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Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis

NCT02950077 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-07-02

No results posted yet for this study

Summary

The study is a 'pilot study' to assess the effect of a mindfulness-based stress reduction (MBSR) intervention on patients with autoimmune liver disease specifically autoimmune hepatitis type I. MBSR is a standardized intervention that has shown benefit in addiction disorders and other psychiatric disorders. There has been no study evaluating or showing the benefit of the use of MBSR in autoimmune liver disease. With published data showing the evidence of an association of stress and relapse in autoimmune hepatitis, it is hypothesized that such an intervention such as MBSR may have therapeutic effect in patients with autoimmune liver disease.

Conditions

  • Autoimmune Hepatitis

Interventions

BEHAVIORAL

mindfulness based stress reduction

The intervention will be delivered in a group setting and the group will meet for 2 hours once per week for 8 weeks. The intervention is based on new neuroscience of stress and resilient adaptive behaviors, mindfulness based stress reduction, therapeutic breath and synchronized yogic movement with a focus on the lower abdomen, integrated with cognitive and behavioral strategies for self-control and healthy decision making.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • James Boyer, MD · Yale University

  • David Assis, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-14
Primary Completion
2018-04-14
Completion
2020-04-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02950077 on ClinicalTrials.gov