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临床试验/NCT00108628
NCT00108628已完成不适用

7857 Cognitive - Behavioral Treatments for PTSD Sleep Disturbance

US Department of Veterans Affairs2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2004年4月最近更新:
适应症

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

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)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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