Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis
Primary Purpose
Autoimmune Hepatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mindfulness based stress reduction
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Hepatitis
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
Sites / Locations
- Yale Liver Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All subjects
Arm Description
Individuals who are under the care of the Yale Liver Center with a diagnosis of autoimmune hepatitis
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
Change in average medication needed
E.g (changes in monthly prednisone dose)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02950077
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 14, 2017 (Actual)
Primary Completion Date
April 14, 2018 (Actual)
Study Completion Date
April 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All subjects
Arm Type
Experimental
Arm Description
Individuals who are under the care of the Yale Liver Center with a diagnosis of autoimmune hepatitis
Intervention Type
Behavioral
Intervention Name(s)
mindfulness based stress reduction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Subjective Stress: The Perceived Stress Scale
Description
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.
Time Frame
12 months
Title
Change in Recent Life Stress: Life Experience Survey
Description
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.
Time Frame
12 months
Title
Daily Hassles Questionnaire
Description
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.
Time Frame
12 months
Title
The Brief Self-Control Scale
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in ALT levels and IgG levels
Description
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.
Time Frame
12 months
Title
Change in average medication needed
Description
E.g (changes in monthly prednisone dose)
Time Frame
12 months
Title
Change in number of relapses
Description
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
Time Frame
up to 2 years
Title
Demonstration of MIF and CD74 have a role as a biomarker for disease activity
Description
Demonstration of a correlation of serum MIF and CD74 levels with autoimmune hepatitis disease activity.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Boyer, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Assis, MD
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
Yale Liver Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35434588
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.
Results Reference
derived
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Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis
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