Online Wellness Activities for Indian College Students
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 513
- 试验地点
- 2
- 主要终点
- Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
研究概览
简要总结
We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with Indian college students. Students will be randomized to the COMET condition or to a wait-list control condition.
Primary outcome measures (depressive symptoms, anxiety symptoms, and subjective well-being) will be measures at two weeks post-intervention, four weeks post-intervention, and twelve weeks post-intervention.
We 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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old and a student at a participating university in India.
排除标准
- 未提供
结局指标
主要结局
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
时间窗: Up to 12 weeks post-intervention
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
Change in Patient Health Questionnaire-9 (PHQ-9)
时间窗: Up to 12 weeks post-intervention
Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
时间窗: Up to 12 weeks post-intervention
Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
次要结局
- Perceived Utility(Immediately after the intervention)
- The Social Connectedness Scale(Up to 12 weeks post-intervention)
- Ratings on the Acceptability of Intervention Measure (AIM)(Immediately after the intervention)
- Ratings on the Intervention Appropriateness Measure (IAM)(Immediately after the intervention)
- Mechanisms of Change(Up to 12 weeks post-intervention)
- Secondary Control(Up to 12 weeks post-intervention)
- Ability to Cope with COVID-19(Up to 12 weeks post-intervention)
- Positive and Negative Affect Schedule(Up to 12 weeks post-intervention)
- Perceived Stress Scale-4(Up to 12 weeks post-intervention)