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

Primary Purpose

Primary Biliary Cholangitis

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Intervention
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cholangitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yale School of Medicine - Digestive Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
Change in measurements of physical activity
Change in measurements of physical activity, measured by BodyGuard compared to baseline.
Change in measurements of physical activity
Change in measurements of physical activity, measured by BodyGuard compared to baseline.
Change in measurements of physical activity
Change in measurements of physical activity, measured by BodyGuard compared to baseline.
Change in measurements of physical activity
Change in measurements of physical activity, measured by BodyGuard compared to baseline.
Change in daytime somnolence
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Change in daytime somnolence
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Change in daytime somnolence
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Change in daytime somnolence
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Change in daytime somnolence
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Change in vasomotor autonomic symptoms
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Change in vasomotor autonomic symptoms
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Change in vasomotor autonomic symptoms
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Change in vasomotor autonomic symptoms
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Change in vasomotor autonomic symptoms
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
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.
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.
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.
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.
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.
Change in cognitive dysfunction
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Change in cognitive dysfunction
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Change in cognitive dysfunction
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Change in cognitive dysfunction
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Change in cognitive dysfunction
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Change in anxiety and depressive symptoms
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Change in anxiety and depressive symptoms
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Change in anxiety and depressive symptoms
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Change in anxiety and depressive symptoms
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Change in anxiety and depressive symptoms
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
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.
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.
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.
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.
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.

Full Information

First Posted
September 21, 2018
Last Updated
September 1, 2023
Sponsor
Yale University
Collaborators
American Liver Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03684187
Brief Title
Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis
Official Title
Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Why Stopped
Unable to recruit and change in funding status.
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
American Liver Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cholangitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stress in Control for Healthy Liver (SynC-HL) Intervention:
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in fatigue severity
Description
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
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in fatigue severity
Description
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.
Time Frame
8 weeks
Title
Change in fatigue severity
Description
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.
Time Frame
24 weeks
Title
Change in fatigue severity
Description
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.
Time Frame
36 weeks
Title
Change in fatigue severity
Description
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.
Time Frame
48 weeks
Title
Change in measurements of physical activity
Description
Change in measurements of physical activity, measured by BodyGuard compared to baseline.
Time Frame
2 weeks
Title
Change in measurements of physical activity
Description
Change in measurements of physical activity, measured by BodyGuard compared to baseline.
Time Frame
8 weeks
Title
Change in measurements of physical activity
Description
Change in measurements of physical activity, measured by BodyGuard compared to baseline.
Time Frame
16 weeks
Title
Change in measurements of physical activity
Description
Change in measurements of physical activity, measured by BodyGuard compared to baseline.
Time Frame
48 weeks
Title
Change in daytime somnolence
Description
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Time Frame
8 weeks
Title
Change in daytime somnolence
Description
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Time Frame
16 weeks
Title
Change in daytime somnolence
Description
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Time Frame
24 weeks
Title
Change in daytime somnolence
Description
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Time Frame
36 weeks
Title
Change in daytime somnolence
Description
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Time Frame
48 weeks
Title
Change in vasomotor autonomic symptoms
Description
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Time Frame
8 weeks
Title
Change in vasomotor autonomic symptoms
Description
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Time Frame
16 weeks
Title
Change in vasomotor autonomic symptoms
Description
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Time Frame
24 weeks
Title
Change in vasomotor autonomic symptoms
Description
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Time Frame
36 weeks
Title
Change in vasomotor autonomic symptoms
Description
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Time Frame
48 weeks
Title
Change in functional status
Description
Change in functional status assessed by the Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire (PROMIS HAQ) compared to baseline.
Time Frame
8 weeks
Title
Change in functional status
Description
Change in functional status assessed by the Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire (PROMIS HAQ) compared to baseline.
Time Frame
16 weeks
Title
Change in functional status
Description
Change in functional status assessed by the Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire (PROMIS HAQ) compared to baseline.
Time Frame
24 weeks
Title
Change in functional status
Description
Change in functional status assessed by the Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire (PROMIS HAQ) compared to baseline.
Time Frame
36 weeks
Title
Improvement in functional status
Description
Improvement in functional status assessed by the Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire (PROMIS HAQ) compared to baseline.
Time Frame
48 weeks
Title
Change in cognitive dysfunction
Description
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Time Frame
8 weeks
Title
Change in cognitive dysfunction
Description
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Time Frame
16 weeks
Title
Change in cognitive dysfunction
Description
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Time Frame
24 weeks
Title
Change in cognitive dysfunction
Description
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Time Frame
36 weeks
Title
Change in cognitive dysfunction
Description
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Time Frame
48 weeks
Title
Change in anxiety and depressive symptoms
Description
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Time Frame
8 weeks
Title
Change in anxiety and depressive symptoms
Description
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Time Frame
16 weeks
Title
Change in anxiety and depressive symptoms
Description
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Time Frame
24 weeks
Title
Change in anxiety and depressive symptoms
Description
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Time Frame
36 weeks
Title
Change in anxiety and depressive symptoms
Description
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Time Frame
48 weeks
Title
Change in overall health status
Description
Change in overall health status, assessed by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) compared to baseline.
Time Frame
8 weeks
Title
Change in overall health status
Description
Change in overall health status, assessed by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) compared to baseline.
Time Frame
16 weeks
Title
Change in overall health status
Description
Change in overall health status, assessed by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) compared to baseline.
Time Frame
24 weeks
Title
Change in overall health status
Description
Change in overall health status, assessed by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) compared to baseline.
Time Frame
36 weeks
Title
Change in overall health status
Description
Change in overall health status, assessed by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) compared to baseline.
Time Frame
48 weeks
Other Pre-specified Outcome Measures:
Title
Changes in anti-mitochondria antibody (AMA) titers
Description
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.
Time Frame
8 weeks
Title
Changes in anti-mitochondria antibody (AMA) titers
Description
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.
Time Frame
16 weeks
Title
Changes in anti-mitochondria antibody (AMA) titers
Description
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.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Silveira, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine - Digestive Diseases
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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