A Randomized Controlled Trial of a Self-Management App for Symptoms of Posttraumatic Stress: The Role of Coaching Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 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 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
- 否
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
研究组 & 干预措施
Renew with coaching
Users will be assigned a study staff member as a support person who is notified when the user engages with the app or if they have not engaged for 7 days. Support persons are provided with psychoeducation material including information about how to be an effective support person for the user and direct messaging capacity to respond to app notifications about user engagement (e.g., user earned X points, user achieved a new level).
干预措施: Renew (Behavioral)
Renew without coaching
Same as "Renew with coaching" except that the users will not be assigned a study staff member as a support person.
干预措施: Renew (Behavioral)
Wait list
No intervention is provided
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)