Clinical trial NCT05718141: An Online Wellness Intervention for University Students
Official title: An Online Wellness Intervention for University Students: Investigating the Efficacy of The Common Elements Toolbox in the UK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: university students
single session intervention
online
self-help
mental well-being
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: University of Reading
name: King's College London
name: University of Roehampton
name: University of Pennsylvania
name: Newcastle University
First posted: 2023-02-08
Enrollment: 346
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Well-being
timeFrame: 4 weeks post randomisation
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 2 weeks, 4 weeks post randomisation
measure: Anxiety symptoms
timeFrame: 2 weeks, 4 weeks post randomisation
measure: Positive and negative affect
timeFrame: 2 weeks, 4 weeks post randomisation
measure: Well-being
timeFrame: 2 weeks post randomisation
Other outcomes:
measure: Acceptability (intervention arm only)
timeFrame: Immediately post intervention
measure: Appropriateness (intervention arm only)
timeFrame: Immediately post intervention
Locations:
city: Bath
country: United Kingdom
facility: University of Bath
state: Banes
Study officials:
References: