A serious game called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), originally developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depression and anxiety in adolescents with mild to moderate depression in studies undertaken in Australasia. However, SPARX has never been trialled in the United Kingdom (UK), and there have been issues relating to low engagement when it has been used in a real-world context. To conduct the first pilot and feasibility randomised controlled trial (RCT) in England to explore the use of SPARX in different settings. The trial will explore whether SPARX supported by an e-coach (assistant psychologists) improves adherence and engagement compared with self-directed (i.e. self-help) use. The trial results will be used to inform the optimal mode of delivery (SPARX supported vs. SPARX self-directed), to calculate an appropriate sample size for a full RCT, and to decide which setting is most suitable. Following consultation with young people to ensure study suitability/appropriateness, a total of 120 adolescents (11–19 years) will be recruited for this three-arm study. Adolescents recruited for the study across England will be randomised to receive either SPARX with human support (from an e-coach), self-directed SPARX, or a waitlist control group. Assessments will be conducted online at baseline, week 4, and 8–10-week post-randomisation. The assessments will include measures which capture demographic, depression (Patient Health Questionnaire modified for adolescents [PHQ-A]) and anxiety (Revised Child Anxiety and Depression Scale [RCADS]) symptomatology, and health-related quality-of-life data (EQ-5D-Y and proxy version). Analyses will be primarily descriptive. Qualitative interviews will be undertaken with a proportion of the participants and clinical staff as part of a process evaluation, and the qualitative data gathered will be thematically analysed. Finally, feasibility data will be collected on recruitment details, overall study uptake and engagement with SPARX, participant retention, and youth-reported acceptability of the intervention. The findings will inform the design of a future definitive RCT of SPARX in the UK. If the subsequent definitive RCT demonstrates that SPARX is effective, then an online serious game utilising CBT principles ultimately has the potential to improve the provision of care within the UK’s health services if delivered en masse. ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804 .

中文翻译：

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针对抑郁症青少年的精准计算机认知行为疗法 (cCBT)：SPARX-UK 的试点和可行性随机对照试验方案

一种名为 SPARX（聪明、积极、主动、现实、X 因素思想）的严肃游戏最初在新西兰开发，并结合了认知行为疗法 (CBT) 原则，已被证明有助于减轻患有轻度抑郁症的青少年的抑郁和焦虑症状。在澳大利亚进行的研究显示，抑郁症的症状为中度抑郁症。然而，SPARX 从未在英国 (UK) 进行过试用，并且在实际环境中使用时存在参与度低的问题。在英国进行第一个试点和可行性随机对照试验 (RCT)，以探索 SPARX 在不同环境中的使用。该试验将探讨与自我指导（即自助）使用相比，由电子教练（助理心理学家）支持的 SPARX 是否可以提高依从性和参与度。试验结果将用于确定最佳交付模式（SPARX 支持与 SPARX 自指导）、计算完整 RCT 的适当样本量，并决定哪种设置最合适。在与年轻人协商以确保研究的适宜性/适当性后，将招募总共 120 名青少年（11-19 岁）参加这项三组研究。英格兰各地招募的青少年将被随机分配接受有人支持（来自电子教练）的 SPARX、自我指导的 SPARX 或候补对照组。评估将在基线、第 4 周以及随机分组后 8-10 周在线进行。评估将包括捕捉人口统计学、抑郁症（针对青少年修改的患者健康问卷[PHQ-A]）和焦虑症（修订版儿童焦虑和抑郁量表[RCADS]）症状学以及与健康相关的生活质量数据（EQ）的措施-5D-Y 和代理版本）。分析将主要是描述性的。作为过程评估的一部分，将对部分参与者和临床工作人员进行定性访谈，并对收集的定性数据进行主题分析。最后，将收集有关招募细节、总体研究吸收率和 SPARX 参与度、参与者保留率以及青年报告的干预可接受性的可行性数据。研究结果将为英国 SPARX 未来最终随机对照试验的设计提供信息。如果随后的最终随机对照试验证明 SPARX 是有效的，那么利用 CBT 原则的在线严肃游戏最终有可能改善英国医疗服务中的护理服务（如果集体提供）。 ISRCTN：ISRCTN15124804。注册于 2023 年 1 月 16 日，https://www.isrctn.com/ISRCTN15124804。