DepressionNCT04740411
Online Wellness Intervention for College Students
A study testing The Common Elements Toolbox (COMET) in people with Depression and Anxiety, run by University of Pennsylvania at 1 site in United States.
Trial summary
We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with college students attending American universities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Well-being
- What is being tested?
- The Common Elements Toolbox (COMET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old and a student at a participating university. Access to the internet.
Who cannot join
- Cannot have participated in a previous version of COMET.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Akash Wasil
About this study
Official title: An Online Wellness Intervention for American College Students: Investigating the Efficacy of The Common Elements Toolbox
We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with college students attending American universities. Students will be randomized to the COMET condition or to a wait-list control condition.
- Conditions
- Depression, Anxiety, Well-being
- Being tested
- The Common Elements Toolbox (COMET)
- 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.
The Common Elements Toolbox (COMET)Behavioural
COMET is an online unguided self-help intervention that lasts approximately 60-80 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Common Elements Toolbox (COMET) | Experimental | Not described Receives: Behavioral: The Common Elements Toolbox (COMET) |
| Wait-list control condition | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Patient Health Questionnaire-9 (PHQ-9)
Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
Measured: Up to 8 weeks post-intervention
Change in the Generalized Anxiety Disorder Screener-7 (GAD-7)
Anxiety questionnaire. Total scores range from 0-21. Lower scores indicate less anxiety.
Measured: Up to 8 weeks post-intervention
Change in the Short Warwick-Edinburgh Mental Well-being Scale
Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
Measured: Up to 8 weeks post-intervention
Change in items from the PERMA Profiler (positive emotion and negative emotion subscales).
Well-being questionnaire with questions related to positive emotion, engagement, relationships, meaning, accomplishment, negative emotion, and health. Scores on each item range from 0 to 5. Lower scores indicate less well-being. We are using a shortened version of this questionnaire with 12 items. We have also modified the items to ask participants about their experiences over the past 48 hours. We predict that our intervention will produce changes in the positive emotion and negative emotion subscales. Each subscale consists of 3 items.
Measured: Up to 8 weeks post-intervention
Secondary outcomes (12)
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
Ability to Cope with COVID-19
2 questions related to their ability to cope with stressors over the past two weeks relating to the COVID-19 pandemic. Participants answered these questions on a 7-point Likert Scale, from "strongly disagree" to "strongly agree". Specifically, we asked participants: a) if they have been able to handle lifestyle changes due to the coronavirus and b) if the pandemic has had an extremely negative impact on their life.
Measured: Up to 8 weeks post-intervention
Change in Secondary Control
We administered three items to assess secondary control, derived from the Secondary Control Scale for Children (Weisz et al., 2010). The items are scored on a 4-point Likert scale, ranging from 0 ("Very false") to 3 ("Very true"). Scores on each item range from 0-4, with higher scores indicating more secondary control.
Measured: Up to 8 weeks post-intervention
Change in the Positive and Negative Affect Schedule
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 8 weeks post-intervention
Perceived Utility Ratings
Participants were asked to rate three items relating to the perceived utility of each module. Specifically, we asked participants: How helpful the module was How engaging the module was How much they will continue applying content from the module. Higher scores indicate greater perceived utility.
Measured: Immediately after the intervention
Change in the Perceived Stress Scale-4
Questionnaire measuring perceived stress. Scores range from 0-16, with higher scores indicating greater stress.
Measured: Up to 8 weeks post-intervention
Change in the Gratitude Adjective Checklist
Gratitude measure. Three items rated on a 1-5 scale with total scores ranging from 3-15. Higher scores indicate higher levels of gratitude.
Measured: Up to 8 weeks post-intervention
Change in the Self-kindness subscale of the Self-Compassion Scale
Self-compassion measure. We are using the 5-item self-kindness subscale. Participants will provide values ranging from 1 to 5. These values will be summed to create a total score on this scale ranging from 5 to 25, with higher scores representing higher levels of self-compassion.
Measured: Up to 8 weeks post-intervention
Change in Cognitive Restructuring
We administered three items to assess cognitive restructuring, derived from the cognitive reappraisal subscale of the Emotion Regulation Questionnaire. Scores range from 3-21, with higher scores representing a higher amount of cognitive restructuring.
Measured: Up to 8 weeks post-intervention
Change in items from the Behavioral Activation for Depression Scale
Behavioral Activation Measure. We selected 3 items from the BADS to use to assess changes in behavioral activation. The scores for these three items are summed to give a total score from 0-18. Higher scores represent higher levels of behavioral activation.
Measured: Up to 8 weeks post-intervention
Beck Hopelessness Scale
Hopelessness Questionnaire. Total score ranges from 0 to 4. Higher scores indicate less hope (more hopelessness).
Measured: Up to 8 weeks post-intervention
Change in module-specific skills
We are administering 4 items designed to detect cognitive or behavioral changes that relate to each intervention module.
Cognitive restructuring: "Over the past two weeks, I have been able to manage negative thoughts."
