None listed
Conditions
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.
Interventions
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
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.
Sponsors
University of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
13 Years to 18 Years
Healthy volunteers
No
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)
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.
Outcome results
None listed