Mind-Body Wellness Program for Primary Biliary Cirrhosis

Overseen By Puneeta Tandon, MD, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Decompensated cirrhosis, Post-liver transplant, Severe substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an online wellness program can help women with Primary Biliary Cholangitis (PBC) manage symptoms such as fatigue, anxiety, and stress. Participants will engage in a 10-week program featuring breathing exercises, meditation, and gentle movement, with some also receiving guidance on the Mediterranean diet. The study will assess the program's ease of use and its impact on mental and physical well-being. Women with PBC who have stable treatment, experience symptoms like anxiety or fatigue, and can commit to online activities are ideal candidates. The results will indicate whether this approach could enhance life quality for people with PBC. As an unphased trial, this study offers participants the chance to contribute to innovative research that may improve symptom management for PBC.

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.

What prior data suggests that this mind-body wellness program is safe for people with PBC?

Research shows that mind-body programs, like the one in this trial, are generally safe for people with Primary Biliary Cholangitis (PBC). Studies suggest these programs are easy to follow and can boost well-being. Participants have shared positive feedback about similar online programs, which include activities like meditation and breathing exercises.

One study found that these mind-body practices are practical and helpful for people with PBC, meaning they can stick with them and find them beneficial. No serious side effects have been reported for these practices in this context.

Adding nutritional counseling might further enhance the benefits. Sources indicate no specific safety concerns with combining mind-body practices and nutrition guidance.

Overall, while mind-body practices are not usually linked to negative effects, consulting a healthcare provider before starting any new health program is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mind-Body Wellness Program for primary biliary cirrhosis because it offers a unique, holistic approach that differs from traditional treatments like ursodeoxycholic acid and obeticholic acid. This program combines mindful movement, meditation, and breathwork, which may help manage symptoms and improve overall well-being without medication. Additionally, one arm of the trial adds nutritional counseling, potentially offering a comprehensive lifestyle intervention that supports liver health in a new way. This innovative approach could provide patients with a non-invasive, accessible option to enhance their quality of life.

What evidence suggests that this trial's treatments could be effective for managing symptoms of PBC?

Research has shown that activities like breathing exercises, meditation, and movement can boost mental health and improve quality of life. These activities have helped reduce tiredness and stress in people with long-term illnesses like primary biliary cholangitis (PBC). In this trial, participants will join one of two groups. One group will participate in an Online Mind-Body Wellness Program, which studies have shown to improve mental health and quality of life, with participants reporting high satisfaction. The other group will receive the same Online Mind-Body Wellness Program plus Nutritional Counselling. Nutritional advice, particularly about the Mediterranean diet, might offer extra help in managing symptoms. Overall, these methods seem promising for helping people with PBC feel and function better in their daily lives. ^{1 2 6 7 8}

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

Can commit to up to 60 minutes of study activities 5 days per week

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

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?

Group I: Experimental: Online Mind-Body Program + Nutritional Counselling Experimental Treatment 1 Intervention

Online program (mindful movement, meditation, breathwork) + nutritional counselling

Group II: Experimental: Online Mind-Body Program Active Control 1 Intervention

Online program (mindful movement, meditation, breathwork)

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

Ursodeoxycholic acid (UDCA) has been shown to improve transplant-free survival in patients with primary biliary cirrhosis, a chronic liver disease affecting bile ducts, based on several randomized placebo-controlled studies.

Despite the benefits of UDCA, about 40% of patients do not respond biochemically to this treatment, highlighting the need for new therapies and research into alternative treatments, including those targeting nuclear receptor hormones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary biliary cirrhosis. Carey, EJ., Ali, AH., Lindor, KD.[2022]

A study of 276 patients with primary biliary cirrhosis (PBC) revealed that their health-related quality of life (HRQOL) is significantly lower than that of a matched control group, particularly in terms of energy levels and emotional reactions.

Fatigue was identified as a key factor negatively impacting the quality of life for PBC patients, highlighting the need for clinicians to consider these aspects when treating individuals with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life in patients with primary biliary cirrhosis. Poupon, RE., Chrétien, Y., Chazouillères, O., et al.[2013]

In a study of 136 patients with primary biliary cirrhosis (PBC), fatigue was found to be a significant issue, with a median fatigue impact score (FIS) of 40, which was notably higher than the scores of age- and sex-matched community controls (28) and chronic liver disease controls (20.5).

The study revealed that while fatigue is a common problem in PBC, it is not universal among all patients, affecting fewer individuals than previously believed, which will help refine future research on the causes and treatments of fatigue in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The true impact of fatigue in primary biliary cirrhosis: a population study. Goldblatt, J., Taylor, PJ., Lipman, T., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 16 patients with primary biliary cirrhosis (PBC), the treatment combining Ursodeoxycholic acid (UDCA) and traditional Chinese medicine led to significant reductions in liver enzymes (ALP and GGT) after 3 and 12 months, indicating improved liver function.

The study highlighted that PBC presents with complex symptoms, including fatigue and jaundice, and that the integrated treatment approach not only improved liver enzyme levels but also alleviated various symptoms associated with the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical features of primary biliary cirrhosis and treatment of it by integrated traditional Chinese and western medicine]. Jiang, J., He, M.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing quality of life in primary biliary cirrhosis. Rannard, A., Buck, D., Jones, DE., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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An online mind-body program improves mental health and ... This intervention improved measures of mental wellness and quality of life with high satisfaction and reasonable adherence.

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Mind-body Wellness Intervention in Primary Biliary ... Online wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in decreasing fatigue and improving ...

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A randomized controlled trial evaluating the impact of a 12- ... INTRODUCTION. • People with primary biliary cholangitis (PBC) experience high rates of mental distress, fatigue and impaired health related quality of life1 ...

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5. utppublishing.com utppublishing.com/doi/10.3138/canlivj-2022-0045

The feasibility and acceptability of an online mind-body ... These findings suggest that a 12-week online mind–body intervention is feasible and acceptable in patients with PBC.

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Mind-Body Wellness Program for Primary Biliary Cirrhosis This trial is for women with Primary Biliary Cholangitis (PBC), a chronic liver disease. Participants should be experiencing symptoms like fatigue, itching, and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06861465?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(empower))&rank=4

Study Details | NCT06861465 | EMPower Mechanisms EMPower Mechanisms: an Evidence-based Mental Wellness Programming Online for People with Primary Biliary Cholangitis - a Feasibility Randomized Controlled Trial.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10652984/

The feasibility and acceptability of an online mind-body ... Persons with primary biliary cholangitis (PBC) experience significantly higher rates of mental distress and impaired health related quality of life (HrQoL) ...