Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000131651
Ethics application status
Approved
Date submitted
28/07/2022
Date registered
8/02/2023
Date last updated
8/02/2023
Date data sharing statement initially provided
8/02/2023
Date results information initially provided
8/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The second usability and efficacy trial of a co-designed wellbeing and preventative mental health app with University students enrolled at an Australian University.
Scientific title
The second usability and efficacy trial of a co-designed wellbeing and preventative mental health app with University students enrolled at an Australian University.
Secondary ID [1] 307668 0
Nil known
Universal Trial Number (UTN)
U1111-1280-9908
Trial acronym
Linked study record
This trial is linked to a previous App trial using the beta (or minimal viable product) version of the same App. UTN: U1111-1275-7425, ACTRN: ACTRN12622001054707.

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 327198 0
Condition category
Condition code
Mental Health 324336 324336 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be using a preventative mental health App known as the THRIVE App over a period of 12 weeks. Participants can use the App as frequently as they wish however it is recommended to interact with the App for at least 5 minutes per day. When using the App participants will be checking in their mood using a gamified 'wheel of feels' that includes top order emotion, additional descriptors of emotion, additional factors causing or related to that emotion, and the option to include a diary entry. From there participants are recommended a mental health related written resource that has been co-designed with University students, these resources may include "understanding anger" or "how to improve procrastination". This, the second iteration of the App, also includes some basic breathing tasks based on box breathing techniques, mindfulness recordings provided by the University, and analytic 'dashboard' views of how the participants have checked in over time. The App also includes easy to access information on how to seek help and access both University, state, and privately provided mental health support.

To measure usage of the App being tested we ask participants in 2 week intervals to report the amount of time they used the App each day, this was measured in minutes where '0' minutes was an option for those who had stopped using the App or were not using it daily.
Intervention code [1] 324139 0
Prevention
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332139 0
Wellbeing using the WHO-5 wellbeing scale.
Timepoint [1] 332139 0
Wellbeing is collected at:
Week 0 (before download and use of the App - this is baseline.)
Week 6 (6 weeks into the App use and halfway through the trial - this is midpoint.)
Week 12 (12 weeks into the App use and at the end of the trial - this is primary endpoint.).
Primary outcome [2] 332140 0
User feedback on App functionality, measured using open response questions including "what are your overall opinions of the App?" alongside the Mobile App Rating Scale.
Timepoint [2] 332140 0
Collected at:
Week 10 of the trial (After 10 weeks of use and 85% of the way through the total trial period).
Secondary outcome [1] 412333 0
Anxiety, as measured by the PROMIS-Anxiety 4a scale.
Timepoint [1] 412333 0
Collected at:
Week 0 (before download and use of the App)
Week 6 (6 weeks into the App use and halfway through the trial)
Week 12 (12 weeks into the App use and at the end of the trial).
Secondary outcome [2] 412334 0
Fatigue, as measured by the PROMIS Fatigue 4a scale
Timepoint [2] 412334 0
Collected at:
Week 0 (before download and use of the App)
Week 6 (6 weeks into the App use and halfway through the trial)
Week 12 (12 weeks into the App use and at the end of the trial).
Secondary outcome [3] 412335 0
Depression, as measured by the PROMIS- Depression 4a scale.
Timepoint [3] 412335 0
Collected at:
Week 0 (before download and use of the App)
Week 6 (6 weeks into the App use and halfway through the trial)
Week 12 (12 weeks into the App use and at the end of the trial).
Secondary outcome [4] 412336 0
Sleep related impairment, as measured by the PROMIS 4a sleep related impairment scale.
Timepoint [4] 412336 0
Collected at:
Week 0 (before download and use of the App)
Week 6 (6 weeks into the App use and halfway through the trial)
Week 12 (12 weeks into the App use and at the end of the trial).
Secondary outcome [5] 412342 0
Help seeking preferences, collected using the General Help Seeking Questionnaire, item 2 (focusing on experiencing emotional and personal difficulties). Additional University specific and digital options have been included (e.g. Monash Counselling Services, websites or forums, and digital apps).
Timepoint [5] 412342 0
Collected at:
Week 0 (before download and use of the App)
Week 6 (6 weeks into the App use and halfway through the trial)
Week 12 (12 weeks into the App use and at the end of the trial).

