Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000761167
Ethics application status
Approved
Date submitted
16/05/2019
Date registered
22/05/2019
Date last updated
29/09/2020
Date data sharing statement initially provided
22/05/2019
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
Anxiety
Mental Health 310685 310685 0 0
Depression
Public Health 311406 311406 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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
Behaviour
Intervention code [2] 314024 0
Prevention
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
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
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 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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2019
Actual
22/10/2019
Date of last participant enrolment
Anticipated
4/11/2019
Actual
24/10/2019
Date of last data collection
Anticipated
20/12/2019
Actual
5/12/2019
Sample size
Target
44
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 302306 0
Government body
Name [1] 302306 0
Australian Government Department of Health
Country [1] 302306 0
Australia
Primary sponsor type
Other
Name
Black Dog Institute
Address
Hospital Rd, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 302313 0
None
Name [1] 302313 0
Address [1] 302313 0
Country [1] 302313 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302981 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 302981 0
Ethics committee country [1] 302981 0
Australia
Date submitted for ethics approval [1] 302981 0
12/02/2019
Approval date [1] 302981 0
27/05/2019
Ethics approval number [1] 302981 0
HC190109

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

Contacts
Principal investigator
Name 92058 0
A/Prof Samuel Harvey
Address 92058 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 92058 0
Australia
Phone 92058 0
+61 2 93828356
Fax 92058 0
Email 92058 0
s.harvey@unsw.edu.au
Contact person for public queries
Name 92059 0
Mark Deady
Address 92059 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 92059 0
Australia
Phone 92059 0
+61 2 93824517
Fax 92059 0
Email 92059 0
m.deady@unsw.edu.au
Contact person for scientific queries
Name 92060 0
Mark Deady
Address 92060 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 92060 0
Australia
Phone 92060 0
+61 2 93824517
Fax 92060 0
Email 92060 0
m.deady@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
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 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.