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Clinical Trials/NCT04592588
NCT04592588
Completed
Not Applicable

Online Wellness Activities for Indian College Students

University of Pennsylvania2 sites in 1 country513 target enrollmentOctober 19, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
University of Pennsylvania
Enrollment
513
Locations
2
Primary Endpoint
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
Status
Completed
Last Updated
2 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 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).

Registry
clinicaltrials.gov
Start Date
October 19, 2020
End Date
December 30, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • At least 18 years old and a student at a participating university in India.

Exclusion Criteria

  • Not provided

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)

Study Sites (2)

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