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Clinical Trials/NCT05093816
NCT05093816
Unknown
N/A

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

University of Pennsylvania0 sites700 target enrollmentOctober 20, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
University of Pennsylvania
Enrollment
700
Primary Endpoint
Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS).
Last Updated
4 years ago

Overview

Brief Summary

The investigators are evaluating if an online single-session intervention, the Common Elements Toolbox (COMET) can improve mental health and wellbeing among UK university students.

Registry
clinicaltrials.gov
Start Date
October 20, 2021
End Date
September 1, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • At least 18 years old

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS).

Time Frame: Change from baseline to four weeks post-intervention

Measure of wellbeing. Scores range from 7-35, with higher scores indicating greater well-being.

Generalized Anxiety Disorder 7-item Checklist (GAD-7)

Time Frame: Change from baseline to four weeks post-intervention

Measure of anxiety symptoms. Scores range from 0-21, with higher scores indicating greater levels of anxiety.

Patient Health Questionnaire-9 (PHQ-9)

Time Frame: Change from baseline to four weeks post-intervention

Measure of depressive symptoms. Scores range from 0-27, with higher scores indicating greater levels of depression.

Positive and Negative Affect Schedule

Time Frame: Change from baseline to four weeks post-intervention

A measure of positive affect and negative affect. Scores on the positive affect subscale range from 10-50, with higher scores indicating greater positive affect. The negative affect subscale also ranges from 10-50, with greater scores indicating greater levels of negative affect.

Intervention Appropriateness Measure

Time Frame: Post-intervention (immediately after participants complete the intervention)

Measure of appropriateness. Scores range from 4-20, with higher scores indicating greater appropriateness.

Acceptability of Intervention Measure (AIM)

Time Frame: Post-intervention (immediately after participants complete the intervention)

Measure of acceptability. Scores range from 4-20, with higher scores indicating greater acceptability.

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