Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000707460
Ethics application status
Approved
Date submitted
25/02/2016
Date registered
27/05/2016
Date last updated
14/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing different engagement strategies, language and content style in an early prototype of a mental health screening smartphone application
Scientific title
Testing the effects of different engagement strategies, language and content style on engagement in an early prototype of a mental health screening smartphone application in healthy Australian adults.
Secondary ID [1] 288608 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health disorders 297751 0
Condition category
Condition code
Mental Health 297983 297983 0 0
Depression
Mental Health 297984 297984 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete quizzes pertaining to: Mood and anxiety symptoms (K6 questionnaire) and Wellbeing (WHO 5 Well-being Index) and sliding scales measuring alcohol use quantity; hours slept; perceived stress; physical and social activity.
Participants who are deemed at-risk of mental health problems on the quizzes will be randomly allocated to receiving one of the following feedback types: normative positive, normative negative, theory-driven, humour-driven. E.g.
*Normative positive: “Your sleep is better than 60% of people/men/women your age over the past week. Learn how to improve your sleep here”
*Normative negative: “Your sleep is worse than 40% of people/men/women your age over the past week. Learn how to improve your sleep here”
*Theory-driven: Your sleep is within the moderate range on the scale. Not getting enough sleep can cause fatigue, poorer judgement and reduced concentration. Learn how to improve your sleep here”
*Humour-driven: Falling asleep can be hard when you're wound up or pissed off-no matter how many sheep you count or foreign films you watch. Learn how to improve your sleep here.”
Immediately following their feedback (provided each time the quiz is completed) they will be provided information and a link to a variety of online self-help or information sites.
Participants then use the app to monitor mood and alcohol quantity, sleep quality, physical and social activity. They also receive feedback on their current risk of mental health problems. Users will be reminded to complete quizzes and enter symptoms weekly and log mood daily (with an option to enter more frequent data). The app will remain available for use as long as the participant does not delete the app.
In a subsequent randomisation participants will receive one of two different mood measurement gauges, These gauges are modified circumplex models of mood using a Valence scale; a 6 core emotions scale and 10x10 Valence Arousal Matrix. Application software will monitor clicks and use occasions by each participant.
Intervention code [1] 294033 0
Early detection / Screening
Comparator / control treatment
Users randomised to different arms (different feedback text types; two different mood monitoring presentations)
Control group
Active

Outcomes
Primary outcome [1] 297452 0
What is the best way to advertise/frame a mental health app to men?
Engagement - (a) click-through rates of the different advertising campaigns; (b) sustained engagement (number of moods logged).
Timepoint [1] 297452 0
Clicks will be assessed weekly over 3-month intervention period.
Primary outcome [2] 297504 0
Engagement - (a) adherence (i.e use of widget, measured by comparison of frequency of mood ratings); (b) persistence (i.e. continued use of overall app over time, measured by comparison of frequency slider/quiz completion); (c) click-through rates.

(randomisation of differing mood widgets, feedback. Comparison of risk level, symptom level, gender, ad campaign)

a. How interested are people in finding out about their risk?
Engagement - (a) click-through rates of the different wording; (b) sustained engagement (number of moods logged).
Timepoint [2] 297504 0
Adherence, persistence, and click through rates data will be collected daily over a 3-month intervention period.
Secondary outcome [1] 321080 0
Do ratings on the mood widget correlate with other standardised tools of symptoms, wellbeing, and risk level?
Cross-sectional and prospective correlations of widget and quiz scores. Baseline algorithms for predicting symptoms etc. from mood signal.
Timepoint [1] 321080 0
Mood monitoring will be assessed daily, and the K6 weekly, over a 3-month intervention period.
Secondary outcome [2] 321243 0
Do users allow/respond to notifications?
This is assessed by application software recording of response.
(a) rate of notification acceptance; (b) rate of notification clicks.
Timepoint [2] 321243 0
Notification data will be collected daily over 3-month intervention period.
Secondary outcome [3] 324178 0
What language do people use to describe their mood?
Factor mapping of different mood labels.
Timepoint [3] 324178 0
Mood monitoring data will be collected daily over a 3-month intervention period.
Secondary outcome [4] 324181 0
How interested are people in finding out about their risk?
Rate of (a) risk quiz selection; (b) risk quiz completion.


