Randomized Controlled Trial (RCT) to Evaluate the Efficacy of an Internet-based Self-help Program for People With Psychological Distress Due to Covid-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire (Löwe et al., 2002)
研究概览
简要总结
As part of the ROCO project, the University of Bern is investigating an online self-help program for people who are psychologically distressed due to the situation surrounding Covid-19. The ROCO program offers support in overcoming this psychological distress. ROCO stands for a 3-week online self-help program comprising 6 modules.
The aim of the study is to investigate the efficacy of an online self-help intervention for people with psychological distress due to the situation surrounding Covid-19. All participants will be randomized to one of two groups: The first group receives direct access to the online self-help intervention and the second group is a waiting control group that receives access to the program 3 weeks later. In both conditions additional care or treatment is allowed.
There are 4 assessments, which all take place online: baseline, post assessment (after 3 weeks) and two follow-up assessments (after 6 and 18 weeks). 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
- •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 a cut-off value of 4 points on the Brief Patient Health Questionnaire (PHQ-9; Löwe, Spitzer, Zipfel, & Herzog, 2002)
- •Be able to specify an emergency address in the event of an acute crisis
排除标准
- •Suicidal tendencies (SBQ-R Score ≥ 8)
- •Existence of a known diagnosis of a psychotic or bipolar disorder
结局指标
主要结局
Patient Health Questionnaire (Löwe et al., 2002)
时间窗: up to 18 weeks
9-item questionnaire assessing depressive symptoms
次要结局
- DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)(up to 18 weeks)
- UCLA Loneliness Scale (Döring & Bortz, 1993)(up to 18 weeks)
- Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018)(up to 18 weeks)
- ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)(at 3 weeks for experimental group and at 6 weeks for waiting control group)
- LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)(up to 18 weeks)
- Berner Verbitterungsinventar Kurzversion (Znoj, 2008)(up to 18 weeks)
- SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)(up to 18 weeks)
- Connor-Davidson Resilience Scale (Sarubin et al., 2015)(up to 18 weeks)
- SF-12: Short Form Health Survey (Ware et al., 1996)(up to 18 weeks)
- SUS: System Usability Scale (Brooke, 1996)(at 3 weeks for experimental group and at 6 weeks for waiting control group)
- Emotion regulation skills SEK-27 (Berking & Znoj, 2008)(up to 18 weeks)