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

University of Bath

Status: Completed

Conditions: Mental Health Wellness 1

Treatments: Other: COMET-GB

Study type: Interventional

Funder types: Other

Identifiers

NCT05718141

COMET-GB

Details and patient eligibility

About

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).

Full 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.

Enrollment: 346 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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346 participants in 2 patient groups

Intervention: COMET-GB

Experimental group

Description:

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

Treatment:

Other: COMET-GB

Waiting List Control

No Intervention group

Description:

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.