Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cho… (NCT03684187) | Clinical Trial Compass
TerminatedNot Applicable
Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis
Stopped: Unable to recruit and change in funding status.
United States6 participantsStarted 2018-11-19
Plain-language summary
To assess the efficacy of mindfulness-based intervention (MBI) intervention in the treatment of moderate or severe fatigue in patients with primary biliary cholangitis (PBC).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Primary Biliary Cholangitis as defined by previously published criteria
* On stable therapy with UDCA for at least 6 months before enrollment
* Primary Biliary Cholangitis-40 fatigue domain score \> 33
* The ability to provide written consent
Exclusion Criteria:
* 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 \<80% one-year survival without transplant) or MELD above 15
* Recurrent variceal bleeding, presence of diuretic-resistant ascites, or spontaneous encephalopathy
* Non-proficiency in English