20 Participants Needed

Mind-Body Wellness Program for Primary Biliary Cirrhosis

PT
Overseen ByPuneeta Tandon, MD, MSc
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The available research does not provide specific safety data for the Mind-Body Wellness Program, but it focuses on its feasibility and acceptability, suggesting it is generally well-received by participants.12345

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

Are able to communicate in English
Have access to an Internet-connected device in their home
I score 3 or higher for depression, anxiety, fatigue, sleep issues, or cognitive problems.
See 3 more

Exclusion Criteria

I have severe liver disease with brain involvement.
Current severe substance use or psychiatric disorder judged to interfere with study testing or program participation
Are receiving compassionate care
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

10 weeks
Weekly online sessions

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.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Online Mind-Body Wellness Program
  • Online Mind-Body Wellness Program + Nutritional Counselling
Trial Overview The trial is testing a 10-week online wellness program that includes breathing exercises, meditation, gentle movement, group sessions, and educational videos. Some will also get advice on the Mediterranean diet to see if it improves outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: Online Mind-Body Program + Nutritional CounsellingExperimental Treatment1 Intervention
Online program (mindful movement, meditation, breathwork) + nutritional counselling
Group II: Experimental: Online Mind-Body ProgramActive Control1 Intervention
Online program (mindful movement, meditation, breathwork)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Published Research Related to This Trial

The study identified 20 different health-related quality of life (HRQOL) measures used in patients with primary biliary cirrhosis (PBC), highlighting a gap in the routine assessment of quality of life in chronic liver disease.
While most measures showed reliability and validity, there was significant variability in their responsiveness and acceptability for PBC patients, indicating a need for more standardized and rigorous reporting to guide clinical practice.
Assessing quality of life in primary biliary cirrhosis.Rannard, A., Buck, D., Jones, DE., et al.[2019]
A 12-week online mind-body wellness program for patients with primary biliary cholangitis (PBC) was found to be feasible and acceptable, with a high retention rate of 91% and 86% adherence to the program.
Participants reported significant improvements in fatigue, anxiety, and depression, along with enhanced health-related quality of life, indicating the program's potential efficacy in managing mental distress associated with PBC.
The feasibility and acceptability of an online mind-body wellness program for patients with primary biliary cholangitis.Watt, M., Hyde, A., Spence, JC., et al.[2023]
The study developed a 12-week mind-body wellness intervention called the Peace Power Pack specifically for individuals with primary biliary cholangitis (PBC), using theoretical frameworks to effectively address barriers to participation.
By employing the Behaviour Change Wheel and behavior change techniques, the intervention aims to help patients manage their symptoms more effectively, ensuring that the program is tailored to their specific needs and motivations.
Development of a Theoretically Informed Web-Based Mind-Body Wellness Intervention for Patients With Primary Biliary Cholangitis: Formative Study.Watt, M., Spence, JC., Tandon, P.[2021]

Citations

Assessing quality of life in primary biliary cirrhosis. [2019]
The feasibility and acceptability of an online mind-body wellness program for patients with primary biliary cholangitis. [2023]
Development of a Theoretically Informed Web-Based Mind-Body Wellness Intervention for Patients With Primary Biliary Cholangitis: Formative Study. [2021]
Quality of life in patients with primary biliary cirrhosis. [2013]
[Clinical features of primary biliary cirrhosis and treatment of it by integrated traditional Chinese and western medicine]. [2019]
The true impact of fatigue in primary biliary cirrhosis: a population study. [2019]
Primary biliary cirrhosis. [2022]
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