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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
University of Alberta
RECRUITING
Edmonton
Contact Information
Primary
Puneeta Tandon, MD, MSc
empower@ualberta.ca
780-492-9844
Time Frame
Start Date: 2025-02-21
Estimated Completion Date: 2026-06
Participants
Target number of participants: 20
Treatments
Active_comparator: Experimental: Online Mind-Body Program
Online program (mindful movement, meditation, breathwork)
Experimental: Experimental: Online Mind-Body Program + Nutritional Counselling
Online program (mindful movement, meditation, breathwork) + nutritional counselling
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov