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Approximately 10% to 12% of New Zealand young people (and 21% of Maori young people) have long-term physical conditions and are more likely to develop psychological problems, particularly anxiety and depression. Delayed treatment leads to worse management of physical conditions, school absence, and poorer long-term outcomes. Recently, electronic health (eHealth) interventions have been shown to be as good as face-to-face therapy and biofeedback techniques have been shown to enhance relaxation during the treatment of anxiety. In addition, young people with long-term physical conditions have expressed a preference for more technologically based support, including game-based interventions, to deal with psychological issues, particularly anxiety.
The aim of this study is to develop a prototype game-based eHealth intervention to address anxiety in young people with long-term physical conditions. The game will be based on the principles of cognitive behavior therapy (CBT) and will integrate a module of biofeedback-based relaxation.
During the first phase of the study, up to 48 young people with long-term physical conditions aged 13 to 18 years, attending a tertiary pediatric hospital will be invited to participate in a 3-stage series of co-design workshops. Following the design, development, and refinement of a working prototype, during the second phase of the study, a further 20 young people with long-term physical conditions and anxiety will be recruited from the same location to participate in an open pilot trial to evaluate its acceptability, usability, and preliminary efficacy.
Changes in anxiety will be measured using the Generalized Anxiety Disorder 7-item scale (GAD-7) and the Spence Child Anxiety Scales (SCAS) at the end of every module (recommended to be completed weekly), post intervention, and 3 months later. Usability of the intervention will be measured using the System Usability Scale (SUS) and by measuring frequency and quantity of use of the intervention. Acceptability of the intervention will be assessed using brief, open-ended questionnaires and semi-structured interviews, the data from which will be analyzed using a general inductive approach. Recruitment to the study commenced in January 2017 and data collection will be completed by the end of December 2017.
If acceptable and useful, this game-based eHealth intervention may offer a cost-effective and clinically useful intervention for addressing the psychological needs of over 16,000 young people with long term health conditions in New Zealand.
Australian New Zealand Clinical Trials Network Registry (ANZCTR): ACTRN12616001253493p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371443 (Archived by WebCite at http://www.webcitation.org/6sYB716lf)
Long-term physical conditions are increasingly common in children and young people and those that last more than 3 months and impair functioning affect 10% to 12% of children globally [
Psychological problems, especially anxiety, are more likely in these individuals such that long-term physical conditions in children have consistently been associated with an increased risk of psychological problems [
Access to, and effectiveness of, treatments for these problems are currently limited. Psychological problems are traditionally addressed using psychotherapies such as cognitive behavior therapy (CBT) and pharmacotherapy (eg, anxiolytic or antidepressant medication). There is limited evidence that these therapies are effective for children with long-term physical conditions [
With the increasing popularity of smart technology, release of app-based interventions, and calls from international organizations such as The Lancet Global Mental Health Group [
Traditional psychological therapies often include a component of psychologically or chemically induced relaxation and there is increasing evidence that newer, more technologically-based forms of therapy, such a biofeedback, may achieve similar results, either alone or in combination with traditional therapies [
The aims of this study are (1) to develop a prototype game-based eHealth intervention for treating anxiety in young people with long-term physical conditions via co-design with end-users at Starship Hospital; (2) to evaluate the acceptability of this intervention with its intended audience; (3) to evaluate the utility of this intervention with its intended audience; (4) to evaluate the efficacy of this intervention in a preliminary manner; and (5) to evaluate the feasibility of delivery of this intervention with its intended audience.
The study will employ a mixed-methods design to co-design, produce, and test a prototype game-based eHealth intervention for treating anxiety in young people with long-term physical conditions.
The study will involve 2 phases. During the first phase, a prototype game-based eHealth intervention will be designed and refined via a co-design process with young people with long-term physical conditions attending a tertiary pediatric hospital in Auckland, New Zealand. Three stages of iterative consultation are planned, with 4 focus groups of up to 12 participants at each stage. At least one focus group at each stage will be arranged for Māori young people to ensure that, in the spirit of biculturalism, the intervention is culturally acceptable to them. By the end of this phase, a working prototype that is ready for pilot testing will be created and refined to ensure it is compatible with end-user expectations. During the second phase, an open pilot trial will be undertaken with 20 young people with long-term physical conditions and anxiety from the same hospital. Each will be loaned a portable device (iPad or similar tablet) on which the prototype intervention, questionnaires, and scales will be preloaded. They will be given up to 8 weeks to complete the intervention at a speed and frequency of their choosing.
Up to 48 young people with long-term physical conditions who are either inpatients or outpatients attending a tertiary pediatric hospital in Auckland, New Zealand will participate in focus groups during each stage of the first phase. Following this, 20 young people will then participate in the second phase, open trial.
Young people will be included in the first phase of the study if they are aged between 13 to 18 years, have any long-term physical condition over 3 months duration (eg, asthma, diabetes, cancer, cystic fibrosis), are of any ethnicity, do and do not have a known anxiety disorder, do or do not have any co-morbid mental health condition, can intellectually and physically use the device and intervention, and if they understand English and are able to provide informed consent or assent. Young people will be included in the second phase of the study if they meet all of the above criteria and have any symptoms of anxiety (not necessarily a diagnosed anxiety disorder).
Young people will be excluded from participation if they do not meet all of the inclusion criteria, if they have an intellectual disability or cannot speak English, or if they have recently undertaken or are undertaking CBT or other forms of psychotherapy, biofeedback therapy, or pharmacotherapy with anxiolytic medication, as these may confound the effectiveness of the prototype game-based eHealth intervention.
The prototype game-based eHealth intervention that will be co-designed with young people with long-term physical conditions will be a 4 to 8 module online, game-based intervention. Its content will be based on the principles of CBT and include an integrated or associated biofeedback-based relaxation component. It is anticipated that modules will take between 30 to 60 minutes each to be completed. Key elements that will be included are education about anxiety and coping strategies for anxiety, using one’s body (relaxation strategies), mind (recognizing unhelpful thoughts and cognitive restructuring), and actions (including graded exposure) to beat anxiety. The precise format and look of the prototype game-based eHealth intervention will be designed in conjunction with end users. The prototype intervention will be stored on a portable tablet, rather than available online or via a mobile app. Due to the co-design process that is being planned, the precise form and content of the intervention is not yet fully defined. However, key CBT-based principles including psychoeducation, relaxation, graded exposure to feared stimuli, and cognitive restructuring will be included. Further refinement of the intervention is likely on the basis of feedback from the pilot trial.
The primary outcomes of the study are (1) acceptability of the prototype intervention, (ie, is the content and format acceptable to users), as assessed via a semi-structured interview following completion of the study at 8 weeks; (2) utility of the intervention (ie, is it useful), as assessed using the System Utility Scale (SUS) [
The secondary outcome of the study is efficacy (ie, does the intervention reduce anxiety and related issues). This will be assessed by measuring changes over time in the Generalized Anxiety Disorder, 7-item (GAD-7) [
Quantitative data will be analyzed using Microsoft Excel and Statistical Software Package (SPSS). Analyses will include basic descriptive statistics (eg, number of sessions completed, number of times device accessed, duration of use, changes in anxiety score, and demographic characteristics of the sample). McNemar’s chi-square tests and
Schedule of assessment procedures.
Baseline | During intervention | Post intervention | 3-month follow-up | |
Demographics | Yes | |||
GAD-7a | Yes | At the completion of each module | Yes | Yes |
SCASb | Yes | At the completion of each module | Yes | Yes |
PedsQLc | Yes | Yes | ||
SUSd | Yes | |||
Online tracking | As used | |||
Semi-structured questionnaire | Yes | Yes |
aGAD-7: Generalized Anxiety Disorder, 7-item.
bSCAS: Spence Children’s Anxiety Scale.
cPedsQL: Pediatric Quality of Life Inventory.
dSUS: System Utility Scale.
Timelines of the study.
Phase | Tasks | Timeframe |
Phase 1 | Ethics approval, securing of funding | September 2016 to December 2016 |
Prototype development via co-design with young people and in conjunction with software company and engineers | January 2017 to December 2017 | |
Phase 2 | Recruitment of participants for open trial | September 2017 to December 2017 |
Open trial | January 2018 to June 2018 | |
Analysis of results, write-up, and dissemination of study results | July 2018 to December 2018 |
The expected timelines of the study are shown in
An initial working CBT-based prototype intervention will be created in conjunction with a software developer and computer engineer. Biofeedback will be applied via a crude and cost-effective hybrid (most likely an existing HRV-based device that is not fully integrated into the new CBT-based intervention, but used with it). Study participants will be loaned an iPad or similar device on which the necessary technology and analysis software has been pre-loaded.
This study received ethics approval from the New Zealand Health and Disability Ethics Committee (16/CEN/136) on the 30th of September 2016. Invitations to the co-design focus groups and pilot study will be forwarded to potential participants through clinicians at Starship Hospital to minimize coercion by direct approach. Consent will be obtained directly for those over 16 years of age and via their parents with participant assent for those under 16 years of age. Participants will be free to discontinue engagement at any stage without consequence and this will be made clear to them. Should any unanticipated distress occur during participation, immediate referral will be undertaken to the hospital-based pediatric consult liaison (mental health) team. Data will be presented in a de-identified manner and will be securely stored for 10 years as per University of Auckland regulations.
Participant recruitment for the first phase of this study commenced in January 2017 and recruitment of participants for the second phase of the study will commence in September 2017. Completion of recruitment is anticipated to occur in June 2018 and analysis of results will be undertaken by December 2018.
Anxiety disorders are among the top causes of disability adjusted life years (DALYs) in New Zealand [
Following the completion of this study, the prototype new game-based eHealth intervention will be refined into a final version for testing in a randomized controlled trial (RCT). If shown in this subsequent study to be clinically effective and acceptable in its final form, it is hoped that the intervention may be hosted on a national eHealth platform and will be made available free of charge to young people in New Zealand. This is currently the case with SPARX, a computerized intervention for depression, but this is contingent on funding from the Ministry of Health.
The potential health impact of this intervention includes improved access to an acceptable and evidence-based treatment for anxiety in young people with long-term physical conditions and an improvement in the management of both psychological and physical conditions. The potential social impact of such an intervention includes improved functioning for young people with long-term physical conditions by means of reduced school absence, improved social integration, and better relationships with family and clinical teams.
Short-term, the potential economic impact of such an intervention includes reduced cost of intervention (compared to face to face treatment) and reduced parental time off work. Long-term, direct improvements in psychological welfare and indirect improvements in physical welfare are likely to lead to improved chances of completed education and employment. From a service delivery point of view, this intervention could address current resource limitations of mental health services to address the needs of young people with long-term physical conditions.
cognitive behavior therapy
electronic health
Generalized Anxiety Disorder, 7-item
heart rate variability
Pediatric Quality of Life Scale
Spence Children’s Anxiety Scale
Smart, Positive, Active, Realistic, X-Factor Thoughts
System Usability Scale
This research is being conducted as part of HT’s PhD at the University of Auckland, New Zealand. The material costs of this study and participant salaries are being funded via the Department of Psychological Medicine and HT’s PhD PRESS fund.
None declared.