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临床试验/NCT02313818
NCT02313818已完成不适用

Variable-length Cognitive Processing Therapy for Combat-Related PTSD

Duke University2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2015年6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
发起方
入组人数
130
试验地点
2
主要终点
Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5)

研究概览

简要总结

The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment.

详细描述

The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment. The study seeks to determine if some service members would benefit from a longer or shorter dose of treatment (4-24 sessions), and to identify which individuals are likely to require more, less, or the standard number of treatment sessions to reach good end-state functioning. Predictors of length of therapy and treatment outcome will be examined. Specifically, we will evaluate factors related to internalizing/externalizing traits, cognitive flexibility, inability to inhibit dysfunctional cognitions, and readiness to change as they are related to the number of treatment sessions required to treat patients to the point of good end-state functioning. Additional outcomes including alcohol use, psychosocial functioning, physical health, and sleep also will be evaluated.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult male and female combat veterans who deployed in support of combat operations following 9/11
  • Diagnosis of PTSD determined by a Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
  • Speak and read English

排除标准

  • Current suicide or homicide risk meriting crisis intervention.
  • Active psychosis.
  • Moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires).
  • Local availability of fewer than 5 months
  • Late-phase Med Board status, awaiting percentages
  • Undergoing a chapter

研究组 & 干预措施

CPT-C

Experimental

Cognitive Processing Therapy-Cognitive Only (CPT-C) conducted twice weekly for 4-24 sessions based on good end state functioning.

干预措施: Cognitive Processing Therapy-Cognitive Only (Behavioral)

结局指标

主要结局

Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5)

时间窗: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment

PCL-5 measures symptoms of posttraumatic stress disorder in response to a specific stressor.

Change from baseline in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5)

时间窗: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment

is an updated version of the gold standard CAPS designed to assess the criteria for PTSD as defined by the DSM-5

次要结局

  • Change from baseline in depressive symptoms as measured by the Patient Health Questionnaire-9(Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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