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Trial registered on ANZCTR


Registration number
ACTRN12617001390370
Ethics application status
Approved
Date submitted
27/09/2017
Date registered
29/09/2017
Date last updated
30/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindtrack: A randomised controlled trial testing different methods of communicating personal mental health risk profiles
Scientific title
The impact of different methods of communicating personal mental health risk profiles on emotional outcomes and engagement within a smartphone App
Secondary ID [1] 292986 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 304890 0
Wellbeing 304891 0
Condition category
Condition code
Mental Health 304207 304207 0 0
Depression
Mental Health 304208 304208 0 0
Anxiety
Mental Health 304209 304209 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 304210 304210 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: MindTrack App
Arm 1: Current personal risk profile; Arm 2: Achievable personal risk profile; Arm 3: (Control) No personal risk profile. The “Mindtrack App” is a software that is NOT being used as a medical device. The purpose of the App is to test different ways of communicating personal risk of future distress. The mode of delivery of the App is via a smartphone, on an individual basis. The Mindtrack App is a mood monitoring App adapted from the “Headgear App” (attention control version) developed by the same team for research purposes (UNSW HREC HC number: HC17021). The University of Sydney hosts the study site. The study is conducted on a smartphone App (Mindtrack), which is available to Apple and Android users in Australia for once-off free-of-charge download. Participants can download and use the App at a time and place convenient to them. The Mindtrack App will be removed from the Apple and Google Play stores after recruitment for the study is closed. The duration of the study is 6 months, with the trial running for 5 weeks. Following baseline assessment participants will be randomly allocated to receive one of 3 risk profiles once only. Following receipt of their allocated condition, all participants will be encouraged to continue engaging with the App for a period of 4 weeks by monitoring their mood once every week (by completing the primary outcome measure (K10) weekly). The application also automatically monitors and records usage and adherence outcomes on a continuous basis, to provide data on level of engagement with the App. At Week 4, participants complete the endpoint measures (K10, SF-12, and ASHQ) via an online wufoo survey. Participants will receive a maximum 3 SMS reminders with a unique link to complete the survey, spaced at least two days apart. At Week 5, participants “unlock” their Mental Fitness Report in the App. After the completion of the study, participants can continue to use the Mindtrack App for as long as they wish. They can remove the App by uninstalling it from their smartphone. The “Mindtrack” App is a mood monitoring App freely available from Apple Store and Google Play. It involves a 4-week challenge to help individuals understand their risk of developing mental health problems through an initial assessment and ongoing mood monitoring. The main features of the MindTrack App are a risk calculator, mood tracking, a weekly quiz (K10), and a Mental Fitness Report, as well as automatically generated weekly reminders and support service resources. Participants are randomised to a study arm after completing of the baseline measures in App. For those in the active arms, each participant receives a personalized risk profile for developing future distress, calculated using the published HILDA risk algorithm for future distress in working adults, based upon their self-report responses to baseline and risk items. This consists of “current” personal risk estimate of developing a common mental health problem within the next 12 months (Arm 1), and additional information of their lowest possible risk if in the “achievable” group (Arm 2). Materials and wording provided to each participant are as follows:
Arm 1:
Current personal mental health risk profile: Participants receive their personal risk estimate of developing a common mental health problem within the next 12 months. They are shown an icon array which displays the numerical risk estimate of that individual, along with a text description “XX out of 100 people with your risk factors are likely to become distressed within the next year”.
Arm 2:
Achievable personal mental health risk profile: Similar to the current risk profile condition, participants first receive their personal risk estimate of developing a common mental health problem within the next 12 months. They are shown an icon array which displays the calculated numerical risk estimate of that individual, along with a text description “XX out of 100 people with your risk factors are likely to become distressed within the next year”. They are then shown on the next screen their “achievable risk”, in which the icon array displays the lowest possible risk estimate for that individual, based on the targets being met for all the modifiable risk factors. The icon array is shown with the accompanying text “Many risk factors are changeable. You could lower your risk to XX out of 100 by improving your mental fitness. Participants will also see a list of their top modifiable risk factors.
Intervention code [1] 299226 0
Lifestyle
Comparator / control treatment
Control group - Arm 3: No personal risk profile. The control group have access to the same mood monitoring Mindtrack App as Arms 1 and 2 but do not receive a personal risk profile. They have access to the same features within the App’s 4-week challenge to help individuals understand their risk of developing mental health problems through an initial assessment and ongoing monitoring, such as the risk calculator, mood tracking, weekly quiz, and a Mental Fitness Report. However, they receive no information about their level of personal risk, and no personal risk profile, thus serving as the control condition.
Control group
Active

