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Trial registered on ANZCTR


Registration number
ACTRN12621000888864p
Ethics application status
Not yet submitted
Date submitted
1/07/2021
Date registered
8/07/2021
Date last updated
8/07/2021
Date data sharing statement initially provided
8/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Trialing the Whitu coping skills app for young people in Managed Isolation and Quarantine (MIQ) in New Zealand
Scientific title
Testing the efficacy of the Whitu coping skills app to support the well-being of youth staying in managed quarantine facilities in New Zealand
Secondary ID [1] 304678 0
Nil known
Universal Trial Number (UTN)
U1111-1267-4760
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental wellbeing 322648 0
depression 322649 0
anxiety 322650 0
Condition category
Condition code
Mental Health 320264 320264 0 0
Anxiety
Mental Health 320265 320265 0 0
Depression
Mental Health 320330 320330 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Whitu 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 10 to 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] 321044 0
Behaviour
Intervention code [2] 321045 0
Lifestyle
Comparator / control treatment
The wait-list control group will be offered the intervention after the intervention/treatment group have completed their 4-week follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 328118 0
Emotional wellbeing: assessed via the World Health Organization Five Well-Being Index (WHO-5)(Bech, Olsen, Kjoller, & Rasmussen, 2003).
Timepoint [1] 328118 0
Baseline, 2-weeks after baseline, and 4-weeks after baseline (primary endpoint).
Primary outcome [2] 328121 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] 328121 0
Baseline, 2-weeks after baseline, and 4-weeks after baseline (primary endpoint).
Secondary outcome [1] 397706 0
Depression: assessed by the short version of the Centre for Epidemiological Studies Depression Scale (CES-D)(Radloff, 1977).
Timepoint [1] 397706 0
Baseline, 2-weeks after baseline, and 4-weeks after baseline.
Secondary outcome [2] 397707 0
Anxiety: assessed by the Generalised Anxiety Disorder seven item scale (GAD-7)(Spitzer, Kroenke, Williams, & Löwe, 2006).
Timepoint [2] 397707 0
Baseline, 2-weeks after baseline, and 4-weeks after baseline.
Secondary outcome [3] 397708 0
Stress: assessed by the shortened 10-item Perceived Stress Scale(Cohen, Kamarck, & Mermelstein, 1983; Cohen, Kamarck, & Mermelstein, 1994).
Timepoint [3] 397708 0
Baseline, 2-weeks after baseline, and 4-weeks after baseline.
Secondary outcome [4] 397709 0
Self-compassion: assessed using the Self-Compassion Scale–Short Form (SCS–SF)(Raes, Pommier, Neff, & Van Gucht, 2011).
Timepoint [4] 397709 0
Baseline, 2-weeks after baseline, and 4-weeks after baseline.
Secondary outcome [5] 397710 0
Sleep: assessed using the Single-Item Sleep Quality Scale (Snyder et al. 2018).
Timepoint [5] 397710 0
Baseline, 2-weeks after baseline, and 4-weeks after baseline.
Secondary outcome [6] 397711 0
Outcome investigating participant experience of using the app:
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 [6] 397711 0
2-weeks after baseline and 4-weeks after baseline

Eligibility
Key inclusion criteria
Aged 16-30 years
Currently in a managed isolation facility in New Zealand
Have access to a smartphone to support the app
Minimum age
16 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to provide informed consent
Currently receiving mental health treatment

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 computer 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 computer software (i.e. computerised sequence generation).. Participants will be randomly allocated to the Whitu coping skills app or a wait-list control group. The waitlist control group will start the app 4-weeks after the initial app intervention group.
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 analysed 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 analysed based on both intention-to-treat and per protocol.

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 outside Australia
Country [1] 23936 0
New Zealand
State/province [1] 23936 0
Auckland

Funding & Sponsors
Funding source category [1] 309045 0
University
Name [1] 309045 0
University of Auckland
Address [1] 309045 0
Department of Psychological Medicine,
Level 3, Building 507,
22-30 Park Avenue,
Grafton,
Auckland 1072
Country [1] 309045 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Psychological Medicine,
Level 3, Building 507,
22-30 Park Avenue,
Grafton,
Auckland 1072
Country
New Zealand
Secondary sponsor category [1] 309985 0
None
Name [1] 309985 0
None
Address [1] 309985 0
None
Country [1] 309985 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 308923 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 308923 0
Auckland Human Participants Ethics Committee
The University of Auckland
Research Office
Private Bag 92019, Auckland 1142
Ethics committee country [1] 308923 0
New Zealand
Date submitted for ethics approval [1] 308923 0
19/07/2021
Approval date [1] 308923 0
Ethics approval number [1] 308923 0

Summary
Brief summary
The aim of the current study is to test the Whitu coping skills app that encompasses evidence-based coping strategies to help people cope with increased isolation and anxiety due to the Covid-19 pandemic. The app is intended for youth aged 16-30 years living in New Zealand. The current study will test the efficacy of the app for 90 youth staying in managed quarantine/ isolation facilities in New Zealand over 4-weeks in order to examine changes in wellbeing and mental health outcomes between the app group and the wait-list control group. The wait-list control group will begin using the app after the 4-week follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112354 0
Dr Anna Serlachius
Address 112354 0
Department of Psychological Medicine,
The University of Auckland,
Level 3, Building 507,
22-30 Park Avenue,
Grafton,
Auckland 1023
Country 112354 0
New Zealand
Phone 112354 0
+64 9 923 3073
Fax 112354 0
Email 112354 0
a.serlachius@auckland.ac.nz
Contact person for public queries
Name 112355 0
Dr Anna Serlachius
Address 112355 0
Department of Psychological Medicine,
The University of Auckland,
Level 3, Building 507,
22-30 Park Avenue,
Grafton,
Auckland 1023
Country 112355 0
New Zealand
Phone 112355 0
+64 9 923 3073
Fax 112355 0
Email 112355 0
a.serlachius@auckland.ac.nz
Contact person for scientific queries
Name 112356 0
Dr Anna Serlachius
Address 112356 0
Department of Psychological Medicine,
The University of Auckland,
Level 3, Building 507,
22-30 Park Avenue,
Grafton,
Auckland 1023
Country 112356 0
New Zealand
Phone 112356 0
+64 9 923 3073
Fax 112356 0
Email 112356 0
a.serlachius@auckland.ac.nz

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 other documents available
Summary results
No Results