An Online Wellness Intervention for University Students

Study Overview
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Brief Summary
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The investigators want to understand the impact of a short online single session programme to improve well-being. Therefore, the investigators are investigating a self-help mental health intervention composed of four distinct modules, all designed to be completed within a single, 60-minute online session.Any university student in the UK can take part. Participants are randomly allocated to either: Complete the COMET programme (lasting about 60 minutes) and to practice the skills learned over the next few weeks. Participants are asked to fill out online questionnaires (10-15 minutes) at two points in the future: two weeks from baseline, and four weeks from baseline. Or Complete a few extra online questionnaires (lasting about 20-30 minutes), and fill out brief questionnaires (10-15 minutes) two weeks and four weeks later. After filling out the questionnaires in four weeks time, participants will then have the opportunity to complete the COMET programme (lasting about 60 minutes).

Detailed Description
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The study will use a randomised controlled trial (RCT) design, with a waiting list control (treatment as usual) group who will have the opportunity to access the intervention 4 weeks after randomisation. The intervention is digital and delivered online via Qualtrics. Participants will answer questions before completing the intervention, and at 2-week and 4-week follow-up. The single session intervention is expected to take < 1 hour to complete, with the research study components taking <20 minutes to complete.

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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Mental Health Wellness 1

Intervention / Treatment
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* Other: COMET-GB


Participation Criteria
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Eligibility Criteria
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The target population for this study are undergraduate and postgraduate students at UK universities. To be eligible to participate, an individual must be: (i) a registered undergraduate or postgraduate student at a university in the UK; and (ii) able to access the internet. Those who cannot access the internet will not be eligible, and neither will those who are under 16 years of age.

Ages Eligible for Study
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Minimum Age: 16 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
Interventional Model Description: Parallel groups (1:1 allocation) Randomised controlled trial (RCT) design, with a waiting list control group who will have the opportunity to access the intervention at the end of the follow-up period (i.e. 4 weeks after randomisation).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: COMET-GB<br>Online single session intervention via qualtrics (any internet connected device) based on cognitive and behavioural principles. | Other: COMET-GB<br>* Online self-guided single session intervention - comprised of 4 modules based on the core principles of CBT, combined with principles from positive psychology. Each module includes short reading exercises, informational videos, and writing exercises. Cognitive Restructuring (labelled Flexible Thinking) Behavioural Activation (labelled Positive Activities) Gratitude Self-Compassion The initial intervention modules and assessment will take participants approximately 60-75 minutes to complete (15-20 minutes for the assessment measures only).<br>|
| No Intervention: Waiting List Control<br>Participants in the control arm will be provided with information about sources of wellbeing support they can access and will also be asked to fill out additional questionnaires at baseline, which will act as a control for time spent completing online activities. These measures are a Symptom Importance Rating Questionnaire, the Chalder Fatigue Questionnaire [32], Pittsburgh Sleep Quality Index [33], Snaith-Hamilton Pleasure Scale [34], Fatigue Associated with Depression Scale [35]. These will not be completed by the intervention group nor reported as main outcomes on the RCT itself, but will be used in separate observational projects. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being | Warwick-Edinburgh Mental Well-being Scale (WEMWBS) - has 14 items that captures participants feelings and thoughts that best describe their experience over the previous 2 weeks using a scale from 1 to 5. Higher scores indicate better wellbeing. | 4 weeks post randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | Patient Health Questionnaire-9 (PHQ-9), a commonly used measure for depressive symptoms. The PHQ-9 has 9 items which capture the frequency of depressive symptoms over the preceding two weeks using a scale from 0-3. A score of 0-4 indicates no depression, 5-9 indicates mild depression, 10-14 indicates moderate depression, 15- 19 indicates moderately severe depression and 20-24 indicates severe depression. The PHQ-9 has a sensitivity and specificity of 88% for detecting clinical depression. | 2 weeks, 4 weeks post randomisation | 
| Anxiety symptoms | General Anxiety Disorder 7-item Checklist (GAD-7), a commonly used measure for symptoms of anxiety. The GAD-7 has 7 items which capture the frequency of anxious symptoms over the preceding two weeks using a scale from 0-3. A score of 0-4 indicates no anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety and ≥15 indicates severe anxiety. The GAD-7 has a sensitivity and specificity of 89% and 82% respectively. | 2 weeks, 4 weeks post randomisation | 
| Positive and negative affect | Positive and Negative Affect Schedule (PANAS), a commonly used measure of positive and negative affect. The PANAS has 20 items that captures participants feelings of positive and negative affect over the past week using a scale from 1 to 5. | 2 weeks, 4 weeks post randomisation | 
| Well-being | Warwick-Edinburgh Mental Well-being Scale (WEMWBS), a commonly used measure of well-being. The WEMWBS has 14 items that captures participants feelings and thoughts that best describe their experience over the previous 2 weeks using a scale from 1 to 5. Higher scores indicate better wellbeing. | 2 weeks post randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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university students, single session intervention, online, self-help, mental well-being