NCT06861465

EMPower Mechanisms

EMPower Mechanisms: an Evidence-based Mental Wellness Programming Online for People with Primary Biliary Cholangitis - a Feasibility Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Biliary Cholangitis (PBC)

Interventions

Type	Name	Description
BEHAVIORAL	Online Mind-Body Wellness Program	Online program (mindful movement, meditation, breathwork)
BEHAVIORAL	Online Mind-Body Wellness Program + Nutritional Counselling	Online program (mindful movement, meditation, breathwork) + nutrition counselling

Timeline

• Start date: 2025-02-21
• Primary completion: 2026-02-01
• Completion: 2026-06-01
• First posted: 2025-03-06
• Last updated: 2025-03-06

Locations

1 site across 1 country: Canada