Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000516987
Ethics application status
Approved
Date submitted
14/04/2020
Date registered
27/04/2020
Date last updated
5/04/2023
Date data sharing statement initially provided
27/04/2020
Date results provided
5/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a wellbeing app to support wellbeing during the Covid-19 pandemic
Scientific title
Testing the efficacy of a coping skills app to support emotional wellbeing in youth during the Covid-19 epidemic
Secondary ID [1] 300978 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 317013 0
depression 317217 0
anxiety 317218 0
Condition category
Condition code
Mental Health 315175 315175 0 0
Depression
Mental Health 315176 315176 0 0
Anxiety
Mental Health 315356 315356 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The app includes seven modules that can be completed within a week to learn evidence-based coping skills based on CBT, psychoeducation and positive psychology techniques. The seven modules are: (1) identifying and rating emotions, (2) relaxation, (3) self-compassion, (4) gratitude, (5) staying connected, (6) physical care, and (7) goal setting. The app uses short videos and interactive activities to allow participants to practice the coping strategies that are taught in each module (e.g. a relaxation technique). Participants are asked to complete one module per day and to complete the modules in one week. Each module takes approximately 15 minutes to complete. Participants will be asked to complete module 1 first, but the other modules can be completed in any order. Adherence will be assessed using self-report.
Intervention code [1] 317314 0
Behaviour
Intervention code [2] 317432 0
Lifestyle
Comparator / control treatment
Wait-list control group will be offered the intervention after the intervention/treatment group have completed their 3-month follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 323450 0
Emotional wellbeing: assessed via the World Health Organization Five Well-Being Index (WHO-5)(Bech, Olsen, Kjoller, & Rasmussen, 2003).
Timepoint [1] 323450 0
Baseline, 4 weeks after baseline and 3 months after baseline
Primary outcome [2] 323451 0
Mental Well-being: assessed by the Short Warwick-Edinburgh Mental Well-being Scale (WEMWBS)(Fat, Scholes, Boniface, Mindell, & Stewart-Brown, 2017; Tennant et al., 2007).
Timepoint [2] 323451 0
Baseline, 4 weeks after baseline and 3 months after baseline
Secondary outcome [1] 381990 0
Depression: assessed by the short version of the Centre for Epidemiological Studies Depression Scale (CES-D)(Radloff, 1977).
Timepoint [1] 381990 0
Baseline, 4 weeks after baseline and 3 months after baseline
Secondary outcome [2] 381991 0
Anxiety: assessed by the Generalised Anxiety Disorder seven item scale (GAD-7)(Spitzer, Kroenke, Williams, & Löwe, 2006).
Timepoint [2] 381991 0
Baseline, 4 weeks after baseline and 3 months after baseline
Secondary outcome [3] 381992 0
Stress: assessed by the shortened 10-item Perceived Stress Scale(Cohen, Kamarck, & Mermelstein, 1983; Cohen, Kamarck, & Mermelstein, 1994).
Timepoint [3] 381992 0
Baseline, 4 weeks after baseline and 3 months after baseline
Secondary outcome [4] 381994 0
Self-compassion: assessed using the Self-Compassion Scale–Short Form (SCS–SF)(Raes, Pommier, Neff, & Van Gucht, 2011).
Timepoint [4] 381994 0
Baseline, 4 weeks after baseline and 3 months after baseline
Secondary outcome [5] 381995 0
In addition to the uMARS, participants will also be asked the following questions about their use of the Whitu app: (1) How many modules did you complete?, (2) On how many days did you use the app?, (3) What module was most useful? Why?, (4) What did you like about the app?, (5) How can we make the app better for young people in the future? and (7) Did you experience any technical difficulties with the app? If yes, what happened?
Timepoint [5] 381995 0
Baseline, 4 weeks after baseline and 3 months after baseline
Secondary outcome [6] 390924 0
This change was made prior to recruitment starting. Sleep was assessed using the Single-Item Sleep Quality Scale (Snyder et al. 2018).
Timepoint [6] 390924 0
Baseline, 4 weeks after baseline, and 3 months after baseline

Eligibility
Key inclusion criteria
Aged 16-30 years
Living in New Zealand
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to provide informed consent
Living outside of New Zealand
Currently receiving mental health treatment

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to the well-being app or a wait-list control group. The control group will start the app 3 months after the initial app group. Randomization will occur using REDCap’s randomization module (using a computer-generated number sequence).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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 will be analyzed in SPSS or SAS. Prior to any data analysis, data will be tested for violations of statistical assumptions and screened for errors and outliers. If parametric assumptions are not met due to non-normality, transformations or alternatively non-parametric tests will be used. Linear mixed models will be used to determine whether changes in psychological outcomes are the result of the interaction between the intervention group and time, with post-hoc tests to assess pairwise comparisons of groups at each time point and within-group changes over time. Means, standard deviations and confidence intervals will be presented with the analysis. Data will be analyzed based on both intention-to-treat and per protocol.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2020
Actual
25/11/2020
Date of last participant enrolment
Anticipated
Actual
14/12/2020
Date of last data collection
Anticipated
15/03/2021
Actual
26/03/2021
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 22482 0
New Zealand
State/province [1] 22482 0
Auckland

Funding & Sponsors
Funding source category [1] 305425 0
Charities/Societies/Foundations
Name [1] 305425 0
Auckland Medical Research Foundation
Country [1] 305425 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland
Private Bag 92019,
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 305816 0
None
Name [1] 305816 0
None
Address [1] 305816 0
None
Country [1] 305816 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305746 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 305746 0
Ethics committee country [1] 305746 0
New Zealand
Date submitted for ethics approval [1] 305746 0
06/04/2020
Approval date [1] 305746 0
20/05/2020
Ethics approval number [1] 305746 0

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

Contacts
Principal investigator
Name 101446 0
Dr Anna Serlachius
Address 101446 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 101446 0
New Zealand
Phone 101446 0
+64 9 923 3073
Fax 101446 0
Email 101446 0
[email protected]
Contact person for public queries
Name 101447 0
Anna Serlachius
Address 101447 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 101447 0
New Zealand
Phone 101447 0
+64 9 923 3073
Fax 101447 0
Email 101447 0
[email protected]
Contact person for scientific queries
Name 101448 0
Anna Serlachius
Address 101448 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 101448 0
New Zealand
Phone 101448 0
+64 9 923 3073
Fax 101448 0
Email 101448 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
Participants have not consented to sharing IPD


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
SourceTitleYear of PublicationDOI
EmbaseWell-being app to support young people during the COVID-19 pandemic: Randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-058144
N.B. These documents automatically identified may not have been verified by the study sponsor.