Evaluating a Single-session Mental Health Intervention for UK University Students
October 25, 2021 updated by: University of Pennsylvania
An Online Wellness Intervention for University Students: Investigating the Efficacy of The Common Elements Toolbox in the UK
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
700
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least 18 years old
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Wait-list control
|
|
|
Experimental: Common Elements Tooplbox
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change from baseline to four weeks post-intervention
|
|
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.
|
Change from baseline to four weeks post-intervention
|
|
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.
|
Change from baseline to four weeks post-intervention
|
|
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.
|
Change from baseline to four weeks post-intervention
|
|
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.
|
Post-intervention (immediately after participants complete the intervention)
|
|
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.
|
Post-intervention (immediately after participants complete the intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 20, 2021
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
October 1, 2021
First Submitted That Met QC Criteria
October 13, 2021
First Posted (Actual)
October 26, 2021
Study Record Updates
Last Update Posted (Actual)
October 28, 2021
Last Update Submitted That Met QC Criteria
October 25, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.