Mind-body therapy for Primary Biliary Cholangitis

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Alberta, Edmonton, Canada
+2 More
Mind-body therapy - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Primary Biliary Cholangitis

Study Summary

Online Wellness Intervention for Primary Biliary Cholangitis (PBC)

See full description

Eligible Conditions

  • Cholangitis
  • Liver Cirrhosis, Biliary
  • Primary Biliary Cholangitis

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Mind-body therapy will improve 1 primary outcome and 5 secondary outcomes in patients with Primary Biliary Cholangitis. Measurement will happen over the course of 12 Weeks.

12 Weeks
Capability, Opportunity, Motivation, Behavior (COM-B) Survey
Connor Davidson Resilience Scale 10
HADS Anxiety and Depression Scale
Modified Fatigue Impact Scale
PBC-40
Perceived Stress Scale

Trial Safety

Trial Design

2 Treatment Groups

Control
Mind-body Intervention arm

This trial requires 34 total participants across 2 different treatment groups

This trial involves 2 different treatments. Mind-body Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Mind-body Intervention arm
Behavioral
Online yoga, meditation, behavior change tips, and nutrition tips
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mind-body therapy
2020
N/A
~70

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 weeks for reporting.

Closest Location

University of Alberta - Edmonton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adults (≥18 years)
Identified diagnosis of PBC
HADS score <=10
English language proficiency to complete questionnaires and read the educational material
Access to the Internet and a computer or smart device at home.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get primary biliary cholangitis a year in the United States?

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The prevalence of PBC in the US has not been known for many years. The increase in incidence of PBC seen in the past 20 years is likely related to the advent of liver biopsy in people suspected of having PBC.

Unverified Answer

What are common treatments for primary biliary cholangitis?

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Corticosteroid injections for PBC are considered curative therapy. If not received, such therapy is indicated as long-termed therapy that requires careful monitoring because of the risk of fibrosis. In regards to the remaining treatment modalities, the use of proton pump inhibitors, antibiotics, and/or immunosuppressants are recommended for PBC treatment. However, there is a strong need for new therapeutic options for PBC.

Unverified Answer

What causes primary biliary cholangitis?

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Primary biliary cholangitis is considered a primary immune-mediated cholangiopathy and presents with distinct clinical, biochemical, and histological features, indicating a different aetiology compared with the classical idiopathic primary biliary cholangitis (PBC). It affects women and, as PBC, can present with cholangitis and liver cirrhosis. However, PBC has also been detected in women who are menopausal, are postmenopausal, and do not have autoimmune liver disease, and PBC is frequently more severe than in men with autoimmune liver disease.

Unverified Answer

What are the signs of primary biliary cholangitis?

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Persistent itching can indicate pancreatobiliary abnormalities, such as gallbladder cancer or primary sclerosing cholangitis, which may also cause itching. Jaundice, which may be associated with cholangiocarcinoma, is a less common finding and is not a definitive sign of cholangiocarcinoma. Patients with unexplained anemia or bone pain, particularly if associated with jaundice or in the elderly, may also have a diagnosis of cholangiocarcinoma.

Unverified Answer

Can primary biliary cholangitis be cured?

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It has not been proven that the clinical presentation of primary biliary cholangitis can be modified or reversed with specific treatment plans. The clinical course is usually progressive, and patients often present with symptoms which are refractory to the management of PBC.

Unverified Answer

What is primary biliary cholangitis?

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The cause of PBC is unknown; however recent studies suggest it is not an autoimmune disease or a B cell disease. In many cases it is not well characterized and there is controversy within the medical community. PBC is a rare chronic inflammatory condition in the biliary tract, which causes progressive destruction of the liver and the biliary ducts. Patients tend to be Caucasian. PBC appears to be more common in the UK and Spain compared to North America. There is usually abnormal liver function tests, including cholesterol. The course of disease is unpredictable, with the disease running a variable time course. Prognosis is hopeful, and if the inflammation subsides a good outcome may be expected.

Unverified Answer

How serious can primary biliary cholangitis be?

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The severity of the disease may range significantly among patients from the same region, but may not differ between countries, or within a country. More research is needed to gather more representative data of PB patients from multiple regions and countries to investigate further the possible heterogeneity of the disease.

Unverified Answer

Has mind-body therapy proven to be more effective than a placebo?

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The MAST results were inconsistent and the differences were small. In summary there is no evidence to support mind-body therapy as a treatment for PBC.

Unverified Answer

Does primary biliary cholangitis run in families?

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A familial pattern of PBC has not been reported. Familial liability for PBC may be explained by either a role for environment in inducing PBC during childhood or by a common mode of inheritance.

Unverified Answer

What is the primary cause of primary biliary cholangitis?

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PBC is a rare disease, especially in men under 60 years of age. Most patients develop PBC in the third to seventh decades of life. This is comparable to the timing of onset for autoimmune disease in general. The pathogenesis of the disorder is not well understood.

Unverified Answer

What are the latest developments in mind-body therapy for therapeutic use?

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MBT (cognitive-emotional therapies) are being applied throughout the world in a variety of clinical circumstances and for psychological and somatic problems. This article discusses recently emerged treatments for the treatment of the physical components of MBT that have been studied extensively in a systematic and controlled way.

Unverified Answer

Does mind-body therapy improve quality of life for those with primary biliary cholangitis?

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MBI improves HRQoL in PBC patients. However, the short-term effects of MBI are not maintained over time, and the clinical significance of an MBI effect has yet to be established. Further assessment of long-term improvements in HRQoL with MBI is needed in this patient population.

Unverified Answer
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