COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000516987p
Ethics application status
Submitted, not yet approved
Date submitted
14/04/2020
Date registered
27/04/2020
Date last updated
27/04/2020
Date data sharing statement initially provided
27/04/2020
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 via app analytics and also 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
User engagement: assessed using two subscales (App Subjective Quality subscale and the Perceived Impact subscale) of the end-user version of the Mobile Application Rating Scale (uMARS)(Stoyanov, Hides, Kavanagh, & Wilson, 2016).
Timepoint [5] 381995 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
Gender
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. Treatment allocations will be computer generated by a biostatistician independent of the intervention delivery. Randomisation will occur 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
Prior to any data analysis, data will be tested for violations of statistical assumptions. A mixed analysis of variance (ANOVA) will be used to assess within and between-group differences in outcome measures. Means, standard deviations and confidence intervals will be presented with the analysis. Data will be analysed based on intention-to-treat.

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] 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
Address [1] 305425 0
Ground Floor, 89 Grafton Road
P O Box 110139, Auckland Hospital
Auckland 1148
New Zealand
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
Submitted, not yet approved
Ethics committee name [1] 305746 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 305746 0
Auckland Human Participants Ethics Committee
The University of Auckland
Research Office
Private Bag 92019, Auckland 1142.
Ethics committee country [1] 305746 0
New Zealand
Date submitted for ethics approval [1] 305746 0
06/04/2020
Approval date [1] 305746 0
Ethics approval number [1] 305746 0

Summary
Brief summary
The aim is to test a smartphone 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 study will test the app for 90 youth living in New Zealand over three months 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 3-month follow-up.
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
a.serlachius@auckland.ac.nz
Contact person for public queries
Name 101447 0
Dr 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
a.serlachius@auckland.ac.nz
Contact person for scientific queries
Name 101448 0
Dr 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
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