Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis
Completed · Not applicable
Conditions studied: Autoimmune Hepatitis
In brief
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.
Key facts
- Study ID
- NCT02950077
- Run by
- Yale University
- People needed
- 21
- Starts
- 2017-04-14
- Expected to finish
- 2020-04-14
- Last updated by the study team
- 2020-07-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Between ages 18-80 years
- Diagnosis of Autoimmune Hepatitis Type I
You may not qualify if…
- Medical
- Hospitalization in the last 30 days
- New immunosuppression agent started <6 weeks prior to study
- Patients with concurrent viral hepatitis and/or alcoholic liver disease
- Patients with decompensated cirrhosis (defined as ascites, encephalopathy, variceal hemorrhage)
- Patients with hepatocellular carcinoma
- Patients post-liver transplantation Psychological
- Any psychotic disorder or current psychiatric symptoms
- Attitudinal
- Inability to commit to program schedule and attendance of classes
- Physical
- Inability to physically attend classes; disability or physical impairment not included as an exclusion criteria Other
- Inadequate English proficiency
- Inability to read and/or write
Where it is running
- Yale Liver Center — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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