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Trial registered on ANZCTR


Registration number
ACTRN12618001877279
Ethics application status
Approved
Date submitted
23/10/2018
Date registered
19/11/2018
Date last updated
27/03/2019
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an app to support emotional wellbeing of adolescents experiencing depression and/or anxiety
Scientific title
Evaluation of “Quest – Te Whitianga”: a HABITs app to support the emotional wellbeing of adolescents experiencing depression and/or anxiety
Secondary ID [1] 296399 0
Nil known
Universal Trial Number (UTN)
U1111-1222-6686
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 310148 0
Depression 310149 0
Condition category
Condition code
Mental Health 308899 308899 0 0
Depression
Mental Health 308900 308900 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention ("Quest - Te Whitianga") is an app available to study participants for download on their personal Android or iOS smart phone, or Chromebook, for self-directed use for the duration of the trial. For this evaluation trial, the treatment period will be approximately four weeks.

The app has been co-designed with Maori and Pasifika young people as part of the HABITs research group. The app consists of six modules, most of which contain at least three ‘levels’, which encourages the user to practise each skill at an increasing level of difficulty. The app is highly visual and requires minimum reading. The content is based on evidence-based strategies derived from Cognitive Behavioural Therapy, Interpersonal Therapy (IPT) and positive psychology approaches.

The app consists of six modules, most of which contain at least three ‘levels’, which encourages the user to practise each skill at an increasing level of difficulty. Each module contains interactive activities (e.g. relaxation activity, entries in a gratitude journal, selecting activities to try out, interactive conversations). Module levels generally take less than 5 minutes to complete. The app is highly visual and requires minimum reading. The content is based on evidence-based strategies derived from Cognitive Behavioural Therapy, Interpersonal Therapy (IPT) and positive psychology approaches. The six modules cover the following core concepts:
1. Relaxation and mindfulness: brief slow and controlled breathing exercises
2. Structured problem solving: STEPS (Say what the problem is, Think of solutions, Examine each one, Pick one, See what happens)
3. Activity scheduling: an activity picker exercise designed to motivate the user to do fun, active and new activities to lift mood
4. Gratitude Journal: each time a user logs into the app s/he is asked to name three things they are grateful that day.
5. Interpersonal skills; Communication, assertiveness and staying in control of strong emotions
6. How thoughts influence emotions and how to deal with negative thoughts through ‘accept, distract, reframe’ methods.

In the first instance, participants are introduced to the first level of each island (activity) sequentially (in the order: gratitude journal, relaxation, activity scheduling, thoughts and emotions, problem solving, interpersonal skills). Thereafter, participants are able to progress and continue at their discretion.

Adherence to the intervention will be assessed using app usage metrics including duration and pattern of use as well as completion of modules and activities in the app. The app is linked through secure individual user accounts to the HABITs IT platform.

The "Quest - Te Whitianga" app will be used in an open-label fashion by participants excluded from the RCT trial, and these participants will contribute data to the 'Acceptability' primary outcome.
Intervention code [1] 312730 0
Treatment: Other
Comparator / control treatment
Participants in the main RCT trial will be randomly allocated to a control group (ICON). The ICON group will receive access to an app (smartphone & tablet) covering four domains of general wellbeing: exercise, nutrition, and sleep hygiene and time management. This information will be brief, written in an easy to follow manner (at a reading age of approximately 12) and the content will be in line with current health-promotion advice, but will not include any specific CBT- or IPT-related strategies. Use of the app is self-directed at participants' discretion. Duration of treatment is approximately 4 weeks.

Adherence to the control intervention will be assessed using app usage metrics including duration and pattern of use as well as completion of modules and activities in the app. The app is linked through secure individual user accounts to the HABITs IT platform.
Control group
Placebo

Outcomes
Primary outcome [1] 307869 0
Efficacy of app for adolescents with mild to moderate symptoms of depression and/or anxiety - assessed using change in the composite Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS).
Timepoint [1] 307869 0
Baseline.
Post-intervention - 4-6 weeks after intervention commencement (primary timepoint).
Follow-up - 8-10 weeks after intervention commencement.
(NB. Only collected at Post-intervention and Follow-up in RCT arm of trial).
Primary outcome [2] 307870 0
Acceptability: App ratings from young people using a brief app rating scale developed for this trial. Participants will also be asked to rate their preferred module within the app and provide a brief review.
Timepoint [2] 307870 0
Post-intervention - 4-6 weeks after intervention commencement (primary timepoint).
Follow-up - 8-10 weeks after intervention commencement.
(NB. Only collected at Follow-up in ICON arm of RCT trial)
Secondary outcome [1] 353181 0
Changes in the subscale components of the PHQ-ADS (specifically, the PHQ-A) compared with baseline.
Timepoint [1] 353181 0
Baseline.
Post-intervention - 4-6 weeks after intervention commencement.
Follow-up - 8-10 weeks after intervention commencement.
(NB. Only collected at Post-intervention and Follow-up in RCT arm of trial).
Secondary outcome [2] 353182 0
Changes in self-reported wellbeing after completion of treatment compared with baseline using the WHO (Five) Wellbeing Index (WHO-5).
Timepoint [2] 353182 0
Baseline.
Post-intervention - 4-6 weeks after intervention commencement.
Follow-up - 8-10 weeks after intervention commencement.
Secondary outcome [3] 353183 0
Changes in self-reported wellbeing after completion of treatment compared with baseline using the Personal Wellbeing Measure (ONS4).
Timepoint [3] 353183 0
Baseline.
Post-intervention - 4-6 weeks after intervention commencement.
Follow-up - 8-10 weeks after intervention commencement.
Secondary outcome [4] 353185 0
Estimate of changes in self-reported life satisfaction using within-app momentary assessments.

Momentary assessments are simple visual sliding scale assessments scheduled immediately before and after completion of the gratitude journal module activities. This within app likert scale (quantified on a scale from 0-1) collects information on perceived satisfaction with life. Through the secure connection to our HABITS IT server, this information is passively collected from the app when connected to wifi. We will analyse these data to gauge whether there is an immediate improvement after using a module and/or a pattern of improvement over the course of the intervention period.
Timepoint [4] 353185 0
Evaluated every time participants start and finish the gratitude module.
Secondary outcome [5] 353186 0
Total time spent using app (seconds)
Timepoint [5] 353186 0
This outcome is collected for the duration of the intervention period. When the app is connected to wifi the app connects to the HABITS IT platform using the HABITs API to send usage information, such as total time spent.
Secondary outcome [6] 353291 0
Changes in the subscale components of the PHQ-ADS (specifically, the GAD-7) compared with baseline.
Timepoint [6] 353291 0
Baseline.
Post-intervention - 4-6 weeks after intervention commencement.
Follow-up - 8-10 weeks after intervention commencement.
(NB. Only collected at Post-intervention and Follow-up in RCT arm of trial).
Secondary outcome [7] 353297 0
Number of times the app is accessed during the intervention period
Timepoint [7] 353297 0
This outcome is collected for the duration of the intervention period. When the app is connected to wifi the app connects to the HABITS IT platform using the HABITs API to send usage information, such as number of times the app is accessed.
Secondary outcome [8] 353298 0
Average duration of each app session (seconds)
Timepoint [8] 353298 0
This outcome is collected for the duration of the intervention period. When the app is connected to wifi the app connects to the HABITS IT platform using the HABITs API to send usage information, such as session duration. The raw data will subsequently be analysed to calculate average duration.
Secondary outcome [9] 353299 0
Number of levels of each module completed
Timepoint [9] 353299 0
This outcome is collected for the duration of the intervention period. When the app is connected to wifi the app connects to the HABITS IT platform using the HABITs API to send usage information, such as number of module levels completed.
Secondary outcome [10] 354073 0
Estimate of changes in self-reported stress level using within-app momentary assessments.

Momentary assessments are simple visual sliding scale assessments scheduled immediately before and after completion of the gratitude journal activities. This within app likert scale (quantified on a scale from 0-1) collects information on perceived stress. Through the secure connection to our HABITS IT server, this information is passively collected from the app when connected to wifi. We will analyse these data to gauge whether there is an immediate improvement after using a module and/or a pattern of improvement over the course of the intervention period.
Timepoint [10] 354073 0
Evaluated every time participants start and finish the relaxation module.

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if:
•They are aged 11-16 years of age (on the day of consent);
•They have approached, or been identified by, a school guidance counsellor, school nurse or primary healthcare provider as needing some support for their emotional wellbeing (‘feeling stressed, down, worried’ or having some symptoms of depression and/or anxiety);
•They have access to a smart phone, tablet or Chromebook at home (Android, iOS or Chromebook);
Minimum age
11 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be ineligible for this study if:
•They are unable to sufficiently understand the nature of study involvement or to provide online informed consent;
•They have, in the judgement of the referring health practitioner, an acute risk of self-harm requiring urgent intervention (i.e. suicidal ideation with a current plan and intent to enact this plan) or a level of emotional distress that warrants face-to face counselling.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is completed by central randomisation programmed in to the web portal and background IT platform.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using a computerised sequence generation with permuted block size of 4. Stratification factors include: the type of study site (school or non-school) and ethnicity subgroup (Maori/Pasifika or non-Maori/Pasifika).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Allowing initially for an attrition of approximately 20%, 100 participants (50 per arm) will be recruited and randomised to either APP or ICON (within the RCT trial). The sample size will ensure there is 80% power to show moderate effect sizes (0.65 - 0.75) as statistically significant (2-tailed alpha=0.05). Effect sizes of this magnitude would equate to differential changes of about 3-4 points on the PHQ-ADS (composite PHQ-A/GAD-7). This difference is considered as a minimal clinically significant benefit from intervention.

We do not have a target sample size for the Engagement and Acceptability open trial. Power calculations are not deemed necessarily due to this being an open engagement and acceptability trial. The sample size will depend on the outcomes of eligibility screening for the primary RCT; however we expect that a minimum of 50 participants should provide sufficient information to determine acceptability and to benchmark engagement. We will cease recruitment when we reach n=100 in the primary RCT.

Changes in the primary and secondary outcome measures from baseline to post-intervention and from baseline to follow-up will be compared between treatment arms using ANCOVA, which will include site type (school, non-school), treatment arm and baseline level for the relevant dependent variable as terms within the analysis model. The differences in the changes between randomised treatments will be summarised as means, differences, and 95% confidence intervals. All analyses will be based on the intention-to-treat principle and a two-tailed p-value <0.05 will be taken to indicate statistical significance.

Additional analyses seeking to identify groups which respond to the intervention will also be undertaken using ANCOVA models. These models will be the same as those tested above but will additionally include between-subject interaction terms (and the main effects for treatment and sub-group) to specifically test for differential intervention vs. control responses depending on sub-group. Of particular interest is the sub-group analyses comparing the relative efficacy of the APP compared with the ICON group among the Maori/Pasifika group (secondary hypothesis). This analysis will compare the relative efficacy of the Maori/Pasifika with the non-Maori/Pasifika group, using the ANCOVA model described above. It is anticipated that approximately 50% of the recruited sample will be Maori or Pasifika. The results from the sub-group analyses will be summarised as the mean differences between randomised groups with 95% confidence intervals for each sub group and the differences in the relative efficacy between subgroups.

Descriptive summaries including means, medians, ranges and standard deviations and frequencies and percentages will be used to describe app usage behaviour and responses provided in the app rating scale. These descriptive summaries will be estimated for the number of times the app is accessed, the average time spent on each module and in each level within the module, adherence over the 4 weeks and the stability of the platform and the app. All app rating scale and app usage data for the Engagement and Acceptability trials and RCT will be analysed separately and combined, where appropriate.

Descriptive data, include means and standard deviations, will be used to describe responses to the within-app Likert scales and the wellbeing measures. Changes over time will be estimated by calculating effect sizes for the Likert scales and wellbeing measures.
The app rating and usage data will be summarised for the all those completing these scales and additionally will be summarised for Maori/Pasifika and non-Maori, non-Pasifika participants and compared between these two groups. These comparisons will be made using non-parametric Mann-Whitney-U tests and chi-square tests, as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
Date of last participant enrolment
Anticipated
1/10/2019
Actual
Date of last data collection
Anticipated
30/11/2019
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 20949 0
New Zealand
State/province [1] 20949 0

Funding & Sponsors
Funding source category [1] 301007 0
Government body
Name [1] 301007 0
Ministry of Business, Innovation and Employment
Country [1] 301007 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Research Office
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 300596 0
None
Name [1] 300596 0
Address [1] 300596 0
Country [1] 300596 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301765 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 301765 0
Ethics committee country [1] 301765 0
New Zealand
Date submitted for ethics approval [1] 301765 0
25/10/2018
Approval date [1] 301765 0
21/03/2019
Ethics approval number [1] 301765 0
18/NTA/191

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

Contacts
Principal investigator
Name 88022 0
Dr Karolina Stasiak
Address 88022 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 88022 0
New Zealand
Phone 88022 0
+64 9 923 3890
Fax 88022 0
Email 88022 0
k.stasiak@auckland.ac.nz
Contact person for public queries
Name 88023 0
Sarah Hopkins
Address 88023 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 88023 0
New Zealand
Phone 88023 0
+64 9 923 2015
Fax 88023 0
Email 88023 0
s.hopkins@auckland.ac.nz
Contact person for scientific queries
Name 88024 0
Karolina Stasiak
Address 88024 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 88024 0
New Zealand
Phone 88024 0
+64 9 923 3890
Fax 88024 0
Email 88024 0
k.stasiak@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
A formal data sharing plan for this research must be considered in the context of prioritising cultural sensitivity of indigenous and minority populations and the sensitivity of data on minors participating in this study.


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.