7857 Cognitive - Behavioral Treatments for PTSD Sleep Disturbance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
The purpose of this study is to compare the effectiveness of two cognitive behavioral group psychotherapy interventions in controlling the subjective sleep disturbance in veterans with Post-traumatic Stress Disorder.
详细描述
Repetitive, stereotypical nightmares and insomnia commonly characterize post-traumatic stress disorder (PTSD). Identifying the pathophysiological mechanisms of disrupted sleep in PTSD has therefore assumed considerable clinical importance. We previously reported an increase in rapid eye movement activity (REM activity) during REM sleep (REMS) in Vietnam War combat veterans with PTSD, and this finding can be seen as consistent with the view that most, although not all, dreaming occurs during REMS and the repeated observation that REM activity correlates with the intensity of dream mentation. There is a growing body of evidence that post-traumatic nightmares can respond to psychological treatment interventions. Namely, a cognitive-behavioral technique entitled imagery rehearsal (IR) has been reported to be effective in the treatment of such nightmares in victims of crime and in women who have been sexually assaulted. In a small pilot study, it has also been reported to be effective in the treatment of Vietnam veterans with combat-related PTSD. The two objectives of this proposal are: 1. To compare, in a study with random assignment and a parallel group design, the effectiveness in controlling the subjective sleep disturbance in veterans with PTSD of IR and Sleep and Nightmare Management (SN), a psychological treatment that targets life stressors and problems with sleep hygiene that may exacerbate insomnia and nightmares. 2. In a subset of these subjects, to compare the effectiveness in reducing REM activity of IR and SN.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vietnam Combat Veteran
- •Diagnosis of combat-related PTSD
- •Stable psychotropic regimen for a minimum of three months
- •Experiences recurrent nightmares
排除标准
- •Bipolar disorder, delirium, dementia, amnestic and other cognitive disorders
- •Schizophrenia and other psychotic disorders
- •Substance abuse or dependence within the last six months
- •Untreated medical disorders known to impact sleep
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: Baseline and 1, 3, and 6 months post-treatment
Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers.
Weekly Number of Nightmares
时间窗: Baseline and 1, 3, and 6 months post-treatment
Weekly Nights With a Nightmare
时间窗: Baseline and 1, 3, and 6 months post-treatment
次要结局
- Pittsburgh Sleep Quality Index - Addendum(Baseline and 1, 3, and 6 months post-treatment)
- Nightmare Effects Survey(Baseline and 1, 3, and 6 months post-treatment)
- PTSD Military Checklist(Baseline and 1, 3, and 6 months post-treatment)
- Beck Depression Inventory(Baseline and 1, 3, and 6 months post-treatment)
- SF-36 Physical Component(Baseline and 1, 3, and 6 months post-treatment)
- SF-36 Mental Component(Baseline and 1, 3, and 6 months post-treatment)
- Clinician-Administered PTSD Scale (CAPS)(Baseline and 1 month post-treatment)
