Clinical Trials Logo
  1. Home
  2. Primary Biliary Cholangitis
  3. NCT03684187
  4. Details
NCT03684187 Clinical Trial

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

Primary Biliary Cholangitis Clinical Trial

Official title:
Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis: A Pilot Study

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT03684187
Other study ID # 2000022299
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date November 19, 2018
Est. completion date June 2025

Study information
Verified date September 2023
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Suspended
Enrollment 20
Est. completion date June 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Mindfulness Based Intervention
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.

Locations
Country Name City State
United States Yale School of Medicine - Digestive Diseases New Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Yale University American Liver Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Changes in anti-mitochondria antibody (AMA) titers Changes in anti-mitochondria antibody (AMA) titers, IL-1ß, IL-6, TNFa, leptin, cortisol, CRP, BDNF, MIF, CD74 levels and other pertinent biomarkers, compared to baseline. 8 weeks
Other Changes in anti-mitochondria antibody (AMA) titers Changes in anti-mitochondria antibody (AMA) titers, IL-1ß, IL-6, TNFa, leptin, cortisol, CRP, BDNF, MIF, CD74 levels and other pertinent biomarkers, compared to baseline. 16 weeks
Other Changes in anti-mitochondria antibody (AMA) titers Changes in anti-mitochondria antibody (AMA) titers, IL-1ß, IL-6, TNFa, leptin, cortisol, CRP, BDNF, MIF, CD74 levels and other pertinent biomarkers, compared to baseline. 48 weeks
Primary 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 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. 8 weeks
Secondary 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. 24 weeks
Secondary 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. 36 weeks
Secondary 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. 48 weeks
Secondary Change in measurements of physical activity Change in measurements of physical activity, measured by BodyGuard compared to baseline. 2 weeks
Secondary Change in measurements of physical activity Change in measurements of physical activity, measured by BodyGuard compared to baseline. 8 weeks
Secondary Change in measurements of physical activity Change in measurements of physical activity, measured by BodyGuard compared to baseline. 16 weeks
Secondary Change in measurements of physical activity Change in measurements of physical activity, measured by BodyGuard compared to baseline. 48 weeks
Secondary Change in daytime somnolence Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline. 8 weeks
Secondary Change in daytime somnolence Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline. 16 weeks
Secondary Change in daytime somnolence Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline. 24 weeks
Secondary Change in daytime somnolence Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline. 36 weeks
Secondary Change in daytime somnolence Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline. 48 weeks
Secondary Change in vasomotor autonomic symptoms Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline. 8 weeks
Secondary Change in vasomotor autonomic symptoms Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline. 16 weeks
Secondary Change in vasomotor autonomic symptoms Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline. 24 weeks
Secondary Change in vasomotor autonomic symptoms Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline. 36 weeks
Secondary Change in vasomotor autonomic symptoms Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline. 48 weeks
Secondary 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. 8 weeks
Secondary 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. 16 weeks
Secondary 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. 24 weeks
Secondary 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. 36 weeks
Secondary 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. 48 weeks
Secondary Change in cognitive dysfunction Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline. 8 weeks
Secondary Change in cognitive dysfunction Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline. 16 weeks
Secondary Change in cognitive dysfunction Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline. 24 weeks
Secondary Change in cognitive dysfunction Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline. 36 weeks
Secondary Change in cognitive dysfunction Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline. 48 weeks
Secondary Change in anxiety and depressive symptoms Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline. 8 weeks
Secondary Change in anxiety and depressive symptoms Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline. 16 weeks
Secondary Change in anxiety and depressive symptoms Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline. 24 weeks
Secondary Change in anxiety and depressive symptoms Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline. 36 weeks
Secondary Change in anxiety and depressive symptoms Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline. 48 weeks
Secondary 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. 8 weeks
Secondary 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. 16 weeks
Secondary 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. 24 weeks
Secondary 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. 36 weeks
Secondary 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. 48 weeks
See also
  Status Clinical Trial Phase
Completed NCT02516605 - A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients Phase 2
Recruiting NCT06051617 - Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis Phase 3
Recruiting NCT06060665 - IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA) Phase 3
Recruiting NCT05450887 - Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis Phase 3
Recruiting NCT05050136 - A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis Phase 2
Recruiting NCT04076527 - Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
Recruiting NCT05151809 - National Database on Primary Biliary Cholangitis
Recruiting NCT04950764 - An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) Phase 1
Completed NCT03545672 - Early Identification of Myocardial Impairment in PBC
Completed NCT06098027 - Study of [14C]CS0159 in China Healthy Subjects Phase 1
Active, not recruiting NCT04594694 - Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC Phase 2
Completed NCT03602560 - ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) Phase 3
Recruiting NCT04617561 - Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II Phase 4
Terminated NCT03092765 - Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid Phase 2
Completed NCT04604652 - Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis Phase 2
Recruiting NCT05919433 - Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
Completed NCT06309589 - The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis N/A
Withdrawn NCT05293938 - A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
Completed NCT05292872 - Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
Terminated NCT03742973 - A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA Phase 2