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Trial registered on ANZCTR


Registration number
ACTRN12616001384448
Ethics application status
Approved
Date submitted
30/09/2016
Date registered
6/10/2016
Date last updated
19/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot-testing of a smartphone application for the prevention of common mental disorders in male-dominated industries
Scientific title
Pilot-testing of a smartphone application for the prevention of common mental disorders in male-dominated industries
Secondary ID [1] 290226 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 300412 0
anxiety 300504 0
Condition category
Condition code
Mental Health 300269 300269 0 0
Depression
Mental Health 300290 300290 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, HeadGear, is a smartphone application-based intervention centred 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 ‘mission’ daily (approximately 10 minutes). These ‘missions’ 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 HILDA derived risk algorithm. The risk factor items are based on participant self-report. The HILDA risk items include: age, gender, Aboriginal and Torres Strait Islander status, active carer, freedom to decide work, satisfaction with hours worked, satisfaction with employment opportunities, three or more times physical activity, alcohol use, episodes of distress in the previous two years, satisfaction with health, satisfaction with the neighbourhood, satisfaction with partner, satisfaction with the way tasks are divided with partner, have someone to confide in, feeling being pushed around, and English as a second language. The HILDA questions and response items were replicated from the original items included in the HILDA survey, apart from age, which is measured here as a continuous measure. Users will receive personalised risk feedback immediately after completing the risk calculator. The personalised risk feedback involves an interactive icon array which displays the calculated numerical risk estimate of developing anxiety and depression within the next year, along with a text description.
Other components of the app include a mood monitoring widget, a toolbox of skills (which is built from the challenge as it is completed), and support service helplines. users will have access to the application indefinitely. The application monitors use time and frequency, and mission completion rates
Intervention code [1] 295999 0
Prevention
Intervention code [2] 296069 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299768 0
The usability and acceptability of the App will be measured with a questionnaire adapted from the System Usability Scale, Post Study System Usability Questionnaire, Technology Assessment Model Measurement Scales, and Usefulness, Satisfaction, and Ease questionnaire. This is a composite measure devised by Ben-Zeev, D., Brenner, C. J., Begale, M., Duffecy, J., Mohr, D. C., & Mueser, K. T. (2014). Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone Intervention for Schizophrenia. Schizophrenia Bulletin. doi:10.1093/schbul/sbu033
Timepoint [1] 299768 0
5 weeks post-baseline
Primary outcome [2] 299769 0
Change in wellbeing and distress measured using the 6-item Kessler Psychological Distress Scale (K6).
Timepoint [2] 299769 0
Measurements will be collected at baseline and 5-weeks post-baseline
Secondary outcome [1] 328067 0
Change in general well-being will be measured using the World Health Organisation-5 (WHO-5) Well-Being Index
Timepoint [1] 328067 0
Measurements will be collected at baseline and 5-weeks post-baseline
Secondary outcome [2] 328070 0
Psychological strength and resilience will be measured with the Brief Resilience Scale (BRS)
Timepoint [2] 328070 0
Measurements will be collected at baseline and 5-weeks post-baseline
Secondary outcome [3] 328071 0
Levels of stress will be measured using the 10-item Perceived Stress Scale (PSS-10)
Timepoint [3] 328071 0
Measurements will be collected at baseline and 5-weeks post-baseline

Eligibility
Key inclusion criteria
Our eligibility criteria will be that participants must be aged 18 years or older, be an Australian resident, own a smartphone, and have a reasonable understanding of the English language, work in a male-dominated industry.
Minimum age
18 Years
Maximum age
No limit
Gender
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
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
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
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 were 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 were used to examine the association categorical variables (e.g. gender) and application use. Paired samples t tests were used to test for differences between pretrial and post-trial clinical outcomes (K6).

Pilot studies tend to be underpowered in order to determine “proof of concept.” In order to ensure adequate development time and resources for developing the web-based program in the current study, the recruitment time window and sample size is purposefully limited. To adjust for these factors, and given the goals for examining initial feasibility of the program, significance was determined at a value of p = .05. This provided adequate power of .80 to detect a medium effect size of Cohen’s d = .60 with a sample size of 40 participants per group using a two tailed test and alpha of p = .05 (Levin, 2014).

