Yokomitsu Kengo, Irie Tomonari, Sekiguchi Mayu, Shimizu Ayako, Matsuoka Hirofumi, Merry Sally Nicola, Stasiak Karolina
College of Comprehensive Psychology, Ritsumeikan University, Osaka, Japan.
School of Education and Culture, Hokusho University, Hokkaido, Japan.
JMIR Res Protoc. 2020 Apr 7;9(4):e15164. doi: 10.2196/15164.
Evidence shows that computerized self-help interventions are effective for reducing symptoms of depression. One such intervention, SPARX, is a gamified mobile computerized cognitive behavioral therapy (cCBT) developed for adolescents in New Zealand, which was shown to be as effective as usual care for young people with mild-to-moderate symptoms of depression. However, gamified cCBT has not yet been tested in Japan.
This trial is designed to investigate whether a Japanese-adapted version of SPARX improves depressive symptoms in Japanese university students with mild-to-moderate depressive symptoms.
In this 7-week, multicenter, stratified, parallel-group, superiority randomized trial, participants will be allocated to either a treatment condition (SPARX) or a wait-list control condition. SPARX is a fully automated program, which will be delivered to the mobile phone or tablet device of the participants. SPARX is designed as an interactive fantasy game to guide the user through seven modules that teach key CBT strategies. All participants will be recruited from universities via advertisements on online bulletin boards, the campus newspaper, and posters. Participants in the treatment condition will use the SPARX program weekly. The primary outcome is the reduction of depressive symptoms (using Patient Health Questionnaires-9) measured at baseline and weekly: once after the 7-week intervention and once at a 1-month follow-up. Secondary outcomes include satisfaction with the program and satisfaction with life, measured by the Satisfaction With Life Scale; positive and negative moods, measured by the Profile of Mood States Second Edition; social functioning, measured by the EuroQol Instrument; rumination, measured by the Ruminative Responses Scale; and coping, measured by the Brief Coping Orientation to Problem Experienced Inventory.
This study received funding from The Research Institute of Personalized Health Sciences, Health Sciences University of Hokkaido, and obtained institutional review board approval in September 2019. Data collection began in April 2019.
Results of this trial may provide further evidence for the efficacy of gamified cCBT for the treatment of depression and, specifically, provide support for using SPARX with Japanese university students.
Japan Primary Registries Network UMIN000034354; https://tinyurl.com/uu7xd77.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15164.
有证据表明,计算机化自助干预措施对于减轻抑郁症状有效。其中一种干预措施SPARX,是一款为新西兰青少年开发的游戏化移动计算机化认知行为疗法(cCBT),对于有轻度至中度抑郁症状的年轻人,它被证明与常规护理一样有效。然而,游戏化cCBT尚未在日本进行过测试。
本试验旨在研究SPARX的日本改编版是否能改善有轻度至中度抑郁症状的日本大学生的抑郁症状。
在这项为期7周的多中心、分层、平行组、优效性随机试验中,参与者将被分配到治疗组(SPARX)或等待名单对照组。SPARX是一个完全自动化的程序,将发送到参与者的手机或平板电脑设备上。SPARX被设计成一款交互式奇幻游戏,引导用户通过七个模块,教授关键的认知行为疗法策略。所有参与者将通过在线公告栏、校园报纸和海报上的广告从大学招募。治疗组的参与者将每周使用SPARX程序。主要结局是在基线和每周测量的抑郁症状减轻情况(使用患者健康问卷-9):在7周干预后一次,在1个月随访时一次。次要结局包括对该程序的满意度和对生活的满意度,通过生活满意度量表测量;积极和消极情绪,通过情绪状态量表第二版测量;社会功能,通过欧洲五维健康量表测量;沉思,通过沉思反应量表测量;以及应对方式,通过经历问题的简短应对取向量表测量。
本研究获得了北海道健康科学大学个性化健康科学研究所的资助,并于2019年9月获得了机构审查委员会的批准。数据收集于2019年4月开始。
本试验的结果可能为游戏化cCBT治疗抑郁症的疗效提供进一步证据,特别是为在日本大学生中使用SPARX提供支持。
日本初级注册网络UMIN000034354;https://tinyurl.com/uu7xd77。
国际注册报告识别码(IRRID):DERR1-10.2196/15164。