Autoimmune HepatitisNCT02950077
Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis
A study testing mindfulness based stress reduction in people with Autoimmune Hepatitis, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- mindfulness based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2017to 14 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between ages 18-80 years
- Diagnosis of Autoimmune Hepatitis Type I
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- mindfulness based stress reduction
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness based stress reductionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | Individuals who are under the care of the Yale Liver Center with a diagnosis of autoimmune hepatitis Receives: Behavioral: mindfulness based stress reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 12 months
Change in average medication needed
E.g (changes in monthly prednisone dose)
Measured: 12 months
Change in number of relapses
Relapse is defined in one of two ways once immunosuppression has been tapered off:
- 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
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start14 Apr 2017
- Primary completion14 Apr 2018
- Study completion14 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Boyer, MD, Principal investigator, Yale UniversityDavid Assis, MD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950077
- Sponsor's protocol ID
- 2000020043
- Status last verified
- Jun 2020
- First submitted
- 27 Oct 2016
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35434588
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis - A Human Pilot Study Protocol
- ClinicalTrials.gov ID
- NCT02950077
- Acronym / sponsor ID
- 2000020043
- Conditions
- Autoimmune Hepatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 14 Apr 2018 (actual)
- Study completion
- 14 Apr 2020 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Behavioral: mindfulness based stress reductionIndividuals who are under the care of the Yale Liver Center with a diagnosis of autoimmune hepatitis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between ages 18-80 years
- Diagnosis of Autoimmune Hepatitis Type I
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness based stress reductionThe 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. | Behavioural | All subjects |
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 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.
4 secondary outcomes
Change in ALT levels and IgG levels
Time frame: 12 months
Change in average medication needed
Time frame: 12 months
Change in number of relapses
Time frame: up to 2 years
Demonstration of MIF and CD74 have a role as a biomarker for disease activity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Derived from this study: PubMed 35434588Alrabadi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Boyer, MD principal investigator
Yale University
David Assis, MD study director
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness based stress reduction in people with Autoimmune Hepatitis, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subjective Stress: The Perceived Stress Scale (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02950077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.