跳至主要内容
临床试验/NCT04155736
NCT04155736已完成不适用

A Randomized Controlled Trial of a Self-Management App for Symptoms of Posttraumatic Stress: The Role of Coaching Support

Palo Alto Veterans Institute for Research2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年7月11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
100
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 this study is to evaluate the acceptability and efficacy of a self-guided behavioral health tool delivered by mobile app (called "Renew") for people who are experiencing symptoms of posttraumatic stress. This study also aims to determine the necessity of coaching support over and above support from peers, shedding light on the critical question of level of support resources needed to maintain mHealth app engagement.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Veterans 18 years or older
  • own an Android smart phone (as the app is only available for Android)
  • self-report having experiencing symptoms of posttraumatic stress (defined as a PCL-5 score of 31 or higher).

排除标准

  • 未提供

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: Approximately 10-weeks after participant enrollment

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

  • Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)(Approximately 10-weeks after participant enrollment)
  • A PTSD coping self-efficacy measure, developed following Bandura's (2006) guidelines(Approximately 10-weeks after participant enrollment)
  • Perceived helpfulness of Renew(Approximately 6-weeks after participant enrollment)
  • Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet, & Farley, (1988)(Approximately 10-weeks after participant enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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