eMPower Mechanisms

May 6, 2026 updated by: University of Alberta

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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%).
Baseline and Week 10
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.
Baseline and Week 10

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 10
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.
Baseline and Week 10
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.
Baseline and Week 10
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.
Baseline and Week 10
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.
Baseline and Week 10
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.
Baseline and Week 10
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.
Baseline and Week 10
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.
Baseline and Week 10
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)
Baseline and Week 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
Baseline and Week 10
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.
Baseline and Week 10
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.
Baseline and Week 10
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
Baseline and Week 10
Changes in Wearable-Based Measures
Time Frame: Baseline and Week 10

Collected via wearable devices to assess cardiovascular function.

Measure: Heart rate variability
Baseline and Week 10
Change in Mediterranean diet score
Time Frame: Baseline and Week 10
Assessed using dietary recall and adherence questionnaires.
Baseline and Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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