Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis

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.

Study Overview

• Status: Completed
• Conditions: Autoimmune Hepatitis
• Intervention / Treatment: Behavioral: mindfulness based stress reduction

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Liver Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: All subjects; Individuals who are under the care of the Yale Liver Center with a diagnosis of autoimmune hepatitis

Behavioral: mindfulness based stress reduction; The intervention will be delivered in a group setting and the group will meet for 2 hours once per week for 8 weeks. The intervention is based on new neuroscience of stress and resilient adaptive behaviors, mindfulness based stress reduction, therapeutic breath and synchronized yogic movement with a focus on the lower abdomen, integrated with cognitive and behavioral strategies for self-control and healthy decision making.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Subjective Stress: The Perceived Stress Scale	Subjective Stress: The Perceived Stress Scale, a 14-item self-report scale that assesses the degree to which individuals appraise situations in their lives as stressful, will be used to assess subjective interpretation of stress and assign subjects to the low stress or high stress condition. Scale It has excellent test-retest reliability and good construct validity and has been used with adults and adolescents. Scale ranges from 0 to 40. A higher score indicates higher stress.	12 months
Change in Recent Life Stress: Life Experience Survey	The LES is a widely used 57 item self-report measure. It shows convergent validity with personality measures (e.g., anxiety) and is not correlated with social desirability measures. Scale ranges from -250 to +250. A higher score indicates higher stress.	12 months
Daily Hassles Questionnaire	This self-report item measures how stressful subjects perceived situations occurring in the past year of their life. Scale ranges from 0 to 351. A higher score indicates higher stress.	12 months
The Brief Self-Control Scale	The Brief Self-Control Scale will be used to measure self-reported self-control and impulsivity. The BSCS also shows good internal consistency (alphas = .83 - .84) and high retest reliability (.87). Scale ranges from 13-65. A higher score indicates better self-control.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ALT levels and IgG levels	Abnormal AST and ALT will be defined as >2x upper limits of normal Normal Lab ranges that will be used are the following: AST (0 - 34 U/L); ALT (0 - 34 U/L); IgG (355 - 1887 mg/dL) These levels are used together for clinical significance and diagnosis.	12 months
Change in average medication needed	E.g (changes in monthly prednisone dose)	12 months
Change in number of relapses	Relapse is defined in one of two ways once immunosuppression has been tapered off: I. An increase in the AST or ALT ≥2 X ULN (upper limit of normal) II. An increase in AST and/or ALT ≥ 2 X the prior level of AST or ALT on routine labs checked at start of clinical study	up to 2 years
Demonstration of MIF and CD74 have a role as a biomarker for disease activity	Demonstration of a correlation of serum MIF and CD74 levels with autoimmune hepatitis disease activity.	12 months

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: James Boyer, MD, Yale University; Study Director: David Assis, MD, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 14, 2017
• Primary Completion (ACTUAL): April 14, 2018
• Study Completion (ACTUAL): April 14, 2020

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (ESTIMATE): October 31, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Inflammation; Hepatitis; Hepatitis A; Hepatitis, Autoimmune
• Other Study ID Numbers: 2000020043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No