An Online Wellness Intervention for University Students

Mental Health Wellness 1 Clinical Trial

— COMET-GB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05718141
• Other study ID #: COMET-GB
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2023
• Source: University of Bath
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	University of Bath	Bath	Banes

Sponsors (6)

Lead Sponsor	Collaborator
University of Bath	King's College London, Newcastle University, University of Pennsylvania, University of Reading, University of Roehampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability (intervention arm only)	Acceptability of Interventions Measure (AIM)	Immediately post intervention
Other	Appropriateness (intervention arm only)	Intervention Appropriateness Measure (IAM)	Immediately post intervention
Primary	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	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
Secondary	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
Secondary	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
Secondary	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