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临床试验/NCT01800773
NCT01800773已完成不适用

Written Exposure Therapy for Post Traumatic Stress Disorder: A Randomized Noninferiority Trial

Boston University2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2013年3月9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
192
试验地点
2
主要终点
Clinician Administered PTSD Scale (CAPS)

研究概览

简要总结

Although evidence-based treatments for PTSD exist, a significant minority of individuals do not benefit from these treatments and many individuals to not seek treatment, citing barriers such as time commitment and expense of treatment. The goal of the proposed study is to establish an alternative PTSD treatment that is efficacious and efficient.

详细描述

Prior research has demonstrated that written exposure therapy (WET), is an efficient, well-tolerated, and efficacious treatment for PTSD. The proposed project takes the next step in establishing WET as an intervention for PTSD by examining whether WET is equally efficacious to an evidence-based treatment for PTSD. Using a randomized noninferiority controlled trial, 126 adults diagnosed with PTSD will be assigned to either WET or Cognitive Processing Therapy (CPT). Outcome data will be collected at baseline and 6-, 12-, 24-, 36- and 60-weeks post-first treatment session. The primary aim is to examine whether PTSD participants assigned to WET demonstrate PTSD symptom severity outcome that is noninferior to PTSD participants assigned to CPT. Secondary aims include examining whether expected treatment gains are sustained for both treatments and whether WET has a lower treatment dropout rate relative to CPT. Exploratory aims include examining moderators and mediators of WET and CPT. If the hypothesis that WET is noninferior to CPT is confirmed then a brief treatment option for PTSD will be established.

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

  • PTSD diagnosis
  • if taking psychotropic medication, on stable dose for 2 months
  • Ability to read and write in English

排除标准

  • not currently engaged in active PTSD treatment
  • no current diagnosis of substance dependence
  • no current diagnosis of psychosis

研究组 & 干预措施

Written Exposure Therapy

Experimental

Written exposure treatment is a 5 session treatment in which participants write about their trauma event in a specified manner.

干预措施: Written Exposure Therapy (Behavioral)

Cognitive Processing Therapy

Active Comparator

cognitive processing therapy will be included as the evidence-based treatment for PTSD in this study.

干预措施: Cognitive Processing Therapy (Behavioral)

结局指标

主要结局

Clinician Administered PTSD Scale (CAPS)

时间窗: change from baseline PTSD symptom severity at 36 weeks post first treatment session

Total score on the CAPS will be used to assess change in PTSD symptom severity from baseline (pre-treatment) until 36- weeks post first treatment session.

次要结局

  • treatment dropout(course of treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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