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

Yale University

Status: Terminated

Conditions: Primary Biliary Cholangitis

Treatments: Behavioral: Mindfulness Based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03684187

2000022299

Details and patient eligibility

About

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).

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Based Intervention