An Online Wellness Intervention for University Students (COMET-GB)

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

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:

1. 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

2. 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).

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness 1
• Intervention / Treatment: Other: COMET-GB

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 346
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Banes
    • Bath, Banes, United Kingdom, BA2 7AY
      • University of Bath

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: COMET-GB; Online single session intervention via qualtrics (any internet connected device) based on cognitive and behavioural principles.	Other: COMET-GB; 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).
No Intervention: Waiting List Control; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability (intervention arm only)	Acceptability of Interventions Measure (AIM)	Immediately post intervention
Appropriateness (intervention arm only)	Intervention Appropriateness Measure (IAM)	Immediately post intervention

Collaborators and Investigators

• Sponsor: University of Bath
• Collaborators: King's College London; University of Pennsylvania; Newcastle University; University of Reading; University of Roehampton

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: university students; online; mental well-being; self-help; single session intervention
• Other Study ID Numbers: COMET-GB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared with other researchers on reasonable request.
• IPD Sharing Time Frame: January 2024 - ongoing
• IPD Sharing Access Criteria: Proof of researcher status.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No