Skip to main content
OpenTrials
Completed

NCT Number: NCT06861465

eMPower Mechanisms

Primary Biliary Cholangitis (PBC) is a chronic liver disease that can cause fatigue, itching, brain fog, and emotional distress, all of which can lower quality of life. While the standard treatment, ursodeoxycholic acid (UDCA), helps slow the disease, it does not relieve these symptoms. Research shows that mind-body practices-such as breathing exercises, meditation, and gentle movement-can help improve mental and physical well-being in people with chronic conditions, but their benefits for PBC are not yet well understood.

This study will test a 10-week online wellness program designed for women with PBC. The program will include guided breathing, meditation, and movement exercises, plus optional weekly group sessions and educational videos. Some participants will also receive nutrition guidance on the Mediterranean diet to see if it adds extra benefits.

The study will evaluate feasibility via recruitment, adherence, and retention. To assess acceptability, participants will provide feedback through surveys and interviews. The study will also explore early signs of effectiveness by measuring changes in symptoms like anxiety, depression, fatigue, and stress, as well as biological markers, brain activity, physical function, and data from wearable devices.

The results will help determine whether an online mind-body program, with or without nutrition support, could be a simple and effective way to help people with PBC manage their symptoms and improve their quality of life.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Biliary Cholangitis (PBC) Behavior Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fatigue Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary Biliary Cholangitis (PBC) as confirmed by a study Hepatologist using accepted clinical criteria
  • Have been on stable medical therapy for PBC for ≥3 months
  • Score ≥3 on a 1-10 numeric rating scale for two of: depression, anxiety, fatigue, sleep disturbance, cognitive impairment
  • Are able to communicate in English
  • Have access to an Internet-connected device in their home
  • Can commit to up to 60 minutes of study activities 5 days per week

Exclusion criteria

  • Unable to provide informed consent
  • Have decompensated cirrhosis including hepatic encephalopathy
  • Are post-liver transplant
  • Current severe substance use or psychiatric disorder judged to interfere with study testing or program participation
  • Are receiving compassionate care
  • Have a clinical condition that makes the intervention unsafe or infeasible (e.g. unable to follow instruction) or unsafe environment for virtual participation
  • Practices mind-body practices more than the study dose
  • Have contraindications for MRI
  • Have colour blindness
  • Are unable to attend baseline testing

Treatment and study plan

Online Mind-Body Wellness Program

Behavioral

Online program (mindful movement, meditation, breathwork)

Online Mind-Body Wellness Program + Nutritional Counselling

Behavioral

Online program (mindful movement, meditation, breathwork) + nutrition counselling

Primary outcomes

  1. Feasibility of the Intervention

    Time frame: Baseline and Week 10

    Feasibility will be assessed by (i) adherence rate (percentage completing ≥70% of intervention, target ≥70%), and (ii) retention rate (percentage completing baseline and follow-up assessments, target ≥70%).

  2. Acceptability of the Intervention

    Time frame: Baseline and Week 10

    Acceptability will be assessed via participant-reported satisfaction with the intervention using numerical surveys and perceived burden of study measures.

Other outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline and Week 10

    Description: Depression and anxiety will be measured on the Hospital Anxiety and Depression Scale. The minimum value is 0, the maximum is 21, and higher scores mean a worse outcome.

  2. Modified Fatigue Impact Scale (MFIS)

    Time frame: Baseline and Week 10

    The Modified Fatigue Impact Scale (MFIS) assesses the effect of fatigue on cognitive functioning, physical functioning, and psychosocial functioning. The minimum value is 0, the maximum value is 84, and higher scores mean a worse outcome.

  3. Primary Biliary Cholangitis-40 (PBC-40)

    Time frame: Baseline and Week 10

    The PBC-40 assesses quality of life (HRQoL) in individuals with PBC. It consists of 40 items across six domains, assessing symptoms, fatigue, emotional well-being, cognitive function, social impact, and itch.

  4. Perceived Stress Scale (PSS)

    Time frame: Baseline and Week 10

    The Perceived Stress Scale (PSS) assesses how unpredictable, uncontrollable, and overwhelming individuals find their lives. The scale is scored from 0 to 40. Higher scores indicate greater perceived stress.

  5. Sleep Disturbance

    Time frame: Baseline and Week 10

    Sleep disturbance will be measured using the PROMIS Sleep Disturbance 6a. The scale ranges from 8 to 40. Higher scores indicate greater sleep disturbance.

  6. Cognitive Function

    Time frame: Baseline and Week 10

    The PROMIS Short Form - Cognitive Function 6a will be used to assess cognitive function. The scale measures self-reported cognitive function on a scale from 6 to 30. Higher scores indicate better cognitive function.

  7. Pain Interference

    Time frame: Baseline and Week 10

    Pain interference will be measured using the PROMIS Short Form - Pain Interference 4a. The measure assesses the impact of pain on daily activities on a scale from 4 to 20. Higher scores indicate greater pain interference.

  8. Itch Interference

    Time frame: Baseline and Week 10

    Itch interference will be measured using the The PROMIS Short Form - Itch Interference 4a. The measure assesses the impact of itching on daily activities on a scale from 4 to 20. Higher scores indicate greater itch interference.

  9. Changes in Biological Markers

    Time frame: Baseline and Week 10

    Blood sample analysis for biomarkers related to stress and inflammation

    Measure: Levels of stress, inflammation, and fatigue biomarkers (e.g., cortisol, cytokines)

  10. Neurophysiological Changes

    Time frame: Baseline and Week 10

    Pre-post intervention changes in brain activity patterns

    Measure: fMRI and fNIRS measures of brain function

  11. Sit-to-stand

    Time frame: Baseline and Week 10

    The Sit-to-Stand Test measures lower body strength and functional mobility by assessing the number of times an individual can rise from a seated position to a standing position within a set time or the time taken to complete a set number of repetitions. Higher repetitions in a given time or a shorter completion time indicate better functional performance.

  12. The 2-Minute Step Test (2MST)

    Time frame: Baseline and Week 10

    The 2-Minute Step Test (2MST) measures aerobic endurance by counting the number of steps a person takes in place within 2 minutes, lifting the knees to a standardized height. Higher step counts indicate better endurance and functional fitness.

  13. Changes in Exercise Tolerance Mechanisms

    Time frame: Baseline and Week 10

    Assessed using physiological testing for exercise tolerance.

    Measures: Non-invasive estimates of pulmonary oxygen uptake, skeletal muscle oxygenation

  14. Changes in Wearable-Based Measures

    Time frame: Baseline and Week 10

    Collected via wearable devices to assess cardiovascular function.

    Measure: Heart rate variability

  15. Change in Mediterranean diet score

    Time frame: Baseline and Week 10

    Assessed using dietary recall and adherence questionnaires.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

eMPower Mechanisms: an Evidence-based Mental Wellness Programming Online for People With Primary Biliary Cholangitis - A Feasibility Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.