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Trial registered on ANZCTR


Registration number
ACTRN12617000548336
Ethics application status
Approved
Date submitted
28/03/2017
Date registered
19/04/2017
Date last updated
2/07/2019
Date data sharing statement initially provided
2/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
HeadGear – A mental health smartphone application for the prevention of depression: A randomised controlled trial
Scientific title
A randomised controlled trial investigating whether a mental health smartphone application, Headgear, can prevent symptoms of depression in working adults.
Secondary ID [1] 290311 0
None
Universal Trial Number (UTN)
U1111-1194-8220
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 300569 0
Anxiety 302709 0
Condition category
Condition code
Mental Health 300425 300425 0 0
Depression
Mental Health 302225 302225 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] 296123 0
Prevention
Intervention code [2] 297658 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 (mentioned above).
Control group
Active

Outcomes
Primary outcome [1] 299866 0
The relative change in depression symptomatology from baseline measured by the Patient Health Questionnaire (PHQ-9).
Timepoint [1] 299866 0
3-month
Secondary outcome [1] 328336 0
Cumulative incidence of provisional major depression at 5-week and 3 months. The incidence of new episode depression caseness over the three-month follow up will be assessed using the depression algorithm (#2a or b and five or more of #2a-i are at least ?More than half the days (count #2i if present at all)) within the PHQ-9 tool.
Timepoint [1] 328336 0
3- and 12-month follow-up.
Secondary outcome [2] 329819 0
Anxiety symptomatology as measured by the Patient Health Questionnaire-2 (PHQ-2)
Timepoint [2] 329819 0
Baseline, post-intervention (5 weeks post-baseline), 3- and 12-month follow-up.
Secondary outcome [3] 329820 0
Levels of wellbeing measured by the World Health Questionnaire-5 (WHO-5) Wellbeing Index.
Timepoint [3] 329820 0
Baseline, post-intervention (5 weeks post-baseline), 3-month and 12-month follow-up.
Secondary outcome [4] 331811 0
Work performance and absenteeism measured by the Health and Work Performance Questionnaire (HPQ).
Timepoint [4] 331811 0
Baseline, post-intervention (5 weeks post-baseline) and 12-month follow-up.
Secondary outcome [5] 331813 0
Service utilisation, using health service use items based on those used in the National Health Survey of Australia (NHS).
Timepoint [5] 331813 0
Baseline, post-intervention (5 weeks post-baseline), 3- and 12-month follow-up.
Secondary outcome [6] 332860 0
To measure reslience, the Connors-Davidson Resilience Scale (CD-RISC 10)
Timepoint [6] 332860 0
Baseline, post-intervention (5 weeks post-baseline), 3- and 12-month follow-up.
Secondary outcome [7] 332960 0
Demographic information, using standard demographic items which include; age, gender, industry and job information
Timepoint [7] 332960 0
Baseline
Secondary outcome [8] 339115 0
4-Item Self-determination Measure
Timepoint [8] 339115 0
Baseline and post-intervention (5 Weeks post-baseline)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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, are 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 meet MDD diagnosis using the PHQ-9 algorithm at baseline assessment

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)
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
Sample size:
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. The size of the effect of the intervention was anticipated to be small, based on recent meta-analyses of similar trials.
Residual variance was set at 12, slightly higher than expected in the sample. Power calculations were carried out using the R package simR . A sample size of 1,050 is required to detect a difference of 2 points on the PHQ-9 scale at a significance level of 5% with a power of 80%. It is predicted that 3.5% of the population will score above the required cut-off, increasing the sample by 37. Finally, using a conservative attrition rate of 50%, an initial sample of 2,174 will be recruited.
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.
Analyses will be conducted on the whole sample (to examine the universal prevention effect), as well as analyses to investigate the relative (moderating) effects of risk level (selective prevention effect) and depression symptom severity (indicated prevention effect) on the applications’ efficacy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/04/2017
Actual
15/05/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
14/08/2017
Date of last data collection
Anticipated
1/12/2018
Actual
19/11/2018
Sample size
Target
2174
Accrual to date
Final
2271
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294693 0
Charities/Societies/Foundations
Name [1] 294693 0
Movember
Country [1] 294693 0
Australia
Funding source category [2] 294694 0
Charities/Societies/Foundations
Name [2] 294694 0
Beyondblue
Country [2] 294694 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW
Kensington
2052 NSW
Country
Australia
Secondary sponsor category [1] 293540 0
Other
Name [1] 293540 0
Black Dog Institute
Address [1] 293540 0
Hospital Rd
Randwick
2031 NSW
Country [1] 293540 0
Australia
Secondary sponsor category [2] 293541 0
University
Name [2] 293541 0
University of Sydney
Address [2] 293541 0
Sydney
NSW 2006
Country [2] 293541 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296128 0
UNSW Human Research Ethics Committee (HREC)
Ethics committee address [1] 296128 0
Ethics committee country [1] 296128 0
Australia
Date submitted for ethics approval [1] 296128 0
25/11/2016
Approval date [1] 296128 0
15/03/2017
Ethics approval number [1] 296128 0
HC17021

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

Contacts
Principal investigator
Name 69622 0
A/Prof Samuel Harvey
Address 69622 0
School of Psychiatry
University of New South Wales
Black Dog Institute Building
Hospital Rd
Randwick
NSW 2031
Country 69622 0
Australia
Phone 69622 0
+61 2 9382 8356
Fax 69622 0
Email 69622 0
s.harvey@unsw.edu.au
Contact person for public queries
Name 69623 0
Samuel Harvey
Address 69623 0
School of Psychiatry
University of New South Wales
Black Dog Institute Building
Hospital Rd
Randwick
NSW 2031
Country 69623 0
Australia
Phone 69623 0
+61 2 9382 8356
Fax 69623 0
Email 69623 0
s.harvey@unsw.edu.au
Contact person for scientific queries
Name 69624 0
Samuel Harvey
Address 69624 0
School of Psychiatry
University of New South Wales
Black Dog Institute Building
Hospital Rd
Randwick
NSW 2031
Country 69624 0
Australia
Phone 69624 0
+61 2 9382 8356
Fax 69624 0
Email 69624 0
s.harvey@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This wasn't included in our original ethics submission.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2576Study protocol Deady M, Johnston DA, Glozier N, et al Smartphone application for preventing depression: study protocol for a workplace randomised controlled trial BMJ Open 2018;8:e020510. doi: 10.1136/bmjopen-2017-020510 https://bmjopen.bmj.com/content/8/7/e020510  371641-(Uploaded-27-06-2019-11-53-56)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSmartphone application for preventing depression: Study protocol for a workplace randomised controlled trial.2018https://dx.doi.org/10.1136/bmjopen-2017-020510
EmbasePreventing depression using a smartphone app: a randomized controlled trial.2022https://dx.doi.org/10.1017/S0033291720002081
N.B. These documents automatically identified may not have been verified by the study sponsor.