EMPower Mechanisms

Not Applicable

Recruiting

• Conditions: Primary Biliary Cholangitis (PBC)

• Registration Number: NCT06861465
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-21
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2026-02
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada