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

Primary Purpose

Depression, Anxiety, Happiness

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Common Elements Toolbox
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • At least 18 years old

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Common Elements Tooplbox

    Wait-list control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Patient Health Questionnaire-9 (PHQ-9)
    Measure of depressive symptoms. Scores range from 0-27, with higher scores indicating greater levels of depression.
    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.
    Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS).
    Measure of wellbeing. Scores range from 7-35, with higher scores indicating greater well-being.
    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.
    Acceptability of Intervention Measure (AIM)
    Measure of acceptability. Scores range from 4-20, with higher scores indicating greater acceptability.
    Intervention Appropriateness Measure
    Measure of appropriateness. Scores range from 4-20, with higher scores indicating greater appropriateness.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2021
    Last Updated
    October 25, 2021
    Sponsor
    University of Pennsylvania
    Collaborators
    University of Bath
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05093816
    Brief Title
    Evaluating a Single-session Mental Health Intervention for UK University Students
    Official Title
    An Online Wellness Intervention for University Students: Investigating the Efficacy of The Common Elements Toolbox in the UK
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 20, 2021 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    September 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pennsylvania
    Collaborators
    University of Bath

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Anxiety, Happiness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    700 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Common Elements Tooplbox
    Arm Type
    Experimental
    Arm Title
    Wait-list control
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Common Elements Toolbox
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Patient Health Questionnaire-9 (PHQ-9)
    Description
    Measure of depressive symptoms. Scores range from 0-27, with higher scores indicating greater levels of depression.
    Time Frame
    Change from baseline to four weeks post-intervention
    Title
    Generalized Anxiety Disorder 7-item Checklist (GAD-7)
    Description
    Measure of anxiety symptoms. Scores range from 0-21, with higher scores indicating greater levels of anxiety.
    Time Frame
    Change from baseline to four weeks post-intervention
    Title
    Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS).
    Description
    Measure of wellbeing. Scores range from 7-35, with higher scores indicating greater well-being.
    Time Frame
    Change from baseline to four weeks post-intervention
    Title
    Positive and Negative Affect Schedule
    Description
    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.
    Time Frame
    Change from baseline to four weeks post-intervention
    Title
    Acceptability of Intervention Measure (AIM)
    Description
    Measure of acceptability. Scores range from 4-20, with higher scores indicating greater acceptability.
    Time Frame
    Post-intervention (immediately after participants complete the intervention)
    Title
    Intervention Appropriateness Measure
    Description
    Measure of appropriateness. Scores range from 4-20, with higher scores indicating greater appropriateness.
    Time Frame
    Post-intervention (immediately after participants complete the intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: At least 18 years old Exclusion Criteria: -

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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