Clinical trial NCT06239545: JoyPop Mobile Mental Health App With Transitional-Aged Youth
Official title: Increasing Access to Mental Health Support for 18-25 Year Old Youth With the JoyPop Mobile Mental Health App: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Depression
Anxiety
Stress
Lead sponsor: Lakehead University
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 110
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, parallel arm randomized controlled superiority trial will be used. Participants will be randomly allocated in a 1:1 ratio to the control (usual practice; UP) or intervention (UP + JoyPop) condition. Stratified block randomization (block size of 10) will be used to randomly assign participants to each condition.
Primary purpose: TREATMENT

Brief summary: New challenges, stressors, and a loss of support often accompany the transition from adolescence to adulthood. Not surprisingly, transitional-aged youth (TAY) between the ages of 18-25 experience some of the highest rates of mental distress. However, access to mental health services diminish for TAY due to gaps in care when transitioning from pediatric to adult services. These challenges are exacerbated in rural communities, such as in Northwestern Ontario, where youth already access mental health services less frequently and face longer wait times than those in more urban areas. Limited access and extended waits can exacerbate symptoms, prolong distress, and increase the risk for adverse outcomes. Novel, innovative approaches are urgently needed to support TAY in Northwestern Ontario. In partnership with St. Joseph Care Group and Thunder Bay Counselling Centre, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for TAY waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - a fundamental difficulty for youth presenting with mental health challenges. A two-arm randomized controlled trial (RCT) will be used to evaluate the effectiveness of the app compared to usual practice while TAY are waiting for mental health services.

Detailed description: Mental health services are less available and accessible in rural and northern communities than in urban areas. These issues are concerning as extended time on wait lists can exacerbate symptoms, prolong symptoms, prolong distress, and increase the risk for suicide, self-harm, and the need for hospitalization. Moreover, delayed access to mental health services negatively impacts treatment engagement, with non-attendance, decreased motivation, and reduced satisfaction with services frequently reported following prolonged wait times. A particularly vulnerable group in this context is Transitional-Aged Youth (TAY), individuals aged 18-25 who typically experience higher levels of mental distress in comparison to the general population. Given the imminent need for and reduced access to accessible mental health services for TAY in Northwestern Ontario, innovative solutions are needed.

In partnership with St. Joseph Care Group and Thunder Bay Counselling Centre, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for TAY who are waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - a key difficulty for youth presenting with mental health challenges. Mobile mental health applications have the potential to increase accessible mental health support for TAY in Northwestern Ontario. Despite this promise of mobile mental health apps, significant gaps exist between the growing number of apps available in the public domain and empirical evidence of the beneficial impacts of apps for users. In particular, most apps that focus on emotion regulation have not been evaluated, are narrow in scope, or have only been evaluated among 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 treatment-seeking TAY in Northwestern Ontario.

Using a randomized controlled trial (RCT) design, the primary objective is to determine the effectiveness of the JoyPop app in improving emotion regulation among TAY (18- 25) who are waiting for mental health services as compared to usual practice (UP; monitoring those on the wait-list). The secondary objectives are to: (1) Assess change in mental health difficulties and treatment readiness between TAY in each condition to better understand the app's broader impact as a wait-list tool; (2) Conduct an economic analysis to determine whether receiving the app while waiting for mental health services reduces other health service use and associated costs; (3) Define the Minimal Clinically Important Difference (MCID) for the primary outcome measure; and (4) Assess TAY perspectives on the quality of the JoyPop app.

Eligibility criteria: Inclusion Criteria:

* Youth must be on the wait-list for mental health services at St. Joseph's Care Group or Thunder Bay Counselling Centre and be between 18-25 years old.
* Eligible youth will also need to be 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 will 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), and after 4 weeks (post)
measure: Change in emotion regulation (strategies)
timeFrame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
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), and after 4 weeks (post)
measure: Change in emotion regulation (impulse)
timeFrame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in emotion regulation (goals)
timeFrame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in emotion regulation (awareness)
timeFrame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in emotion regulation (clarity)
timeFrame: Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Secondary outcomes:
measure: Change in psychological distress
timeFrame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in depressive symptoms
timeFrame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in anxious symptoms
timeFrame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in stress
timeFrame: Depression Anxiety and Stress Scale 21 will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in overall difficulties
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in emotional problems
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in conduct problems
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in hyperactivity
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in peer problems
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in prosocial behaviour
timeFrame: Strengths and Difficulties Questionnaire will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Change in treatment readiness
timeFrame: Treatment Readiness subscale of the Motivation for Youth's Treatment Scale will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
Other outcomes:
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)
measure: Service utilization
timeFrame: Service utilization measure will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)
measure: Minimal Clinically Important Difference (MCID)
timeFrame: GRC will be administered to the intervention group after 2 weeks (mid) and 4 weeks (post)
Locations:
city: Thunder Bay
country: Canada
facility: Lakehead University
state: Ontario
Study officials:
References: