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

Yale University6 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Biliary Cholangitis

Interventions

Mindfulness Based InterventionBEHAVIORAL

Mindfulness - Based Intervention (MBI) Course: The 8-week MBI program is comprised of an orientation session, 8 separate weekly sessions of 2.5 hours and also a 7.5 hour retreat session on a weekend day. The orientation session will include an introductory session, description of the course and will include completion of stress surveys. During the orientation session, there will be explanation to the patients of objectively the basis of mindfulness teaching. The role of the stress surveys that are conducted are to assess an individual's degree of stress prior to the initiation of any mindfulness practice teaching. Subjects will also be asked to wear a BodyGuard 2 (BG2) for parts of the study, on average of 7 days at baseline, end of the control phase, end of intervention phase, and end of 48 week follow up period. This will track subjects heart rate (HR), HR variability, VO2, energy expenditure and activity.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale School of Medicine - Digestive Diseases

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Change in fatigue severity

Change in fatigue severity, assessed by the fatigue domain of the Primary Biliary Cholangitis-40 (PBC-40) questionnaire, of greater than 5 units at 16 weeks (end of MBI program) compared to baseline

Time frame: 16 weeks

Secondary Outcomes

Change in fatigue severity

Change in fatigue severity, assessed by the fatigue domain of the Primary Biliary Cholangitis-40 (PBC-40) questionnaire of greater than 5 units compared to baseline.

Time frame: 8 weeks

Change in fatigue severity

Change in fatigue severity, assessed by the fatigue domain of the Primary Biliary Cholangitis-40 (PBC-40) questionnaire of greater than 5 units compared to baseline.

Time frame: 24 weeks

Change in fatigue severity

Change in fatigue severity, assessed by the fatigue domain of the Primary Biliary Cholangitis-40 (PBC-40) questionnaire of greater than 5 units compared to baseline.

Time frame: 36 weeks

Change in fatigue severity

Change in fatigue severity, assessed by the fatigue domain of the Primary Biliary Cholangitis-40 (PBC-40) questionnaire of greater than 5 units compared to baseline.

Time frame: 48 weeks

Change in measurements of physical activity

Change in measurements of physical activity, measured by BodyGuard compared to baseline.

Time frame: 2 weeks

Change in measurements of physical activity

Change in measurements of physical activity, measured by BodyGuard compared to baseline.

Data from ClinicalTrials.gov

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Change in measurements of physical activity

Change in measurements of physical activity, measured by BodyGuard compared to baseline.

Time frame: 16 weeks

Change in measurements of physical activity

Change in measurements of physical activity, measured by BodyGuard compared to baseline.

Time frame: 48 weeks

Change in daytime somnolence

Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.

Time frame: 8 weeks

Change in daytime somnolence

Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.

Time frame: 16 weeks

Change in daytime somnolence

Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.

Time frame: 24 weeks

Change in daytime somnolence

Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.

Time frame: 36 weeks

Change in daytime somnolence

Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.

Time frame: 48 weeks

Change in vasomotor autonomic symptoms