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Trial registered on ANZCTR


Registration number
ACTRN12617000547347
Ethics application status
Approved
Date submitted
28/03/2017
Date registered
19/04/2017
Date last updated
3/07/2019
Date data sharing statement initially provided
3/07/2019
Date results information initially provided
3/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
HeadGear – A mental health smartphone application for those with elevated symptoms of depression
Scientific title
Efficacy of a mental health smartphone application, HeadGear, as a tool for treatment of common mental disorders in those with elevated symptoms of depression: A randomised controlled trial
Secondary ID [1] 291559 0
NA
Universal Trial Number (UTN)
U1111-1194-8063
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 302127 0
Anxiety 302128 0
Condition category
Condition code
Mental Health 301741 301741 0 0
Depression
Mental Health 301742 301742 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention condition takes the form of a smartphone application (app) called Headgear. Headgear is designed for self-directed use by an individual on a smartphone device. The application features interactive content, delivered on-screen and by audio using text, static and interactive image displays and videos. The app software is compatible with both Apple and Android operating systems and available for download online via the user’s respective app store (iTunes or Google Play) or the Trial website. The application can be accessed by the participant on their smartphone /mobile phone at a time and location of their choosing. The app monitors usage data including time (amount of time spent in-app) and frequency of use, number of log-ins and 'challenge' completion rates. This data will be used to examine program engagement. Participants will have access to the application indefinitely. The intervention application is designed around a 30-day timeframe. However, the active phase of this trial during which the experimental condition will be delivered and monitored is 30 days from baseline, with follow-up assessments at 5-weeks post-baseline, 3 months and 12 months.

The intervention, HeadGear, is a smartphone application (‘app’)-based intervention centered on behavioural activation and mindfulness therapy. The main therapeutic component of the HeadGear app takes the form of a 30-day challenge in which users’ complete one ’challenge’ daily (approximately 5-10 minutes per day, for 30 days). These ‘challenges’ include: psychoeducational videos on coping skills/resiliency, mindfulness, and behavioural activation; mindfulness exercises; value-driven activity planning, goal-setting, and review; and coping skill development (problem solving, sleep, grounding, alcohol use, assertiveness, and training in adaptive forms of coping).

The first daily challenge will involve the completion of a risk calculator, which will assess and provide participants with personalised feedback regarding their risk for future mental health issues. The risk calculator consists of 20 items developed from the Household, Income and Labour Dynamics in Australia Survey (HILDA) derived risk algorithm.
Intervention code [1] 297214 0
Treatment: Other
Intervention code [2] 297659 0
Behaviour
Comparator / control treatment
Attention-matched control condition:
The attention-matched control condition, ‘HeadGear lite’, is a simplified version of the same application used in the intervention condition, and is designed to control for time spent interacting with an application. This ‘lite’ application features daily mood monitoring for 30 days, instead of the 30-day ‘challenge’ component, it does also include the risk calculator, which will assess and provide participants with personalised feedback regarding their risk for future mental health issues. The risk calculator consists of 20 items developed from the Household, Income and Labour Dynamics in Australia Survey (HILDA) derived risk algorithm.
Control group
Active

Outcomes
Primary outcome [1] 301139 0
The relative change in depression symptomatology from baseline at 3-month follow-up measured by the Patient Health Questionnaire (PHQ-9).
Timepoint [1] 301139 0
Baseline, post-intervention (5 weeks post-baseline), 3-month [primary timepoint] and 12-month follow-up.
Secondary outcome [1] 331823 0
Levels of wellbeing measured by the World Health Questionnaire-5 (WHO-5) Wellbeing Index.
Timepoint [1] 331823 0
Baseline, post-intervention (5 weeks post-baseline), 3-month and 12-month follow-up.
Secondary outcome [2] 331826 0
Work performance and absenteeism measured by the Health and Work Performance Questionnaire (HPQ).
Timepoint [2] 331826 0
Baseline, post-intervention (5 weeks post-baseline), 3-month and 12-month follow-up.
Secondary outcome [3] 331827 0
Demographic information, using standard demographic items which include; age, gender, industry and job information
Timepoint [3] 331827 0
Baseline
Secondary outcome [4] 332957 0
To measure resilience, the Connors-Davidson Resilience Scale (CD-RISC10)
Timepoint [4] 332957 0
Baseline, post-intervention (5 weeks post-baseline), 3-month and 12-month follow-up.
Secondary outcome [5] 332958 0
Anxiety symptomatology as measured by the Patient Health Questionnaire - 2 (PHQ-2)
Timepoint [5] 332958 0
Baseline, post-intervention (5 weeks post-baseline), 3-month and 12-month follow-up.
Secondary outcome [6] 332959 0
Service utilisation, using health service use items based on those used in the National Health Survey of Australia (NHS).
Timepoint [6] 332959 0
Baseline, post-intervention (5 weeks post-baseline), 3-month and 12-month follow-up.
Secondary outcome [7] 339114 0
4-Item Self-determination Measure
Timepoint [7] 339114 0
Baseline and 5 week follow-up

Eligibility
Key inclusion criteria
Key eligibility criteria include: participants must be: Be an Australian resident, have a valid email address and telephone number, own a smartphone, have a reasonable understanding of the English language, and are currently employed. Participants will also be included in this trial if they score >14 on the PHQ-9 or meet MDD diagnosis using the PHQ-9 algorithm.
This change was made prior to recruitment.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they do not own an Apple/Android-operating smartphone, do not have reliable Internet access at home or work, unable to comfortably read and comprehend English or are not in the workforce. Participants will also be excluded from this trial if they score <14 on the PHQ-9 or fail to meet MDD diagnosis using the PHQ-9 algorithm.
This change was made prior to recruitment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed as randomisation of participants into intervention or attention-matched control condition will occur immediately following completion of the baseline assessment using automated procedures integrated into the trial management software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The algorithm for randomisation will consist of a stratified block design.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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 primary outcome will look for a difference in depression symptomatology (using the PHQ-9 score) between the intervention and control group. Linear mixed models will be employed to analyse the effect of intervention on the PHQ-9 scale, adjusted for potential confounders risk score (high/med/low), baseline score, and allowing a random effect for employer. After review of Headgear pilot data, the effect size was estimated to be 0.35. This effect size was entered into the statistical program R (R Core Team (2013). Power was set at 80% and conservative 2-tailed tests were assumed even though a directional hypothesis is proposed. Based on this testing a sample size of 266 per group was needed (total N = 532). A conservative dropout rate of 40% at follow-up was estimated, which increased the sample required to be 851 participants.
Analysis plan:
Data coding and analysis will be carried out by the authors using available software packages including STATA version 12.0 and the Statistical Package for the Social Sciences (SPSS) version 20.0. Data on screening, refusals, and dropout are coded and reported as per CONSORT. Primary analyses will be undertaken on an intention-to-treat (ITT) basis, including data for all participants who were randomised and completed risk assessment, irrespective of their level of adherence to the intervention or whether they withdrew at any point in time. Categorical and continuous measures of outcome will be examined using mixed or marginal longitudinal models (i.e., mixed model repeated measures, generalised estimating equation modelling) as appropriate. A ‘completers’ analysis on all participants completing at least 75% of the intervention will be undertaken as a secondary analysis. Transformations, including dichotomisation or other categorisation, will be undertaken as necessary to meet distributional assumptions and to accommodate outlying observations. The potential effects of a number of covariates and confounders will be modelled in the major analyses.

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] 295659 0
Charities/Societies/Foundations
Name [1] 295659 0
Movember
Address [1] 295659 0
PO Box 60
East Melbourne
VIC 8002
Country [1] 295659 0
Australia
Funding source category [2] 295660 0
Charities/Societies/Foundations
Name [2] 295660 0
Beyondblue
Address [2] 295660 0
PO Box 6100
Hawthorn Vic 3122
Australia
Country [2] 295660 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW
Kensington
2052 NSW
Country
Australia
Secondary sponsor category [1] 294505 0
University
Name [1] 294505 0
University of Sydney
Address [1] 294505 0
Sydney
NSW 2006
Country [1] 294505 0
Australia
Secondary sponsor category [2] 294832 0
Other
Name [2] 294832 0
Black Dog Institute
Address [2] 294832 0
Hospital Rd
Randwick
2031 NSW
Country [2] 294832 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296976 0
UNSW Human Research Ethics Committee (HREC)
Ethics committee address [1] 296976 0
UNSW
Sydney
NSW 2052
Ethics committee country [1] 296976 0
Australia
Date submitted for ethics approval [1] 296976 0
25/11/2016
Approval date [1] 296976 0
15/03/2017
Ethics approval number [1] 296976 0
HC17021

Summary
Brief summary
Our research team has recently been awarded an Australian Mental Health Award by Beyondblue and the Movember Foundation that will fund a program of research aimed at developing and evaluating a range of new e-health interventions for Australian Workers.. This is intended to cover the evaluation via a multisite randomised controlled trial (RCT) of a smartphone intervention aimed at promoting mental health and well-being. Specifically, this study aims to evaluate the efficacy of a smartphone application (‘app’) designed to treat depression in workers, with an intervention condition (‘HeadGear’ app) and attention-matched control condition (‘HeadGear lite’ app). Specifically, the relative efficacy of the application as a tool for treatment of common mental disorders will be evaluated.
All employees of several partner organisations will be invited to participate, and directed to their app store via advertisements or via visiting the trial website. Upon downloading the app, participants will undergo initial screening, provide informed consent, and complete baseline assessments of outcomes including: depression (PHQ-9) and anxiety (PHQ-2) symptomatology, wellbeing (WHO-5 Well-being Index), Overall health (SF-12), resilience (CD-RISC 10) and work performance (HPQ). Participants scoring below 14 or not meeting diagnostic criteria on the PHQ-9 on the PHQ-9 at baseline will be excluded from this trial. Eligible users will then be randomised to receive either the intervention ‘HeadGear’ application or the attention-matched control version of the app (users will also be provided with appropriate referral information to health services and crisis lines, and will be encouraged to seek help from their GP).
Participants are encouraged to use the smartphone application for 30 days. Post-intervention assessment will occur at 5 weeks post-baseline, and 3 and 12 months later at follow-up, with measures similar to those assessed at baseline. All assessment (apart from diagnostic interviews) will be completed online. Individuals whose results indicate depressive symptomatology or diagnosis (via PHQ-9); and a random sample of 5% of participants at 3 months, will receive a follow-up diagnostic telephone calls from trial staff. Project researchers will be evaluating the relative impact of the smartphone application intervention on the treatment of common mental disorders, primarily depression, and its effects on health and well-being outcomes, immediately after trial participation, and 3 and 12 months later.
Trial website
www.HeadGear.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36958 0
A/Prof Samuel Harvey
Address 36958 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 36958 0
Australia
Phone 36958 0
+6129382 8356
Fax 36958 0
Email 36958 0
s.harvey@unsw.edu.au
Contact person for public queries
Name 36959 0
Mr David Johnston
Address 36959 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 36959 0
Australia
Phone 36959 0
+6129382 4517
Fax 36959 0
Email 36959 0
david.johnston@unsw.edu.au
Contact person for scientific queries
Name 36960 0
Dr Mark Deady
Address 36960 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 36960 0
Australia
Phone 36960 0
+61293824517
Fax 36960 0
Email 36960 0
M.Deady@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary