Evaluating an Online Single-session Intervention for Mental Health and Wellness of Greek Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Change in Patient Health Questionnaire-8 (PHQ-8)
研究概览
简要总结
The investigators are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, the investigators are conducting a randomized controlled trial with Greek adolescents attending high school in the Attica region in Greece. Students will be randomized to the COMET condition or to an active control condition.
Primary outcome measures (depressive symptoms, anxiety symptoms, subjective well-being) will be measured at two weeks post-intervention and four weeks post-intervention.
The investigators will evaluate COMET as a universal intervention (using the full sample) and as a targeted intervention (analyzing those who reported elevated depressive symptoms or anxiety symptoms at baseline).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 13 and 20 years old and a student at a participating Greek high school. Access to the internet.
排除标准
- 未提供
结局指标
主要结局
Change in Patient Health Questionnaire-8 (PHQ-8)
时间窗: Up to 4 weeks post-intervention
Depression questionnaire. Scores range from 0 to 24. Lower scores indicate less depression.
Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
时间窗: Up to 4 weeks post-intervention
Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
时间窗: Up to 4 weeks post-intervention
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
次要结局
- Ratings on the Intervention Appropriateness Measure (IAM)(Immediately after the intervention)
- Ratings on the Acceptability of Intervention Measure (AIM)(Immediately after the intervention)
- Secondary Control(Up to 4 weeks post-intervention)
- Perceived Utility(Immediately after intervention)
- Positive and Negative Affect Schedule (PANAS)(Up to 4 weeks post-intervention)