Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000555954
Ethics application status
Approved
Date submitted
15/04/2020
Date registered
11/05/2020
Date last updated
30/11/2023
Date data sharing statement initially provided
11/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of an app-based intervention, Anchored, to support the mental health of Australians recently unemployed due to COVID-19.
Scientific title
Randomised controlled trial of an app-based intervention, Anchored, to support the mental health of Australians recently unemployed due to COVID-19.
Secondary ID [1] 300929 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This record is a sub-study of ACTRN12620000178943.
ACTRN12619000761167 represents a pilot trial of this same app.

Health condition
Health condition(s) or problem(s) studied:
Depression
 316904 0
Anxiety 316905 0
Emotional wellbeing 316906 0
Stress 316907 0
Suicidal ideation 317050 0
Condition category
Condition code
Mental Health 315081 315081 0 0
Anxiety
Mental Health 315082 315082 0 0
Depression
Public Health 315083 315083 0 0
Health promotion/education
Public Health 315084 315084 0 0
Other public health
Mental Health 315217 315217 0 0
Suicide

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 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); and is being currently being evaluated in a large scale randomised controlled trial (ACTRN12620000178943). Due to the unexpected changes to the workforce brought about by COVID-19 (coronavirus) the present study seeks to evaluate the efficacy of the Anchored app in individuals who are unemployed as a consequence of COVID-19.

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] 317244 0
Prevention
Intervention code [2] 317245 0
Behaviour
Comparator / control treatment
Participants allocated to the control condition will be placed in a waitlist group and provided with support referral resources. After 6-months, participants allocated to the control group will be provided access to Anchored app.
Control group
Active

Outcomes
Primary outcome [1] 323377 0
Depressive symptom change as measured by the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [1] 323377 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Primary outcome [2] 323378 0
Depression caseness (change or onset) as measured by the Patient Health Questionnaire-9 (PHQ-9) diagnostic algorithm.
Timepoint [2] 323378 0
Data will be aggregated across follow-up timepoints (30 days, 3 months and 6 months).
Secondary outcome [1] 381695 0
Anxiety symptom change as measured by the Generalized Anxiety Disorder (GAD) 7-item scale.
Timepoint [1] 381695 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [2] 381696 0
Change in wellbeing as measured by the World Health Organisation (Five) Well-being Index (WHO-5).
Timepoint [2] 381696 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [3] 381698 0
Depression caseness (change or onset) as measured by the Patient Health Questionnaire-9 (PHQ-9) diagnostic algorithm.
Timepoint [3] 381698 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [4] 381699 0
Change in resilience as measured using six items from the Brief Resilience Scale (BRS).
Timepoint [4] 381699 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [5] 381700 0
Change in Personal burnout as measured by the Copenhagen Burnout Inventory (7 items).
Timepoint [5] 381700 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [6] 381701 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 [6] 381701 0
Data will be collected 30 days after baseline.
Secondary outcome [7] 381702 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 [7] 381702 0
Data will be collected 30 days after baseline.
Secondary outcome [8] 381703 0
Change in Alcohol use measured by the AUDIT-C
Timepoint [8] 381703 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [9] 381704 0
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 [9] 381704 0
Data will be collected at baseline, and 30 days, 3 months and 6 months after baseline.
Secondary outcome [10] 382020 0
Suicidal ideation as measured by the five-item Suicidal Ideation Attributes Scale (SIDAS)
Timepoint [10] 382020 0
Baseline survey, post-intervention survey, 3-month follow-up survey, and 6-month follow-up survey

Eligibility
Key inclusion criteria
To be included in the study participants must:
- Be over 18 years of age
- Be recently unemployed as a result of the COVID-19 pandemic
- Have satisfactory English comprehension
- Be a current Australian resident
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
- Currently employed

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)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size:
The within group effect size from the pilot trial examining the Anchored app in a sample of Australian workers (ACTRN12619000761167), was 0.77 (Cohen's d) for those not meeting PHQ-9 depression criteria (d=.77). As this was uncontrolled we expect the between group effect to be greatly reduced. Deady et al (2017), found .29 for universal type eHealth prevention interventions. Thus the sample size required for the study is 390, with 50% dropout, 780 users are to be recruited.

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, as well as the effect for prevention (in those not meeting depression criteria on the PhQ-9).

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2020
Actual
15/06/2020
Date of last participant enrolment
Anticipated
30/06/2020
Actual
3/08/2020
Date of last data collection
Anticipated
31/03/2021
Actual
4/02/2021
Sample size
Target
780
Accrual to date
Final
754
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305375 0
Government body
Name [1] 305375 0
Australian Government Department of Health
Country [1] 305375 0
Australia
Primary sponsor type
University
Name
UNSW
Address
UNSW Australia, Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 305752 0
Other
Name [1] 305752 0
Black Dog Institute
Address [1] 305752 0
Hospital Road, Randwick NSW 2031
Country [1] 305752 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305705 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 305705 0
Ethics committee country [1] 305705 0
Australia
Date submitted for ethics approval [1] 305705 0
06/04/2020
Approval date [1] 305705 0
24/04/2020
Ethics approval number [1] 305705 0
HC190914

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

Contacts
Principal investigator
Name 101298 0
Dr Mark Deady
Address 101298 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 101298 0
Australia
Phone 101298 0
+61 2 9382 8507
Fax 101298 0
Email 101298 0
[email protected]
Contact person for public queries
Name 101299 0
Mark Deady
Address 101299 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 101299 0
Australia
Phone 101299 0
+61 2 9382 8507
Fax 101299 0
Email 101299 0
[email protected]
Contact person for scientific queries
Name 101300 0
Mark Deady
Address 101300 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 101300 0
Australia
Phone 101300 0
+612 9382 8507
Fax 101300 0
Email 101300 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
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.TypeCitationLinkEmailOther DetailsAttachment
7493Ethical approval https://research.unsw.edu.au/recs/human-research-ethics-home[email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.