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Mental Health Wellness 1COMET-GBNCT05718141

An Online Wellness Intervention for University Students

A study testing COMET-GB in people with Mental Health Wellness 1, run by University of Bath at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health Wellness 1
What is being tested?
COMET-GB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
346 participants
Where
1 siteUnited Kingdom
Study dates
1 Oct 2021to 1 Feb 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 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University of Bath

    Bath, Banes, BA2 7AY

Other trials in United Kingdom

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 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).
Read the 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.

Being tested
COMET-GB
Keywords
university students, single session intervention, online, self-help, mental well-being
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COMET-GBOther

    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).

Study groups in NCT05718141
Study groupRoleWhat they receive
Intervention: COMET-GBExperimentalOnline single session intervention via qualtrics (any internet connected device) based on cognitive and behavioural principles.
Receives: Other: COMET-GB
Waiting List ControlNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 weeks post randomisation

Secondary outcomes (4)

  1. 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.

    Measured: 2 weeks, 4 weeks post randomisation

  2. 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.

    Measured: 2 weeks, 4 weeks post randomisation

  3. 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.

    Measured: 2 weeks, 4 weeks post randomisation

  4. 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.

    Measured: 2 weeks post randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start1 Oct 2021
  3. Primary completion1 Feb 2023
  4. Study completion1 Feb 2023

Resources

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
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
346 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05718141
Sponsor's protocol ID
COMET-GB
Acronym
COMET-GB
Status last verified
May 2023
First submitted
19 Dec 2022
Last updated
17 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared with other researchers on reasonable request.

Publications

  • Lambert J, Loades M, Marshall N, Higson-Sweeney N, Chan S, Mahmud A, Pile V, Maity A, Adam H, Sung B, Luximon M, MacLennan K, Berry C, Chadwick P. Investigating the Efficacy of the Web-Based Common Elements Toolbox (COMET) Single-Session Interventions in Improving UK University Student Well-Being: Randomized Controlled Trial. J Med Internet Res. 2025 Jan 31;27:e58164. doi: 10.2196/58164.

    PubMed 39888663

Questions about this trial

What is this clinical trial studying?

A study testing COMET-GB in people with Mental Health Wellness 1, run by University of Bath at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Well-being (time frame: 4 weeks post randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05718141, which also lists 1 linked publication.

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 17 May 2023.

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