Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis - A Human Pilot Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in Subjective Stress: The Perceived Stress Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between ages 18-80 years
- •Diagnosis of Autoimmune Hepatitis Type I
排除标准
- •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
- •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
结局指标
主要结局
Change in Subjective Stress: The Perceived Stress Scale
时间窗: 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.
Daily Hassles Questionnaire
时间窗: 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
时间窗: 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.
Change in Recent Life Stress: Life Experience Survey
时间窗: 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.
次要结局
- Change in ALT levels and IgG levels(12 months)
- Demonstration of MIF and CD74 have a role as a biomarker for disease activity(12 months)
- Change in number of relapses(up to 2 years)
- Change in average medication needed(12 months)