Primary Biliary CholangitisNCT03684187

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

A study testing Mindfulness Based Intervention in people with Primary Biliary Cholangitis, run by Yale University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Primary Biliary Cholangitis
What is being tested?: Mindfulness Based Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 19 Nov 2018to 17 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Yale School of Medicine - Digestive Diseases
New Haven, Connecticut, 06510

Other trials in United States

About this study

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

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).

Read the 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.

Conditions: Primary Biliary Cholangitis
Being tested: Mindfulness Based Intervention
Medical subject headings: Liver Cirrhosis, Biliary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness Based InterventionBehavioural
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.

Study groups in NCT03684187
Study group	Role	What they receive
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. Receives: Behavioral: Mindfulness Based Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 16 weeks

Secondary outcomes (38)

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.
Measured: 8 weeks
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.
Measured: 24 weeks
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.
Measured: 36 weeks
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.
Measured: 48 weeks
Change in measurements of physical activity
Change in measurements of physical activity, measured by BodyGuard compared to baseline.
Measured: 2 weeks
Change in measurements of physical activity
Change in measurements of physical activity, measured by BodyGuard compared to baseline.
Measured: 8 weeks
Change in measurements of physical activity
Change in measurements of physical activity, measured by BodyGuard compared to baseline.
Measured: 16 weeks
Change in measurements of physical activity
Change in measurements of physical activity, measured by BodyGuard compared to baseline.
Measured: 48 weeks
Change in daytime somnolence
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Measured: 8 weeks
Change in daytime somnolence
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Measured: 16 weeks
Change in daytime somnolence
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Measured: 24 weeks
Change in daytime somnolence
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Measured: 36 weeks
Change in daytime somnolence
Change in daytime somnolence, assessed using the Epworth Sleepiness Scale (ESS) compared to baseline.
Measured: 48 weeks
Change in vasomotor autonomic symptoms
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Measured: 8 weeks
Change in vasomotor autonomic symptoms
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Measured: 16 weeks
Change in vasomotor autonomic symptoms
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Measured: 24 weeks
Change in vasomotor autonomic symptoms
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Measured: 36 weeks
Change in vasomotor autonomic symptoms
Change in vasomotor autonomic symptoms assessed by the Orthostatic Grading Scale (OGS) compared to baseline.
Measured: 48 weeks
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.
Measured: 8 weeks
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.
Measured: 16 weeks
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.
Measured: 24 weeks
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.
Measured: 36 weeks
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.
Measured: 48 weeks
Change in cognitive dysfunction
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Measured: 8 weeks
Change in cognitive dysfunction
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Measured: 16 weeks
Change in cognitive dysfunction
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Measured: 24 weeks
Change in cognitive dysfunction
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Measured: 36 weeks
Change in cognitive dysfunction
Change in cognitive dysfunction assessed by the Cognitives Failures (COGFAIL) questionnaire compared to baseline.
Measured: 48 weeks
Change in anxiety and depressive symptoms
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Measured: 8 weeks
Change in anxiety and depressive symptoms
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Measured: 16 weeks
Change in anxiety and depressive symptoms
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Measured: 24 weeks
Change in anxiety and depressive symptoms
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Measured: 36 weeks
Change in anxiety and depressive symptoms
Change in anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS) compared to baseline.
Measured: 48 weeks
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.
Measured: 8 weeks
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.
Measured: 16 weeks
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.
Measured: 24 weeks
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.
Measured: 36 weeks
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.
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 201817 Apr 2023

First posted25 Sep 2018
Study start19 Nov 2018
Primary completion26 Jun 2019
Study completion17 Apr 2023

Why it stopped: Unable to recruit and change in funding status.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03684187
Sponsor's protocol ID: 2000022299
Status last verified: May 2025
First submitted: 21 Sep 2018
Last updated: 25 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
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RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
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RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis

All Primary Biliary Cholangitis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis: A Pilot Study
ClinicalTrials.gov ID: NCT03684187
Acronym / sponsor ID: 2000022299
Conditions: Primary Biliary Cholangitis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unable to recruit and change in funding status.
Enrolment: 6 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: American Liver Foundation
Study start: 19 Nov 2018 (actual)
Primary completion: 26 Jun 2019 (actual)
Study completion: 17 Apr 2023 (actual)
First posted: 25 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Stress in Control for Healthy Liver (SynC-HL) Intervention:	Experimental	Behavioral: Mindfulness Based InterventionThis mindfulness based intervention to target healthy liver focuses on teaching skills of mindfulness, yoga and self-control to improve lifestyle choices and decision making.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness Based InterventionMindfulness - 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.	Behavioural	Stress in Control for Healthy Liver (SynC-HL) Intervention:

Primary outcome

Change in fatigue severity
Time frame: 16 weeks
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

38 secondary outcomes

Change in fatigue severity
Time frame: 8 weeks
Change in fatigue severity
Time frame: 24 weeks
Change in fatigue severity
Time frame: 36 weeks
Change in fatigue severity
Time frame: 48 weeks
Change in measurements of physical activity
Time frame: 2 weeks
Change in measurements of physical activity
Time frame: 8 weeks
Change in measurements of physical activity
Time frame: 16 weeks
Change in measurements of physical activity
Time frame: 48 weeks
Change in daytime somnolence
Time frame: 8 weeks
Change in daytime somnolence
Time frame: 16 weeks
Change in daytime somnolence
Time frame: 24 weeks
Change in daytime somnolence
Time frame: 36 weeks
Change in daytime somnolence
Time frame: 48 weeks
Change in vasomotor autonomic symptoms
Time frame: 8 weeks
Change in vasomotor autonomic symptoms
Time frame: 16 weeks
Change in vasomotor autonomic symptoms
Time frame: 24 weeks
Change in vasomotor autonomic symptoms
Time frame: 36 weeks
Change in vasomotor autonomic symptoms
Time frame: 48 weeks
Change in functional status
Time frame: 8 weeks
Change in functional status
Time frame: 16 weeks
Change in functional status
Time frame: 24 weeks
Change in functional status
Time frame: 36 weeks
Improvement in functional status
Time frame: 48 weeks
Change in cognitive dysfunction
Time frame: 8 weeks
Change in cognitive dysfunction
Time frame: 16 weeks
Change in cognitive dysfunction
Time frame: 24 weeks
Change in cognitive dysfunction
Time frame: 36 weeks
Change in cognitive dysfunction
Time frame: 48 weeks
Change in anxiety and depressive symptoms
Time frame: 8 weeks
Change in anxiety and depressive symptoms
Time frame: 16 weeks
Change in anxiety and depressive symptoms
Time frame: 24 weeks
Change in anxiety and depressive symptoms
Time frame: 36 weeks
Change in anxiety and depressive symptoms
Time frame: 48 weeks
Change in overall health status
Time frame: 8 weeks
Change in overall health status
Time frame: 16 weeks
Change in overall health status
Time frame: 24 weeks
Change in overall health status
Time frame: 36 weeks
Change in overall health status
Time frame: 48 weeks

Results and safety

The study was stopped early (reason given: Unable to recruit and change in funding status.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.

Related trials for Primary Biliary Cholangitis

Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marina Silveira, MD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Intervention in people with Primary Biliary Cholangitis, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Unable to recruit and change in funding status.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fatigue severity (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03684187.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.