DepressionNCT05093816
Evaluating a Single-session Mental Health Intervention for UK University Students
A study testing Common Elements Toolbox in people with Depression and Anxiety, run by University of Pennsylvania.
Trial summary
The investigators are evaluating if an online single-session intervention, the Common Elements Toolbox (COMET) can improve mental health and wellbeing among UK university students. 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, 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
- 700 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2021to 1 Sep 2023
- 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
Who cannot join
- -
About this study
Official title: An Online Wellness Intervention for University Students: Investigating the Efficacy of The Common Elements Toolbox in the UK
The investigators are evaluating if an online single-session intervention, the Common Elements Toolbox (COMET) can improve mental health and wellbeing among UK university students.
- Conditions
- Depression, Anxiety, Happiness
- Being tested
- Common Elements Toolbox
- 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
The Common Elements Toolbox (COMET) is an online single-session intervention. It is entirely self-guided and lasts about 60 minutes. Participants complete a series of reading and writing exercises focused on four modules: cognitive restructuring, behavioral activation, gratitude, and self-compassion. The intervention is entirely unguided and completed in a single sitting.
| Study group | Role | What they receive |
|---|---|---|
| Common Elements Tooplbox | Experimental | Not described Receives: Behavioral: Common Elements Toolbox |
| Wait-list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
Measure of depressive symptoms. Scores range from 0-27, with higher scores indicating greater levels of depression.
Measured: Change from baseline to four weeks post-intervention
Generalized Anxiety Disorder 7-item Checklist (GAD-7)
Measure of anxiety symptoms. Scores range from 0-21, with higher scores indicating greater levels of anxiety.
Measured: Change from baseline to four weeks post-intervention
Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS).
Measure of wellbeing. Scores range from 7-35, with higher scores indicating greater well-being.
Measured: Change from baseline to four weeks post-intervention
Positive and Negative Affect Schedule
A measure of positive affect and negative affect. Scores on the positive affect subscale range from 10-50, with higher scores indicating greater positive affect. The negative affect subscale also ranges from 10-50, with greater scores indicating greater levels of negative affect.
Measured: Change from baseline to four weeks post-intervention
Acceptability of Intervention Measure (AIM)
Measure of acceptability. Scores range from 4-20, with higher scores indicating greater acceptability.
Measured: Post-intervention (immediately after participants complete the intervention)
Intervention Appropriateness Measure
Measure of appropriateness. Scores range from 4-20, with higher scores indicating greater appropriateness.
Measured: Post-intervention (immediately after participants complete the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start20 Oct 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bath
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093816
- Sponsor's protocol ID
- 21-212
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Wellness Intervention for University Students: Investigating the Efficacy of The Common Elements Toolbox in the UK
- ClinicalTrials.gov ID
- NCT05093816
- Acronym / sponsor ID
- 21-212
- Conditions
- Depression, Anxiety, Happiness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Bath
- Study start
- 20 Oct 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 26 Oct 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 if an online single-session intervention, the Common Elements Toolbox (COMET) can improve mental health and wellbeing among UK university students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common Elements Tooplbox | Experimental | Behavioral: Common Elements Toolbox |
| Wait-list control | 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
Key exclusion criteria (1 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 ToolboxThe Common Elements Toolbox (COMET) is an online single-session intervention. It is entirely self-guided and lasts about 60 minutes. Participants complete a series of reading and writing exercises focused on four modules: cognitive restructuring, behavioral activation, gratitude, and self-compassion. The intervention is entirely unguided and completed in a single sitting. | Behavioural | Common Elements Tooplbox |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from baseline to four weeks post-intervention
Measure of depressive symptoms. Scores range from 0-27, with higher scores indicating greater levels of depression.
Generalized Anxiety Disorder 7-item Checklist (GAD-7)
Time frame: Change from baseline to four weeks post-intervention
Measure of anxiety symptoms. Scores range from 0-21, with higher scores indicating greater levels of anxiety.
Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS).
Time frame: Change from baseline to four weeks post-intervention
Measure of wellbeing. Scores range from 7-35, with higher scores indicating greater well-being.
Positive and Negative Affect Schedule
Time frame: Change from baseline to four weeks post-intervention
A measure of positive affect and negative affect. Scores on the positive affect subscale range from 10-50, with higher scores indicating greater positive affect. The negative affect subscale also ranges from 10-50, with greater scores indicating greater levels of negative affect.
Acceptability of Intervention Measure (AIM)
Time frame: Post-intervention (immediately after participants complete the intervention)
Measure of acceptability. Scores range from 4-20, with higher scores indicating greater acceptability.
Intervention Appropriateness Measure
Time frame: Post-intervention (immediately after participants complete the intervention)
Measure of appropriateness. Scores range from 4-20, with higher scores indicating greater appropriateness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Common Elements Toolbox in people with Depression and Anxiety, run by University of Pennsylvania.
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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Change from baseline to four weeks post-intervention). The study lists 6 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 28 Oct 2021.