Evaluating a Single-session Mental Health Intervention for UK University Students

Not Applicable

• Conditions: Happiness; Depression; Anxiety
• Interventions: Behavioral: Common Elements Toolbox

• Registration Number: NCT05093816
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-13
• Study Start: 2021-10-20
• Last Update Submitted: 2021-10-25
• Study First Posted: 2021-10-26
• Last Update Posted: 2021-10-28
• Primary Completion: 2022-10-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• At least 18 years old

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Common Elements Tooplbox	Common Elements Toolbox	-

Primary Outcome Measures

Name	Time	Method
Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS).	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)	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)	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	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	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)	Post-intervention (immediately after participants complete the intervention)	Measure of acceptability. Scores range from 4-20, with higher scores indicating greater acceptability.