational Intervention, Hypnosis intervention
Keywords
Liver Cirrhosis, Biliary, Female, Cholangitis, Hypnosis, Psychological treatment
Medical subject headings
Liver Cirrhosis, Biliary, Cholangitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychoeducational InterventionBehavioural

    Also called EG-EDU

    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.

  • Hypnosis interventionBehavioural

    Also called EG-HYP

    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.

Study groups in NCT03630718
Study groupRoleWhat they receive
Control Group (CG)No interventionPatients assigned to no intervention
Psychoeducational Intervention Group (EG-EDU)Active comparatorPatients assigned to psychoeducational intervention
Receives: Behavioral: Psychoeducational Intervention
Hypnosis intervention Group (EG-HYP)Active comparatorPatients assigned to hypnosis intervention
Receives: Behavioral: Hypnosis intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PBC-40 questionaire

    Measured: At month 3

Secondary outcomes (23)

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

    Measured: At Day 0

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

    Measured: At week 5

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

    Measured: At month 3

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

    Measured: At month 6

  5. Multidimensional fatigue inventory (MFI) (1)

    Measured: At Day 0

  6. Multidimensional fatigue inventory (MFI) (2)

    Measured: At week 5

  7. Multidimensional fatigue inventory (MFI) (3)

    Measured: At month 3

  8. Multidimensional fatigue inventory (MFI) (4)

    Measured: At month 6

  9. PBC-40 questionaire (1)

    Measured: At Day 0

  10. PBC-40 questionaire (2)

    Measured: At week 5

  11. PBC-40 questionaire (3)

    Measured: At month 6

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

    Measured: At Day 0

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

    Measured: At week 5

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

    Measured: At month 3

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

    Measured: At month 6

  16. Epworth Sleeping Scale (ESS) (1)

    Measured: At Day 0

  17. Epworth Sleeping Scale (ESS) (2)

    Measured: At week 5

  18. Epworth Sleeping Scale (ESS) (3)

    Measured: At month 3

  19. Epworth Sleeping Scale (ESS) (4)

    Measured: At month 6

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

    Measured: At Day 0

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

    Measured: At week 5

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

    Measured: At month 3

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

    Measured: At month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2018
  2. Study start27 May 2019
  3. Primary completion17 May 2023
  4. Study completion22 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03630718
Sponsor's protocol ID
K180401J
Acronym
CBP-HOPE
Status last verified
Jun 2025
First submitted
15 Jun 2018
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Untas A, Goffette C, Flahault C, Vioulac C, Chazouilleres O, Soret PA, Ben Belkacem K, Gaouar F, Bernard N, Rousseau A, Corpechot C. PBC-HOPE: A Randomized Controlled Trial of Hypnosis and Psychoeducation in Women With Primary Biliary Cholangitis and Fatigue. Am J Gastroenterol. 2025 Jul 14. doi: 10.14309/ajg.0000000000003639. Online ahead of print.

    PubMed 40658125

Questions about this trial

What is this clinical trial studying?

A study testing Psychoeducational Intervention and Hypnosis intervention in people with Liver Cirrhosis, Biliary, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PBC-40 questionaire (time frame: At month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03630718, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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