ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

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]

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.

Condition category

Condition code

Mental Health

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]

Prevention

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Perceived Stress (PSS-10)

Timepoint [1]

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]

Anxiety (PROMIS 4a Anxiety scale)

Timepoint [2]

Primary outcome [3]

Depression (PROMIS Depression 4a)

Timepoint [3]

Secondary outcome [1]

Mobile App Rating Scale (MARS)

Timepoint [1]

Day 28 of 28 of trial. Four weeks after App has been downloaded and installed.

Secondary outcome [2]

Sleep (PROMIS Sleep Related Impairment 4a and Sleep quality single item)

Timepoint [2]

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]

Help seeking intention (General Help Seeking Questionnaire item 2 only).

Timepoint [3]

Secondary outcome [4]

Emotional Support (PROMIS Emotional Support 4a)

Timepoint [4]

Secondary outcome [5]

Social Isolation (PROMIS Social Isolation Scale 4a)

Timepoint [5]

Secondary outcome [6]

Coping behaviours (written by researchers)

Timepoint [6]

Secondary outcome [7]

Perceived and Personal stigma 4 items taken from the Healthy Minds Study design (https://healthymindsnetwork.org/hms/)

Timepoint [7]

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

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3800 - Monash University

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

AWP Australia Pty Ltd trading as Allianz Global Assistance (ABN: 52 097 227 177)

Address [1]

Level 16
310 Ann St, Brisbane QLD 4000

Country [1]

Australia

Funding source category [2]

University

Name [2]

Monash University

Address [2]

Wellington Road, Clayton, Victoria, Australia 3800

Country [2]

Australia

Primary sponsor type

University

Name

Monash University

Address

Wellington Road, Clayton, Victoria, Australia 3800

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Ethics Committee

Ethics committee address [1]

Wellington Road, Clayton, Victoria, 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/11/2021

Approval date [1]

30/11/2021

Ethics approval number [1]

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

Ms Melinda McCabe

Address

504, 18 Innovation Walk, Monash University, Clayton, Victoria, 3800

Country

Australia

Phone

+61 03 9905 5393

Fax

melinda.mccabe@monash.edu

Contact person for public queries

Name

Melinda McCabe

Address

504, 18 Innovation Walk, Monash University, Clayton, Victoria, 3800

Country

Australia

Phone

+61 03 9905 5393

Fax

melinda.mccabe@monash.edu

Contact person for scientific queries

Name

Melinda McCabe

Address

504, 18 Innovation Walk, Monash University, Clayton, Victoria, 3800

Country

Australia

Phone

+61 03 9905 5393

Fax

melinda.mccabe@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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