Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001475235
Ethics application status
Approved
Date submitted
27/08/2018
Date registered
4/09/2018
Date last updated
1/08/2019
Date data sharing statement initially provided
1/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot trial of a smartphone application to support the mental health of young apprentices
Scientific title
A pilot trial of a smartphone application to support the mental health of young apprentices
Secondary ID [1] 295914 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 309389 0
anxiety 309390 0
Wellbeing 309391 0
Resilience 309392 0
Work performance 309393 0
Condition category
Condition code
Mental Health 308248 308248 0 0
Depression
Mental Health 308249 308249 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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. 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 is developed from the validated HILDA risk algorithm for future distress in working Australian adults [1]. 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 chart which displays the current risk estimate of developing mental ill-health within the next year, the lowest risk possible, and risk factors for targeting. 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, and links to resources for apprentices.

Participants will be encouraged to use the app at least once a day for thirty days. The 'challenges' take 5–10 minutes to complete.
As this is an unguided app, no administration/instruction will be delivered.
Data on adherence and usage will be collected via the app itself.


1. Fernandez A, Salvador-Carulla L, Choi I, Calvo R, Harvey SB, Glozier N. Development and validation of a prediction algorithm for the onset of common mental disorders in a working population. Australian & New Zealand Journal of Psychiatry. 2017;52(1):47-58
Intervention code [1] 312239 0
Prevention
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307222 0
Depression symptom change as measured by the patient health questionnaire (PHQ-9)
Timepoint [1] 307222 0
5weeks post baseline
Secondary outcome [1] 351160 0
Anxiety symptom change as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale.
Timepoint [1] 351160 0
5 weeks post-baseline
Secondary outcome [2] 351161 0
App acceptability as measured by app usage and a composite set of open feedback items via a study-specific questionnaire,
Timepoint [2] 351161 0
5 weeks post-baseline
Secondary outcome [3] 351162 0
Confidence in managing stressors as measured by items of the TENS questionnaire
Timepoint [3] 351162 0
5 weeks post-baseline
Secondary outcome [4] 351346 0
Change in work performance as measured by the Health and Work Performance Questionnaire
Timepoint [4] 351346 0
5-weeks post baseline
Secondary outcome [5] 351347 0
Wellbeing change as measured by the WHO (Five) Well-being Index (WHO5)
Timepoint [5] 351347 0
5 weeks post-baseline

Eligibility
Key inclusion criteria
Aged between 16 to 30, resident in Australia, enrolled in an apprenticeship program, have a valid email address and mobile number, owning an Apple or Android- operating smartphone.
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
inability to comprehend English, failure to provide phone number or email.

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/09/2018
Actual
25/03/2019
Date of last participant enrolment
Anticipated
30/11/2018
Actual
25/05/2019
Date of last data collection
Anticipated
22/02/2019
Actual
6/07/2019
Sample size
Target
63
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300511 0
University
Name [1] 300511 0
UNSW
Country [1] 300511 0
Australia
Funding source category [2] 300512 0
Commercial sector/Industry
Name [2] 300512 0
Safework NSW
Country [2] 300512 0
Australia
Funding source category [3] 300556 0
University
Name [3] 300556 0
Univerity of Sydney
Country [3] 300556 0
Australia
Primary sponsor type
University
Name
Mark Deady
Address
Black Dog Institute, UNSW, Hospital Rd, NSW 2031
Country
Australia
Secondary sponsor category [1] 299986 0
University
Name [1] 299986 0
Isabella Choi
Address [1] 299986 0
University of Sydney, Camperdown, NSW 2006
Country [1] 299986 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301302 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 301302 0
Ethics committee country [1] 301302 0
Australia
Date submitted for ethics approval [1] 301302 0
22/08/2018
Approval date [1] 301302 0
05/11/2018
Ethics approval number [1] 301302 0

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

Contacts
Principal investigator
Name 86558 0
Dr Mark Deady
Address 86558 0
Black Dog Institute, UNSW, Hospital Rd Randwick, NSW 2031
Country 86558 0
Australia
Phone 86558 0
+61293824517
Fax 86558 0
Email 86558 0
[email protected]
Contact person for public queries
Name 86559 0
Mark Deady
Address 86559 0
Black Dog Institute, UNSW, Hospital Rd Randwick, NSW 2031
Country 86559 0
Australia
Phone 86559 0
+61293824517
Fax 86559 0
Email 86559 0
[email protected]
Contact person for scientific queries
Name 86560 0
Mark Deady
Address 86560 0
Black Dog Institute, UNSW, Hospital Rd Randwick, NSW 2031
Country 86560 0
Australia
Phone 86560 0
+61293824517
Fax 86560 0
Email 86560 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not a part of ethics approval


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.