Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000053729
Ethics application status
Approved
Date submitted
10/12/2021
Date registered
17/01/2022
Date last updated
5/04/2023
Date data sharing statement initially provided
17/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Trialing the Whitu app for university students
Scientific title
Trialing the Whitu app for university students
Secondary ID [1] 306000 0
Nil known
Universal Trial Number (UTN)
U1111-1272-3976
Trial acronym
Linked study record
Trial Id: ACTRN12620000516987
This record is a sub-study of this study.

Health condition
Health condition(s) or problem(s) studied:
mental wellbeing 324643 0
depression 324644 0
anxiety 324645 0
Condition category
Condition code
Mental Health 322095 322095 0 0
Anxiety
Mental Health 322096 322096 0 0
Depression
Mental Health 322097 322097 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 to the modules will be assessed using self-report.
Intervention code [1] 322412 0
Behaviour
Intervention code [2] 322413 0
Lifestyle
Comparator / control treatment
The control group will be sent a link via email to the University of Auckland’s existing ‘Be Well’ website. The control group will be given no specific instruction - participants access to the website is wholly at their own discretion.
After the completion of the 3-month follow-up, we will offer the control group access to the Whitu wellbeing app as a thank you for participating in the study. The active control group will not be followed up past the 3-month time point.
Control group
Active

Outcomes
Primary outcome [1] 329851 0
Emotional wellbeing: assessed via the World Health Organization Five Well-Being Index (WHO-5)(Bech, Olsen, Kjoller, & Rasmussen, 2003).
Timepoint [1] 329851 0
Baseline, 4 weeks after baseline (primary timepoint), 3 months after baseline
Primary outcome [2] 329852 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] 329852 0
Baseline, 4 weeks after baseline (primary timepoint), 3 months after baseline
Secondary outcome [1] 404051 0
Depression: assessed by the short version of the Centre for Epidemiological Studies Depression Scale (CES-D)(Radloff, 1977).
Timepoint [1] 404051 0
Baseline, 4 weeks after baseline, 3 months after baseline
Secondary outcome [2] 404052 0
Anxiety: assessed by the Generalised Anxiety Disorder seven item scale (GAD-7)(Spitzer, Kroenke, Williams, & Löwe, 2006).
Timepoint [2] 404052 0
Baseline, 4 weeks after baseline, 3 months after baseline
Secondary outcome [3] 404053 0
Stress: assessed by the shortened 10-item Perceived Stress Scale(Cohen, Kamarck, & Mermelstein, 1983; Cohen, Kamarck, & Mermelstein, 1994).
Timepoint [3] 404053 0
Baseline, 4 weeks after baseline, 3 months after baseline
Secondary outcome [4] 404054 0
Self-compassion: assessed using the Self-Compassion Scale–Short Form (SCS–SF)(Raes, Pommier, Neff, & Van Gucht, 2011).
Timepoint [4] 404054 0
Baseline, 4 weeks after baseline, 3 months after baseline
Secondary outcome [5] 404055 0
Sleep: assessed using the Single-Item Sleep Quality Scale (Snyder et al. 2018).
Timepoint [5] 404055 0
Baseline, 4 weeks after baseline, 3 months after baseline
Secondary outcome [6] 404056 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] 404056 0
4 weeks after baseline, 3 months after baseline

Eligibility
Key inclusion criteria
Aged 18-25 years
Currently living in New Zealand
Currently studying at the University of Auckland
Have access to an iPhone or Android smartphone to use the app
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Live outside of New Zealand
Unable to provide informed consent or complete evaluation forms in English
Currently receiving mental health treatment
Have participated in a focus group or previous study using the Whitu wellbeing app

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)
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 control group. The control group will be sent a link via email to the University of Auckland’s ‘Be Well’ website. After the completion of the 3-month follow-up, we will offer the control group access to the Whitu wellbeing app as a thank you.
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
Completed
Date of first participant enrolment
Anticipated
1/02/2022
Actual
24/02/2022
Date of last participant enrolment
Anticipated
1/06/2022
Actual
25/04/2022
Date of last data collection
Anticipated
30/09/2022
Actual
13/09/2022
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 24393 0
New Zealand
State/province [1] 24393 0
Auckland

Funding & Sponsors
Funding source category [1] 310340 0
University
Name [1] 310340 0
University of Auckland
Country [1] 310340 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Psychological Medicine,
Building 507,
22-30 Park Avenue,
Grafton,
Auckland 1072
Country
New Zealand
Secondary sponsor category [1] 311472 0
None
Name [1] 311472 0
None
Address [1] 311472 0
None
Country [1] 311472 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309999 0
Auckland Health Research Ethics Committee (AHREC)
Ethics committee address [1] 309999 0
Ethics committee country [1] 309999 0
New Zealand
Date submitted for ethics approval [1] 309999 0
04/08/2021
Approval date [1] 309999 0
08/12/2021
Ethics approval number [1] 309999 0
AH22968

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

Contacts
Principal investigator
Name 116130 0
Dr Anna Serlachius
Address 116130 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 116130 0
New Zealand
Phone 116130 0
+64 09 9233073
Fax 116130 0
Email 116130 0
[email protected]
Contact person for public queries
Name 116131 0
Anna Serlachius
Address 116131 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 116131 0
New Zealand
Phone 116131 0
+64 09 9233073
Fax 116131 0
Email 116131 0
[email protected]
Contact person for scientific queries
Name 116132 0
Anna Serlachius
Address 116132 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 116132 0
New Zealand
Phone 116132 0
+64 09 9233073
Fax 116132 0
Email 116132 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 will not be consenting 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
No additional documents have been identified.