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Clinical Trials/NCT04815681
NCT04815681
Withdrawn
Not Applicable

Evaluating an Online Single-session Intervention for Mental Health and Wellness of Greek Adolescents

University of Pennsylvania2 sites in 2 countries400 target enrollmentMarch 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
University of Pennsylvania
Enrollment
400
Locations
2
Primary Endpoint
Change in Patient Health Questionnaire-8 (PHQ-8)
Status
Withdrawn
Last Updated
10 months ago

Overview

Brief Summary

The investigators are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, the investigators are conducting a randomized controlled trial with Greek adolescents attending high school in the Attica region in Greece. Students will be randomized to the COMET condition or to an active control condition.

Primary outcome measures (depressive symptoms, anxiety symptoms, subjective well-being) will be measured at two weeks post-intervention and four weeks post-intervention.

The investigators 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
March 2021
End Date
December 2022
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Between 13 and 20 years old and a student at a participating Greek high school. Access to the internet.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Patient Health Questionnaire-8 (PHQ-8)

Time Frame: Up to 4 weeks post-intervention

Depression questionnaire. Scores range from 0 to 24. Lower scores indicate less depression.

Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)

Time Frame: Up to 4 weeks post-intervention

Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.

Change in Generalized Anxiety Disorder Screener-7 (GAD-7)

Time Frame: Up to 4 weeks post-intervention

Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.

Secondary Outcomes

  • Ratings on the Intervention Appropriateness Measure (IAM)(Immediately after the intervention)
  • Ratings on the Acceptability of Intervention Measure (AIM)(Immediately after the intervention)
  • Secondary Control(Up to 4 weeks post-intervention)
  • Perceived Utility(Immediately after intervention)
  • Positive and Negative Affect Schedule (PANAS)(Up to 4 weeks post-intervention)

Study Sites (2)

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