A Randomized Controlled Study Comparing the Influence of a Mindfulness-based Stress Reduction Program vs. Routine Management on Psychological Variables and Biological Markers Related to Immuno-inflammation Associated With Psychological Stress in Caregivers of Patients With Severe Psychiatric Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- measurement of inflammation by analysis of US-CRP blood levels
研究概览
简要总结
The objective of this project is to study the influence of mindfulness meditation on psychological health (stress level, affects, emotions) and physical health parameters (rate of inflammatory markers in the blood, activity of white blood cells involved in immuno-inflammation) in caregivers of people with psychiatric disorders. This study will provide the objective scientific data required for the development of mindfulness meditation programs for psychiatric caregivers.
80 participants will be randomly assigned to one of the following two groups:
- 40 participants in the "Mindfulness" group who will attend mindfulness meditation sessions in addition to their standard follow-up
- 40 participants in the "Control" group who will have a standard follow-up The duration of participation is 12 months and includes 3 visits and 8 mindfulness-based meditation sessions for the "Mindfulness" group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who has given oral consent
- •adult patient
- •a caregiver of a person with a severe psychiatric disorder (schizophrenia, recurrent depression, bipolar disorder, obsessive-compulsive disorder)
排除标准
- •protected adult
- •patient not affiliated to the national health insurance system
- •pregnant, parturient or breastfeeding woman
- •person suffering from a severe psychiatric disorder indicating a state of decompensated stress (with risk of associated biological inflammatory disturbances)
- •person suffering from an inflammatory disease (autoimmune, infectious, neoplastic, cardio-vascular pathologies
研究组 & 干预措施
"Mindfulness" group
干预措施: stress reduction program based on mindfulness (Other)
"Mindfulness" group
干预措施: venipunctures (Biological)
Control group
Treatment as Usual
干预措施: venipunctures (Biological)
"Mindfulness" group
干预措施: psychometric questionnaires (Other)
Control group
Treatment as Usual
干预措施: psychometric questionnaires (Other)
结局指标
主要结局
measurement of inflammation by analysis of US-CRP blood levels
时间窗: Change from Baseline US-CRP blood levels at 3 and 12 months
measurement of lymphocyte activity Th1 Th2 Th17 Treg
时间窗: Change from Baseline lymphocytes activity Th1 Th2 Th17 Treg at 3 and 12 months
measurement of inflammation by analysis of IL-6 blood levels
时间窗: Change from Baseline IL-6 blood levels at 3 and 12 months
次要结局
未报告次要终点