Using Complementary and Alternative Medicine (CAM) to Promote Stress Resilience in Those With Co-Occurring Mild TBI and PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Trier Social Stress Test
研究概览
简要总结
The current study will assess the efficacy of acupressure, a type of complementary and alternative medicine (CAM) in the Veteran population. Veterans with co-occurring mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) will be consented and randomly assigned to either an active or placebo acupressure treatment series of 8 sessions. The investigators will determine if acupressure affects aspects of day-to-day function, such as memory, sleep, mood, psychiatric health and stress resilience. This information will help identify potential treatment strategies to improve quality of life and overall function in this particular Veteran 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18-60
- •Diagnosis of mild TBI and PTSD as assessed by interview and/or chart review
- •Currently receiving or eligible to receive physical and/or mental healthcare through the VA Eastern Colorado Health Care System
排除标准
- •History of other significant neurological disease (e.g., Alzheimer's, Parkinson's, multiple sclerosis etc.) as assessed by interview and/or chart review. Such conditions could affect outcome measures independently, thereby creating an experimental confound.
- •History or diagnosis of lifetime moderate to severe TBI, as assessed by interview and/or chart review.
- •History of psychotic disorder or bipolar I disorder as assessed by structured interview. Such conditions could affect outcome measures independently, thereby creating an experimental confound.
- •Inability to read the informed consent document or adequately respond to questions regarding the informed consent procedure.
- •Prior experience with acupressure, as this would result in individuals potentially being able to detect Placebo treatments if randomly assigned to that group.
结局指标
主要结局
Trier Social Stress Test
时间窗: 72 hours post final acupressure treatment
次要结局
未报告次要终点
研究者
Lisa Brenner
Director of MIRECC (Mental Illness Research, Education and Clinical Center
VA Eastern Colorado Health Care System