NCT06154369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

November 23, 2023

Last Update Submit

September 2, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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

    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

    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

    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 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)

  • +2 more secondary outcomes

Other Outcomes (8)

  • 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)

  • App quality (overall)

    User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)

  • App quality (engagement)

    User Version of the Mobile Application Rating Scale will be administered to the intervention group after 4 weeks (post)

  • +5 more other outcomes

Study Arms (2)

JoyPop

EXPERIMENTAL

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

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.

Interventions

JoyPopBEHAVIORAL

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.

JoyPop

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lakehead University

Thunder Bay, Ontario, P7B5E1, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Emotional RegulationDepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehaviorBehavioral SymptomsMental DisordersPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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).
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 4, 2023

Study Start

November 22, 2023

Primary Completion

November 25, 2024

Study Completion

November 25, 2024

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations