eMPower Mechanisms

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Biliary Cholangitis (PBC)
• Intervention / Treatment: Behavioral: Online Mind-Body Wellness Program; Behavioral: Online Mind-Body Wellness Program + Nutritional Counselling

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2X8
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental: Online Mind-Body Program; Online program (mindful movement, meditation, breathwork)	Behavioral: Online Mind-Body Wellness Program; Online program (mindful movement, meditation, breathwork)
Experimental: Experimental: Online Mind-Body Program + Nutritional Counselling; Online program (mindful movement, meditation, breathwork) + nutritional counselling	Behavioral: Online Mind-Body Wellness Program + Nutritional Counselling; Online program (mindful movement, meditation, breathwork) + nutrition counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Intervention	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%).	Baseline and Week 10
Acceptability of the Intervention	Acceptability will be assessed via participant-reported satisfaction with the intervention using numerical surveys and perceived burden of study measures.	Baseline and Week 10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale (HADS)	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.	Baseline and Week 10
Modified Fatigue Impact Scale (MFIS)	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.	Baseline and Week 10
Primary Biliary Cholangitis-40 (PBC-40)	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.	Baseline and Week 10
Perceived Stress Scale (PSS)	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.	Baseline and Week 10
Sleep Disturbance	Sleep disturbance will be measured using the PROMIS Sleep Disturbance 6a. The scale ranges from 8 to 40. Higher scores indicate greater sleep disturbance.	Baseline and Week 10
Cognitive Function	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.	Baseline and Week 10
Pain Interference	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.	Baseline and Week 10
Itch Interference	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.	Baseline and Week 10
Changes in Biological Markers	Blood sample analysis for biomarkers related to stress and inflammation Measure: Levels of stress, inflammation, and fatigue biomarkers (e.g., cortisol, cytokines)	Baseline and Week 10
Neurophysiological Changes	Pre-post intervention changes in brain activity patterns Measure: fMRI and fNIRS measures of brain function	Baseline and Week 10
Sit-to-stand	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.	Baseline and Week 10
The 2-Minute Step Test (2MST)	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.	Baseline and Week 10
Changes in Exercise Tolerance Mechanisms	Assessed using physiological testing for exercise tolerance. Measures: Non-invasive estimates of pulmonary oxygen uptake, skeletal muscle oxygenation	Baseline and Week 10
Changes in Wearable-Based Measures	Collected via wearable devices to assess cardiovascular function. Measure: Heart rate variability	Baseline and Week 10
Change in Mediterranean diet score	Assessed using dietary recall and adherence questionnaires.	Baseline and Week 10

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2025
• Primary Completion (Actual): July 16, 2025
• Study Completion (Actual): July 16, 2025

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; Quality of Life; Fatigue; Physical Function; Cognitive Function; Mind Body Wellness
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Biliary Tract Diseases; Liver Diseases; Bile Duct Diseases; Fibrosis; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Personal Satisfaction; Fatigue; Liver Cirrhosis, Biliary; Psychological Well-Being
• Other Study ID Numbers: Pro00144631

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No