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Phase Pilot

Mindfulness to treat fatigue in patients with PBC

  • Study HIC#:2000022299
  • Last Updated:07/15/2021

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
  • Start Date07/30/2018
  • End Date01/01/2023

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

Principal Investigator

Sub-Investigators

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