Clinical trial NCT03684187: Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis
Official title: Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Biliary Cholangitis
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Liver Foundation
First posted: 2018-09-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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-1β, IL-6, TNFα, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in fatigue severity
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in fatigue severity
timeFrame: 8 weeks
measure: Change in fatigue severity
timeFrame: 24 weeks
measure: Change in fatigue severity
timeFrame: 36 weeks
measure: Change in fatigue severity
timeFrame: 48 weeks
measure: Change in measurements of physical activity
timeFrame: 2 weeks
measure: Change in measurements of physical activity
timeFrame: 8 weeks
measure: Change in measurements of physical activity
timeFrame: 16 weeks
measure: Change in measurements of physical activity
timeFrame: 48 weeks
measure: Change in daytime somnolence
timeFrame: 8 weeks
measure: Change in daytime somnolence
timeFrame: 16 weeks
measure: Change in daytime somnolence
timeFrame: 24 weeks
measure: Change in daytime somnolence
timeFrame: 36 weeks
measure: Change in daytime somnolence
timeFrame: 48 weeks
measure: Change in vasomotor autonomic symptoms
timeFrame: 8 weeks
measure: Change in vasomotor autonomic symptoms
timeFrame: 16 weeks
measure: Change in vasomotor autonomic symptoms
timeFrame: 24 weeks
measure: Change in vasomotor autonomic symptoms
timeFrame: 36 weeks
measure: Change in vasomotor autonomic symptoms
timeFrame: 48 weeks
measure: Change in functional status
timeFrame: 8 weeks
measure: Change in functional status
timeFrame: 16 weeks
measure: Change in functional status
timeFrame: 24 weeks
measure: Change in functional status
timeFrame: 36 weeks
measure: Improvement in functional status
timeFrame: 48 weeks
measure: Change in cognitive dysfunction
timeFrame: 8 weeks
measure: Change in cognitive dysfunction
timeFrame: 16 weeks
measure: Change in cognitive dysfunction
timeFrame: 24 weeks
measure: Change in cognitive dysfunction
timeFrame: 36 weeks
measure: Change in cognitive dysfunction
timeFrame: 48 weeks
measure: Change in anxiety and depressive symptoms
timeFrame: 8 weeks
measure: Change in anxiety and depressive symptoms
timeFrame: 16 weeks
measure: Change in anxiety and depressive symptoms
timeFrame: 24 weeks
measure: Change in anxiety and depressive symptoms
timeFrame: 36 weeks
measure: Change in anxiety and depressive symptoms
timeFrame: 48 weeks
measure: Change in overall health status
timeFrame: 8 weeks
measure: Change in overall health status
timeFrame: 16 weeks
measure: Change in overall health status
timeFrame: 24 weeks
measure: Change in overall health status
timeFrame: 36 weeks
measure: Change in overall health status
timeFrame: 48 weeks
Other outcomes:
measure: Changes in anti-mitochondria antibody (AMA) titers
timeFrame: 8 weeks
measure: Changes in anti-mitochondria antibody (AMA) titers
timeFrame: 16 weeks
measure: Changes in anti-mitochondria antibody (AMA) titers
timeFrame: 48 weeks
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine - Digestive Diseases
state: Connecticut
Study officials:
affiliation: Yale University
name: Marina Silveira, MD
role: PRINCIPAL_INVESTIGATOR
References: