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临床试验/NCT02236390
NCT02236390已完成不适用

Integrating Sleep and PTSD Treatment: Examining the Role of Emotion Regulation

University of Tulsa2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年8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
90
试验地点
2
主要终点
Nightmare Frequency

研究概览

简要总结

The purpose of the proposed pilot study is to extend previous findings regarding the efficacy of a brief treatment for chronic posttrauma nightmares and sleep problems by integrating this treatment with evidence-based treatment for posttraumatic stress disorder (PTSD). Cognitive processing therapy (CPT) (Resick & Schnicke, 1996) is a well-established and efficacious evidence-based psychological treatment for PTSD in both civilian and veteran populations (Forbes et al., 2012; Monson et al., 2006; Resick et al., 2008; Resick, Nishith, Weaver, Astin, & Feuer, 2002). The U.S. Department of Veterans Affairs (VA) includes CPT among the first-line treatments for PTSD (National Center for PTSD, 2012). A modified protocol without the utilization of written exposure (CPT-C) may be more effective than the original protocol. However, despite such promising evidence, individuals who experience chronic nightmares and sleep problems tend to show smaller gains and persistent nightmares following PTSD treatment (Nappi, Drummond, & Hall, 2012). Given that nightmares are considered the hallmark of PTSD (Ross, Ball, Sullivan, & Caroff, 1989) and their treatment-resistant nature (Davis & Wright, 2007), specific psychological treatments have been developed to target sleep disturbances and nightmares.

Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. Though further evidence is needed, ERRT has exhibited strong support in reducing the frequency and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. In addition, significant decreases in PTSD and depression symptoms have been reported following treatment (Davis et al., 2011; Davis & Wright, 2007; Long et al., 2011; Swanson, Favorite, Horin, & Arnedt, 2009). ERRT is currently an evidence-level B suggested treatment (Cranston, Davis, Rhudy, & Favorite, 2011).

There is a call to research suggesting the importance of treatment studies which focus on interventions that integrate nightmare and sleep symptom treatment with evidence-based treatment for PTSD (Nappi et al., 2012). In an effort to respond to this call, we propose to tailor ERRT for use in conjunction with CPT, and preliminarily test ERRT's additive effect to CPT in treating PTSD in community outpatients. We hypothesize that ERRT would increase CPT's treatment efficacy by its specific focus on trauma-related nightmares and sleep disturbances. Sleep difficulties are known to increase tension, and reduce one's ability to cope adaptively (Bonn-Miller, Babson, Vujanovic, & Feldner, 2010; Hofstetter, Lysaker, & Mayeda, 2005; Nishith, Resick, & Mueser, 2001). Thus, with improved sleep an individual may have additional personal coping resources for which s/he can use to address the broader trauma issues (Nappi et al., 2012). To test this integration, we will compare ERRT + CPT, CPT + ERRT, and CPT alone.

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

入选标准

  • 18 Years of Age minimal
  • Experienced a trauma
  • One nightmare per week for past month, minimal
  • meet full criteria for PTSD

排除标准

  • 17 years of age or younger
  • acute psychosis
  • bipolar disorder
  • intellectual disability
  • active suicidality
  • untreated substance use disorder within past 6 months

结局指标

主要结局

Nightmare Frequency

时间窗: up to 6-months follow-up

A fill-in-the blank question (range = 0-X nightmares) from the Trauma Related Nightmare Survey will be utilized to determine the past week nightmare frequency at baseline, and 3 and 6 months follow-up. Higher values indicate more nightmares.

次要结局

  • Clinician Administered PTSD Scale(Past Month symptoms measured at baseline, and 3 and 6 month follow-up)

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

Professor

University of Tulsa

研究点 (2)

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