Timepoint [4] 324181 0
Risk quiz selection will be data will be collected upon initial use and at 3-month point.
Secondary outcome [5] 324182 0
What do users want to measure?
(a) rate of different slider use; (b) manual addition of new sliders.
Timepoint [5] 324182 0
Slider use data will be collected daily over a 3-month intervention period.

Eligibility
Key inclusion criteria
Although the smartphone application we are developing will ultimately be aimed at men, for this study we will recruit both men and women, in order to allow us to look at any gender differences. Our eligibility criteria will be that participants must be aged 18 years or older, be resident in Australia, own a smartphone and have a reasonable understanding of the English language.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
no smartphone ownership
under 18 years of age
inability to understand english

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data from this study will be analysed using either STATA or SPSS statistical software. The sample size has been calculated based on the key analysis of which of four different feedback arms is most effective and following this which of the five different mood measures are most effective. In order to have 80% power to able to detect these differences 5% more often than chance alone would predict, with an alpha type 1 error rate of 5%, a total of 2,152 at-risk individuals (those scoring above population norms) will need to be recruited (1:1 males:females). Given the social media networks used for recruitment have a total following of more than 500,000 people, this sample size should be easily achieved. However, based on preliminary work with an early version of the program approximately one third of the sample is likely to fall into the low risk category for all risk items and as such approximately 3,000 screened participants will be required.
Simple counts and Chi squared tests will be used to assess the relative success and popularity of different advertising strategies and the different question topics offered. Rates of questionnaire completion will also be compared, both between topics and dependent on whether immediate feedback was provided. Finally, the trajectory of responses will be compared between those who received immediate feedback and those whose feedback came after completing all questionnaires using linear regression.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
30/05/2016
Actual
30/05/2016
Date of last participant enrolment
Anticipated
30/07/2016
Actual
28/02/2017
Date of last data collection
Anticipated
Actual
31/05/2017
Sample size
Target
3000
Accrual to date
Final
811
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 7914 0
New Zealand
State/province [1] 7914 0
Country [2] 7915 0
United States of America
State/province [2] 7915 0
Country [3] 7916 0
United Kingdom
State/province [3] 7916 0

Funding & Sponsors
Funding source category [1] 292950 0
Charities/Societies/Foundations
Name [1] 292950 0
Beyondblue
Country [1] 292950 0
Australia
Funding source category [2] 292996 0
Charities/Societies/Foundations
Name [2] 292996 0
Movember
Country [2] 292996 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW
Kensington
2052 NSW
Country
Australia
Secondary sponsor category [1] 291721 0
Other
Name [1] 291721 0
Black Dog Institute
Address [1] 291721 0
Hospital Rd
Randwick
2031 NSW
Country [1] 291721 0
Australia
Secondary sponsor category [2] 291768 0
University
Name [2] 291768 0
The University of Sydney
Address [2] 291768 0
Sydney
NSW 2006
Australia
Country [2] 291768 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294458 0
UNSW HREC
Ethics committee address [1] 294458 0
Ethics committee country [1] 294458 0
Australia
Date submitted for ethics approval [1] 294458 0
08/04/2016
Approval date [1] 294458 0
12/04/2016
Ethics approval number [1] 294458 0
HC15584

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63806 0
A/Prof Samuel Harvey
Address 63806 0
School of Psychiatry
University of New South Wales
Black Dog Institute Building
Hospital Rd
Randwick
NSW 2031
Country 63806 0
Australia
Phone 63806 0
+61 2 9382 8356
Fax 63806 0
Email 63806 0
[email protected]
Contact person for public queries
Name 63807 0
Samuel Harvey
Address 63807 0
School of Psychiatry
University of New South Wales
Black Dog Institute Building
Hospital Rd
Randwick
NSW 2031
Country 63807 0
Australia
Phone 63807 0
+61 2 9382 8356
Fax 63807 0
Email 63807 0
[email protected]
Contact person for scientific queries
Name 63808 0
Samuel Harvey
Address 63808 0
School of Psychiatry
University of New South Wales
Black Dog Institute Building
Hospital Rd
Randwick
NSW 2031
Country 63808 0
Australia
Phone 63808 0
+61 2 9382 8356
Fax 63808 0
Email 63808 0
[email protected]

No information has been provided regarding IPD availability


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.