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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis - A Human Pilot Study Protocol

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 Summary:

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.


Sponsor: Yale University

Current Primary Outcome:

  • Change in Subjective Stress: The Perceived Stress Scale [ Time Frame: 12 months ]

    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.

  • Change in Recent Life Stress: Life Experience Survey [ Time Frame: 12 months ]

    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.

  • Daily Hassles Questionnaire [ Time Frame: 12 months ]

    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.

  • The Brief Self-Control Scale [ Time Frame: 12 months ]

    The Brief Sel

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Change in ALT levels and IgG levels [ Time Frame: 12 months ]

      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.

    • Change in average medication needed [ Time Frame: 12 months ]
      E.g (changes in monthly prednisone dose)
    • Change in number of relapses [ Time Frame: up to 2 years ]

      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

    • Demonstration of MIF and CD74 have a role as a biomarker for disease activity [ Time Frame: 12 months ]
      Demonstration of a correlation of serum MIF and CD74 levels with autoimmune hepatitis disease activity.


    Original Secondary Outcome: Same as current

    Information By: Yale University

    Dates:
    Date Received: October 27, 2016
    Date Started: February 14, 2017
    Date Completion: April 2018
    Last Updated: April 25, 2017
    Last Verified: April 2017