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Mindfulness Based Intervention for Primary Biliary Cholangitis
N/A
Waitlist Available
Led By Marina Silveira, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if mindfulness exercises can help reduce severe tiredness in people with a liver disease called primary biliary cholangitis. The exercises aim to help patients manage stress better, which might make them feel less tired and more active.
Eligible Conditions
- Primary Biliary Cholangitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in anxiety and depressive symptoms
Change in cognitive dysfunction
Somnolence
+6 moreOther study objectives
Changes in anti-mitochondria antibody (AMA) titers
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Stress in Control for Healthy Liver (SynC-HL) Intervention:Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Based Intervention
2018
N/A
~150
Find a Location
Who is running the clinical trial?
American Liver FoundationUNKNOWN
Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,662 Total Patients Enrolled
Marina Silveira, MDPrincipal InvestigatorYale University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition like anemia, thyroid problems, kidney disease, or untreated depression that can cause fatigue.You currently use drugs or alcohol, or have a history of drug or stimulant abuse.You have ongoing bleeding from swollen blood vessels, fluid buildup in your abdomen that doesn't respond to medication, or sudden brain problems without an obvious cause.You have made changes to your treatment for primary biliary cholangitis (PBC) in the last six months.You have other serious health conditions, like advanced cancer or severe heart or lung disease, that may shorten your lifespan.You have been diagnosed with a liver disease called Primary Biliary Cholangitis based on specific medical criteria.You have a history of mental illness that includes experiencing hallucinations or delusions.
Research Study Groups:
This trial has the following groups:- Group 1: Stress in Control for Healthy Liver (SynC-HL) Intervention:
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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