PTSD Coach Sweden: Evaluating a Self-help Mobile App for Posttraumatic Stress in a Community Sample
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
Individuals who experience potentially traumatic events might develop long-lasting mental health problems. Limitations to health care resources, particularly in the context of mass disasters, indicate that self-help interventions could serve as important complementary offers to people in need.
The aim of this study is to evaluate whether the Swedish version of the Swedish version of the PTSD Coach self-help smartphone application can reduce levels of posttraumatic stress and related difficulties. The study is a randomized controlled trial in which participants' levels of posttraumatic stress and related difficulties after three months use of PTSD Coach will be compared to a waitlist condition. Additionally, in order to better understand the interplay between app use and health status, participants in both groups will receive text messages in which they are asked to respond to a small number of very brief questions about specific behaviors and current health status for three weeks during the intervention period.
详细描述
A majority of humans experience a potentially traumatic event during their lifetime, and many experience more than one. These events are of overwhelming emotional nature and have the capacity to evoke intensive distress. For many people, the distress dissipates either spontaneously or with the help from professional supports over the course of a couple of weeks. However, a substantial minority of people go on to develop significant levels of posttraumatic stress.
Chronic posttraumatic stress is often experienced together with clinical levels of other forms of psychopathology such as depression or anxiety disorders and the chronic condition can become debilitating over many years. There are effective interventions, however, they are as of yet difficult to access.
An uncontrolled pilot study of the Swedish PTSD Coach smartphone app indicated favorable outcomes and feasibility of the intervention (Cernvall, Sveen, Johannesson, & Arnberg, 2018). The app includes four modules: psychoeducation, rating and monitoring of distress, information about help and support, and strategies to cope with distress. The app is designed to be used with or without internet connection and uses little space on the smartphone.
This study will investigate whether the Swedish version of the PTSD Coach self-help smartphone application is beneficial for people who experience elevated levels of posttraumatic stress after a potentially traumatic event. The study is a randomized controlled trial with two conditions. In the intervention condition, participants are allowed free use of the PTSD Coach smartphone app. The control group is a waitlist condition. The intervention will take place during three months and is powered to detect a between-group effect size at the post-intervention assessment of d=0.5.
This study will also use an intensive longitudinal data collection method within the intervention period in order to better understand the interplay between app use and health status. Participants in both groups will receive text messages in which they are asked to respond to six very brief questions about specific behaviors and current health status for three weeks during the intervention period.
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
- None
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
- •Age ≥ 18 years
- •Adequate Swedish language comprehension
- •Experienced a potentially traumatic event according to DSM-5 PTSD Criterion A during the past 2 years
- •At least mild forms of posttraumatic stress, i.e., PCL-5 total score ≥ 10
- •Access to smartphone able to run PTSD Coach app
排除标准
- •Positive screening for bipolar disorder, psychotic disorder, ongoing substance disorder, or severe suicidality according to Mini International Neuropsychiatric Interview version 7.0.0
- •current or planned psychological treatment within next three months
- •current use of medication that may influence psychological treatment
- •change in medication in the past months or planned changes within next three months
- •ongoing potential traumatic context (e.g., ongoing domestic violence)
研究组 & 干预措施
Intervention
Free access to the Swedish PTSD Coach smartphone app for three months.
干预措施: Swedish PTSD Coach smartphone app (Behavioral)
Waitlist
Delayed access to the Swedish PTSD Coach smartphone app. Access is given after post-intervention data collection at three months.
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: 3 months (post)
Self-report questionnaire for posttraumatic stress
次要结局
- Trimbos Questionnaire for Costs (TiC-P)(3 months (post intervention))
- PHQ-9(9 months (6 months after intervention end))
- PTSD Checklist for DSM-5(9 months (6 months after intervention end))
- WHODAS(9 months (6 months after intervention end))
- Patient Health Questionnaire for physical symptoms (PHQ-15)(3 months (post intervention))
- Patient Health Questionnaire (PHQ-9)(3 months (post intervention))
- WHO Disability Assessment Schedule 2.0 (WHODAS)(3 months (post intervention))
- TiC-P(9 months (6 months after intervention end))
- PHQ-15(9 months (6 months after intervention end))
- PTSD Checklist for DSM-5(6 months (3 months after intervention end))
- PHQ-9(6 months (3 months after intervention end))
- WHODAS(6 months (3 months after intervention end))
- TiC-P(6 months (3 months after intervention end))
- PHQ-15(6 months (3 months after intervention end))