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Evaluating an Online Wellness Intervention for Greek Adolescents

NCT04815681 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-06-11

No results posted yet for this study

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

Interventions

BEHAVIORAL

Common Elements Toolbox

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

BEHAVIORAL

Active Control

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.

Sponsors & Collaborators

  • National and Kapodistrian University of Athens, Greece

    collaborator UNKNOWN

  • University Mental Health, Neurosciences and Precision Medicine Research Institute "Costas Stefanis," Greece

    collaborator UNKNOWN

  • University of Pennsylvania

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • United States
  • Greece

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04815681 on ClinicalTrials.gov