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Evaluating an Online Wellness Intervention for Greek Adolescents

Primary Purpose

Depressive Symptoms, Anxiety, Happiness

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Common Elements Toolbox
Active Control
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depressive Symptoms

Eligibility Criteria

13 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • University of PennsylvaniaRecruiting
  • Eginition Hospital National and Kapodistrian University of Athens School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Common Elements Toolbox (COMET)

Active Control Condition

Arm Description

Outcomes

Primary Outcome Measures

Change in Patient Health Questionnaire-8 (PHQ-8)
Depression questionnaire. Scores range from 0 to 24. Lower scores indicate less depression.
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
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.

Secondary Outcome Measures

Ratings on the Acceptability of Intervention Measure (AIM)
Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate higher acceptability ratings.
Ratings on the Intervention Appropriateness Measure (IAM)
Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate higher appropriateness.
Secondary Control
The investigators will ask participants three items to assess secondary control (Weisz et al., 2010). The items are scored on a 4-point Likert scale, ranging from 0 ("Very false") to 3 ("Very true"). The three items are: When something bad happens, I can find a way to think about it that makes me feel better. After a really hard day, I can make myself feel better by remembering some good things that happened. When bad things happen to me that I can't control, there are lots of things I can do to feel better. Higher scores indicate greater secondary control.
Perceived Utility
Participants will be asked to rate three items relating to the perceived utility of each module. Specifically, the investigators asked participants: How helpful the module was; How engaging the module was; How much they will continue applying content from the module. If items are at least moderately correlated (r > .5) the investigators will combine them in a single measure of perceived utility. Higher scores indicate greater perceived utility.
Positive and Negative Affect Schedule (PANAS)
Questionnaire measuring positive affect and negative affect. Scores on the positive affect subscale range from 10-50, with higher scores representing higher levels of positive affect. Scores on the negative affect subscale range from 10-50, with lower scores representing lower levels of negative affect.

Full Information

First Posted
March 22, 2021
Last Updated
October 18, 2021
Sponsor
University of Pennsylvania
Collaborators
National and Kapodistrian University of Athens, Greece, University Mental Health, Neurosciences and Precision Medicine Research Institute "Costas Stefanis," Greece
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1. Study Identification

Unique Protocol Identification Number
NCT04815681
Brief Title
Evaluating an Online Wellness Intervention for Greek Adolescents
Official Title
Evaluating an Online Single-session Intervention for Mental Health and Wellness of Greek Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National and Kapodistrian University of Athens, Greece, University Mental Health, Neurosciences and Precision Medicine Research Institute "Costas Stefanis," Greece

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety, Happiness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Common Elements Toolbox (COMET)
Arm Type
Experimental
Arm Title
Active Control Condition
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Common Elements Toolbox
Other Intervention Name(s)
COMET
Intervention Description
COMET is an online unguided self-help intervention that lasts approximately 40-50 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-8 (PHQ-8)
Description
Depression questionnaire. Scores range from 0 to 24. Lower scores indicate less depression.
Time Frame
Up to 4 weeks post-intervention
Title
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
Description
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
Time Frame
Up to 4 weeks post-intervention
Title
Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Description
Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
Time Frame
Up to 4 weeks post-intervention
Secondary Outcome Measure Information:
Title
Ratings on the Acceptability of Intervention Measure (AIM)
Description
Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate higher acceptability ratings.
Time Frame
Immediately after the intervention
Title
Ratings on the Intervention Appropriateness Measure (IAM)
Description
Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate higher appropriateness.
Time Frame
Immediately after the intervention
Title
Secondary Control
Description
The investigators will ask participants three items to assess secondary control (Weisz et al., 2010). The items are scored on a 4-point Likert scale, ranging from 0 ("Very false") to 3 ("Very true"). The three items are: When something bad happens, I can find a way to think about it that makes me feel better. After a really hard day, I can make myself feel better by remembering some good things that happened. When bad things happen to me that I can't control, there are lots of things I can do to feel better. Higher scores indicate greater secondary control.
Time Frame
Up to 4 weeks post-intervention
Title
Perceived Utility
Description
Participants will be asked to rate three items relating to the perceived utility of each module. Specifically, the investigators asked participants: How helpful the module was; How engaging the module was; How much they will continue applying content from the module. If items are at least moderately correlated (r > .5) the investigators will combine them in a single measure of perceived utility. Higher scores indicate greater perceived utility.
Time Frame
Immediately after intervention
Title
Positive and Negative Affect Schedule (PANAS)
Description
Questionnaire measuring positive affect and negative affect. Scores on the positive affect subscale range from 10-50, with higher scores representing higher levels of positive affect. Scores on the negative affect subscale range from 10-50, with lower scores representing lower levels of negative affect.
Time Frame
Up to 4 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between 13 and 20 years old and a student at a participating Greek high school. Access to the internet.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akash Wasil
Phone
6317669466
Email
wasil@sas.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert DeRubeis, PhD
Facility Name
Eginition Hospital National and Kapodistrian University of Athens School of Medicine
City
Athens
ZIP/Postal Code
15121
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Bechraki
Email
anna.bxrk123@gmail.com
First Name & Middle Initial & Last Name & Degree
Marina Economou

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluating an Online Wellness Intervention for Greek Adolescents

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