Autoimmune Hepatitis Clinical Trial
Official title:
Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis - A Human Pilot Study Protocol
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.
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.
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