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临床试验/NCT01009112
NCT01009112已完成不适用

Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
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)

研究组 & 干预措施

CBT for Insomnia

Experimental

Patients change their sleep times and habits in order to reduce alertness and "over thinking" when they are trying to sleep. This helps them learn how to sleep overnight in one solid block of time

干预措施: PTSD + IRT/CBT-I (Behavioral)

Imagery Rehearsal Therapy

Experimental

Patients "rescript" the narrative of a nightmare to eliminate the distressing elements and create a new pleasant dream scene. They then rehearse this scene in their imagination at least twice each day. This reduces the frequency and intensity of the target nightmare and often reduces other nightmares, too.

干预措施: PTSD + IRT/CBT-I (Behavioral)

Prolonged Exposure

Experimental

This behavioral treatment for PTSD involves 1) systematic and repeated exposure to objects and situations that are avoided due to trauma-related distress, 2) prolonged, repeated recounting of trauma memories through visualization, and 3)therapist-guided discussions of thoughts and emotions related to the exposure exercises. The goals of PE are to reduce the anxiety and distress elicited by trauma-related memories and situations, show patients these memories and situations are distinct from the trauma, and teach patients they can tolerate the distress caused by these memories and situations.

干预措施: PTSD + IRT/CBT-I (Behavioral)

Prolonged Exposure

Experimental

This behavioral treatment for PTSD involves 1) systematic and repeated exposure to objects and situations that are avoided due to trauma-related distress, 2) prolonged, repeated recounting of trauma memories through visualization, and 3)therapist-guided discussions of thoughts and emotions related to the exposure exercises. The goals of PE are to reduce the anxiety and distress elicited by trauma-related memories and situations, show patients these memories and situations are distinct from the trauma, and teach patients they can tolerate the distress caused by these memories and situations.

干预措施: PTSD + Supportive Care Therapy (Behavioral)

Suportive Care Therapy

Active Comparator

This is an active therapy where the focus of the intervention is on helping patients better understand their emotional response to their PTSD and sleep symptoms.

干预措施: PTSD + Supportive Care Therapy (Behavioral)

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

  • daytime (non-sleep) PTSD symptoms(pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment)
  • health-related quality of life(pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sean P.A. Drummond

Associate Professor

University of California, San Diego

研究点 (1)

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