NCT06861465Completed
eMPower Mechanisms
eMPower Mechanisms: an Evidence-based Mental Wellness Programming Online for People With Primary Biliary Cholangitis - A Feasibility Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 24 Feb 2025
- Start date
- 21 Feb 2025
- Primary completion date
- 16 Jul 2025
- Lead sponsor
- University of Alberta
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT06861465
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 21 Feb 2025 to the primary completion date, 16 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Are post-liver transplant
- Are receiving compassionate care
Other illness
- Current severe substance use or psychiatric disorder judged to interfere with study testing or program participation
- Have a clinical condition that makes the intervention unsafe or infeasible (e.g. unable to follow instruction) or unsafe environment for virtual participation
Other
- Unable to provide informed consent
- Have decompensated cirrhosis including hepatic encephalopathy
- Practices mind-body practices more than the study dose
- Have contraindications for MRI
- Have colour blindness
- Are unable to attend baseline testing
Who the study is looking for
- 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
Age in the registry: 40 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.