Feasibility and Acceptability of Stress Induction, Physiological Data Collection, and Mindfulness-Based Stress Reduction Among Combat Veterans With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Qualitative Interview Targeting Feasibility of MBSR
研究概览
简要总结
Investigators will recruit up to 20 veterans with PTSD. Participants will be randomized into two conditions: MBSR and Health and Wellness Education (HWE; control group). Participants will be randomized at a 1:1 ratio. Purpose of the study is to learn how mindfulness meditation may be helpful in treating PTSD. Participants will undergo 2 screening sessions, 8 weekly sessions of intervention (MBSR or HWE), 3 laboratory visits that will include completing survey questionnaires, stress test and recording of heart rate, blood pressure and breathing rate.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18-85yo)
- •Military veteran
- •Experiencing PTSD symptoms
- •Reading and speaking in English
- •Be able to travel to OHSU for three two-hour lab visits, 8 weekly intervention sessions and one long extended session, and a two- hour focus group
排除标准
- •Pregnancy
- •Severe untreated depression, cognitive impairment, or active suicidality*
- •Life-threatening or severely disabling medical conditions
- •Excessive use of alcohol, nicotine, or cannabis
研究组 & 干预措施
Mindfulness-Based Stress Reduction
干预措施: Mindfulness-Based Stress Reduction (MBSR) (Behavioral)
Health and Wellness Education
干预措施: Health and Wellness Education (HWE) (Behavioral)
结局指标
主要结局
Qualitative Interview Targeting Feasibility of MBSR
时间窗: 2 weeks post conclusion of intervention
Qualitative data generated via focus group interviews. Questions will include common barriers to completing the intervention and strategies utilized by participants to maximize adherence.
Qualitative Interview Targeting Acceptability of MBSR
时间窗: 2 weeks post conclusion of intervention. Data were not collected due to prematurely study closure due to PI change of career.
Qualitative data generated via focus group interviews. Questions will include ratings of the relevance of the content presented to participants' lives, as well as assessment of the method of presentation.
次要结局
- Psychological Resilience 1(Pre (week 0), mid (week 4), and post intervention (week 10). Data were not collected due to prematurely study closure due to PI change of career.)
- Blood Pressure Reactivity(Pre (week 0), mid (week 4), and post intervention (week 10).)
- PTSD Symptoms 1(Pre (week 0), mid (week 4), and post intervention (week 10).)
- Psychological Resilience 2(Pre (week 0), mid (week 4), and post intervention (week 10).)
- PTSD Symptoms(Pre (week 0), mid (week 4), and post intervention (week 10).)
研究者
Joshua Kaplan
Principal Investigator
Oregon Health and Science University