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      Protocol for Co-Design, Development, and Open Trial of a Prototype Game-Based eHealth Intervention to Treat Anxiety in Young People With Long-Term Physical Conditions

      , B BiomedSci (Hons), BMed, FRACP, FRANZCP 1 , , , PhD 1 , , MB ChB, MD 1
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      long-term physical conditions, chronic illness, anxiety, eHealth, gaming, young people, treatment, cognitive behavior therapy, biofeedback

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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.

          Trial Registration

          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)

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          Most cited references29

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          The effectiveness of SPARX, a computerised self help intervention for adolescents seeking help for depression: randomised controlled non-inferiority trial

          Objective To evaluate whether a new computerised cognitive behavioural therapy intervention (SPARX, Smart, Positive, Active, Realistic, X-factor thoughts) could reduce depressive symptoms in help seeking adolescents as much or more than treatment as usual. Design Multicentre randomised controlled non-inferiority trial. Setting 24 primary healthcare sites in New Zealand (youth clinics, general practices, and school based counselling services). Participants 187 adolescents aged 12-19, seeking help for depressive symptoms, with no major risk of self harm and deemed in need of treatment by their primary healthcare clinicians: 94 were allocated to SPARX and 93 to treatment as usual. Interventions Computerised cognitive behavioural therapy (SPARX) comprising seven modules delivered over a period of between four and seven weeks, versus treatment as usual comprising primarily face to face counselling delivered by trained counsellors and clinical psychologists. Outcomes The primary outcome was the change in score on the children’s depression rating scale-revised. Secondary outcomes included response and remission on the children’s depression rating scale-revised, change scores on the Reynolds adolescent depression scale-second edition, the mood and feelings questionnaire, the Kazdin hopelessness scale for children, the Spence children’s anxiety scale, the paediatric quality of life enjoyment and satisfaction questionnaire, and overall satisfaction with treatment ratings. Results 94 participants were allocated to SPARX (mean age 15.6 years, 62.8% female) and 93 to treatment as usual (mean age 15.6 years, 68.8% female). 170 adolescents (91%, SPARX n=85, treatment as usual n=85) were assessed after intervention and 168 (90%, SPARX n=83, treatment as usual n=85) were assessed at the three month follow-up point. Per protocol analyses (n=143) showed that SPARX was not inferior to treatment as usual. Post-intervention, there was a mean reduction of 10.32 in SPARX and 7.59 in treatment as usual in raw scores on the children’s depression rating scale-revised (between group difference 2.73, 95% confidence interval −0.31 to 5.77; P=0.079). Remission rates were significantly higher in the SPARX arm (n=31, 43.7%) than in the treatment as usual arm (n=19, 26.4%) (difference 17.3%, 95% confidence interval 1.6% to 31.8%; P=0.030) and response rates did not differ significantly between the SPARX arm (66.2%, n=47) and treatment as usual arm (58.3%, n=42) (difference 7.9%, −7.9% to 24%; P=0.332). All secondary measures supported non-inferiority. Intention to treat analyses confirmed these findings. Improvements were maintained at follow-up. The frequency of adverse events classified as “possibly” or “probably” related to the intervention did not differ between groups (SPARX n=11; treatment as usual n=11). Conclusions SPARX is a potential alternative to usual care for adolescents presenting with depressive symptoms in primary care settings and could be used to address some of the unmet demand for treatment. Trial registration Australian New Zealand Clinical Trials ACTRN12609000249257.
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            Psychometric properties of the Spence Children's Anxiety Scale with young adolescents.

            The psychometric properties of the Spence Children's Anxiety Scale (SCAS) were examined with 875 adolescents aged 13 and 14 years. This self-report measure was designed to evaluate symptoms relating to separation anxiety, social phobia, obsessive-compulsive disorder, panic-agoraphobia, generalized anxiety, and fears of physical injury. Results of confirmatory and exploratory factor analyses supported six factors consistent with the hypothesized subtypes of anxiety. There was support also for a model in which the first-order factors loaded significantly on a single second-order factor of anxiety in general. The internal consistency of the total score and sub-scales was high, and 12-week test-retest reliability was satisfactory. The SCAS correlated strongly with a frequently used child self-report measure of anxiety and significantly, albeit at a lower level, with a measure of depression.
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              The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders.

              Various studies find relationships among anxiety and depressive disorders of adolescence and adulthood. This study prospectively examines the magnitude of longitudinal associations between adolescent and adult anxiety or depressive disorders. An epidemiologically selected sample of 776 young people living in upstate New York received DSM-based psychiatric assessments in 1983, 1985, and 1992 using structured interviews. The magnitude of the association between adolescent and adult anxiety or depressive disorders was quantified using odds ratios generated from logistic regression analyses and from a set of latent Markov analyses. We focus on longitudinal associations among narrowly defined DSM anxiety or depressive disorders. In simple logistic models, adolescent anxiety or depressive disorders predicted an approximate 2- to 3-fold increased risk for adulthood anxiety or depressive disorders. There was evidence of specificity in the course of simple and social phobia but less specificity in the course of other disorders. Results from the analyses using latent variables suggested that while most adolescent disorders were no longer present in young adulthood, most adult disorders were preceded by adolescent disorders. An anxiety or depressive disorder during adolescence confers a strong risk for recurrent anxiety or depressive disorders during early adulthood. Most anxiety and depressive disorders in young adults may be preceded by anxiety or depression in adolescence.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                September 2017
                22 September 2017
                : 6
                : 9
                : e171
                [1] 1 University of Auckland Department of Psychological Medicine Auckland New Zealand
                Author notes
                Corresponding Author: Hiran Thabrew h.thabrew@ 123456auckland.ac.nz
                Author information
                ©Hiran Thabrew, Karolina Stasiak, Sally Merry. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.09.2017.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 7 May 2017
                : 17 June 2017
                : 20 June 2017
                : 14 July 2017

                long-term physical conditions,chronic illness,anxiety,ehealth,gaming,young people,treatment,cognitive behavior therapy,biofeedback


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