EMPower Mechanisms
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2025
CompletedFirst Submitted
Initial submission to the registry
February 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedMarch 6, 2025
February 1, 2025
12 months
February 24, 2025
February 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (15)
Hospital Anxiety and Depression Scale (HADS)
Baseline and Week 10
Modified Fatigue Impact Scale (MFIS)
Baseline and Week 10
Primary Biliary Cholangitis-40 (PBC-40)
Baseline and Week 10
- +12 more other outcomes
Study Arms (2)
Experimental: Online Mind-Body Program
ACTIVE COMPARATOROnline program (mindful movement, meditation, breathwork)
Experimental: Online Mind-Body Program + Nutritional Counselling
EXPERIMENTALOnline program (mindful movement, meditation, breathwork) + nutritional counselling
Interventions
Online program (mindful movement, meditation, breathwork)
Online program (mindful movement, meditation, breathwork) + nutrition counselling
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alberta
Edmonton, Alberta, T6G 2X8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Principal Investigator
Study Record Dates
First Submitted
February 24, 2025
First Posted
March 6, 2025
Study Start
February 21, 2025
Primary Completion
February 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
March 6, 2025
Record last verified: 2025-02