Outcomes
Primary outcome [1] 303507 0
Psychological distress measured using the 10-item Kessler Psychological Distress Scale (K10) (Kessler et al, 2002).
Kessler, R.C., Andrews, G., Colpe, L.J., Hiripi, E., Mroczek, D.K., Normand, S.L., Walters, E.E. and Zaslavsky, A.M., 2002. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychological Medicine, 32(6), pp.959-976.
Timepoint [1] 303507 0
Baseline, weekly (once per week) for 4 weeks, and endpoint (4 weeks post-baseline). The Week 4 K10 value is used as the primary endpoint outcome.
Secondary outcome [1] 339121 0
Wellbeing measured using the 12-item Short Form Health Survey (SF-12) (Sanderson and Andrews, 2002).
Sanderson, K. and G. Andrews, The SF-12 in the Australian population: cross-validation of item selection. Australian and New Zealand Journal of Public Health, 2002. 26(4): p. 343-345
Timepoint [1] 339121 0
Endpoint (4 weeks post-baseline).
Secondary outcome [2] 339122 0
Help-seeking behaviour in the past month measured using 1 item adapted from the General Help-seeking Questionnaire (GHSQ) (Wilson et al, 2005).
Wilson, C. J., Deane, F. P., Ciarrochi, J., & Rickwood, D. (2005). Measuring help-seeking intentions: Properties of the general help-seeking questionnaire. Canadian Journal of Counselling, 39(1), 15-28.
Timepoint [2] 339122 0
Endpoint (4 weeks post-baseline).
Secondary outcome [3] 339123 0
App usage (defined as “level of activity within a program”).
The usage measures recorded will be: number of times App opened, number of mood and activities logged, time spent in App per week, total time spent in App.
Timepoint [3] 339123 0
Data is automatically collected by the software in a continuous manner over the 4-week period of participant engagement with the App.
Secondary outcome [4] 339124 0
App adherence (defined as “the degree the user’s activity within the program matches the pattern of activity that was intended by the program developers”).
The adherence measure recorded will be: number of weekly K10 measures completed.
Timepoint [4] 339124 0
Data is automatically collected by the software in a continuous manner over the 4-week period of participant engagement with the App.

Eligibility
Key inclusion criteria
Eligibility criteria are:
• Adult aged between 18 years and 70 years
• An Australian resident
• In employed work
• Fluent in the English language
• Has access to their own smartphone
• Has a valid mobile phone number
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no a priori exclusion criteria.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Non-inferiority randomised controlled trial with 3 arms. Allocation was concealed using central computerised randomisation within the App, and stratified according to level of risk. The participant will be enrolled into the study after the informed consent process has been completed and the participant has met all inclusion criteria within the App. All enrolled participants will complete the baseline measures. Following completion of baseline measures, enrolled participants will then be randomised using the above process through central allocation to one of three groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. An automatic random allocation sequence generated by Math.random() javascript.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power calculations were based on a non-inferiority trial design comparing parallel-groups.
The convention is to set the alpha level at half the type 1 error rate of 2-sided tests (2.5%) as only the lower bounds of the confidence intervals are relevant. Test criterion for non-inferiority was that the lower bound of the 95% CI of the mean difference should fall within *. * was defined as 4.6 points on the K10, which was the difference between the normative Australian score (M=14.5, SD=9.4) and the mean score for people with a mental disorder (M=19.1) in the most recent National Survey of Mental Health and Wellbeing. This margin was selected because the intervention would be unacceptably worse than the no personal risk profile group if it caused distress to the level of people with a mental disorder. The intervention would be non-inferior to providing no personal risk profile if the lower bounds of the 95% CI is less than 4.6 points difference. Given the effect sizes from meta-analysis, it is expected that the actual difference between groups at the endpoint is 0.05.

The sample size was estimated on the K10 total score at endpoint for a non-inferiority research of personal risk profile compared to providing no risk profile, using a one-sided Student’s t-test for independent samples at 2.5% type I error. Considering a predefined non-inferiority margin fixed at 4.6 points on the K10, 68 participants per group allow to conclude that the personal risk profile group is non-inferior to providing no risk profile with a power of 80%. To allow for a 40% dropout rate, 340 participants need to be recruited in total.

