Online Wellness Activities for Indian College Students
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 513
- Locations
- 2
- Primary Endpoint
- Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
Study 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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •At least 18 years old and a student at a participating university in India.
Exclusion Criteria
- Not provided
Arms & Interventions
Common Elements Toolbox (COMET)
The Common Elements Toolbox is an online intervention consisting of modules from empirically supported treatments for common mental health problems.
Intervention: Common Elements Toolbox (Behavioral)
Wait-list control condition
Intervention: Wait-list control (Behavioral)
Outcomes
Primary Outcomes
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
Time Frame: 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)
Time Frame: 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)
Time Frame: Up to 12 weeks post-intervention
Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
Secondary Outcomes
- 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)