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

NCT02950077 | Completed

• 1 other identifier: 2000020043
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Hepatitis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change in ALT levels and IgG levels

  12 months

• Change in average medication needed

  12 months

• Change in number of relapses

  up to 2 years

• Demonstration of MIF and CD74 have a role as a biomarker for disease activity

  12 months

Study Arms (1)

All subjects

EXPERIMENTAL

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

Behavioral: mindfulness based stress reduction

Interventions

mindfulness based stress reduction 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.

All subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between ages 18-80 years
• Diagnosis of Autoimmune Hepatitis Type I

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Liver Center

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

• 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.

  PMID: 35434588 DERIVED

MeSH Terms

Conditions

Hepatitis, Autoimmune

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• James Boyer, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• David Assis, MD

  Yale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: October 31, 2016
• Study Start: April 14, 2017
• Primary Completion: April 14, 2018
• Study Completion: April 14, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)