Randomized Controlled Trial (RCT) to Evaluate the Efficacy and Cost-effectiveness of an Internet-based Self-help Program for People With Adjustment Problems After an Accident
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
研究概览
简要总结
In this study, people who suffer from adjustment problems after having experienced an accident will be randomized to one of two study groups. The first group receives access to the internet-based self-help intervention immediately. The second group is a waiting control group that receives access to the program 12 weeks later. In both conditions additional care or treatment is allowed. The aim of the study is to investigate the efficacy and cost-effectiveness of an internet-based self-help intervention for people with adjustment problems after an accident compared to a waiting list. There are 6 assessments, which all take place online: baseline, two between-measurements (after 4 and 8 weeks), post assessment (after 12 weeks) and two follow-up assessments (after 3 and 6 months). All participants from both groups are asked to fill out all assessments.
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
- •All participants must...
- •be at least 18 years old
- •give a declaration of consent to participate in the study
- •have access to the Internet
- •understand and master the German language to the degree that they understand the contents and instructions of the study
- •exceed the cut-off value for at least a mild psychological burden on the depression-anxiety stress scale (DASS- 21)
- •be able to specify an emergency address in the event of an acute crisis
- •have experienced and can specify an accident during a period of two weeks to two years prior to participation in the current study that lead to the conditions described above.
排除标准
- •Excluded are persons who...
- •show severe depressive symptoms (Beck depression inventory [BDI-II] > 29)
- •show suicidal tendencies (BDI-II Suicide item > 1)
- •have a known diagnosis of psychotic or bipolar disorder.
研究组 & 干预措施
Internet-based self-help
The self-help program consists of eight text- and video-based modules. All participants in this group receive immediate access to the self-help program. The program's self-management approach does not provide for regular support from a specialist. However, participants can contact the study team if they need or want additional help.
干预措施: Internet-based self-help (Behavioral)
Waiting control group
Access to internet-based intervention after 12 weeks.
结局指标
主要结局
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
时间窗: 7 minutes
21-item questionnaire assessing depression, anxiety and stress symptoms
次要结局
- LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)(3 minutes)
- BVI: Berner Verbitterungsinventar (Znoj, 2008)(3 minutes)
- TIC-P: Treatment inventory of Costs in Psychiatric Patients (Bouwmans et al., 2013)(20 minutes)
- FAB: Fragebogen Arbeit und Wohlbefinden (Abegglen et al., 2017)(5 minutes)
- BDI-II:Beck Depression Inventory (Beck et al., 1996; Margraf & Ehlers, 1998)(5-10 minutes)
- ADNM-20: Adjustment Disorder - New Module 20 (Lorenz et al., 2016)(6 minutes)
- SF-12: Short Form Health Survey (Ware et al., 1996)(5 minutes)
- ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)(2 minutes)
- SUS: System Usability Scale (Brooke, 1996)(3 minutes)
- SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)(3 minutes)