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
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.

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

University of Pennsylvania

Collaborators

University of Bath

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.

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