Evaluating an Online Wellness Intervention for Greek Adolescents

NCT04815681 | Withdrawn

• 1 other identifier: 844481
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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).

Conditions

Depressive Symptoms; Anxiety; Happiness

Outcome Measures

Primary Outcomes (3)

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

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

  Up to 4 weeks post-intervention

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

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

  Up to 4 weeks post-intervention

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

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

  Up to 4 weeks post-intervention

Secondary Outcomes (5)

• Ratings on the Acceptability of Intervention Measure (AIM)

  Immediately after the intervention

• Ratings on the Intervention Appropriateness Measure (IAM)

  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 Arms (2)

Common Elements Toolbox (COMET)

EXPERIMENTAL

Behavioral: Common Elements Toolbox

Active Control Condition

ACTIVE COMPARATOR

Behavioral: Active Control

Interventions

Common Elements Toolbox BEHAVIORAL

COMET is an online unguided self-help intervention that lasts approximately 40-50 minutes.

Also known as: COMET

Common Elements Toolbox (COMET)

Active Control BEHAVIORAL

The active control condition includes an online self-awareness program that lasts approximately 40-50 minutes. Participants in the control condition will receive access to the intervention after data collection for the study has been completed.

Active Control Condition

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National and Kapodistrian University of Athens, Greece: collaborator
• University Mental Health, Neurosciences and Precision Medicine Research Institute "Costas Stefanis," Greece: collaborator

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Eginition Hospital National and Kapodistrian University of Athens School of Medicine

Athens, 15121, Greece

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 25, 2021
• Study Start: March 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); GR (1)