Evaluating an Online Wellness Intervention for Greek Adolescents

NCT ID: NCT04815681

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Depressive Symptoms Anxiety Happiness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Common Elements Toolbox (COMET)

Group Type EXPERIMENTAL

Common Elements Toolbox

Intervention Type BEHAVIORAL

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

Active Control Condition

Group Type ACTIVE_COMPARATOR

Active Control

Intervention Type 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.

Interventions

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Common Elements Toolbox

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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COMET

Eligibility Criteria

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Inclusion Criteria

* Between 13 and 20 years old and a student at a participating Greek high school. Access to the internet.
Minimum Eligible Age

13 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National and Kapodistrian University of Athens, Greece

UNKNOWN

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Eginition Hospital National and Kapodistrian University of Athens School of Medicine

Athens, , Greece

Site Status

Countries

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United States Greece

Other Identifiers

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844481

Identifier Type: -

Identifier Source: org_study_id

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