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
About this trial
This is an interventional treatment trial for Primary Biliary Cholangitis
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
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
NCT ID
NCT03684187
First Posted
September 21, 2018
Last Updated
September 1, 2023
Sponsor
Yale University
Collaborators
American Liver Foundation
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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