NCT03684187

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-19
• Primary completion: 2019-06-26
• Completion: 2023-04-17
• First posted: 2018-09-25
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States