Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 7/1/2018 |
| Start Date: | April 14, 2017 |
| End Date: | April 2019 |
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.
(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.
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.
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
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