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Clinical Trials/NCT06154369
NCT06154369
Completed
N/A

Promoting Mental Health and Wellbeing Among Post-secondary Students With the Joypop App: A Randomized Controlled Trial

Lakehead University1 site in 1 country160 target enrollmentNovember 22, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Emotion Regulation
Sponsor
Lakehead University
Enrollment
160
Locations
1
Primary Endpoint
Change in emotion regulation (clarity)
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 22, 2023
End Date
November 25, 2024
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aislin Mushquash

Associate Professor

Lakehead University

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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 (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 (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.

Secondary Outcomes

  • Change in anxious symptoms(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(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 well-being(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 depressive symptoms(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(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 psychological distress(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 resilience(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))

Study Sites (1)

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