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

NCT ID: NCT02950077

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-14
• Study Completion Date: 2020-04-14

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.

Conditions

Autoimmune Hepatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All subjects

Individuals who are under the care of the Yale Liver Center with a diagnosis of autoimmune hepatitis

Group Type: EXPERIMENTAL

mindfulness based stress reduction

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Inadequate English proficiency
• Inability to read and/or write

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Boyer, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

David Assis, MD

Role: STUDY_DIRECTOR

Yale University

Locations

Yale Liver Center

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35434588 (View on PubMed)

Other Identifiers

2000020043

Identifier Type: -

Identifier Source: org_study_id