Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001054707
Ethics application status
Approved
Date submitted
28/03/2022
Date registered
29/07/2022
Date last updated
29/07/2022
Date data sharing statement initially provided
29/07/2022
Date results information initially provided
29/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring the efficacy of a user-focused and co-designed preventative mental health smartphone application amongst University students in Australia.
Scientific title
Trial of the efficacy and user uptake of a co-designed preventative mental health smartphone application with University students
Secondary ID [1] 306681 0
None
Universal Trial Number (UTN)
U1111-1275-7425
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of anxiety and depression. 325622 0
Condition category
Condition code
Mental Health 322980 322980 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention utilised is a co-designed user-focused smartphone application known as the Monash THRIVE App for students. This app does not record any data that is send to researchers, all data is stored locally on the users device and is deleted permanently if the App is deleted from the device. Key functions of the Monash THRIVE App for students is to help students check-in their daily mood (or more frequently) using interactive and gamified tools that harness students language and interests. Gamified tools currently available in the beta being tested include a 'wheel of feels' that uses student language taken through qualitative research to help students check in their mood and what their mood relates to in a fun and interactive way. The App also includes a character called 'Moody' who mimics mood check ins and send reminders to check in. From these responses the Monash THRIVE App recommends mental health information and help seeking information that is relevant to them as students at our institution. The overarching goal of the Monash THRIVE App is to increase mental health literacy, awareness of emotions, and help seeking intentions (through the reduction of misconception and bias) to prevent students from developing any concerning mental health symptoms. All resources presented to students are adapted from our online resources (available here: https://monash.edu/medicine/thrive/initiatives/) with some also being custom made for the App. Estimated usage time for participants throughout the study is 5 minutes per day for four weeks. Usage is measured through separate weekly surveys hosted by Monash Qualtrics services, participants are not given any specific directions for use and are asked to use the App as much as they would like.
Intervention code [1] 323129 0
Prevention
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330755 0
Perceived Stress (PSS-10)
Timepoint [1] 330755 0
Day 0 of 28 of trial. Before App has been downloaded and installed. This is the primary time point for baseline outcomes.
Day 14 of 28 of trial. Two weeks post App downloaded and installed.
Day 28 of 28 of trial. Four week post App downloaded and installed. This is the primary time point for end point outcomes (final outcomes).
Primary outcome [2] 330756 0
Anxiety (PROMIS 4a Anxiety scale)
Timepoint [2] 330756 0
Day 0 of 28 of trial. Before App has been downloaded and installed. This is the primary time point for baseline outcomes.
Day 14 of 28 of trial. Two weeks post App downloaded and installed.
Day 28 of 28 of trial. Four week post App downloaded and installed. This is the primary time point for end point outcomes (final outcomes).
Primary outcome [3] 330757 0
Depression (PROMIS Depression 4a)
Timepoint [3] 330757 0
Day 0 of 28 of trial. Before App has been downloaded and installed. This is the primary time point for baseline outcomes.
Day 14 of 28 of trial. Two weeks post App downloaded and installed.
Day 28 of 28 of trial. Four week post App downloaded and installed. This is the primary time point for end point outcomes (final outcomes).
Secondary outcome [1] 407458 0
Mobile App Rating Scale (MARS)
Timepoint [1] 407458 0
Day 28 of 28 of trial. Four weeks after App has been downloaded and installed.
Secondary outcome [2] 407459 0
Sleep (PROMIS Sleep Related Impairment 4a and Sleep quality single item)
Timepoint [2] 407459 0
Day 0 of 28 of trial. Before App has been downloaded and installed.
Day 14 of 28 of trial. Two weeks post App downloaded and installed.
Day 28 of 28 of trial. Four week post App downloaded and installed.
Secondary outcome [3] 407460 0
Help seeking intention (General Help Seeking Questionnaire item 2 only).
Timepoint [3] 407460 0
Day 0 of 28 of trial. Before App has been downloaded and installed.
Day 14 of 28 of trial. Two weeks post App downloaded and installed.
Day 28 of 28 of trial. Four week post App downloaded and installed.
Secondary outcome [4] 407461 0
Emotional Support (PROMIS Emotional Support 4a)
Timepoint [4] 407461 0
Day 0 of 28 of trial. Before App has been downloaded and installed.
Day 14 of 28 of trial. Two weeks post App downloaded and installed.
Day 28 of 28 of trial. Four week post App downloaded and installed.
Secondary outcome [5] 407462 0
Social Isolation (PROMIS Social Isolation Scale 4a)
Timepoint [5] 407462 0
Day 0 of 28 of trial. Before App has been downloaded and installed.
Day 14 of 28 of trial. Two weeks post App downloaded and installed.
Day 28 of 28 of trial. Four week post App downloaded and installed.
Secondary outcome [6] 407463 0
Coping behaviours (written by researchers)
Timepoint [6] 407463 0
Day 0 of 28 of trial. Before App has been downloaded and installed.
Day 14 of 28 of trial. Two weeks post App downloaded and installed.
Day 28 of 28 of trial. Four week post App downloaded and installed.
Secondary outcome [7] 407465 0
Perceived and Personal stigma 4 items taken from the Healthy Minds Study design (https://healthymindsnetwork.org/hms/)
Timepoint [7] 407465 0
Day 0 of 28 of trial. Before App has been downloaded and installed.
Day 14 of 28 of trial. Two weeks post App downloaded and installed.
Day 28 of 28 of trial. Four week post App downloaded and installed.

