An Online Wellness Intervention for University Students

NCT05718141 | Completed

• 1 other identifier: COMET-GB
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

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. 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.
2. 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).

Conditions

Mental Health Wellness 1

Keywords

university students; single session intervention; online; self-help; mental well-being

Outcome Measures

Primary Outcomes (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.

  4 weeks post randomisation

Secondary Outcomes (4)

• Depressive symptoms

  2 weeks, 4 weeks post randomisation

• Anxiety symptoms

  2 weeks, 4 weeks post randomisation

• Positive and negative affect

  2 weeks, 4 weeks post randomisation

• Well-being

  2 weeks post randomisation

Other Outcomes (2)

• Acceptability (intervention arm only)

  Immediately post intervention

• Appropriateness (intervention arm only)

  Immediately post intervention

Study Arms (2)

Intervention: COMET-GB

EXPERIMENTAL

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

Other: COMET-GB

Waiting List Control

NO INTERVENTION

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.

Interventions

COMET-GB 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).

Intervention: COMET-GB

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Bath: lead
• University of Reading: collaborator
• King's College London: collaborator
• University of Roehampton: collaborator
• University of Pennsylvania: collaborator
• Newcastle University: collaborator

Study Sites (1)

University of Bath

Bath, Banes, BA2 7AY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39888663 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist, Reader in Clinical Psychology

Model Details: 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).

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: February 8, 2023
• Study Start: October 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: January 2024 - ongoing
• Access Criteria: Proof of researcher status.

Locations

GB (1)