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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05093816
• Other study ID #: 21-212
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: September 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years old

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Anxiety
• Depression
• Happiness

Intervention

Behavioral:
• Common Elements Toolbox
The Common Elements Toolbox (COMET) is an online single-session intervention. It is entirely self-guided and lasts about 60 minutes. Participants complete a series of reading and writing exercises focused on four modules: cognitive restructuring, behavioral activation, gratitude, and self-compassion. The intervention is entirely unguided and completed in a single sitting.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	University of Bath

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire-9 (PHQ-9)	Measure of depressive symptoms. Scores range from 0-27, with higher scores indicating greater levels of depression.	Change from baseline to four weeks post-intervention
Primary	Generalized Anxiety Disorder 7-item Checklist (GAD-7)	Measure of anxiety symptoms. Scores range from 0-21, with higher scores indicating greater levels of anxiety.	Change from baseline to four weeks post-intervention
Primary	Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS).	Measure of wellbeing. Scores range from 7-35, with higher scores indicating greater well-being.	Change from baseline to four weeks post-intervention
Primary	Positive and Negative Affect Schedule	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.	Change from baseline to four weeks post-intervention
Primary	Acceptability of Intervention Measure (AIM)	Measure of acceptability. Scores range from 4-20, with higher scores indicating greater acceptability.	Post-intervention (immediately after participants complete the intervention)
Primary	Intervention Appropriateness Measure	Measure of appropriateness. Scores range from 4-20, with higher scores indicating greater appropriateness.	Post-intervention (immediately after participants complete the intervention)