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Trial registered on ANZCTR


Registration number
ACTRN12620000312943
Ethics application status
Approved
Date submitted
20/02/2020
Date registered
6/03/2020
Date last updated
6/03/2020
Date data sharing statement initially provided
6/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Treating depressed Australian workers using an app-based intervention: A randomised controlled trial (Anchored)
Scientific title
Treating depressed Australian workers using an app-based intervention: A randomised controlled trial (Anchored)
Secondary ID [1] 300405 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record
This record is a sub-study of ACTRN12620000178943

Health condition
Health condition(s) or problem(s) studied:
Depression 316040 0
Anxiety 316041 0
Emotional wellbeing 316042 0
Stress 316046 0
Condition category
Condition code
Mental Health 314319 314319 0 0
Depression
Mental Health 314320 314320 0 0
Anxiety
Public Health 314321 314321 0 0
Health promotion/education
Public Health 314322 314322 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
'Anchored' is a smartphone application-based intervention that includes therapeutic content centred on behavioural activation (BA), mindfulness, and cognitive behavioural tasks. It was adapted from HeadGear, an existing smartphone application designed for individuals working in male-dominated industries. Anchored is more broadly aimed at all working adults, and has a more gender-neutral look and feel, achieved through use of colour scheme, imagery, font/typography, inclusion of male and female ‘characters’, and delivery of in-app content by both male and female presenters. 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. This app/intervention has been used previously in a pilot study: Pilot-testing of a mobile phone application to support the mental health of Australian workers (ACTRN12619000761167).

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). Users can also complete an optional 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 tracker for monitoring mood, physical activity and sleep, a toolbox of skills (which is gradually filled as the intervention is completed), and support service helplines.
Intervention code [1] 316694 0
Treatment: Devices
Intervention code [2] 316695 0
Behaviour
Comparator / control treatment
Participants allocated to the attention control condition will be provided with access to an mobile-enabled online health and psychoeducation program consisting of four modules: 1) stress; 2) anxiety and depression; 3) lifestyle and physical health; and 4) occupational health and safety. The online program will seek to replicate participant time spent using the Anchored app; however, without the therapeutic content.
Control group
Active

Outcomes
Primary outcome [1] 322713 0
Depressive symptom change as measured by the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [1] 322713 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [1] 379383 0
Change in depression caseness as measured by the Patient Health Questionnaire-9 (PHQ-9) diagnostic algorithm.
Timepoint [1] 379383 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [2] 379384 0
Work-related stress symptom change as measured using the Perceived Stress Scale (PSS).
Timepoint [2] 379384 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [3] 379385 0
Anxiety symptom change as measured by the Generalized Anxiety Disorder (GAD) 7-item scale.
Timepoint [3] 379385 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [4] 379386 0
Change in wellbeing as measured by the World Health Organisation (Five) Well-being Index (WHO-5).
Timepoint [4] 379386 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [5] 379387 0
Change in work performance as measured by three items: (1) an item from the Health and Work Performance Questionnaire (HPQ), asking about job performance during the past 4 weeks; (2) an item pertaining to past month sickness absence (days absent, days absent for mental health reasons); and, (3) an item regarding past 6-month weeklong sickness absence (weeks absent, weeks absent for mental health reasons).
Timepoint [5] 379387 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [6] 379388 0
Change in resilience as measured using six items from the Brief Resilience Scale (BRS).
Timepoint [6] 379388 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [7] 379389 0
Change in Workplace burnout as measured by the Copenhagen Burnout Inventory (7 items).
Timepoint [7] 379389 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [8] 379390 0
Application engagement/feedback as measured using questions adapted from the Mobile Application Rating Scale; including questions measuring likelihood to recommend the app to others, overall rating, appropriateness to the target audience, as well as questions assessing how easy and interesting the app was to use.
Timepoint [8] 379390 0
Data will be collected 30 days after baseline.
Secondary outcome [9] 379391 0
Objective application engagement as measured through in-app data collection, including: (1) number of times App opened; (2) number of "challenges" completed; (3) number of “toolbox” items accessed; and, (4) total time spent in App.
Timepoint [9] 379391 0
Data will be collected 30 days after baseline.
Secondary outcome [10] 379392 0
General health outcomes (functioning, quality of life) as measured by the Assessment of Quality of Life (AQoL-4D).
Timepoint [10] 379392 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [11] 379393 0
Alcohol use measured by the AUDIT-C
Timepoint [11] 379393 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [12] 379394 0
Exercise as measured by single item (how often do you participate in moderate or intensive physical activity for at least 30 minutes? )
Timepoint [12] 379394 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after 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
- Have satisfactory English comprehension
- Be a current Australian resident
- Respond >=3 ("to some extent") to Single-Item Stress Question (SISQ) at screening
- Meet diagnosis of major depressive disorder (MDD) using the PHQ-9 algorithm
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- No smartphone ownership
- Under 18 years of age
- Inability to understand English
- Respond <3 on Single Item Stress Question (SISQ) at screening
- Not meet diagnostic criteria for major depressive disorder using PHQ-9 algorithm at screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed as randomisation of participants into intervention or 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)
Computer-generated block randomisation (in blocks of four).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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 and allowing a random effect for employer. After review of pilot data, the effect size was estimated to be 0.35. This effect size was entered into the statistical program R (R Core Team (2013). Power was set at 80% and conservative 2-tailed tests were assumed even though a directional hypothesis is proposed. Based on this testing a sample size of 266 per group was needed (total N = 532). A conservative dropout rate of 40% at follow-up was estimated, which increased the sample required to be 851 participants

Analysis plan:
Data coding and analysis will be carried out by the authors using available software packages including STATA version 12.0 (StataCorp, 2011) and the Statistical Package for the Social Sciences (SPSS) version 25.0. Data on screening, refusals, and dropout will be coded and reported as per CONSORT guidelines. Primary analyses will be undertaken on an intention-to-treat (ITT) basis, including data for all participants who were randomised and completed the initial baseline assessment, irrespective of their level of adherence to the intervention or control condition. 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. These approaches enable the inclusion of participants with missing data, without using inferior techniques such as last observation carried forward, when data is missing at random. 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. A number of a priori-defined stratified analyses will be conducted to examine the dose-response effect of the intervention.


Publication plan:
Papers will be produced separately for short-term and long-term outcomes. Primary and specific secondary outcomes will similarly be divided across manuscripts.

Recruitment
Recruitment status
Not yet recruiting
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] 304829 0
Government body
Name [1] 304829 0
Australian Government Department of Health
Address [1] 304829 0
GPO Box 9848,
Canberra ACT 2601
Country [1] 304829 0
Australia
Primary sponsor type
University
Name
UNSW
Address
UNSW Australia, Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 305160 0
Other
Name [1] 305160 0
Black Dog Institute
Address [1] 305160 0
Hospital Rd, Randwick NSW 2031
Country [1] 305160 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305240 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 305240 0
The University of New South Wales, Sydney NSW 2052
Ethics committee country [1] 305240 0
Australia
Date submitted for ethics approval [1] 305240 0
20/12/2019
Approval date [1] 305240 0
21/01/2020
Ethics approval number [1] 305240 0
HC190914

Summary
Brief summary
This application is for the purpose of conducting a randomised controlled trial (RCT) of a smartphone-based intervention (Anchored) aimed at reducing depression and promoting mental health and wellbeing within Australian workers. The app has previously undergone pilot testing for feasibility, usability and acceptability.
Participants will be randomised to one of two conditions: (1) the Anchored app (a CBT, mindfulness, and behavioral activation-based smartphone app) and (2) a psycho-educational online resource. Post-intervention assessment will occur 30 days after baseline, and follow-up assessment will occur 3 and 6 months after baseline. All assessment will be completed online.
Key outcomes include: depression symptoms, anxiety symptoms, stress, wellbeing, resilience, function, burnout, work productivity, and lifestyle elements.
Trial website
https://www.blackdoginstitute.org.au/research/key-research-areas/workplace-mental-health/anchored
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99730 0
Dr Mark Deady
Address 99730 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 99730 0
Australia
Phone 99730 0
+612 9382 8507
Fax 99730 0
Email 99730 0
m.deady@unsw.edu.au
Contact person for public queries
Name 99731 0
Dr Mark Deady
Address 99731 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 99731 0
Australia
Phone 99731 0
+612 9382 8507
Fax 99731 0
Email 99731 0
m.deady@unsw.edu.au
Contact person for scientific queries
Name 99732 0
Dr Mark Deady
Address 99732 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 99732 0
Australia
Phone 99732 0
+612 9382 8507
Fax 99732 0
Email 99732 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
All data will be de-identified and will only be used for the purposes of the trial. Results of statistical analyses will be made available during publication; however, individual participant data will not be made publicly available.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6706 0
Ethical approval
Citation [1] 6706 0
Email [1] 6706 0
humanethics@unsw.edu.au
Other [1] 6706 0
Summary results
No Results