跳至主要内容
临床试验/NCT04000217
NCT04000217已完成不适用

A Randomized Control Trial Comparing Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy Delivered Online

Palo Alto Veterans Institute for Research2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)

研究概览

简要总结

The purpose of the study is to compare the efficacy of two different versions of a brief online exposure therapy program for PTSD: written versus verbal trauma narrative recounting in reducing PTSD symptom severity. Both treatments will be delivered through an interactive online program with coaching from a trained peer support specialist. Treatment will be a variable length, such that 4 to 8 sessions will be delivered, depending on each participants' rate of PTSD symptom recovery.

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 (Investigator)

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

  • Able to read/write English
  • Internet connection allowing stable access to the Vets Prevail website
  • A clinically significant PCL-5 score of 31 or above.

排除标准

  • A score on the suicidality item of the PHQ-9 of 3 or higher.

结局指标

主要结局

Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)

时间窗: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).

Self report measure of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate greater PTSD severity.

次要结局

  • Brief version of the difficulties in emotion regulation scale (DERS-16; Bjureberg et al,. 2016)(Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).)
  • Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001).(Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).)
  • Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)(Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).)

研究者

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

Carmen McLean

Principal Investigator

Palo Alto Veterans Institute for Research

研究点 (2)

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