Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis
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About
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.
Full description
With the understanding that autoimmune hepatitis has a relationship with psychological stress, the use of a strategy such as mindfulness stress based reduction (MBSR) may similarly have a substantial impact as seen in other disease conditions. The proposed hypothesis is that undergoing MBSR has potential to benefit patients with autoimmune hepatitis in relation to decreased relapse rate and ultimately improved quality of life.
The focus of this study is surrounding the possibility of psychosocial stress for relapse in AIH. The investigators, however, would like to also understand the role of serological testing at the time of these relapses and during states of psychosocial stress to demonstrate if the association can be found. During active disease activity or relapses of autoimmune hepatitis, there is an expected rise in alanine aminotransferase (ALT) and immunoglobulin G (IgG) levels. Demonstrating the correlation of ALT and IgG with disease status and possible improvement with stress modifications is also key for this proposed study.
Enrollment
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Volunteers
Inclusion criteria
- Between ages 18-80 years
- Diagnosis of Autoimmune Hepatitis Type I
Exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
21 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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