Evaluating an Online Wellness Intervention for Greek Adolescents

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04815681
• Other study ID #: 844481
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: University of Pennsylvania
• Contact: Akash Wasil
• Phone: 6317669466
• Email: wasil[@]sas.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 20 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Happiness

Intervention

Behavioral:
• Common Elements Toolbox
COMET is an online unguided self-help intervention that lasts approximately 40-50 minutes.
• 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.

Locations

Country	Name	City	State
Greece	Eginition Hospital National and Kapodistrian University of Athens School of Medicine	Athens
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	National and Kapodistrian University of Athens, Greece, University Mental Health, Neurosciences and Precision Medicine Research Institute "Costas Stefanis," Greece

Countries where clinical trial is conducted

United States,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Immediately after the intervention
Secondary	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.	Immediately after the intervention
Secondary	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.	Up to 4 weeks post-intervention
Secondary	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.	Immediately after intervention
Secondary	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.	Up to 4 weeks post-intervention