JoyPop Mobile Mental Health App With Post-Secondary Students

Sponsor
Lakehead University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06154369
Collaborator
(none)
120
1
2
24.3
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: JoyPop
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (Investigator)
Masking Description:
Given the nature of this trial, it will not be possible to blind participants to their allocation. As measures are self report, blinding of outcome measures is also not possible. Protect against bias will occur by blinding investigators to condition (i.e., only staff directly managing participants will be unblinded).
Primary Purpose:
Other
Official Title:
Promoting Mental Health and Wellbeing Among Post-secondary Students With the Joypop App: A Randomized Controlled Trial
Actual Study Start Date :
Nov 22, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: JoyPop

Participants will receive access to the Joypop app for 8 weeks.

Behavioral: JoyPop
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in emotion regulation (overall) [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.

  2. Change in emotion regulation (strategies) [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.

  3. Change in emotion regulation (non-acceptance) [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.

  4. Change in emotion regulation (impulse) [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.

  5. Change in emotion regulation (goals) [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.

  6. Change in emotion regulation (awareness) [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.

  7. Change in emotion regulation (clarity) [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.

Secondary Outcome Measures

  1. 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)]

    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.

  2. 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)]

    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.

  3. 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)]

    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.

  4. 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)]

    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.

  5. 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)]

    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.

  6. 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)]

    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.

  7. 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)]

    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.

Other Outcome Measures

  1. Self-reported healthcare utilization [Service utilization measure will be administered at baseline (pre), after two weeks (mid), after four weeks (post), and after 8 weeks (follow up)]

    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.

  2. App quality (overall) [User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)]

    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.

  3. App quality (engagement) [User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)]

    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).

  4. App quality (functionality) [User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)]

    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).

  5. App quality (aesthetics) [User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)]

    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).

  6. App quality (information) [User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)]

    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).

  7. App quality (subjective) [User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)]

    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).

  8. App quality (perceived impact) [User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lakehead University Thunder Bay Ontario Canada P7B5E1

Sponsors and Collaborators

  • Lakehead University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aislin Mushquash, Associate Professor, Lakehead University
ClinicalTrials.gov Identifier:
NCT06154369
Other Study ID Numbers:
  • 100251
First Posted:
Dec 4, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 4, 2023