Evaluating a Single-session Mental Health Intervention for UK University Students

Study Overview
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Brief Summary
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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.

Official Title
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An Online Wellness Intervention for University Students: Investigating the Efficacy of The Common Elements Toolbox in the UK

Conditions
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Depression, Anxiety, Happiness

Intervention / Treatment
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* Behavioral: Common Elements Toolbox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Common Elements Tooplbox<br> | Behavioral: Common Elements Toolbox<br>* 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.<br>|
| No Intervention: Wait-list control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ-9) | Measure of depressive symptoms. Scores range from 0-27, with higher scores indicating greater levels of depression. | 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. | 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. | 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. | 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. | 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. | Post-intervention (immediately after participants complete the intervention) |