- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06154369
JoyPop Mobile Mental Health App With Post-Secondary Students
Promoting Mental Health and Wellbeing Among Post-secondary Students With the Joypop App: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Students within post-secondary education settings are presented with many exciting opportunities and challenges. However, this is a time when many students experience increasing stress, distress, and mental health difficulties. Many post-secondary education settings have identified student mental health and wellbeing as a priority and yet are struggling to adequately meet the needs of students. This has led to exploring whether technology can be used to help promote mental health and wellbeing among students. Mobile mental health applications (apps) are of particular interest given students' access and use of mobile devices. Despite the promise of mobile mental health apps, significant gaps exist between the growing number of apps available in the public domain and empirical demonstration of the beneficial impacts of apps for users.
The JoyPop app is one mobile mental health app with a growing evidence base. It was developed to support improved emotion regulation - a key challenge among students struggling with distress and mental health difficulties. Of the apps that address emotion regulation, most have not been evaluated, are narrow in scope, or have only been evaluated among non-diverse adult populations. The JoyPop app includes a broader focus, and this research is unique given its focus on rigorously evaluating the JoyPop app as a tool for students within post-secondary settings.
Using a randomized controlled trial (RCT) design, the primary objective is to determine the effectiveness of the JoyPop app in improving emotion regulation among post-secondary students when compared to no intervention. The secondary objectives are to: (1) Assess change in mental health, wellbeing, and resilience between students in each condition to better understand the app's broader impact; (2) Conduct an economic analysis to determine whether receiving the app reduces other health service use and associated costs; (4) Assess students' perspective on the quality of the JoyPop app.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Thunder Bay, Ontario, Canada, P7B5E1
- Lakehead University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Post-secondary student
- Between 18-25 years old
- Speak/read fluently in English
- Available to attend a virtual or in-person orientation session
- In order to download the JoyPop app, participants will need access to an iOS device (e.g., iPhone, iPad). Refurbished iPhones containing just the JoyPop app may be provided to participants to use for the duration of the trial if they do not have access to their own
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: JoyPop
Participants will receive access to the Joypop app for 8 weeks.
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Participants will be asked to use the app at least twice daily for the first 4 weeks with no further instructions on feature usage or time spent using the app.
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No Intervention: No Intervention
No intervention will be offered.
After 8 weeks in the control condition, participants will be offered access to the JoyPop app.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in emotion regulation (overall)
Time Frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Emotion regulation will be assessed with the Difficulties in Emotion Regulation Scale - Short Form.
Total scores range from 18 to 90 with higher scores indicating greater difficulties in emotion regulation.
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Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Change in emotion regulation (strategies)
Time Frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form strategies subscale.
Total scores range from 3 to 15 with higher scores indicating greater difficulties.
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Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Change in emotion regulation (non-acceptance)
Time Frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form non-acceptance subscale.
Total scores range from 3 to 15, with higher scores indicating greater difficulties.
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Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Change in emotion regulation (impulse)
Time Frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form impulse subscale.
Total scores range from 3 to 15, with higher scores indicating greater difficulties.
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Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Change in emotion regulation (goals)
Time Frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form impulse subscale.
Total scores range from 3 to 15, with higher scores indicating greater difficulties.
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Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Change in emotion regulation (awareness)
Time Frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form awareness subscale.
Total scores range from 3 to 15, with higher scores indicating greater difficulties.
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Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Change in emotion regulation (clarity)
Time Frame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form clarity subscale.
Total scores range from 3 to 15, with higher scores indicating greater difficulties.
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Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in psychological distress
Time Frame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Psychological distress will be assessed with the total score for all items on the Depression Anxiety and Stress Scale 21.
Total scores range from 0 to 63, with higher scores indicating greater psychological distress.
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Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Change in depressive symptoms
Time Frame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Depressive symptoms will be assessed with the Depression subscale of the Depression Anxiety and Stress Scale 21.
Total scores range from 0 to 21, with higher scores indicating greater depressive symptoms.
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Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Change in anxious symptoms
Time Frame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Anxious symptoms will be assessed with the Anxiety subscale of the Depression Anxiety and Stress Scale 21.
Total scores range from 0 to 21 with higher scores indicating greater anxious symptoms.
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Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Change in stress
Time Frame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Stress will be assessed with the Stress subscale of the Depression Anxiety and Stress Scale 21.
Total scores range from 0 to 21, with higher scores indicating greater stress.
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Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post) and after 8 weeks (follow up)
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Change in mental health symptoms
Time Frame: General Health Questionnaire 12 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post), and after 8 weeks (follow up)
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Mental health symptoms will be assessed with the total score for all items on the General Health Questionnaire 12.
Total scores range from 0 to 36 with higher scores indicating greater distress.
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General Health Questionnaire 12 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post), and after 8 weeks (follow up)
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Change in mental well-being
Time Frame: Warwick Edinburgh Mental Wellbeing Scale will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post), and after 8 weeks (follow up)
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Mental well-being will be assessed with the total score for all items on the 14-item Warwick Edinburgh Mental Wellbeing Scale.
Total scores range from 14 to 70 with a higher score indicating greater mental well-being.
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Warwick Edinburgh Mental Wellbeing Scale will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post), and after 8 weeks (follow up)
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Change in resilience
Time Frame: Connor-Davidson Resilience Scale-10 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post), and after 8 weeks (follow up)
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Resiliency will be assessed with the total score for all items on the Conner-Davidson Resilience Scale-10.
Total scores range from 0 to 40 with higher scores indicating greater resiliency.
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Connor-Davidson Resilience Scale-10 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post), and after 8 weeks (follow up)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-reported healthcare utilization
Time Frame: Service utilization measure will be administered at baseline (pre), after two weeks (mid), after four weeks (post), and after 8 weeks (follow up)
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Service utilization will be assessed with 5 items asking about frequency of healthcare services accessed over the prior 2 weeks.
Response options are open-ended and will be analyzed individually and as a total score across service types.
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Service utilization measure will be administered at baseline (pre), after two weeks (mid), after four weeks (post), and after 8 weeks (follow up)
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App quality (overall)
Time Frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (overall) will be assessed with the User Version of the Mobile Application Rating Scale.
Total scores range from 1 to 5, with higher scores indicating greater quality.
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User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (engagement)
Time Frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (engagement) will be assessed with the Engagement subscale of the User Version of the Mobile Application Rating Scale.
Total scores range from 1 to 5, with higher scores indicating greater quality (engagement).
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User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (functionality)
Time Frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (functionality) will be assessed with the Functionality subscale of the User Version of the Mobile Application Rating Scale.
Total scores range from 1 to 5, with higher scores indicating greater quality (functionality).
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User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (aesthetics)
Time Frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (aesthetics) will be assessed with the Aesthetics subscale of the User Version of the Mobile Application Rating Scale.
Total scores range from 1 to 5, with higher scores indicating greater quality (aesthetics).
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User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (information)
Time Frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (information) will be assessed with the Information subscale of the User Version of the Mobile Application Rating Scale.
Total scores range from 1 to 5, with higher scores indicating greater quality (information).
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User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (subjective)
Time Frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (subjective) will be assessed with the App Subjective Quality items of the User Version of the Mobile Application Rating Scale.
Items will be assessed individually and as a total score (range from 1 to 5), with higher scores indicating greater quality (subjective).
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User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (perceived impact)
Time Frame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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App quality (perceived impact) will be assessed with the Perceived Impact subscale of the User Version of the Mobile Application Rating Scale.
Items will be assessed individually and as a total score (range from 1 to 5), with higher scores indicating greater quality (perceived impact).
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User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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