Mind-Body Wellness Program for Primary Biliary Cirrhosis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must have been on stable medical therapy for PBC for at least 3 months to participate.
Is the Mind-Body Wellness Program safe for humans?
How does the Mind-Body Wellness Program treatment for primary biliary cirrhosis differ from other treatments?
The Mind-Body Wellness Program is unique because it focuses on improving mental well-being and quality of life through an online platform, which is particularly important for patients with primary biliary cirrhosis who experience high levels of mental distress. Unlike traditional treatments that target the liver directly, this program aims to address the psychological and emotional aspects of the condition.12346
What data supports the effectiveness of the treatment for the Mind-Body Wellness Program for Primary Biliary Cirrhosis?
The research suggests that mind-body interventions, like the online wellness program, could help reduce symptoms in people with primary biliary cholangitis (a liver disease), as they are designed using proven behavior change techniques. While direct evidence is limited, these programs are considered feasible and acceptable for patients, indicating potential benefits.12347
Are You a Good Fit for This Trial?
This trial is for women with Primary Biliary Cholangitis (PBC), a chronic liver disease. Participants should be experiencing symptoms like fatigue, itching, and emotional distress. The study seeks individuals who have not found symptom relief from standard treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage in a 10-week online wellness program including guided breathing, meditation, movement exercises, and optional weekly group sessions and educational videos. Some participants receive additional nutrition guidance on the Mediterranean diet.
Follow-up
Participants are monitored for changes in symptoms like anxiety, depression, fatigue, and stress, as well as biological markers, brain activity, and physical function.
What Are the Treatments Tested in This Trial?
Interventions
- Online Mind-Body Wellness Program
- Online Mind-Body Wellness Program + Nutritional Counselling
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor