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Trial registered on ANZCTR


Registration number
ACTRN12616001253493
Ethics application status
Approved
Date submitted
3/09/2016
Date registered
7/09/2016
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Game for Health: Development of a Prototype eHealth Intervention to Treat Anxiety in Young People with Long-term Physical Conditions
Scientific title
Game for Health: Development of a Prototype eHealth Intervention to Treat Anxiety in Young People with Long-term Physical Conditions
Secondary ID [1] 290093 0
None
Universal Trial Number (UTN)
U1111-1187-2466
Trial acronym
GFH
Linked study record
ACTRN12616001244493

Health condition
Health condition(s) or problem(s) studied:
Anxiety 300181 0
Long-term Physical Conditions (such as asthma, diabetes and cystic fibrosis) 300182 0
Condition category
Condition code
Mental Health 300065 300065 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will employ a mixed methods design to produce a prototype eHealth intervention for treating anxiety in young people with long-term physical conditions. The study will involve two phases:

During the first phase, a prototype eHealth intervention will be designed and refined via a co-design process with young people from Starship Hospital with long-term physical conditions. 3 stages of consultation will be undertaken, with 4 focus groups of up to 12 participants at each stage. At least one focus group at each stage will be arranged for Maori young people. By the end of this phase, a working prototype that is ready for pilot testing will be created and beta-tested to de-bug it and ensure it is compatible with end-user expectations.

During the second phase, an open trial will be undertaken with 20 young people aged 13-18 years. with long-term physical conditions from Starship Hospital. Each will be loaned a device (ipad or similar tablet) on which the prototype intervention, questionnaires and scales have been pre-loaded. They will be given up to 4 weeks to complete the intervention, at a rate of their choice. The intervention is likely to be an eHealth game comprising of between 5-10 modules of CBT-based therapy (i.e. relaxation training, cognitive restructuring and others) and to take between 1-5 hours to complete. The specifics of the intervention will be determined during the CO-DESIGN process. Intervention use will be assessed using an inbuilt tracker. No strategies will be used to improve fidelity.

Intervention code [1] 295845 0
Treatment: Other
Intervention code [2] 295846 0
Behaviour
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299533 0
Acceptability of prototype intervention, as assessed via semi-structured interview following completion.
Timepoint [1] 299533 0
End of study (4 weeks)
Primary outcome [2] 299534 0
Utility of intervention, as assessed using the System Utility Scale (SUS) following completion.
Timepoint [2] 299534 0
End of study (4 weeks)
Primary outcome [3] 299535 0
Efficacy of intervention, as assessed using GAD-7 and SCAS anxiety scales.
Timepoint [3] 299535 0
Due to the final game being designed to be used in a more flexible way, GAD-7 and SCAS scores will only be collected at the start and the end of the game. Sliding scale scores of anxiety (ecological momentary assessments) will be collected during each module. There will be no change to the frequency or type of other outcome measures.
Secondary outcome [1] 327470 0
Acceptability for Maori young people, as assessed via semi-structured interview feedback following completion.
Timepoint [1] 327470 0
End of study (4 weeks)

Eligibility
Key inclusion criteria
Young people will be included in one or both phases if they are aged between 13-18 years, have a long-term physical condition over 3 months duration, are of any ethnicity, with or without a known anxiety disorder, with or without any co-morbid mental health condition, can intellectually and physically use the device and intervention and if they are able to provide informed consent or assent. (NB: The cohort will by definition not be 'healthy' as they have a long-term physical illness)
Minimum age
13 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Young people will be excluded from participation if they do not meet all inclusion criteria or if they have recently undertaken or are undertaking cognitive behaviour therapy, biofeedback therapy or pharmacotherapy with anxiolytic medication as these may cloud the effectiveness of the prototype eHealth intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Statistical methodology: Associate Professor Chris Frampton will provide statistical advice for the study. He will assist in the development of a statistical analysis plan and oversee the analysis of quantitative data. Quantitative data will be analysed using Microsoft Excel and SPSS (Statistical Software Package). Analyses will include basic descriptive statistics (e.g., number of duration of use, changes in anxiety score and demographic characteristics of the sample). t Tests and McNemar’s chi-square tests will be used to assess the statistical significance of changes in anxiety scores over time. A p-value of <0.05 will be taken to indicate statistical significance and 95% confidence intervals will be used to establish the extent of any difference between pre and post measures. A sample size of n=20 will enable detection of changes within the study group with effect sizes of 0.40 or more as statistically significance (alpha = 0.05) with 80% power. Qualitative data will be analysed using a general inductive approach with collated text analysed to identify emerging themes, which will then be independently coded by two researchers and consensus reached by adjudication. Data analysis will be conducted once saturation of themes has been achieved.

Recruitment
Recruitment status
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] 8191 0
New Zealand
State/province [1] 8191 0
Auckland

Funding & Sponsors
Funding source category [1] 294462 0
University
Name [1] 294462 0
University of Auckland
Address [1] 294462 0
Department of Psychological Medicine, University of Auckland
Level 12 Support Block, Auckland Hospital
Park Road, Grafton, Auckland 1142
Country [1] 294462 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Psychological Medicine, University of Auckland, Level 12 Support Block, Auckland Hospital, Park Road, Grafton, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 293328 0
None
Name [1] 293328 0
Address [1] 293328 0
Country [1] 293328 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295893 0
Northern Regional Health and Disability Ethics Committee, New Zealand
Ethics committee address [1] 295893 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6041
Ethics committee country [1] 295893 0
New Zealand
Date submitted for ethics approval [1] 295893 0
26/09/2016
Approval date [1] 295893 0
12/06/2018
Ethics approval number [1] 295893 0

Summary
Brief summary
This study aims to co-design and test a prototype eHealth game for treating anxiety in young people with long-term physical conditions such as asthma, diabetes, and cystic fibrosis. A series of focus groups will be undertaken with young people (particularly Maori young people) at Starship Hospital to refine the prototype intervention. The intervention will be based on well-established cognitive behaviour therapy and integrate biofeedback relaxation, for which there is recent evidence off effectiveness. An open trial with 20 young people will be undertaken to determine how acceptable, usable and effective the prototype intervention is. The information from this study will inform the design of a larger randomised controlled trial. If acceptable and useful, this eHealth intervention may offer a cost-effective and clinically useful solution for addressing the psychological needs of over 16,000 young people in New Zealand.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68830 0
Dr Hiran Thabrew
Address 68830 0
Department of Psychological Medicine
Level 12 Support Block
Auckland Hospital
Park Road
Grafton
Auckland 1142
Country 68830 0
New Zealand
Phone 68830 0
+ 64277068557
Fax 68830 0
Email 68830 0
h.thabrew@auckland.ac.nz
Contact person for public queries
Name 68831 0
Dr Hiran Thabrew
Address 68831 0
Department of Psychological Medicine
Level 12 Support Block
Auckland Hospital
Park Road
Grafton
Auckland 1142
Country 68831 0
New Zealand
Phone 68831 0
+ 64277068557
Fax 68831 0
Email 68831 0
h.thabrew@auckland.ac.nz
Contact person for scientific queries
Name 68832 0
Dr Hiran Thabrew
Address 68832 0
Department of Psychological Medicine
Level 12 Support Block
Auckland Hospital
Park Road
Grafton
Auckland 1142
Country 68832 0
New Zealand
Phone 68832 0
+ 64277068557
Fax 68832 0
Email 68832 0
h.thabrew@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
Not planned during study design
What supporting documents are/will be available?
No other documents available
Summary results
No Results