Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- nightmares and insomnia symptoms
研究概览
简要总结
Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD), results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. This study will examine whether treatments specifically targeted at those sleep disorders can improve clinical outcomes and increase health-related quality of life in individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of life.
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
- Single (Outcomes Assessor)
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
- •1 or more deployments to OEF or OIF
- •Exposure to Trauma
- •Nightmares 2 or more times per week
- •Insomnia for 1 month or more
- •Live in greater San Diego County region
排除标准
- •Use of medications for sleep or nightmares in the past 2 weeks
- •Current enrollment in psychotherapy for PTSD
- •Current or recent substance or alcohol abuse or dependence
- •Other untreated sleep disorders (e.g., sleep apnea)
结局指标
主要结局
nightmares and insomnia symptoms
时间窗: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
次要结局
- health-related quality of life(pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment)
- daytime (non-sleep) PTSD symptoms(pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment)
研究者
Sean P.A. Drummond
Associate Professor
University of California, San Diego