Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001014842p
Ethics application status
Submitted, not yet approved
Date submitted
13/07/2021
Date registered
4/08/2021
Date last updated
6/07/2022
Date data sharing statement initially provided
4/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of a wellbeing app in the general public
Scientific title
A randomised controlled trial of the effectiveness of a wellbeing app in increasing the wellbeing of the general public
Secondary ID [1] 304770 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Wellbeing 322825 0
Condition category
Condition code
Mental Health 320415 320415 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 12-week trial involving a 6-week intervention with 2 arms and 3 measurement occasions. The trial will recruit participants from the user base of the wellbeing app, and the aim will be to measure the participants’ levels of wellbeing over time and to determine whether the app is effective at increasing their wellbeing when used for a 6-week period.

The wellbeing app was designed for this study. It is not yet readily available in the Apple Store, but will become available upon start of the clinical trial.

After downloading the app and accepting the terms and conditions, new users will be given a choice between using the app as a regular subscriber or participating in the trial and using the app for free for the 12-week period. Those who choose to participate will be taken through the informed consent process and will answer screening questions to ensure eligibility. Consenting eligible participants will be enrolled in the trial and randomly allocated to one of the two arms (Intervention or Active Control).

All participants will complete an online survey immediately before starting week 1 of the intervention (pre-test), a second online survey immediately after finishing week 6 of the intervention (post-test), and a third online survey 6 weeks after finishing the intervention (follow-up). All aspects of the trial (e.g., the consent form, screening questions, and surveys) will be administered via the app in an automated process. If the minimum sample size requirement is met, each arm will comprise at least 243 participants for a total sample size of 486.

In the intervention arm, the participants will be instructed to use the wellbeing app for at least 10 minutes a day over the initial 6-week period. The app measures the users’ wellbeing profile and then provides a personalised range of psycho-educational readings and interactive activities suited to their profile to complete each week. Each week, a new set of activities are recommended until all the readings and activities are completed, after which the user will cycle through the resources again. The priority of activities are based on their wellbeing profile, with a new profile computed every 4 weeks. The activities are designed to be repeated regularly, so the user can cycle through the full set of resources again and again until the end of the study period. After using the app for 6 weeks, the intervention participants will be suggested to use the app for another 6 weeks if they wish to until the final survey is completed.

At each of the three measurement occasions, the intervention participants will complete an online survey measuring their levels of mental wellbeing as well as other relevant variables including work performance, satisfaction with the app, and mood symptoms of depression, anxiety, and stress. The app will also record the user’s activity (e.g., how many minutes of usage per day, how many activities completed, etc.), allowing the researchers to measure treatment compliance.
Intervention code [1] 321152 0
Behaviour
Comparator / control treatment
In the active control arm, the participants will receive an alternative version of the wellbeing app. This version provides a reduced set of neutral activities that are not expected to have a significant impact on the outcome variables. The neutral activities will include, for example, a task focused on neutral reminiscence for the active control group, whereas in the intervention group they would instead receive an activity focused on positive reminiscence. These neutral activities have been used in a previous study.

Users will be provided these neutral activities to use during the 6-week period. After using the app for 6 weeks, the control participants will be instructed that they are free to continue using the app for another 6 weeks if they wish to. After the 12-week study period, the control participants will be given 12 weeks of free access to the proper version of the wellbeing app to use, and they will be advised this is the end consumer product.

At each of the three measurement occasions, the control participants will complete the same surveys as the Intervention group.
Control group
Active

Outcomes
Primary outcome [1] 328246 0
Mental wellbeing, as measured by the COMPAS-W scale (Gatt et al., 2014)
Timepoint [1] 328246 0
Week 1 (immediately before starting the intervention)
Week 6 (immediately after finishing the intervention) – this is the primary endpoint
Week 12 (6 weeks after finishing the intervention)
Secondary outcome [1] 398247 0
Psychological distress (i.e. symptoms of depression, anxiety, and stress) as measured by the DASS-21 scale (Lovibond & Lovibond, 1995)
Timepoint [1] 398247 0
Week 1 (immediately before starting the intervention)
Week 6 (immediately after finishing the intervention)
Week 12 (6 weeks after finishing the intervention)
Secondary outcome [2] 398248 0
Work performance, as measured by the HPQ (Employee Version) Work Performance Scale (Kessler et al., 2003, 2004)
Timepoint [2] 398248 0
Week 1 (immediately before starting the intervention)
Week 6 (immediately after finishing the intervention)
Week 12 (6 weeks after finishing the intervention)
Secondary outcome [3] 398249 0
App satisfaction (i.e. whether the participant enjoyed using the app and found it helpful), as measured by the App Satisfaction Questionnaire (developed specifically for the present study)
Timepoint [3] 398249 0
Week 6 (immediately after finishing the intervention)
Secondary outcome [4] 398925 0
Psychological distress as measured by the K10 (Kessler et al., 2002)
Timepoint [4] 398925 0
Week 1 (immediately before starting the intervention)
Week 6 (immediately after finishing the intervention)
Week 12 (6 weeks after finishing the intervention)

Eligibility
Key inclusion criteria
Aged 18 years or older
Can understand written English
Has no current moderate to severe mental illness symptoms
Residing in Australia, New Zealand, the UK, Ireland, USA, or Canada
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
N/A

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)
This procedure will be automated via the app. After downloading the app and accepting the terms and conditions, new users will be given a choice between using the app as a regular subscriber or participating in the trial and using the app for free for the 12-week period. Those who choose to participate will be taken through the informed consent process and will answer screening questions to ensure eligibility. Consenting eligible participants will be enrolled in the trial by the app and the app will use an internal algorithm to randomly allocate each user to one of the two arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation via the app’s internal algorithm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Participants will be told that two versions of the app will be tested and compared. They will not be told that the two versions correspond to an intervention and active control, nor will they be told which version they have been allocated to.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The minimum total sample size for the project is 486, with 243 participants in each of the two arms. Power calculations indicate that the minimum sample size required to detect small effects at 95% power in two groups across at least two time-points is 324. However, allowing for 50% attrition, the minimum sample size will need to be 486.

Repeated-measures models will be used to analyse the data. Any missing values (e.g. due to attrition) will be imputed before the analysis is carried out. The primary analysis will employ an intention-to-treat approach, examining group by time interactions in predicting the outcome variables. Secondary analyses will determine whether any effect of the intervention is moderated or mediated by another relevant variable (e.g., demographic or lifestyle variables, and app usage metrics). The conventional significance level of p < 0.05 (two-tailed) will be used for the statistical tests, and will be corrected for multiple comparisons.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
486
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 23960 0
New Zealand
State/province [1] 23960 0
Country [2] 23961 0
Ireland
State/province [2] 23961 0
Country [3] 23962 0
United Kingdom
State/province [3] 23962 0
Country [4] 23963 0
United States of America
State/province [4] 23963 0
Country [5] 23964 0
Canada
State/province [5] 23964 0

Funding & Sponsors
Funding source category [1] 309140 0
Government body
Name [1] 309140 0
NHMRC
Country [1] 309140 0
Australia
Funding source category [2] 309266 0
Other Collaborative groups
Name [2] 309266 0
Mindgardens Neuroscience Network
Country [2] 309266 0
Australia
Funding source category [3] 309267 0
Other Collaborative groups
Name [3] 309267 0
Neuroscience Research Australia
Country [3] 309267 0
Australia
Funding source category [4] 309268 0
University
Name [4] 309268 0
University of New South Wales
Country [4] 309268 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Neuroscience Research Australia
Address
Margarete Ainsworth Building
Barker Street, Randwick, Sydney NSW 2031
Country
Australia
Secondary sponsor category [1] 310094 0
None
Name [1] 310094 0
Address [1] 310094 0
Country [1] 310094 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309007 0
University of New South Wales Human Research Ethics Committee A
Ethics committee address [1] 309007 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
High Street
Sydney NSW 2052 Australia
Ethics committee country [1] 309007 0
Australia
Date submitted for ethics approval [1] 309007 0
19/04/2021
Approval date [1] 309007 0
Ethics approval number [1] 309007 0
HC210302

Summary
Brief summary
This is a 12-week RCT trial involving a 6-week wellbeing program delivered via the app. The trial will recruit healthy adults from the app user base with the aim of measuring the participants’ levels of mental wellbeing over time and determining whether the app is effective at increasing their wellbeing, compared to an active control version of the app.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45458 0
A/Prof Justine M. Gatt
Address 45458 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street, Randwick, NSW 2031
Country 45458 0
Australia
Phone 45458 0
+61 2 9399 1812
Fax 45458 0
Email 45458 0
[email protected]
Contact person for public queries
Name 45459 0
A/Prof Justine M. Gatt
Address 45459 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street, Randwick, NSW 2031
Country 45459 0
Australia
Phone 45459 0
+61 2 9399 1812
Fax 45459 0
Email 45459 0
[email protected]
Contact person for scientific queries
Name 45460 0
A/Prof Justine M. Gatt
Address 45460 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street, Randwick, NSW 2031
Country 45460 0
Australia
Phone 45460 0
+61 2 9399 1812
Fax 45460 0
Email 45460 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
No ethical approval to share


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.