Online wellness program for women with Primary Biliary Cholangitis
EMPower Mechanisms: an Evidence-based Mental Wellness Programming Online for People with Primary Biliary Cholangitis - a Feasibility Randomized Controlled Trial
NA · University of Alberta · NCT06861465
This study is testing an online wellness program with breathing exercises, meditation, and gentle movement to see if it can help women with Primary Biliary Cholangitis feel better and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | Female |
| Sponsor | University of Alberta (other) |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT06861465 on ClinicalTrials.gov |
What this trial studies
This study evaluates a 10-week online wellness program aimed at improving the quality of life for women suffering from Primary Biliary Cholangitis (PBC). The program includes guided breathing exercises, meditation, and gentle movement, with optional weekly group sessions and educational videos. Additionally, some participants will receive nutritional guidance based on the Mediterranean diet to assess any added benefits. The study will measure feasibility through recruitment, adherence, and retention, while acceptability will be gauged through participant feedback.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with Primary Biliary Cholangitis who experience symptoms like fatigue, anxiety, or cognitive impairment.
Not a fit: Patients with severe psychiatric disorders or those unable to participate in online activities may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly enhance the mental and physical well-being of patients with PBC.
How similar studies have performed: While mind-body practices have shown promise in improving well-being in chronic conditions, this specific approach for PBC is novel and not yet tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (RECRUITING)
Study contacts
- Study coordinator: Puneeta Tandon, MD, MSc
- Email: empower@ualberta.ca
- Phone: 780-492-9844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Biliary Cholangitis, Mind Body Wellness, Quality of Life, Fatigue, Cognitive Function, Physical Function, Mental Health