Behavior activation: "Over the past two weeks, I have intentionally spent time performing hobbies and activities that make me happy."
Gratitude: "Over the past two weeks, I have been able to focus my attention toward noticing and appreciating good things."
Self-compassion: "Over the past two weeks, I have been able to treat myself with empathy and compassion."
For each item, participants respond using a 7-point scale ranging from strongly disagree to strongly agree. Higher scores indicate favorable cognitions and behaviors related to each construct.
Measured: Up to 8 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 posted5 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, Ohio State University, University of Missouri, St. Louis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740411
- Sponsor's protocol ID
- 844589
- Status last verified
- May 2021
- First submitted
- 1 Feb 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Steinberg JS, Lorenzo-Luaces L, Wasil AR, Howard J, Murphy ST, Strunk DR, DeRubeis RJ. An online wellness intervention for internalizing symptoms in college students: A multi-site randomized controlled trial evaluating the efficacy of the Common Elements Toolbox (COMET). Behav Res Ther. 2026 Aug;203:105074. doi: 10.1016/j.brat.2026.105074. Epub 2026 May 14.
PubMed 42161216
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Wellness Intervention for American College Students: Investigating the Efficacy of The Common Elements Toolbox
- ClinicalTrials.gov ID
- NCT04740411
- Acronym / sponsor ID
- 844589
- Conditions
- Depression, Anxiety, Well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Indiana University, Ohio State University, University of Missouri, St. Louis
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 5 Feb 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.
We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with college students attending American universities. Students will be randomized to the COMET condition or to a wait-list control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common Elements Toolbox (COMET) | Experimental | Behavioral: The Common Elements Toolbox (COMET) |
| Wait-list control condition | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 18 years old and a student at a participating university. Access to the internet.
Key exclusion criteria (1 listed)
- Cannot have participated in a previous version of COMET.
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 |
|---|---|---|
| The Common Elements Toolbox (COMET)COMET is an online unguided self-help intervention that lasts approximately 60-80 minutes. | Behavioural | Common Elements Toolbox (COMET) |
Primary outcome
Change in the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Up to 8 weeks post-intervention
Depression questionnaire. Scores range from 0 to 27. Lower scores indicate less depression.
Change in the Generalized Anxiety Disorder Screener-7 (GAD-7)
Time frame: Up to 8 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
Time frame: Up to 8 weeks post-intervention
Subjective Well-being questionnaire. Total scores range from 7 to 35. Higher values indicate higher well-being scores.
Change in items from the PERMA Profiler (positive emotion and negative emotion subscales).
Time frame: Up to 8 weeks post-intervention
Well-being questionnaire with questions related to positive emotion, engagement, relationships, meaning, accomplishment, negative emotion, and health. Scores on each item range from 0 to 5. Lower scores indicate less well-being. We are using a shortened version of this questionnaire with 12 items. We have also modified the items to ask participants about their experiences over the past 48 hours. We predict that our intervention will produce changes in the positive emotion and negative emotion subscales. Each subscale consists of 3 items.
12 secondary outcomes
Ratings on the Acceptability of Intervention Measure (AIM)
Time frame: Immediately after the intervention
Ability to Cope with COVID-19
Time frame: Up to 8 weeks post-intervention
Change in Secondary Control
Time frame: Up to 8 weeks post-intervention
Change in the Positive and Negative Affect Schedule
Time frame: Up to 8 weeks post-intervention
Perceived Utility Ratings
Time frame: Immediately after the intervention
Change in the Perceived Stress Scale-4
Time frame: Up to 8 weeks post-intervention
Change in the Gratitude Adjective Checklist
Time frame: Up to 8 weeks post-intervention
Change in the Self-kindness subscale of the Self-Compassion Scale
Time frame: Up to 8 weeks post-intervention
Change in Cognitive Restructuring
Time frame: Up to 8 weeks post-intervention
Change in items from the Behavioral Activation for Depression Scale
Time frame: Up to 8 weeks post-intervention
Beck Hopelessness Scale
Time frame: Up to 8 weeks post-intervention
Change in module-specific skills
Time frame: Up to 8 weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Derived from this study: PubMed 42161216Steinberg JS, Lorenzo-Luaces L, Wasil AR, Howard J, Murphy ST, Strunk DR, DeRubeis RJ. An online wellness intervention for internalizing symptoms in college students: A multi-site randomized controlled trial evaluating the efficacy of the Common Elements Toolbox (COMET). Behav Res Ther. 2026 Aug;203:105074. doi: 10.1016/j.brat.2026.105074. Epub 2026 May 14.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Common Elements Toolbox (COMET) in people with Depression and Anxiety, run by University of Pennsylvania at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Akash Wasil, MA (631-766-9466, wasil@sas.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Patient Health Questionnaire-9 (PHQ-9) (time frame: Up to 8 weeks post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04740411, which also lists 1 linked publication.
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 14 May 2021; AzTrials last refreshed its copy on 29 Oct 2026.