An Online Wellness Intervention for American College Students: Investigating the Efficacy of The Common Elements Toolbox
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- University of Pennsylvania
- Enrollment
- 850
- Locations
- 1
- Primary Endpoint
- Change in the Patient Health Questionnaire-9 (PHQ-9)
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 18 years old and a student at a participating university. Access to the internet.
Exclusion Criteria
- •Cannot have participated in a previous version of COMET.
Outcomes
Primary Outcomes
Change in the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 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
Time Frame: 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)
Time Frame: 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).
Time Frame: 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.
Secondary Outcomes
- 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)