Depressive SymptomsNCT04815681
Evaluating an Online Wellness Intervention for Greek Adolescents
A study testing Common Elements Toolbox in people with Depressive Symptoms and Anxiety, run by University of Pennsylvania at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 13 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety, Happiness
- What is being tested?
- Common Elements Toolbox
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between 13 and 20 years old and a student at a participating Greek high school. Access to the internet.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Greece1 site
Eginition Hospital National and Kapodistrian University of Athens School of Medicine
Athens, 15121
About this study
Official title: Evaluating an Online Single-session Intervention for Mental Health and Wellness of Greek Adolescents
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
- Being tested
- Common Elements Toolbox, Active Control
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common Elements ToolboxBehavioural
Also called COMET
COMET is an online unguided self-help intervention that lasts approximately 40-50 minutes.
Active ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Common Elements Toolbox (COMET) | Experimental | Not described Receives: Behavioral: Common Elements Toolbox |
| Active Control Condition | Active comparator | Not described Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-8 (PHQ-8)
Depression questionnaire. Scores range from 0 to 24. Lower scores indicate less depression.
Measured: 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.
Measured: 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.
Measured: Up to 4 weeks post-intervention
Secondary outcomes (5)
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.
Measured: Immediately after the intervention
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.
Measured: Immediately after the intervention
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.
Measured: Up to 4 weeks post-intervention
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.
Measured: Immediately after intervention
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.
Measured: Up to 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study startMar 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: unable to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, University Mental Health, Neurosciences and Precision Medicine Research Institute "Costas Stefanis," Greece
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815681
- Sponsor's protocol ID
- 844481
- Status last verified
- Jun 2025
- First submitted
- 22 Mar 2021
- Last updated
- 11 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Online Single-session Intervention for Mental Health and Wellness of Greek Adolescents
- ClinicalTrials.gov ID
- NCT04815681
- Acronym / sponsor ID
- 844481
- Conditions
- Depressive Symptoms, Anxiety, Happiness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to enroll participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, University Mental Health, Neurosciences and Precision Medicine Research Institute "Costas Stefanis," Greece
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common Elements Toolbox (COMET) | Experimental | Behavioral: Common Elements Toolbox |
| Active Control Condition | Active comparator | Behavioral: Active Control |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Between 13 and 20 years old and a student at a participating Greek high school. Access to the internet.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Common Elements ToolboxAlso: COMETCOMET is an online unguided self-help intervention that lasts approximately 40-50 minutes. | Behavioural | Common Elements Toolbox (COMET) |
| Active ControlThe 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. | Behavioural | Active Control Condition |
Primary outcome
Change in Patient Health Questionnaire-8 (PHQ-8)
Time frame: Up to 4 weeks post-intervention
Depression questionnaire. Scores range from 0 to 24. Lower scores indicate less depression.
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
Time frame: Up to 4 weeks post-intervention
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Time frame: Up to 4 weeks post-intervention
Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
5 secondary outcomes
Ratings on the Acceptability of Intervention Measure (AIM)
Time frame: Immediately after the intervention
Ratings on the Intervention Appropriateness Measure (IAM)
Time frame: Immediately after the intervention
Secondary Control
Time frame: Up to 4 weeks post-intervention
Perceived Utility
Time frame: Immediately after intervention
Positive and Negative Affect Schedule (PANAS)
Time frame: Up to 4 weeks post-intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Common Elements Toolbox in people with Depressive Symptoms and Anxiety, run by University of Pennsylvania at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-8 (PHQ-8) (time frame: Up to 4 weeks post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.