Mindfulness-based Stress Reduction for Pediatric Mental Health
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Behavioral Assessment System for Children - 2nd Edition
研究概览
简要总结
Mindfulness-based stress reduction (MBSR) is a group program in which participants are taught to be mindful or present-focused. MBSR programs consist of instruction in a variety of mindfulness meditations including body scan, sitting meditation, mindful yoga, and discussion of these practices. Our study purpose is to develop and conduct a pilot mixed-methods randomized controlled trial (RCT), combining clinical outcomes, qualitative interviews, and brain imaging to assess the impact of the intervention on children with mental health challenges.
详细描述
This study will be a 2 arm controlled clinical trial (CCT) comparing usual care to usual care plus MBSR. Participants will be residents of a local inpatient treatment facility for adolescents with serious mental health issues. Outcomes the investigators will measure include mental health status as well as mindfulness. The investigators will also conduct qualitative interviews to assess the personal impact of the intervention on the patients and their families. In order to map and measure cognitive changes during MBSR the investigators will conduct brain imaging using functional magnetic resonance imaging (fMRI) and Event-Related Potential (ERP) recordings. Through this study the investigators will determine if MBSR is helpful to our population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the ages of 12 and 18
- •residents of study site
- •communication and comprehension of English
- •not currently abusing substances
排除标准
- •participants diagnosed with psychosis, as meditation has rarely been associated with precipitation of psychosis and/or psychotic episodes in individuals with pre-existing schizophrenia or significant thought disorders
结局指标
主要结局
Behavioral Assessment System for Children - 2nd Edition
时间窗: change from baseline at 10 weeks after start of intervention (or control period)
次要结局
- Child Acceptance and Mindfulness Measure (CAMM)(change from baseline 3 months after intervention is complete and same time frame for control group)
- EEG and fMRI(change from baseline at 10 weeks after start of intervention (or control period))
- Adverse events(at any stage during the study)
- Qualitative interview(12 weeks after start of intervention)
- Emotion regulation in childhood and adolescence(ERQ-CA)(change from baseline 3 months after intervention is complete and same time frame for control group)
- Behavioral Assessment System for Children - 2nd Edition(change from baseline 3 months after intervention is complete and same time frame for control group)
- Perceived Stress Scale (PSS)(change from baseline 3 months after intervention is complete and same time frame for control group)
研究者
Sunita Vohra
Professor
University of Alberta