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

NCT03684187 | Terminated DMC

• 1 other identifier: 2000022299
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Biliary Cholangitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (38)

• Change in fatigue severity

  8 weeks

• Change in fatigue severity

  24 weeks

• Change in fatigue severity

  36 weeks

• Change in fatigue severity

  48 weeks

• Change in measurements of physical activity

  2 weeks

Other Outcomes (3)

• Changes in anti-mitochondria antibody (AMA) titers

  8 weeks

• Changes in anti-mitochondria antibody (AMA) titers

  16 weeks

• Changes in anti-mitochondria antibody (AMA) titers

  48 weeks

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Mindfulness Based Intervention BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• American Liver Foundation: collaborator

Study Sites (1)

Yale School of Medicine - Digestive Diseases

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marina Silveira, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 25, 2018
• Study Start: November 19, 2018
• Primary Completion: June 26, 2019
• Study Completion: April 17, 2023
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

US (1)