Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
The EMPower Mechanisms trial is studying how a 10-week online wellness program can help women with Primary Biliary Cholangitis (PBC), a long-lasting liver disease that can cause symptoms like fatigue, itching, and emotional challenges. While the usual treatment can slow the disease down, it doesn't really help with these uncomfortable symptoms. This program includes activities like breathing exercises, meditation, and gentle movements, along with optional group sessions and educational videos. Some participants will also get guidance on following a Mediterranean diet to see if that makes a positive difference.
To join the study, women must have a confirmed diagnosis of PBC, have been on stable treatment for at least three months, and score moderately high on measures of anxiety, depression, fatigue, or sleep issues. Participants will spend about 60 minutes a day, five days a week, on study activities and will provide feedback on their experience. Researchers will look at how well the program works in helping manage symptoms and improving quality of life, making it a potential new tool for those living with PBC.
Gender
FEMALE
Eligibility criteria
- 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
About University Of Alberta
The University of Alberta, a leading research institution in Canada, is dedicated to advancing healthcare through innovative clinical trials. With a strong commitment to scientific excellence and community health, the university facilitates cutting-edge research across various medical disciplines. Its interdisciplinary approach fosters collaboration among researchers, clinicians, and students, ensuring that clinical trials are designed and conducted with the utmost rigor and ethical standards. By leveraging its extensive resources and expertise, the University of Alberta aims to translate research findings into meaningful advancements in patient care and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Edmonton, Alberta, Canada
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported