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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis: A Pilot Study

Conditions
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Primary Biliary Cholangitis

Intervention / Treatment
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* Behavioral: Mindfulness Based Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress in Control for Healthy Liver (SynC-HL) Intervention:<br>This mindfulness based intervention to target healthy liver focuses on teaching skills of mindfulness, yoga and self-control to improve lifestyle choices and decision making. | Behavioral: Mindfulness Based Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 48 weeks | 
| Change in measurements of physical activity | Change in measurements of physical activity, measured by BodyGuard compared to baseline. | 2 weeks | 
| Change in measurements of physical activity | Change in measurements of physical activity, measured by BodyGuard compared to baseline. | 8 weeks | 
| Change in measurements of physical activity | Change in measurements of physical activity, measured by BodyGuard compared to baseline. | 16 weeks | 
| Change in measurements of physical activity | Change in measurements of physical activity, measured by BodyGuard compared to baseline. | 48 weeks | 
| Change in daytime somnolence | Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline. | 8 weeks | 
| Change in daytime somnolence | Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline. | 16 weeks | 
| Change in daytime somnolence | Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline. | 24 weeks | 
| Change in daytime somnolence | Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline. | 36 weeks | 
| Change in daytime somnolence | Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline. | 48 weeks | 
| Change in vasomotor autonomic symptoms | Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline. | 8 weeks | 
| Change in vasomotor autonomic symptoms | Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline. | 16 weeks | 
| Change in vasomotor autonomic symptoms | Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline. | 24 weeks | 
| Change in vasomotor autonomic symptoms | Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline. | 36 weeks | 
| Change in vasomotor autonomic symptoms | Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline. | 48 weeks | 
| Change in functional status | Change in functional status assessed by the Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire (PROMIS HAQ) compared to baseline. | 8 weeks | 
| Change in functional status | Change in functional status assessed by the Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire (PROMIS HAQ) compared to baseline. | 16 weeks | 
| Change in functional status | Change in functional status assessed by the Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire (PROMIS HAQ) compared to baseline. | 24 weeks | 
| Change in functional status | Change in functional status assessed by the Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire (PROMIS HAQ) compared to baseline. | 36 weeks | 
| Improvement in functional status | Improvement in functional status assessed by the Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire (PROMIS HAQ) compared to baseline. | 48 weeks | 
| Change in cognitive dysfunction | Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline. | 8 weeks | 
| Change in cognitive dysfunction | Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline. | 16 weeks | 
| Change in cognitive dysfunction | Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline. | 24 weeks | 
| Change in cognitive dysfunction | Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline. | 36 weeks | 
| Change in cognitive dysfunction | Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline. | 48 weeks | 
| Change in anxiety and depressive symptoms | Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline. | 8 weeks | 
| Change in anxiety and depressive symptoms | Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline. | 16 weeks | 
| Change in anxiety and depressive symptoms | Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline. | 24 weeks | 
| Change in anxiety and depressive symptoms | Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline. | 36 weeks | 
| Change in anxiety and depressive symptoms | Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline. | 48 weeks | 
| Change in overall health status | Change in overall health status, assessed by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) compared to baseline. | 8 weeks | 
| Change in overall health status | Change in overall health status, assessed by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) compared to baseline. | 16 weeks | 
| Change in overall health status | Change in overall health status, assessed by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) compared to baseline. | 24 weeks | 
| Change in overall health status | Change in overall health status, assessed by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) compared to baseline. | 36 weeks | 
| Change in overall health status | Change in overall health status, assessed by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) compared to baseline. | 48 weeks |