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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 Research1 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
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
否

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.

研究组 & 干预措施

Written Exposure Therapy

Active Comparator

Written exposure therapy (Sloan et al., 2012) is a brief evidence-based treatment for PTSD (US Dept. of VA & DoD, 2017), wherein patients are asked to write about their trauma memories for 30 minutes, with therapist instruction and feedback before and after each writing exercise.

干预措施: Written Exposure Therapy (Behavioral)

Imaginal Exposure Therapy

Active Comparator

Imaginal exposure therapy will involve verbal recounting of trauma memories for 30 minutes with therapist instruction and feedback before and after each recounting exercise.

干预措施: Imaginal Exposure Therapy (Behavioral)

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 (1)

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