An Online Wellness Intervention for University Students

NCT ID: NCT05718141

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-02-01

Brief 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).

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.

Conditions

Mental Health Wellness 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention: COMET-GB

Online single session intervention via qualtrics (any internet connected device) based on cognitive and behavioural principles.

Group Type: EXPERIMENTAL

COMET-GB

Intervention Type: OTHER

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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Reading

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: collaborator

University of Roehampton

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Newcastle University

OTHER

Sponsor Role: collaborator

University of Bath

OTHER

Sponsor Role: lead

Responsible Party

Dr Maria Loades

Clinical Psychologist, Reader in Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Bath

Bath, Banes, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39888663 (View on PubMed)

Other Identifiers

COMET-GB

Identifier Type: -

Identifier Source: org_study_id