Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000710628
Ethics application status
Not yet submitted
Date submitted
28/05/2014
Date registered
4/07/2014
Date last updated
4/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a new online wellbeing resource for young people aged 16-25 - “The Toolbox: the best apps for your brain and body
Scientific title
Wait list condition controlled trial to evaluate online interventions for wellbeing and mental health in young people (16-25): the case of the Toolbox
Secondary ID [1] 284443 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 291618 0
Mental health 291658 0
Condition category
Condition code
Mental Health 291995 291995 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 292397 292397 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will evaluate the effectiveness and cost-effectiveness of the “Toolbox” which consists of a website and virtual application as an online space for young people to access a personalised, ongoing recommendation service for evidence based tools and applications (apps) to support their wellbeing and mental health. The Toolbox has been developed by ReachOut.com by Inspire Foundation under contract with the Young and Well Cooperative Research Centre (Young and Well CRC). The Toolbox has over 50 different tools that have been reviewed by a panel of both mental health professionals and consumers for their usefulness, effectiveness and usability.

The Toolbox focuses on wellbeing and positive functioning, and is designed to improve (a) emotional wellbeing (i.e. positive affect and life satisfaction); (b) psychological wellbeing (i.e. self-acceptance, personal growth, purpose in life, environmental mastery, autonomy and positive relations with others; (c) social wellbeing (i.e. social acceptance, social contribution, social coherence social integration, and social actualization); and (d) physical wellbeing (Shochet, Keyes & Smith, 2011).

This study will evaluate the Toolbox by assessing changes in the participant’s wellbeing levels before and after using the website and associated apps.

We intend to recruit young people living in Australia who are between 16-25 years old by using online and community based recruitment strategies.

After login participants will be randomized into two groups. The intervention group will have immediate access to the Toolbox while the control group will be allocated to waiting list for 4 weeks. All participants will be asked to provide general demographics and significant covariate variables at sign up and prompted to complete surveys tracking wellbeing changes at baseline, 4 weeks, 3 and 6 months.

The Toolbox houses over 50 mental health and wellbeing tools and apps that have been reviewed by a panel of both mental health professionals and consumers for their credibility, functionality, engagement and aesthetics according to the Mobile Application Rating Scale developed by Queensland University of Technology (Stoyanov et al. 2014). During the intervention, users can select one or more wellbeing goals and are recommended trusted apps that will help them to achieve their goal. If they are unsure where to start, a short quiz will help them to discern the area they’d like to focus on and recommend relevant apps to them. They can come back any time using a secure log in to update their goals and download new apps. Users will also have the ability to track their progress in real time.

Participants are free to use the Toolbox at their own discretion. The intervention group will have access to the Toolbox for a total of 6 months.

To ensure adherence, emails and text messages will be sent to participants at evaluation points throughout the trial to remind them to log in and complete follow-up measures.
Intervention code [1] 289192 0
Lifestyle
Intervention code [2] 289199 0
Behaviour
Comparator / control treatment
Wait list control

After login participants will be randomized into two groups. The intervention group will have immediate access to the Toolbox while the control group will be allocated to waiting list for 4 weeks. Once this phase is over all participants will be granted access to the Toolbox and will be followed up tracking wellbeing changes at 3 and 6 months. The control group will have access to the Toolbox for a total of 5 months.
Control group
Active

Outcomes
Primary outcome [1] 291919 0
Evaluate the effect of the use of virtual tools (Toolbox) in supporting wellbeing and mental health in young
Australians.

The results of the Mental Health Continuum- Short Form (MHC-SF) will track changes in wellbeing at different
times according to the research design. This validated scale measures three components constituent of wellbeing: social wellbeing, psychological wellbeing and emotional wellbeing.
Timepoint [1] 291919 0
at baseline, 4 weeks, 3 and 6 months
Secondary outcome [1] 307816 0
Determine the factors that contribute to the variance in wellbeing scores through time.

Information about wellbeing fluctuations will be contrasted with significant covariates as found in previous wellbeing studies (Boiler at al, 2013; Sawyer, 2000; Keyes, 2002; 2005). These covariates are: age, gender, educational level, geographical location, occupation, education, accommodation, living circumstances and cultural background. Similarly, changes in wellbeing will be contrasted with data collected by ReachOut.com according to their own protocols: number of visits to the Toolbox, user duration, user experience, goal tracking and preferred apps.
Timepoint [1] 307816 0
at baseline, 4 weeks, 3 and 6 months
Secondary outcome [2] 307817 0
Determine significant intervention areas for wellbeing improvement in young people.

The analysis described previously will enable us to find potential relationships and patterns that could guide future significant research and interventions to improve wellbeing in young people e.g. improving personal relationships, improving inclusion policies, etc.
Timepoint [2] 307817 0
at 6 months
Secondary outcome [3] 307818 0
Determine the relative cost-effectiveness of the Toolbox compared to the waiting list in supporting wellbeing and mental health in young Australians.

An economic evaluation will be conducted alongside the trial estimating the relative cost-effectiveness of the Toolbox compared to the waiting list. The evaluation will take the form of a cost-effectiveness analysis based on a primary outcome of cost per unique visit to the Toolbox. Utility-based outcomes will also be incorporated into the analysis allowing a secondary outcome to be cost per quality-adjusted life year (QALY) gained (based on AQoL 8D values). Cost and outcome data will be collected on every participant within the trial.
Timepoint [3] 307818 0
at baseline, 4 weeks, 3 and 6 months
Secondary outcome [4] 308460 0
Determine any associations between depression and wellbeing fluctuations.

Previous trials have shown high association between depression and wellbeing (Boiler et al, 2013; Sin, 2009). Results from the Center for Epidemiologic Studies Depression Scale (CESD) will be used to measure associations between depression and wellbeing fluctuations in the context of the two continua model of wellbeing proposed by Keyes (2002).
Timepoint [4] 308460 0
at baseline, 4 weeks, 3 and 6 months

Eligibility
Key inclusion criteria
People between the ages of 16 to 25 who reside in Australia.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who are outside the specified age bracket of 16-25 and/or reside outside Australia will be excluded from the study.

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)
Online and community based recruitment.

Once recruited, participants will be randomised in two groups. The intervention group will have direct access to the Toolbox while the control group will be allocated in a waiting list for four weeks. Once this phase is over all participants will be granted access to the Toolbox and will be followed up tracking wellbeing changes at 3 and 6 months.

Allocation concealment will be conducted using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Wait list control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 180 completed participants (90/arm) are required in order to provide 90% power to detect a difference in improvement between arms of 0.37 with a 2-tailed type 1 error of 0.05. This assumes an overall standard deviation of 0.63 at baseline and 0.87 at 1 month follow up scores as found in (Boiler et al, 2013). that a positive response rate of 30% in the placebo arm. Given the fact that screening and randomisation are completed electronically we intend to recruit 250 subjects.

The primary analysis is intention to treat and missing values from all randomised subjects will be imputed with 50 resamples drawn. The primary outcome measure is change in well-being between arms and will be assessed using random effects mixed modelling, with dependent variable well-being score (MHC-SF), independent variables time, group and the interaction (product) term time x group, and clustered over different times (YYYY) to account for possible correlated readings. Sensitivity and secondary continuous outcomes will be assessed similarly, but also adjusting for potential confounders such as age, gender, region, work status, ethnicity, education level and living conditions. All results will be reported with 95% confidence intervals and p-values. A p-value of 0.05 (two tailed) is considered statistically significant. All analyses will be conducted using Stata 13.1 (Statacorp, Texas, USA).

An economic evaluation will be conducted alongside the trial estimating the relative cost-effectiveness of The Toolbox compared to the waiting list. The evaluation will take the form of a cost-effectiveness analysis based on a primary outcome of cost per unique visit to the online wellbeing centre. Utility-based outcomes will also be incorporated into the analysis allowing a secondary outcome to be cost per quality-adjusted life year (QALY) gained (based on AQoL 8D values).

Cost and outcome data will be collected on every participant within the trial. Costs will be estimated by combining data on resource use associated with both the intervention and control groups with unit costs for each of the resource items. Resource use data will be collected using a resource use questionnaire. Unit costs (e.g. staff, drug and equipment costs) will be collected from published data sets including Pharmaceutical Benefits Scheme (PBS), Medical Benefits Scheme (MBS) and the Australian Refined Diagnosis Related Groups (AR-DRG) cost weights. A patient level analysis will be undertaken to determine the mean costs, increases in number of visits to the online wellbeing centre and QALYs for each trial arm. To test the robustness of the economic evaluation results, non-parametric bootstrapping and appropriate sensitivity analyses will be carried out and results will be reported in terms of incremental cost effectiveness ratios and cost effectiveness acceptability curves. The final results will be presented in the CONSORT (Altman et al. 2001 ) format for reporting randomised trials.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 289067 0
Government body
Name [1] 289067 0
Young and Well Cooperative Research Centre
Country [1] 289067 0
Australia
Primary sponsor type
Government body
Name
Young and Well Cooperative Research Centre
Address
Unit 17
71 Victoria Crescent Abbotsford
VIC 3067
Country
Australia
Secondary sponsor category [1] 287761 0
University
Name [1] 287761 0
Flinders University
Address [1] 287761 0
Bedford Park
SA
5042
Country [1] 287761 0
Australia
Secondary sponsor category [2] 287762 0
Government body
Name [2] 287762 0
Country Health SA Local Health Network
Address [2] 287762 0
NAB Building
Level 2, 22 King William St
Adelaide, SA 5000
Country [2] 287762 0
Australia
Other collaborator category [1] 277978 0
Charities/Societies/Foundations
Name [1] 277978 0
ReachOut.com by Inspire Foundation
Address [1] 277978 0
Sydney Office
Ground Floor, 97 Church Street
Camperdown NSW 2050
Country [1] 277978 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290861 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 290861 0
Ethics committee country [1] 290861 0
Australia
Date submitted for ethics approval [1] 290861 0
07/04/2014
Approval date [1] 290861 0
Ethics approval number [1] 290861 0

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

Contacts
Principal investigator
Name 47638 0
A/Prof Niranjan Bidargaddi
Address 47638 0
Room 4T101
Flinders Human Behaviour & Health Research Unit
Margaret Tobin Centre
Flinders Medical Centre
Bedford Park, South Australia 5042
Australia
Country 47638 0
Australia
Phone 47638 0
+61 8 84042851
Fax 47638 0
Email 47638 0
[email protected]
Contact person for public queries
Name 47639 0
Gaston Antezana
Address 47639 0
Room 4T101
Flinders Human Behaviour & Health Research Unit
Margaret Tobin Centre
Flinders Medical Centre
Bedford Park, South Australia 5042
Australia
Country 47639 0
Australia
Phone 47639 0
+61 8 84042851
Fax 47639 0
Email 47639 0
[email protected]
Contact person for scientific queries
Name 47640 0
Gaston Antezana
Address 47640 0
Room 4T101
Flinders Human Behaviour & Health Research Unit
Margaret Tobin Centre
Flinders Medical Centre
Bedford Park, South Australia 5042
Australia
Country 47640 0
Australia
Phone 47640 0
+61 8 84042851
Fax 47640 0
Email 47640 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseEfficacy of a Web-Based Guided Recommendation Service for a Curated List of Readily Available Mental Health and Well-Being Mobile Apps for Young People: Randomized Controlled Trial.2017https://dx.doi.org/10.2196/jmir.6775
N.B. These documents automatically identified may not have been verified by the study sponsor.