Comparison of Mindfulness-Wellness Class Versus Brain Health Education in Veterans With mTBI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 3
- 主要终点
- Mayo-Portland Adaptability Inventory
研究概览
简要总结
This study is testing the usefulness of two types of Brain Health & Wellness classes for Veterans with a history of concussion to improve mental health.
详细描述
This is a pragmatic, randomized controlled trial of Mindfulness-based Stress Reduction (MBSR) in 120 Veterans with comorbid PTSD and chronic mTBI. Half of the participants are randomly assigned to MBSR and the other half, to a Brain Health education class, which serves as an active control group. A battery of standardized psychological and cognitive measures are administered prior to and following the class interventions to assess change in response to the intervention, with an additional 6-month follow-up assessment to test for lasting changes. The primary outcome measures include the Mayo-Portland Adaptability Inventory IV (functional outcome), PTSD Checklist (psychological outcome), and cognitive control test (cognitive outcome).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •chronic history (>6 months) of one or more mTBIs
- •current diagnosis of PTSD
- •at least one self-reported cognitive symptom
排除标准
- •no history of other neurologic disease (e.g., tumor, stroke, dementia, Parkinson's)
- •no history of major brain surgery
- •no history of moderate or severe TBI
- •no active alcohol or drug dependence or abuse within previous 30 days
- •no history of severe psychotic disorder (e.g., schizophrenia)
- •no current suicidal ideation/risk
- •no clinically severe medical illness requiring treatment
研究组 & 干预措施
Mindfulness-based Stress Reduction class
Mindfulness-based Stress Reduction (MBSR) is a 9-week class that meets 2.5 hours/week and involves training in mindfulness (being present in the moment), meditation, and yoga. The MBSR course is taught by a certified MBSR instructor.
干预措施: Mindfulness-based Stress Reduction class (Behavioral)
Brain Health Education Class
the Brain Health Education Class is a 9-week class that meets 2.5 hours/week and involves lectures/discussion about how the brain works, how the brain ages, neuroplasticity, and other topics on the brain.
干预措施: Brain Health Education class (Behavioral)
结局指标
主要结局
Mayo-Portland Adaptability Inventory
时间窗: Within 2 weeks post-intervention
Measure of Instrumental Activities of Daily Living with overall score of 0-111, with higher scores indicate greater impairment
次要结局
未报告次要终点