Clinical trial NCT02950077: Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis
Official title: Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis - A Human Pilot Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autoimmune Hepatitis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Subjective Stress: The Perceived Stress Scale
timeFrame: 12 months
measure: Change in Recent Life Stress: Life Experience Survey
timeFrame: 12 months
measure: Daily Hassles Questionnaire
timeFrame: 12 months
measure: The Brief Self-Control Scale
timeFrame: 12 months
Secondary outcomes:
measure: Change in ALT levels and IgG levels
timeFrame: 12 months
measure: Change in average medication needed
timeFrame: 12 months
measure: Change in number of relapses
timeFrame: up to 2 years
measure: Demonstration of MIF and CD74 have a role as a biomarker for disease activity
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Liver Center
state: Connecticut
Study officials:
affiliation: Yale University
name: James Boyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: David Assis, MD
role: STUDY_DIRECTOR
References:
citation: Alrabadi LS, Dutton A, Rabiee A, Roberts SJ, Deng Y, Cusack L, Silveira MG, Ciarleglio M, Bucala R, Sinha R, Boyer JL, Assis DN. Mindfulness-based stress reduction may decrease stress, disease activity, and inflammatory cytokine levels in patients with autoimmune hepatitis. JHEP Rep. 2022 Feb 18;4(5):100450. doi: 10.1016/j.jhepr.2022.100450. eCollection 2022 May.