Clinical trial NCT06154369: JoyPop Mobile Mental Health App With Post-Secondary Students
Official title: Promoting Mental Health and Wellbeing Among Post-secondary Students With the Joypop App: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Depression
Anxiety
Stress
Well-Being, Psychological
Lead sponsor: Lakehead University
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in emotion regulation (overall)
timeFrame: 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)
measure: Change in emotion regulation (strategies)
timeFrame: 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)
measure: Change in emotion regulation (non-acceptance)
timeFrame: 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)
measure: Change in emotion regulation (impulse)
timeFrame: 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)
measure: Change in emotion regulation (goals)
timeFrame: 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)
measure: Change in emotion regulation (awareness)
timeFrame: 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)
measure: Change in emotion regulation (clarity)
timeFrame: 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:
measure: Change in psychological distress
timeFrame: 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)
measure: Change in depressive symptoms
timeFrame: 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)
measure: Change in anxious symptoms
timeFrame: 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)
measure: Change in stress
timeFrame: 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)
measure: Change in mental health symptoms
timeFrame: General Health Questionnaire 12 will be administered at baseline (pre), after 2 weeks (mid), after 4 weeks (post), and after 8 weeks (follow up)
measure: Change in mental well-being
timeFrame: 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)
measure: Change in resilience
timeFrame: 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)
Other outcomes:
measure: Self-reported healthcare utilization
timeFrame: Service utilization measure will be administered at baseline (pre), after two weeks (mid), after four weeks (post), and after 8 weeks (follow up)
measure: App quality (overall)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: App quality (engagement)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: App quality (functionality)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: App quality (aesthetics)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: App quality (information)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: App quality (subjective)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
measure: App quality (perceived impact)
timeFrame: User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)
Locations:
city: Thunder Bay
country: Canada
facility: Lakehead University
state: Ontario
Study officials:
References: