Emotion RegulationNCT06154369
JoyPop Mobile Mental Health App With Post-Secondary Students
A study testing JoyPop in people with Emotion Regulation and Depression, run by Lakehead University at 1 site in Canada.
Trial summary
Students within post-secondary education settings are experiencing 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Depression, Anxiety
- What is being tested?
- JoyPop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- 22 Nov 2023to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Mental Health and Wellbeing Among Post-secondary Students With the Joypop App: A Randomized Controlled Trial
Students within post-secondary education settings are experiencing 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. 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. Using a randomized controlled trial (RCT) design, the primary objective of this research 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.
Read the 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.
- Conditions
- Emotion Regulation, Depression, Anxiety, Stress, Well-Being, Psychological
- Being tested
- JoyPop
- Medical subject headings
- Emotional Regulation, Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JoyPopBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| JoyPop | Experimental | Participants will receive access to the Joypop app for 8 weeks. Receives: Behavioral: JoyPop |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in emotion regulation (overall)
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.
Measured: 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)
Change in emotion regulation (strategies)
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.
Measured: 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)
Change in emotion regulation (non-acceptance)
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.
Measured: 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)
Change in emotion regulation (impulse)
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.
Measured: 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)
Change in emotion regulation (goals)
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.
Measured: 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)
Change in emotion regulation (awareness)
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.
Measured: 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)
Change in emotion regulation (clarity)
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.
Measured: 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)
Secondary outcomes (7)
Change in psychological distress
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.
Measured: 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)
Change in depressive symptoms
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.
Measured: 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)
Change in anxious symptoms
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.
Measured: 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)
Change in stress
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.
Measured: 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)
Change in mental health symptoms
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.
Measured: General Health Questionnaire 12 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post), and after 8 weeks (follow up)
Change in mental well-being
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.
Measured: 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)
Change in resilience
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start22 Nov 2023
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic, randomized controlled trial will be used. Participants will be randomly allocated in a 1:1 ratio to the control (no intervention) or intervention (JoyPop) condition. Block randomization (block size of 8) will be used to randomly assign participants to each condition.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakehead University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aislin Mushquash, Lakehead University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154369
- Sponsor's protocol ID
- 100251
- Status last verified
- Sep 2025
- First submitted
- 23 Nov 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MacIsaac A, Mann V, Toombs E, Schmidt F, Olthuis JV, Stewart SH, Newton A, Ohinmaa A, Mushquash AR. Promoting mental health and wellbeing among post-secondary students with the JoyPop app: study protocol for a randomized controlled trial. Trials. 2024 Sep 2;25(1):576. doi: 10.1186/s13063-024-08424-y.
PubMed 39223596
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Mental Health and Wellbeing Among Post-secondary Students With the Joypop App: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06154369
- Acronym / sponsor ID
- 100251
- Conditions
- Emotion Regulation, Depression, Anxiety, Stress, Well-Being, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Lakehead UniversityUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Students within post-secondary education settings are experiencing 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. 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. Using a randomized controlled trial (RCT) design, the primary objective of this research 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A pragmatic, randomized controlled trial will be used. Participants will be randomly allocated in a 1:1 ratio to the control (no intervention) or intervention (JoyPop) condition. Block randomization (block size of 8) will be used to randomly assign participants to each condition.
| Arm | Type | Receives |
|---|---|---|
| JoyPop | Experimental | Behavioral: JoyPopParticipants will receive access to the Joypop app for 8 weeks. |
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JoyPopParticipants 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. | Behavioural | JoyPop |
Primary outcome
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
7 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Derived from this study: PubMed 39223596MacIsaac A, Mann V, Toombs E, Schmidt F, Olthuis JV, Stewart SH, Newton A, Ohinmaa A, Mushquash AR. Promoting mental health and wellbeing among post-secondary students with the JoyPop app: study protocol for a randomized controlled trial. Trials. 2024 Sep 2;25(1):576. doi: 10.1186/s13063-024-08424-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JoyPop in people with Emotion Regulation and Depression, run by Lakehead University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06154369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.