An Online Wellness Intervention for American College Students: Investigating the Efficacy of The Common Elements Toolbox
试验速览
- 阶段
- 不适用
- 入组人数
- 850
- 试验地点
- 2
- 主要终点
- Change in the Patient Health Questionnaire-9 (PHQ-9)
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 college students attending American universities. Students will be randomized to the COMET condition or to a wait-list control condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •At least 18 years old and a student at a participating university. Access to the internet.
排除标准
- •Cannot have participated in a previous version of COMET.
结局指标
主要结局
Change in the Patient Health Questionnaire-9 (PHQ-9)
时间窗: Up to 8 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
时间窗: Up to 8 weeks post-intervention
Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
Change in the Generalized Anxiety Disorder Screener-7 (GAD-7)
时间窗: Up to 8 weeks post-intervention
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
Change in items from the PERMA Profiler (positive emotion and negative emotion subscales).
时间窗: Up to 8 weeks post-intervention
Well-being questionnaire with questions related to positive emotion, engagement, relationships, meaning, accomplishment, negative emotion, and health. Scores on each item range from 0 to 5. Lower scores indicate less well-being. We are using a shortened version of this questionnaire with 12 items. We have also modified the items to ask participants about their experiences over the past 48 hours. We predict that our intervention will produce changes in the positive emotion and negative emotion subscales. Each subscale consists of 3 items.
次要结局
- Ratings on the Acceptability of Intervention Measure (AIM)(Immediately after the intervention)
- Ability to Cope with COVID-19(Up to 8 weeks post-intervention)
- Change in the Gratitude Adjective Checklist(Up to 8 weeks post-intervention)
- Change in module-specific skills(Up to 8 weeks post-intervention)
- Perceived Utility Ratings(Immediately after the intervention)
- Change in the Perceived Stress Scale-4(Up to 8 weeks post-intervention)
- Change in items from the Behavioral Activation for Depression Scale(Up to 8 weeks post-intervention)
- Change in Secondary Control(Up to 8 weeks post-intervention)
- Change in the Positive and Negative Affect Schedule(Up to 8 weeks post-intervention)
- Change in the Self-kindness subscale of the Self-Compassion Scale(Up to 8 weeks post-intervention)
- Change in Cognitive Restructuring(Up to 8 weeks post-intervention)
- Beck Hopelessness Scale(Up to 8 weeks post-intervention)