Eligibility
Key inclusion criteria
Must be currently enrolled as a Monash University student.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Are not currently enrolled at Monash University.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
None, Single group tested. Multiple longitudinal measurement of the mental health related outcomes listed within this application.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Within subjects ANOVA comparing the three mental health surveys at day 0, day 14, and day 28.
This study will also be taking a measure of user-engagements from usage surveys once per week throughout the 4 week trial. In addition to this the MARS (as listed previously) survey and focus groups held at the end of the trial will be used to interpret user feedback and will incorporated into plans for development of the next version of the THRIVE App.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/03/2022
Date of last participant enrolment
Anticipated
Actual
20/04/2022
Date of last data collection
Anticipated
Actual
19/05/2022
Sample size
Target
100
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 38188 0
3800 - Monash University

Funding & Sponsors
Funding source category [1] 311011 0
Commercial sector/Industry
Name [1] 311011 0
AWP Australia Pty Ltd trading as Allianz Global Assistance (ABN: 52 097 227 177)
Country [1] 311011 0
Australia
Funding source category [2] 311023 0
University
Name [2] 311023 0
Monash University
Country [2] 311023 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road, Clayton, Victoria, Australia 3800
Country
Australia
Secondary sponsor category [1] 312457 0
None
Name [1] 312457 0
None
Address [1] 312457 0
None
Country [1] 312457 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310560 0
Monash University Human Ethics Committee
Ethics committee address [1] 310560 0
Wellington Road, Clayton, Victoria, 3800
Ethics committee country [1] 310560 0
Australia
Date submitted for ethics approval [1] 310560 0
29/11/2021
Approval date [1] 310560 0
30/11/2021
Ethics approval number [1] 310560 0
30475

Summary
Brief summary
University students and young people are already a known high risk group for experiencing poor mental health and wellbeing. This at-risk group also demonstrates low uptake for early help seeking where the largest barrier often experienced by this group to seek help early is lack of awareness and understanding about the process and often associated bias or stigma. It is critically important to develop the resources and tools to support students in feeling like they understand mental health, can recognise early trends in mood and behaviours that might be early symptoms of poor mental health, and feel supported and empowered to reach out for help when they need it. The Monash THRIVE App is being developed to help students track their own feelings and set, and achieve, their own wellbeing goals through a tailor made resource that is private and secure on their own device. Through using the Monash THRIVE App students will learn more about mental health, and themselves and feel more supported to seek help early when they are struggling. This trial has been designed to measure both efficacy in terms of perceived willingness to seek help and overall wellbeing as well as the user feedback on the design, functionality, and usability of the Monash THRIVE App in a true co-design and co-development process with users.

Note that no specific mental health condition or diagnosis is explored in this trial as all participants are pre-clinical. The core outcome of this trial is to explore improved wellbeing and improved intentions to seek help if in need amongst a healthy population of University students.
Trial website
https://www.monash.edu/medicine/thrive/thrive-app
Trial related presentations / publications
Public notes
Final results (de-identified and in summarised and analysed form) will be available through published peer-reviewed papers.

Contacts
Principal investigator
Name 118086 0
Ms Melinda McCabe
Address 118086 0
504, 18 Innovation Walk, Monash University, Clayton, Victoria, 3800
Country 118086 0
Australia
Phone 118086 0
+61 03 9905 5393
Fax 118086 0
Email 118086 0
melinda.mccabe@monash.edu
Contact person for public queries
Name 118087 0
Ms Melinda McCabe
Address 118087 0
504, 18 Innovation Walk, Monash University, Clayton, Victoria, 3800
Country 118087 0
Australia
Phone 118087 0
+61 03 9905 5393
Fax 118087 0
Email 118087 0
melinda.mccabe@monash.edu
Contact person for scientific queries
Name 118088 0
Ms Melinda McCabe
Address 118088 0
504, 18 Innovation Walk, Monash University, Clayton, Victoria, 3800
Country 118088 0
Australia
Phone 118088 0
+61 03 9905 5393
Fax 118088 0
Email 118088 0
melinda.mccabe@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data collected is not being shared in order to ensure that participants of the study and their results have the highest level of privacy and security possible. As the findings are part of a internal review for resources specifically developed for Monash University students, sharing data outside of the University and University service providers is not deemed necessary.
Note: findings will be published in peer review journals as summarised findings and research protocol.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.