Independent t-tests and chi-square analyses will be used to estimate between-group differences in demographics and baseline measures. The primary objective is analysed using a mixed ANCOVA to compare the current risk profile group and the achievable risk profile group to the no risk profile group on the primary outcome of distress (K10) at Week 4 (endpoint) for establishing non-inferiority. Mixed ANCOVAs will be used to compare the current risk profile group and the achievable risk profile group to the no risk profile group on the secondary outcome of wellbeing (SF-12). One-way ANOVAs will be used to compare groups on the secondary outcomes of usage and adherence. Two-way between group ANOVAs will test for differences in K10 and engagement among participants with high, average, and low risk, across risk profiling groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 297611 0
Charities/Societies/Foundations
Name [1] 297611 0
Beyondblue
Address [1] 297611 0
PO Box 6100
Hawthorne
Vic 3122
Country [1] 297611 0
Australia
Funding source category [2] 297612 0
Charities/Societies/Foundations
Name [2] 297612 0
Movember Foundation
Address [2] 297612 0
PO Box 60
East Melbourne
VIC 8002
Country [2] 297612 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Sydney
2000 NSW
Country
Australia
Secondary sponsor category [1] 296624 0
Other
Name [1] 296624 0
Black Dog Institute
Address [1] 296624 0
Hospital Rd
Randwick
2031 NSW
Country [1] 296624 0
Australia
Secondary sponsor category [2] 296625 0
University
Name [2] 296625 0
University of New South Wales
Address [2] 296625 0
High St
Kensington
NSW 2052
Country [2] 296625 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298703 0
University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 298703 0
University of Sydney Human Research Ethics Committee
Ethics and Research Integrity
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 298703 0
Australia
Date submitted for ethics approval [1] 298703 0
21/08/2017
Approval date [1] 298703 0
29/09/2017
Ethics approval number [1] 298703 0

Summary
Brief summary
There is growing research on using risk algorithms to identify individuals at increased risk for future mental ill-health and for prevention interventions. However, there is lack of research on the effects of communicating personal mental health risk profiles on psychological or behavioral outcomes. There is potential that personal risk profiles can cause short term distress but motivate people to modify behavior to reduce their risks. Our research team has developed a risk algorithm to predict the 12-month risk of psychological distress in working Australian adults (Fernandez et al, 2017). This study explores the impact of communicating different types of personal mental health risk profiles on psychological outcomes and engagement with a smartphone App. The aim of this study is to investigate the effect of communicating different personal mental health risk profile on psychological distress and engagement with a smartphone App (Mindtrack). The secondary aim of the study is to explore how level of risk affects the psychological outcomes and engagement. The study’s purpose is to answer three main research questions namely: (1) What is the impact of different methods of communicating personal mental health risk profile on psychological outcomes in the medium term? (2) What is the impact of different methods of communicating personal mental health risk profile on engagement with an App? (3) Is an individual’s current or achievable risk an effect modifier of these outcomes? In order to achieve these objectives, a randomized controlled non-inferiority design will compare the effects of communicating (1) their current personal risk profile or (2) achievable personal risk profile or (3) no personal risk profile on psychological outcomes and engagement in the Mindtrack App. The 3 main study hypotheses are:
i) The participants provided with the current risk profile and the achievable risk profile do not have unacceptably worse levels of psychological distress (defined as the lower bounds of the 95% CI is less than 4.6 points difference on the K10 between groups) compared to participants who do not receive personal risk profile at the endpoint (4 weeks). ii) The participants provided with the current risk profile and achievable risk profile will have higher levels of psychological distress (defined as a significant difference in K10) compared to participants who do not receive personal risk profile at 1-week post-test. iii) The participants provided with the current risk profile and the achievable risk profile do not have significantly different levels of wellbeing (defined as a significant difference in SF-12) compared to participants who do not receive personal risk profile at the endpoint (4 weeks). Other hypotheses available on request.
Trial website
Not applicable
Trial related presentations / publications
Fernandez, A., Salvador-Carulla, L., Choi, I., Calvo, R., Harvey, S., & Glozier, N. (2017). Development and validation of a prediction algorithm for the onset of common mental disorders in a working population. Australian & New Zealand Journal of Psychiatry, 1-12.
Public notes

Contacts
Principal investigator
Name 77950 0
Prof Nicholas Glozier
Address 77950 0
Level 5, Professor Marie Bashir Centre
67-73 Missenden Road
Camperdown, NSW 2050
Brain and Mind Centre
University of Sydney
Sydney, NSW 2000.
Country 77950 0
Australia
Phone 77950 0
+61 2 9515 1596
Fax 77950 0
Email 77950 0
nick.glozier@sydney.edu.au
Contact person for public queries
Name 77951 0
Prof Nicholas Glozier
Address 77951 0
Level 5, Professor Marie Bashir Centre
67-73 Missenden Road
Camperdown, NSW 2050
Brain and Mind Centre
University of Sydney
Sydney
Country 77951 0
Australia
Phone 77951 0
+61 2 9515 1596
Fax 77951 0
Email 77951 0
nick.glozier@sydney.edu.au
Contact person for scientific queries
Name 77952 0
Prof Nicholas Glozier
Address 77952 0
Level 5, Professor Marie Bashir Centre
67-73 Missenden Road
Camperdown, NSW 2050
Brain and Mind Centre
University of Sydney
Sydney
Country 77952 0
Australia
Phone 77952 0
+61 2 9515 1596
Fax 77952 0
Email 77952 0
nick.glozier@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary