ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000178943

Ethics application status

Approved

Date submitted

3/02/2020

Date registered

17/02/2020

Date last updated

5/08/2021

Date data sharing statement initially provided

17/02/2020

Date results information initially provided

5/08/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Randomised controlled trial of Anchored, an app-based intervention to support the mental health of Australian workers.

Scientific title

Randomised controlled trial of Anchored, an app-based intervention to support the mental health of Australian workers.

Secondary ID [1]

Nil known.

Universal Trial Number (UTN)

Trial acronym

Linked study record

ACTRN12619000761167 represents a pilot trial of this same app.

Health condition

Health condition(s) or problem(s) studied:

Depression

Anxiety

Emotional wellbeing

Stress

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Public Health

Health promotion/education

Public Health

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.

Adherence measures include challenge completion, time spent in challenges, toolbox completion, session times.

Intervention code [1]

Prevention

Intervention code [2]

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]

Depression incidence (onset) as measured by the Patient Health Questionnaire-9 (PHQ-9) diagnostic algorithm.

Timepoint [1]

Incidence data will be aggregated across follow-up timepoints (30 days, 3 months and 6 months).

Secondary outcome [1]

Depressive symptom change as measured by the Patient Health Questionnaire-9 (PHQ-9).

Timepoint [1]

Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.

Secondary outcome [2]

Work-related stress symptom change as measured using the Perceived Stress Scale (PSS).

Timepoint [2]

Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.

Secondary outcome [3]

Anxiety symptom change as measured by the Generalized Anxiety Disorder (GAD) 7-item scale.

Timepoint [3]

Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.

Secondary outcome [4]

Change in wellbeing as measured by the World Health Organisation (Five) Well-being Index (WHO-5).

Timepoint [4]

Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.

Secondary outcome [5]

Change in work presenteeism as measured by a single item from the Health and Work Performance Questionnaire (HPQ), asking about job performance during the past 4 weeks

Timepoint [5]

Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.

Secondary outcome [6]

Depression incidence (onset) as measured by the Patient Health Questionnaire-9 (PHQ-9) diagnostic algorithm.

Timepoint [6]

Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.

Secondary outcome [7]

Change in resilience as measured using six items from the Brief Resilience Scale (BRS).

Timepoint [7]

Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.

Secondary outcome [8]

Change in Workplace burnout as measured by the Copenhagen Burnout Inventory (7 items).

Timepoint [8]

Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.

Secondary outcome [9]

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 [9]

Data will be collected 30 days after baseline.

Secondary outcome [10]

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 [10]

Data will be collected 30 days after baseline.

Secondary outcome [11]

Change in General health outcomes (functioning, quality of life) as measured by the Assessment of Quality of Life (AQoL-4D).

Timepoint [11]

Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.

Secondary outcome [12]

Change in Alcohol use measured by the AUDIT-C

Timepoint [12]

Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.

Secondary outcome [13]

Change in exercise as measured by single item (how often do you participate in moderate or intensive physical activity for at least 30 minutes? )

Timepoint [13]

Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.

Secondary outcome [14]

Change in Effective work days using the Health and Work Performance Questionnaire (HPQ), A composite measure for effective work days will be constructed by multiplying days present at work (absenteeism) by absolute work productivity score (presenteeism) as calculated by the HPQ, replicating previous work in the area (Wang et al. 2007).

Timepoint [14]

Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.

Secondary outcome [15]

Change in work absenteeism as measured by a single item from the Health and Work Performance Questionnaire (HPQ), pertaining to past month sickness absence (days absent, days absent for mental health reasons)

Timepoint [15]

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
- Not meet diagnosis of major depressive disorder (MDD) using the PHQ-9 algorithm

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 <3 on Single Item Stress Question (SISQ) at screening
- Meet diagnostic criteria for major depressive disorder using PHQ-9 algorithm at screening

Study design

Purpose of the study

Prevention

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

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.

Sample Size:
As a population based prevention intervention, the size of the effect of the intervention is anticipated to be relatively small. Meta-analysis of previous trials of workplace prevention of depression showed an odds ratio of 2.04 (P=0.005, 95%CI:1.24–3.35) aggregated over 3-month follow-up period. Power calculations were carried out using STATA-12, which can undertake power calculations for models proposed to use in this study using simulation techniques. Power was set at 80%, alpha at 0.05, with a two-sided hypothesis test and an assumption of correlation at .50 between pre- and post- intervention scores. This estimated a sample size of 1,028 is required to detect a proportional difference in incidence rates similar to that reported in previous research. Finally, using a conservative attrition rate of 50%, an initial total sample of 2,056 will need to be recruited and randomised.

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

Completed

Date of first participant enrolment

Anticipated

28/02/2020

Actual

25/03/2020

Date of last participant enrolment

Anticipated

30/04/2020

Actual

26/04/2020

Date of last data collection

Anticipated

30/11/2020

Actual

25/10/2020

Sample size

Target

2056

Accrual to date

Final

2115

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Department of Health

Address [1]

GPO Box 9848,
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

UNSW Australia

Address

UNSW Australia, Kensington NSW 2052

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Black Dog Institute

Address [1]

Hospital Rd, Randwick NSW 2031

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales Human Research Ethics Committee

Ethics committee address [1]

The University of New South Wales, Sydney NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/12/2019

Approval date [1]

21/01/2020

Ethics approval number [1]

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 preventing 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 caseness, 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

Dr Mark Deady

Address

Black Dog Institute
Hospital Rd, Randwick NSW 2031

Country

Australia

Phone

+612 9382 8507

Fax

[email protected]

Contact person for public queries

Name

Dr Mark Deady

Address

Black Dog Institute
Hospital Rd, Randwick NSW 2031

Country

Australia

Phone

+612 9382 8507

Fax

[email protected]

Contact person for scientific queries

Name

Dr Mark Deady

Address

Black Dog Institute
Hospital Rd, Randwick NSW 2031

Country

Australia

Phone

+612 9382 8507

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6546	Ethical approval		https://research.unsw.edu.au/recs/human-research-ethics-home	[email protected]		378592-(Uploaded-22-01-2020-12-59-52)-Study-related document.Pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Selective Prevention of Depression in Workers Using a Smartphone App: Randomized Controlled Trial.	2023	https://dx.doi.org/10.2196/45963

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically