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Clinical Trials/NCT05718141
NCT05718141
Completed
Not Applicable

An Online Wellness Intervention for University Students: Investigating the Efficacy of The Common Elements Toolbox in the UK

University of Bath1 site in 1 country346 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Health Wellness 1
Sponsor
University of Bath
Enrollment
346
Locations
1
Primary Endpoint
Well-being
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
February 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Maria Loades

Clinical Psychologist, Reader in Clinical Psychology

University of Bath

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Well-being

Time Frame: 4 weeks post randomisation

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.

Secondary Outcomes

  • 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)

Study Sites (1)

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