Levin, M. E., Pistorello, J., Seeley, J. R., & Hayes, S. C. (2014). Feasibility of a Prototype Web-Based Acceptance and Commitment Therapy Prevention Program for College Students. J of ACH, 62(1), 10.1080/07448481.2013.843533. http://doi.org/10.1080/07448481.2013.843533

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] 294604 0
Charities/Societies/Foundations
Name [1] 294604 0
Beyondblue
Address [1] 294604 0
PO Box 6100
Hawthorne
Vic 3122
Country [1] 294604 0
Australia
Funding source category [2] 294605 0
Charities/Societies/Foundations
Name [2] 294605 0
Movember
Address [2] 294605 0
PO Box 60
East Melbourne
VIC 8002
Country [2] 294605 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW
Kensington
2052 NSW
Country
Australia
Secondary sponsor category [1] 293468 0
Other
Name [1] 293468 0
Black Dog Institute
Address [1] 293468 0
Hospital Rd
Randwick
2031 NSW
Country [1] 293468 0
Australia
Secondary sponsor category [2] 293469 0
University
Name [2] 293469 0
The University of Sydney
Address [2] 293469 0
Sydney
NSW 2006
Country [2] 293469 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296048 0
UNSW Human Research Ethics Committee (HREC)
Ethics committee address [1] 296048 0
UNSW
Sydney
NSW 2052
Ethics committee country [1] 296048 0
Australia
Date submitted for ethics approval [1] 296048 0
27/07/2016
Approval date [1] 296048 0
07/09/2016
Ethics approval number [1] 296048 0
HC16646

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 male dominated industries. Necessary preliminary steps include the pilot-testing of these interventions to ensure the programs are acceptable and feasible. This application is intended to cover the conducting of a pilot testing of the interventions. The working title for this new smartphone application is ‘Headgear.’
This project aims to develop an App which will enable workers in male-dominated industries to identify and problem solve aspects of mental health, triggers and lifestyle related factors, and develop personalised goals and strategies. Objectives include:
(1) Developing and testing a high quality wellbeing phone App for working men and women; and
(2) Conducting a mixed-methods study of the acceptability of the App.
With the pilot testing and feedback, we aim to design and prototype an app that is engaging for workers in the target industries. It is hoped that by engaging users throughout the development process, we will be able to produce a range of e-health products that these individuals will be able to engage with.
Data Collection:
Eligible participants will be directed to the program’s website in order to provide consent via the online participant information statement. From here they will complete a battery of assessment measures including:
1. Demographic information (age, gender, education, occupational status, and industry group; email, phone number)
2. Mood and anxiety symptoms (K6 questionnaire)
2. Wellbeing (WHO 5 Well-being Index)
3. Psychological strength and resilience (Connors-Davidson Resilience Scale (CD-RISC 10))
4. Stress (Perceived Stress Scale (PSS-10))
Participants will then be invited to download the app via the Testflight application and are encouraged to use the app for 30 days. At which point participants will be contacted via phone and email by research assistants to complete the follow-up survey comprised of the same measures in the initial battery with the addition of the acceptability/usability questionnaire (comprised of adapted items from the System Usability Scale, Post Study System Usability Questionnaire, Technology Assessment Model Measurement Scales, and Usefulness, Satisfaction, and Ease questionnaire. Usage data will be automatically collected by the app including time spent in app, number of logins, and specific responses to exercises. This data will be used to examine program engagement and usage.
Trial website
www.headgear.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69298 0
A/Prof Samuel Harvey
Address 69298 0
School of Psychiatry
University of New South Wales
Black Dog Institute Building
Hospital Rd
Randwick
NSW 2031
Country 69298 0
Australia
Phone 69298 0
+61 2 9382 8356
Fax 69298 0
Email 69298 0
s.harvey@unsw.edu.au
Contact person for public queries
Name 69299 0
A/Prof Samuel Harvey
Address 69299 0
School of Psychiatry
University of New South Wales
Black Dog Institute Building
Hospital Rd
Randwick
NSW 2031
Country 69299 0
Australia
Phone 69299 0
+61 2 9382 8356
Fax 69299 0
Email 69299 0
s.harvey@unsw.edu.au
Contact person for scientific queries
Name 69300 0
A/Prof Samuel Harvey
Address 69300 0
School of Psychiatry
University of New South Wales
Black Dog Institute Building
Hospital Rd
Randwick
NSW 2031
Country 69300 0
Australia
Phone 69300 0
+61 2 9382 8356
Fax 69300 0
Email 69300 0
s.harvey@unsw.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