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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot-testing of a mobile phone application to support the mental health of Australian workers.
Scientific title
Pilot-testing of a mobile phone application to support the mental health of Australian workers.
Secondary ID [1] 297783 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 312131 0
Anxiety 312132 0
Wellbeing 312248 0
Resilience 312249 0
Work performance 312250 0
Stress 312857 0
Condition category
Condition code
Mental Health 310684 310684 0 0
Mental Health 310685 310685 0 0
Public Health 311406 311406 0 0
Health promotion/education

Study type
Description of intervention(s) / exposure
'Anchored' is a smartphone application-based intervention that is adapted from HeadGear, a smartphone application centred on behavioural activation (BA) and mindfulness. The HeadGear app was designed for individuals working in male-dominated industries, while the new Anchored app is more broadly aimed at all working adults. The Anchored app is designed for self-directed use by an individual on a smartphone device. It features interactive content, delivered by on-screen text, audio, static and interactive image displays and videos. The app can be accessed by the participant on their smartphone at a time and location of their choosing. The main therapeutic component of the Anchored app takes the form of a 30 day intervention in which users complete one ‘challenge’ daily (5- 10 minutes per day). These 'challenges' feature a variety of evidence-based therapeutic techniques delivered using a range of formats including: psychoeducational videos (on coping skills and resilience, 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). At the commencement of the intervention, users complete a risk calculator that assesses risk for future common mental disorders and provides participants with personalised feedback regarding this risk. The risk calculator uses an algorithm based on 20 inventory questions developed from the Household, Income and Labour Dynamics in Australia Survey (HILDA), and has been validated in the Australian adult population.
Other components of the Anchored app include a mood tracker, a toolbox of skills (which is filled as the intervention is completed), and support service helplines. Users will have access to the application indefinitely. As this is an unguided app, no administration/instruction will be delivered. The application monitors use time and frequency, and 'challenge' completion rates.
Intervention code [1] 314023 0
Intervention code [2] 314024 0
Comparator / control treatment
No control group.
Control group

Primary outcome [1] 319536 0
Depression symptom change as measured by the patient health questionnaire (PHQ-9).
Timepoint [1] 319536 0
Measurements will be collected at baseline and 5-weeks post-baseline.
Secondary outcome [1] 368595 0
Anxiety symptom change as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale.
Timepoint [1] 368595 0
Measurements will be collected at baseline and 5-weeks post-baseline.
Secondary outcome [2] 368596 0
Wellbeing change as measured by the WHO (Five) Well-being Index (WHO5).
Timepoint [2] 368596 0
Measurements will be collected at baseline and 5-weeks post-baseline.
Secondary outcome [3] 368597 0
Change in resilience as measured by Brief Resilience Scale (BRS).
Timepoint [3] 368597 0
Measurements will be collected at baseline and 5-weeks post-baseline.
Secondary outcome [4] 368598 0
Change in work performance as measured by the Health and Work Performance Questionnaire.
Timepoint [4] 368598 0
Measurements will be collected at baseline and 5-weeks post-baseline.
Secondary outcome [5] 370491 0
Change in work-related stress as measured by the Single-item Stress Question (SISQ).
Timepoint [5] 370491 0
Measurements will be collected at baseline and 5-weeks post-baseline.
Secondary outcome [6] 370492 0
App acceptability as measured by app usage and a composite set of open feedback items via a study-specific questionnaire,
Timepoint [6] 370492 0
Measurements will be collected at 5-weeks post-baseline.

Key inclusion criteria
To be included in the study participants must:
- Be over 18 years of age
- Be currently employed either on a casual basis, part time, or full time
- Reside in Australia
- Have satisfactory English comprehension
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- No smartphone ownership
- Under 18 years of age
- Inability to understand english
- Respond <4 ("rather much") on SISQ at screening

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Data will be analysed via descriptive statistics derived from participants’ smartphone use data to characterise feasibility and acceptability in the pilot study. Pearson product-moment correlation coefficients will be used to examine the association between baseline continuous variables (e.g. K6) and application use (ie, days used, number of times used per day). Spearman’s rank correlation coefficients will be used to examine the association between categorical variables (e.g. gender) and application use. Paired samples t tests will be used to test for differences between pretrial and post-trial clinical outcomes (e.g. K6).

The intended number of participants to be recruited for this pilot is 63 with an expected attrition rate of 30% resulting in a final sample of 44 participants. In order to ensure adequate time and resources for developing the web-based program in the current study, the recruitment time window and sample size is purposefully limited. In the pilot study of Headgear, a small to moderate within group effect size (.28) was observed on the PHQ-9. Power calculations show that we would need 44 participants to achieve this effect size with 80% power at alpha=.05. To account for a 30% dropout rate, 63 participants need to be recruited.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 302306 0
Government body
Name [1] 302306 0
Australian Government Department of Health
Address [1] 302306 0
GPO Box 9848,
Canberra ACT 2601
Country [1] 302306 0
Primary sponsor type
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Secondary sponsor category [1] 302313 0
Name [1] 302313 0
Address [1] 302313 0
Country [1] 302313 0

Ethics approval
Ethics application status
Ethics committee name [1] 302981 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 302981 0
The University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 302981 0
Date submitted for ethics approval [1] 302981 0
Approval date [1] 302981 0
Ethics approval number [1] 302981 0

Brief summary
Our research team is part of a group that has been awarded a grant to establish the Prevention Hub Mental Health Research Program. The Prevention Hub will focus on implementing and evaluating preventative strategies for anxiety and depression in workplace, school, and healthcare settings to achieve the greatest possible impact and reach. This application is intended to cover pilot of a smartphone-based intervention (Anchored) aimed at promoting mental health and wellbeing within Australian workers. Participants will complete assessments at baseline and 5 weeks post-baseline.

The primary aim of the pilot is to test the impact of the Anchored app on reducing depressive symptoms among employed Australians. The pilot also aims to:
- test the impact of the Anchored app on anxiety, wellbeing, resilience, and work productivity.
- explore participant engagement with the activities in the app.
- explore level of satisfaction with the app and confidence in managing stressors.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 92058 0
A/Prof Samuel Harvey
Address 92058 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 92058 0
Phone 92058 0
+61 2 93828356
Fax 92058 0
Email 92058 0
Contact person for public queries
Name 92059 0
Dr Mark Deady
Address 92059 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 92059 0
Phone 92059 0
+61 2 93824517
Fax 92059 0
Email 92059 0
Contact person for scientific queries
Name 92060 0
Dr Mark Deady
Address 92060 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 92060 0
Phone 92060 0
+61 2 93824517
Fax 92060 0
Email 92060 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
As this is a pilot version of the Anchored app, individual participant data will be used to establish feasibility and acceptability, and to inform modifications to the app before it is implemented in a large-scale trial. For this reason, individual data from the present study will not be made publicly available.
What supporting documents are/will be available?
No other documents available
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