Eligibility
Key inclusion criteria
Must be a student currently studying at the chosen Australian University (Monash University)
Must be enrolled at an Australian campus
Must be located in Australia (for the purposes of access to the App)
Must have a smartphone device capable of hosting the App (e.g. iPhones capable of installing iOS 16)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures analysis of quantitative primary and secondary outcomes. Thematic analysis of qualitative primary outcome.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/07/2022
Date of last participant enrolment
Anticipated
Actual
12/09/2022
Date of last data collection
Anticipated
Actual
20/12/2022
Sample size
Target
150
Accrual to date
Final
177
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 38187 0
3800 - Monash University

Funding & Sponsors
Funding source category [1] 311936 0
University
Name [1] 311936 0
Monash University
Country [1] 311936 0
Australia
Funding source category [2] 311940 0
Commercial sector/Industry
Name [2] 311940 0
Allianz Partners Australia
Country [2] 311940 0
Australia
Primary sponsor type
University
Name
Monash University
Address
18 Innovation Walk, Monash University, Clayton, Victoria, 3800
Country
Australia
Secondary sponsor category [1] 313424 0
None
Name [1] 313424 0
Address [1] 313424 0
Country [1] 313424 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311369 0
Monash University Human Ethics Committee
Ethics committee address [1] 311369 0
Room 116, Chancellery Building D,
26 Sports Walk, Clayton Campus
Wellington Rd
Clayton VIC 3800, Australia
Ethics committee country [1] 311369 0
Australia
Date submitted for ethics approval [1] 311369 0
25/06/2022
Approval date [1] 311369 0
05/07/2022
Ethics approval number [1] 311369 0
Project ID: 32761

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 App feedback amongst a healthy population of University students.

It is hypothesised that through a 12-week period of using the THRIVE App to actively monitor emotions and engage in feedback from the app students will show an improvement in mental health awareness and psychological literacy outcomes, as well as a potential improvement in overall wellbeing and intention to seek help.
Trial website
www.monash.edu/medicine/thrive/thrive-app
Trial related presentations / publications
Public notes
None

Contacts
Principal investigator
Name 120858 0
Ms Melinda McCabe
Address 120858 0
504, 18 Innovation Walk, Monash University Clayton Campus, Clayton, Victoria, 3800.
Country 120858 0
Australia
Phone 120858 0
+61 3 9905 5393
Fax 120858 0
Email 120858 0
[email protected]
Contact person for public queries
Name 120859 0
Ms Melinda McCabe
Address 120859 0
504, 18 Innovation Walk, Monash University Clayton Campus, Clayton, Victoria, 3800.
Country 120859 0
Australia
Phone 120859 0
+61 3 9905 5393
Fax 120859 0
Email 120859 0
[email protected]
Contact person for scientific queries
Name 120860 0
Ms Melinda McCabe
Address 120860 0
504, 18 Innovation Walk, Monash University Clayton Campus, Clayton, Victoria, 3800.
Country 120860 0
Australia
Phone 120860 0
+61 3 9905 5393
Fax 120860 0
Email 120860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data being collected is focusing on the development of the Monash THRIVE App. This data will be published in peer-reviewed journals, and summarised and de-identified results may also be available on our Monash THRIVE website for students. Given this, and in accordance with the approved ethics application, Monash students data will not be shared outside of the research team.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16758Study protocol    This will be made available when the results are p... [More Details]
16759Statistical analysis plan    This will be made available when the results are p... [More Details]
16760Informed consent form    This will be made available when the results are p... [More Details]
16761Ethical approval    This will be made available when the results are p... [More Details]



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.