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

Not Applicable

Suspended

• Conditions: Primary Biliary Cholangitis
• Interventions: Behavioral: Mindfulness Based Intervention

• Registration Number: NCT03684187
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Study Start: 2018-11-19
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-07
• Primary Completion: 2025-02
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stress in Control for Healthy Liver (SynC-HL) Intervention:	Mindfulness Based 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.

Primary Outcome Measures

Name	Time	Method
Change in fatigue severity	16 weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yale School of Medicine - Digestive Diseases; 🇺🇸 New Haven, Connecticut, United States