Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in fatigue severity
研究概览
简要总结
To assess the efficacy of mindfulness-based intervention (MBI) intervention in the treatment of moderate or severe fatigue in patients with primary biliary cholangitis (PBC).
详细描述
Aim 1: To assess the efficacy of mindfulness-based intervention (MBI) in the treatment of moderate or severe fatigue in patients with primary biliary cholangitis (PBC).
Hypothesis: MBI is feasible in PBC patients with fatigue and will result in improvement in symptoms of fatigue.
Aim 2: To assess the impact of MBI in physical activity levels, daytime somnolence, autonomic symptoms, functional status, cognitive dysfunction and anxiety and depressive symptoms of patients with PBC with moderate or severe fatigue.
Hypothesis: MBI will result in an improvement in physical activity levels, daytime somnolence, autonomic symptoms, functional status, cognitive dysfunction and anxiety and depressive symptoms in patients with PBC who have moderate or severe fatigue.
Aim 3: To evaluate the effects of MBI on candidate markers and/or cytokines of fatigue and physiological stress, including hepatic panel, antimitochondrial (AMA) titers, IL-1β, IL-6, TNFα, cortisol, leptin, CRP, BDNF, MIF, and CD74 levels and other relevant markers.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Biliary Cholangitis as defined by previously published criteria
- •On stable therapy with UDCA for at least 6 months before enrollment
- •Primary Biliary Cholangitis-40 fatigue domain score > 33
- •The ability to provide written consent
排除标准
- •A known medical condition or metabolic disorder sufficient to explain fatigue such as anemia, thyroid disease, renal failure, use of beta-blockers and untreated depression
- •Active drug or alcohol use or history of drug and/or stimulant abuse
- •History of psychosis
- •Modification of treatment for underlying PBC in the preceding six months
- •Other serious coexistent conditions such as pre-existing advanced malignancy or severe cardiopulmonary disease which would be expected to limit their life expectancy
- •Anticipated need for transplantation in one year (Mayo survival model <80% one-year survival without transplant) or MELD above 15
- •Recurrent variceal bleeding, presence of diuretic-resistant ascites, or spontaneous encephalopathy
- •Non-proficiency in English
结局指标
主要结局
Change in fatigue severity
时间窗: 16 weeks
Change in fatigue severity, assessed by the fatigue domain of the Primary Biliary Cholangitis-40 (PBC-40) questionnaire, of greater than 5 units at 16 weeks (end of MBI program) compared to baseline
次要结局
- Change in functional status(36 weeks)
- Change in fatigue severity(48 weeks)
- Change in vasomotor autonomic symptoms(48 weeks)
- Change in cognitive dysfunction(48 weeks)
- Change in measurements of physical activity(48 weeks)
- Change in daytime somnolence(48 weeks)
- Improvement in functional status(48 weeks)
- Change in anxiety and depressive symptoms(48 weeks)
- Change in overall health status(48 weeks)