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临床试验/NCT01220401
NCT01220401已完成不适用

Efficacy of a Brief Nightmare Treatment for Veterans

University of Tulsa2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Past Week Nightmare Frequency

研究概览

简要总结

The purpose of this study is to find out what effects Exposure, Rescripting, and Relaxation Therapy (ERRT) has on nightmares and associated problems in veterans.

详细描述

The purpose of the proposed pilot study is to extend previous findings regarding the impact of a brief cognitive behavioral treatment for chronic nightmares by examining the emotional, cognitive, behavioral, and health-related changes following treatment. Experiencing a traumatic event may initiate or exacerbate the occurrence of nightmares. Indeed, sleep disturbance, including nightmares, is considered a hallmark of posttraumatic stress disorder (PTSD). Nightmares have been related to a variety of factors including stress, medications, trauma, and substance use. Among veterans, especially combat veterans or those reporting sexual assaults, symptoms of traumatic stress and nightmares are extremely common. Few studies have investigated the efficacy of nightmare treatment in a veteran population, and the impact of nightmare treatment on suicidal ideation has never been assessed.

Imagery Rehearsal Treatment (IRT) has received increased attention in the past decade for use with chronic nightmares. Studies suggest that the treatment is promising for the reduction of frequency and intensity of chronic nightmares in trauma exposed persons and may have a generalized impact on symptoms of posttraumatic stress disorder and depression and quality/quantity of sleep, although there is mixed evidence for sleep improvement among veterans. The principal investigator has completed two randomized controlled trials of a modified version of IRT, Exposure, Rescripting, and Relaxation Treatment (ERRT) and is currently conducting a third randomized controlled trial (Davis, 2008; Davis & Wright, 2007). The current randomized controlled trial is comparing ERRT to an active treatment (relaxation). Results demonstrated positive treatment response. Although these trials have included some veteran participants, veterans have not been studied as a group using this protocol. The purpose of this prospective study is to conduct a pre- and post-treatment comparison of suicidal ideation and posttraumatic, depressive, and health symptoms in a single group of veterans.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • veteran/military, 18+ years old, english proficiency, nightmares once per week, exposure to a criterion A traumatic event -

排除标准

  • under 18, psychotic illness, mental retardation, imminent suicidal intent

结局指标

主要结局

Past Week Nightmare Frequency

时间窗: pre, one week, two months

This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares). Higher values indicate more nightmares (worse outcome).

Number of Nights With Nightmares

时间窗: pre, one week, two months

This fill-in-the-blank variable assesses the number of nights the individual experienced nightmares in the past week (range = 0 - 7 nights). Higher values indicate more nights with nightmares (worse outcome).

Clinician Administered PTSD Scale

时间窗: pre, one week, two months

This semi-structured clinical interview assesses each of 17 DSM-IV-TR criteria for PTSD utilizing separate queries for frequency and severity on a 5-point scale (0 - 4). This study utilized the "FI/I2" rule, where frequency ratings of one or more and intensity ratings of two or more must be present in order for a symptom to count towards diagnosis. Total scores are comprised of the three factors (reexperiencing, avoidance, and hyperarousal), with 136 being the maximum. 0-19 = asymptomatic or few symptoms. 20-39 = mild PTSD, subthreshold. 40-59 = moderate PTSD at threshold. 60-79 = severe PTSD. 80+ = extreme PTSD.

次要结局

  • Beck Depression Inventory(Baseline, 1 week, 2 months)

研究者

发起方
University of Tulsa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanne Davis

PI

University of Tulsa

研究点 (2)

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