Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    20
  • sponsor
    Yale University
Updated on 17 February 2021
fatigue
cirrhosis
cholangitis
ursodiol

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).

Description

Aim 1: To assess the efficacy of mindfulness-based intervention (MBI) in the treatment of moderate or severe fatigue in patients with primary biliary cholangitis (PBC).

Hypothesis: MBI is feasible in PBC patients with fatigue and will result in improvement in symptoms of fatigue.

Aim 2: To assess the impact of MBI in physical activity levels, daytime somnolence, autonomic symptoms, functional status, cognitive dysfunction and anxiety and depressive symptoms of patients with PBC with moderate or severe fatigue.

Hypothesis: MBI will result in an improvement in physical activity levels, daytime somnolence, autonomic symptoms, functional status, cognitive dysfunction and anxiety and depressive symptoms in patients with PBC who have moderate or severe fatigue.

Aim 3: To evaluate the effects of MBI on candidate markers and/or cytokines of fatigue and physiological stress, including hepatic panel, antimitochondrial (AMA) titers, IL-1, IL-6, TNF, cortisol, leptin, CRP, BDNF, MIF, and CD74 levels and other relevant markers.

Hypothesis: MBI will result in a decrease of levels of above mentioned markers of fatigue and physiological stress in patients with PBC who have moderate or severe fatigue.

Details
Condition Primary Biliary Cholangitis
Treatment Mindfulness based Intervention
Clinical Study IdentifierNCT03684187
SponsorYale University
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Primary Biliary Cholangitis??
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
Clear my responses

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