Mind-Body Wellness Program for Primary Biliary Cirrhosis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alberta
Disqualifiers: Decompensated cirrhosis, Post-liver transplant, Severe substance use, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
23456How 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.
23457Eligibility Criteria
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.
+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
+7 more
Trial Timeline
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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of AlbertaEdmonton, Canada
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Who Is Running the Clinical Trial?
University of AlbertaLead Sponsor
References
Assessing quality of life in primary biliary cirrhosis. [2019]Assessment of health-related quality of life (HRQOL) is not routinely reported in the literature on chronic liver disease (CLD). Few studies have examined quality of life (QOL) in patients with primary biliary cirrhosis (PBC) despite its significant functional impact. One of the reasons for the lack of HRQOL measurement in patients with PBC may be the absence of a well-recognized and widely used measure that clinicians can use in ordinary clinical practice. The aim of this study is to evaluate HRQOL measures used in patients with PBC and examine the suitability of the measures for these patients.
The feasibility and acceptability of an online mind-body wellness program for patients with primary biliary cholangitis. [2023]Persons with primary biliary cholangitis (PBC) experience significantly higher rates of mental distress and impaired health related quality of life (HrQoL) than the general population. Given limited evidence, but a high need, our primary aim was to assess feasibility and acceptability of a 12-week, online, mind-body wellness program in people with PBC.
Development of a Theoretically Informed Web-Based Mind-Body Wellness Intervention for Patients With Primary Biliary Cholangitis: Formative Study. [2021]Mind-body interventions have the potential to positively impact the symptom burden associated with primary biliary cholangitis (PBC). Interventions are more likely to be effective if they are informed by a theoretical framework. The Behaviour Change Wheel (BCW) and the behaviour change technique taxonomy version 1 (BCTv1) provide frameworks for intervention development.
Quality of life in patients with primary biliary cirrhosis. [2013]The impact of primary biliary cirrhosis (PBC) on health-related quality of life (HRQOL) is poorly documented. We assessed quality of life in a group of 276 unselected patients with PBC using the Nottingham Health Profile (NHP). This is a generic scale that assesses six major areas commonly associated with HRQOL. Data were compared with those of a sex- and age-matched control group. The associations between NHP scores and the severity of PBC were tested. Patients (86% women) had a median age of 62 years (range 33-87). Most patients were treated with UDCA. PBC patients showed a strong statistically significant difference in energy compared to controls (respectively, 40.6 vs. 22.9, P
[Clinical features of primary biliary cirrhosis and treatment of it by integrated traditional Chinese and western medicine]. [2019]To investigate the clinical features of primary biliary cirrhosis (PBC) and its treatment by integrated traditional Chinese and western medicine.
The true impact of fatigue in primary biliary cirrhosis: a population study. [2019]Patient surveys suggest that fatigue is a common problem in primary biliary cirrhosis (PBC). The actual extent of the problems caused by fatigue in PBC has yet to be determined as previous studies addressing this question have tended to use selected patient subgroups and subjective or non-quantitative fatigue assessment tools. Here, we have attempted to more accurately assess the extent of fatigue in PBC, and the specificity of the symptom for this disease, by the application of an objective measure of fatigue impact (the fatigue impact score [FIS]) to a geographically based patient cohort, age- and sex-matched normal controls, and chronic liver disease controls.
Primary biliary cirrhosis. [2022]Primary biliary cirrhosis is a chronic cholestatic liver disease characterised by destruction of small intrahepatic bile ducts, leading to fibrosis and potential cirrhosis through resulting complications. The serological hallmark of primary biliary cirrhosis is the antimitochondrial antibody, a highly disease-specific antibody identified in about 95% of patients with primary biliary cirrhosis. These patients usually have fatigue and pruritus, both of which occur independently of disease severity. The typical course of primary biliary cirrhosis has changed substantially with the introduöction of ursodeoxycholic acid (UDCA). Several randomised placebo-controlled studies have shown that UDCA improves transplant-free survival in primary biliary cirrhosis. However, about 40% of patients do not have a biochemical response to UDCA and would benefit from new therapies. Liver transplantation is a life-saving surgery with excellent outcomes for those with decompensated cirrhosis. Meanwhile, research on nuclear receptor hormones has led to the development of exciting new potential treatments. This Seminar will review the current understanding of the epidemiology, pathogenesis, and natural history of primary biliary cirrhosis, discuss management of the disease and its sequelae, and introduce research on new therapeutic options.