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

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

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).

Study Overview

• Status: Suspended
• Conditions: Primary Biliary Cholangitis
• Intervention / Treatment: Behavioral: Mindfulness Based Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marina Silveira, MD; Phone Number: 203-737-6060; Email: marina.silveira@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine - Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Stress in Control for Healthy Liver (SynC-HL) Intervention: 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in anti-mitochondria antibody (AMA) titers	Changes in anti-mitochondria antibody (AMA) titers, IL-1β, IL-6, TNFα, leptin, cortisol, CRP, BDNF, MIF, CD74 levels and other pertinent biomarkers, compared to baseline.	8 weeks
Changes in anti-mitochondria antibody (AMA) titers	Changes in anti-mitochondria antibody (AMA) titers, IL-1β, IL-6, TNFα, leptin, cortisol, CRP, BDNF, MIF, CD74 levels and other pertinent biomarkers, compared to baseline.	16 weeks
Changes in anti-mitochondria antibody (AMA) titers	Changes in anti-mitochondria antibody (AMA) titers, IL-1β, IL-6, TNFα, leptin, cortisol, CRP, BDNF, MIF, CD74 levels and other pertinent biomarkers, compared to baseline.	48 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: American Liver Foundation
• Investigators: Principal Investigator: Marina Silveira, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Cholangitis; Liver Cirrhosis, Biliary
• Other Study ID Numbers: 2000022299

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No