Phase Pilot
Mindfulness to treat fatigue in patients with PBC
- Study HIC#:2000022299
- Last Updated:01/01/0001
The purpose of this research study is to assess the efficacy of mindfulness-based stress reduction (MBSR) intervention in the treatment of moderate or severe fatigue in patients with primary biliary cholangitis (PBC).
- Age18 years - 75 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Suzie Christopher
- Phone Number: 1-203-785-4138
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You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
Inclusion:
- Age 18-75
- PBC as defined by previously published criteria [13]
- On stable therapy with UDCA for at least 6 months before enrollment
- PBC-40 fatigue domain score greater than 33
- The ability to provide written consent
Exclusion:
- A known medical condition or metabolic disorder sufficient to explain fatigue such as anemia,
- thyroid disease, renal failure, use of beta-blockers and untreated depression
- Active drug or alcohol use or history of drug and/or stimulant abuse;
- History of psychosis
- Modification of treatment for underlying PBC in the preceding six months
- Other serious coexistent conditions such as pre-existing advanced malignancy or severe
- cardiopulmonary disease which would be expected to limit their life expectancy
- Anticipated need for transplantation in one year (Mayo survival model less than 80% one-year survival
- without transplant) or MELD above 15
- Recurrent variceal bleeding, presence of diuretic-resistant ascites, or spontaneous
- encephalopathy