Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 15, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date August 15, 2018
Estimated Study Start Date  ICMJE September 2018
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
  • Multidimensional fatigue inventory (MFI) (1) [ Time Frame: At Day 0 ]
  • Multidimensional fatigue inventory (MFI) (2) [ Time Frame: At week 5 ]
  • Multidimensional fatigue inventory (MFI) (3) [ Time Frame: At month 3 ]
  • Multidimensional fatigue inventory (MFI) (4) [ Time Frame: At month 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
  • Short Form Health Survey (SF36) (1) [ Time Frame: At Day 0 ]
  • Short Form Health Survey (SF36) (2) [ Time Frame: At week 5 ]
  • Short Form Health Survey (SF36) (3) [ Time Frame: At month 3 ]
  • Short Form Health Survey (SF36) (4) [ Time Frame: At month 6 ]
  • PBC-40 questionaire (1) [ Time Frame: At Day 0 ]
  • PBC-40 questionaire (2) [ Time Frame: At week 5 ]
  • PBC-40 questionaire (3) [ Time Frame: At month 3 ]
  • PBC-40 questionaire (4) [ Time Frame: At month 6 ]
  • Pittsburg Sleep Quality Inventory (PSQI) (1) [ Time Frame: At Day 0 ]
  • Pittsburg Sleep Quality Inventory (PSQI) (2) [ Time Frame: At week 5 ]
  • Pittsburg Sleep Quality Inventory (PSQI) (3) [ Time Frame: At month 3 ]
  • Pittsburg Sleep Quality Inventory (PSQI) (4) [ Time Frame: At month 6 ]
  • Epworth Sleeping Scale (ESS) (1) [ Time Frame: At Day 0 ]
  • Epworth Sleeping Scale (ESS) (2) [ Time Frame: At week 5 ]
  • Epworth Sleeping Scale (ESS) (3) [ Time Frame: At month 3 ]
  • Epworth Sleeping Scale (ESS) (4) [ Time Frame: At month 6 ]
  • Hospital Anxiety and Depression Scale (HADS) (1) [ Time Frame: At Day 0 ]
  • Hospital Anxiety and Depression Scale (HADS) (2) [ Time Frame: At week 5 ]
  • Hospital Anxiety and Depression Scale (HADS) (3) [ Time Frame: At month 3 ]
  • Hospital Anxiety and Depression Scale (HADS) (4) [ Time Frame: At month 6 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women
Official Title  ICMJE Randomized Controlled Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With Primary Biliary Cholangitis in Women (CBP-HOPE)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Liver Cirrhosis, Biliary
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • No Intervention: Control Group (CG)
    Patients assigned to no intervention
  • Active Comparator: Psychoeducational Intervention Group (EG-EDU)
    Patients assigned to psychoeducational intervention
    Intervention: Behavioral: Psychoeducational Intervention
  • Active Comparator: Hypnosis intervention Group (EG-HYP)
    Patients assigned to hypnosis intervention
    Intervention: Behavioral: Hypnosis intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2018)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03630718
Other Study ID Numbers  ICMJE K180401J
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE University of Paris 5 - Rene Descartes
Investigators  ICMJE
Principal Investigator: Christophe CORPECHOT, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP