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Trial registered on ANZCTR


Registration number
ACTRN12621001391864
Ethics application status
Approved
Date submitted
7/07/2021
Date registered
15/10/2021
Date last updated
15/10/2021
Date data sharing statement initially provided
15/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a computer game for anxiety in young people with long-term physical conditions
Scientific title
Game for Health Level 3: Randomised Controlled Trial of Efficacy of an eHealth Intervention for Anxiety in Children and Young People with Long-term Physical Conditions
Secondary ID [1] 304716 0
None
Universal Trial Number (UTN)
U1111-1266-1836
Trial acronym
Linked study record
This study follows from an open trial of Starship Rescue conducted in 2018. The trial ID is: ACTRN12616001253493.

Health condition
Health condition(s) or problem(s) studied:
Anxiety 322735 0
Condition category
Condition code
Mental Health 320325 320325 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial testing the effectiveness of an electronic health game (Starship Rescue: The Vortex of Anxiety) designed to combat anxiety among children and adolescents with long-term physical illnesses. Starship Rescue is a 5-module based eHealth game developed to address anxiety symptoms and quality of life. The game in the controlled arm has been designed to improve nutrition and physical activity.
Both experimental and control games will be loaned for 4-6 weeks and if needed, participants
will be given more time. Participants will have the choice to play the game at a rate of their own choice. However, individuals can complete 1 module per week. Hence the time-frame given for each arm.

Experimental game:

5 module-based game
Module 1 - Rate anxiety, reflection on what makes them worry/anxious. Information on anxiety/emotions (what anxiety is, what it feels like and what anxious thoughts are) and how to help yourself.

Module 2 - Rate anxiety. Quiz on types of emotions, origin of anxiety. Heart Rate Monitor will be used in this module. Breathing exercises will be practiced and participants will be asked to play a game wearing the HRM to help control breathing when the heart rate goes too high.

Module 3 - Rate anxiety, reflect on signs of anxiety and relax body parts to help anxiety. Learning about helpful and unhelpful thoughts and a sub-game involving collecting helpful and unhelpful thought crystals.

Module 4 - Learn two different methods of overcoming or combatting their listed worries/anxiety. Participants will be asked to choose one method and resume the game to apply it in their life.

Module 5 - Rate anxiety and reflection quiz of everything taught in the game.

Games will be installed on a Samsung tablet and loaned for the 4-6 week period. Approximate duration of each module is an hour.
After the participant has completed the game, a member of the research team will select an option from the game to send player data which will be received via the trial email address. Information such as anxiety rating, how many days/attempts it took to complete the modules will be collected.
Intervention code [1] 321094 0
Treatment: Other
Intervention code [2] 321342 0
Behaviour
Comparator / control treatment
The game (Starship Rescue: The Voyage of Wellness) is also a 5-module based game and in the controlled arm has been designed to improve nutrition and physical activity.
Both experimental and control games will be loaned for 4-6 weeks and if needed, participants
will be given more time.

Controlled game:

Module 1 - information of aspects of good health.
A sub-game presented and participants will collect tokens of health from the sea of possibilities. Tokens of health are:
- Sleeping well
- Drinking Water
- Regular Exercise
- Healthy eating
- Relaxation
- Staying connected

Module 2 –Moving regularly
- Learn about how to feel better by moving regularly
- Pick types of activities that you enjoy
- Create a weekly planner on when to engage in these physical activities

Module 3 – planet of sustenance
- Another sub-game, it involves collecting healthy food orbs.
- Learn about health eating and what types of food are nutritious and how it can make you feel.
Module 4 – dream chamber
- Information on sleep
- Repair a ship game and learn about the importance of sleep

Module 5 – review what they have learned about overall health wellbeing

Games will be installed on a Samsung tablet and loaned for the 4-6 week period. Approximate duration of each module is an hour.
After the participant has completed the game, a member of the research team will select an option from the game to send player data which will be received via the trial email address. Information such as anxiety rating, how many days/attempts it took to complete the modules will be collected.
Control group
Active

Outcomes
Primary outcome [1] 328174 0
Change in anxiety assessed via Generalized Anxiety Disorder 7 item (GAD-7) and the Spence Children’s Anxiety Scale (SCAS).
Timepoint [1] 328174 0
Baseline, post-intervention (4-6 weeks from baseline) and 3 months post-baseline
Primary outcome [2] 329220 0
Quality of life via the Pediatric Quality of Life Inventory (PedsQL)
Timepoint [2] 329220 0
Baseline, post-intervention (4-6 weeks from baseline) and 3 months post-baseline
Secondary outcome [1] 397940 0
Acceptability assessed using a feedback questionnaire that has been specifically designed for this study.
Timepoint [1] 397940 0
Post-intervention (4-6 weeks from baseline)

Eligibility
Key inclusion criteria
Eligible participants will be aged between 8-18 years, have a long-term physical condition of over 3 months duration, be of any ethnicity, have anxiety symptoms that are above a designated threshold (GAD-7 score >5), not have any co-morbid mental health condition, be intellectually and physically use the eHealth intervention and able to provide informed consent or assent.
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be excluded from participation if they have recently undertaken or are undertaking cognitive behaviour therapy, biofeedback therapy or pharmacotherapy with anxiolytic medication, with comorbid mental health conditions, those intellectually and physically unable to use the game and those unable or unwilling to provide individual or paired consent/assent.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/10/2021
Actual
Date of last participant enrolment
Anticipated
25/10/2022
Actual
Date of last data collection
Anticipated
25/01/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 23946 0
New Zealand
State/province [1] 23946 0

Funding & Sponsors
Funding source category [1] 309086 0
Charities/Societies/Foundations
Name [1] 309086 0
Starship Foundation
Country [1] 309086 0
New Zealand
Primary sponsor type
Individual
Name
Dr Hiran Thabrew
Address
Department of Psychological Medicine, Level 3, Building 507, 22-30 Park Avenue, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 310034 0
Charities/Societies/Foundations
Name [1] 310034 0
Starship Foundation
Address [1] 310034 0
2 Park Road, Grafton, Auckland 1023
Country [1] 310034 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308960 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 308960 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 308960 0
New Zealand
Date submitted for ethics approval [1] 308960 0
14/06/2021
Approval date [1] 308960 0
17/06/2021
Ethics approval number [1] 308960 0

Summary
Brief summary
Long-term physical conditions (LTPC), including asthma and diabetes, lasting more than 3 months and impair functioning affect 10-12% of children and young people globally and are becoming increasingly prevalent. Psychological problems, especially anxiety occur more often in children and young people with LTPC and may be associated with school absence, poor academic performance and lower quality of life. Access to face-to-face mental health support is usually limited for this group due to competing medical demands and the limited number of available services. Delayed treatment can result in worse management of physical conditions and increase the risk of developing adult psychiatric disorders.

Psychotherapies such as cognitive behaviour therapy (CBT) and pharmacotherapy (e.g. anxiolytic medication) are traditionally used for addressing psychological problems. However, there is limited evidence of the effectiveness of these therapies for young people with LTPC. Approximately 40% of children who receive CBT treatment for anxiety show inadequate response, suggesting room for improvement. In recent years, eHealth interventions have demonstrated similar effectiveness to face-to-face therapies. CBT-based eHealth interventions appear to have the largest benefit for reducing anxiety in all age groups. Biofeedback-based interventions also show some promise. Following systematic reviews of eHealth, non-eHealth and biofeedback interventions for addressing anxiety and depression in children and young people with LTPC, a hybrid CBT and biofeedback-based computer game called Starship Rescue was developed by our team. A recent open trial of the game demonstrated its acceptability, safety and preliminary evidence of effectiveness.

In this randomised controlled trial, we aim to confirm the clinical effectiveness of Starship Rescue vs an active control eHealth intervention. 30 participants will be allocated to each group and use the intervention for 4-6 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112482 0
Dr Hiran Thabrew
Address 112482 0
Department of Psychological Medicine, School of Medicine, University of Auckland, Level 3, Building 507, 22-30 Park Avenue, Grafton, Auckland 1023
Country 112482 0
New Zealand
Phone 112482 0
+64 21 402 055
Fax 112482 0
Email 112482 0
[email protected]
Contact person for public queries
Name 112483 0
Hiran Thabrew
Address 112483 0
Department of Psychological Medicine, School of Medicine, University of Auckland, Level 3, Building 507, 22-30 Park Avenue, Grafton, Auckland 1023
Country 112483 0
New Zealand
Phone 112483 0
+64 21 402 055
Fax 112483 0
Email 112483 0
[email protected]
Contact person for scientific queries
Name 112484 0
Hiran Thabrew
Address 112484 0
Department of Psychological Medicine, School of Medicine, University of Auckland, Level 3, Building 507, 22-30 Park Avenue, Grafton, Auckland 1023
Country 112484 0
New Zealand
Phone 112484 0
+64 21 402 055
Fax 112484 0
Email 112484 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data from questionnaires/measures may be anonymised prior to being made available for future research. Anonymised data will be irreversibly stripped of the unique participant code and any other identifiers. Participants will be informed that anonymous/anonymised data is unable to be accessed, corrected, or withdrawn; and that return of individual results will not be possible.
When will data be available (start and end dates)?
De-identified data will be available after the manuscript of the trial has been published.

Estimated dates are:
06/31/2023- no end date
Available to whom?
Future researchers
Available for what types of analyses?
Available for all types of analyses.
How or where can data be obtained?
Data will be made available upon request and the process will involve emailing the principal investigator Hiran Thabrew at [email protected] to obtain the trial data.


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.