Michalak Erin E, Barnes Steven J, Morton Emma, O'Brien Heather L, Murray Greg, Hole Rachelle, Meyer Denny
Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.
Department of Psychology, University of British Columbia, Vancouver, BC, Canada.
JMIR Res Protoc. 2022 Aug 4;11(8):e36213. doi: 10.2196/36213.
Quality of life (QoL) is increasingly being recognized as a key outcome of interventions for bipolar disorder (BD). Mobile phone apps can increase access to evidence-based self-management strategies and provide real-time support. However, although individuals with lived experiences desire support with monitoring and improving broader health domains, existing BD apps largely target mood symptoms only. Further, evidence from the broader mobile health (mHealth) literature has shown that the desires and goals of end users are not adequately considered during app development, and as a result, engagement with mental health apps is suboptimal. To capitalize on the potential of apps to optimize wellness in BD, there is a need for interventions developed in consultation with real-world users designed to support QoL self-monitoring and self-management.
This mixed methods pilot study was designed to evaluate the alpha version of the newly developed PolarUs app, developed to support QoL self-monitoring and self-management in people with BD. Co-designed using a community-based participatory research framework, the PolarUs app builds on the web-based adaptation of a BD-specific QoL self-assessment measure and integrates material from a web-based portal providing information on evidence-informed self-management strategies in BD. The primary objectives of this project were to evaluate PolarUs app feasibility (via behavioral use metrics), the impact of PolarUs (via the Brief Quality of Life in Bipolar Disorder scale, our primary outcome measure), and explore engagement with the PolarUs app (via quantitative and qualitative methods).
Participants will be residents of North America (N=150), aged >18 years, with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of BD type 1, BD type 2, or BD not otherwise specified as assessed by structured diagnostic interview. An embedded mixed methods research design will be adopted; qualitative interviews with a purposefully selected subsample (approximately, n=30) of participants will be conducted to explore in more depth feasibility, impact, and engagement with the PolarUs app over the 12-week study period.
At the time of publication of this protocol, the development of the alpha version of the PolarUs app was complete. Participant enrollment has begun in June 2022. Data collection is expected to be completed by December 2022.
Beyond contributing knowledge on the feasibility and impact of a novel app to support QoL and self-management in BD, this study will also provide new insights related to engagement with mHealth apps. Furthermore, it will function as a case study of successful co-design between people with BD, health care providers, and BD researchers, providing a template for the future use of community-based participatory research frameworks in mHealth intervention development. The results will be used to further refine the PolarUs app and inform the design of a larger clinical trial.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/36213.
生活质量（QoL）日益被视为双相情感障碍（BD）干预措施的关键结果。手机应用程序可以增加获取循证自我管理策略的机会，并提供实时支持。然而，尽管有实际生活经验的个体希望在监测和改善更广泛的健康领域方面获得支持，但现有的双相情感障碍应用程序主要仅针对情绪症状。此外，更广泛的移动健康（mHealth）文献的证据表明，在应用程序开发过程中未充分考虑最终用户的愿望和目标，因此，与心理健康应用程序的互动并不理想。为了利用应用程序的潜力来优化双相情感障碍患者的健康状况，需要与现实世界的用户协商开发旨在支持生活质量自我监测和自我管理的干预措施。
这项混合方法试点研究旨在评估新开发的PolarUs应用程序的alpha版本，该应用程序旨在支持双相情感障碍患者的生活质量自我监测和自我管理。PolarUs应用程序采用基于社区的参与性研究框架进行共同设计，基于双相情感障碍特定生活质量自我评估措施的网络改编版本构建，并整合了来自基于网络的门户网站的材料，该网站提供有关双相情感障碍循证自我管理策略的信息。该项目的主要目标是评估PolarUs应用程序的可行性（通过行为使用指标）、PolarUs的影响（通过双相情感障碍简明生活质量量表，我们的主要结局指标），并通过定量和定性方法探索对PolarUs应用程序的参与度。
参与者将是年龄大于18岁的北美居民（N = 150），通过结构化诊断访谈评估，符合《精神障碍诊断与统计手册》第四版，修订版中1型双相情感障碍、2型双相情感障碍或未另行指定的双相情感障碍的诊断标准。将采用嵌入式混合方法研究设计；将对有目的地选择的参与者子样本（约n = 30）进行定性访谈，以在为期12周的研究期间更深入地探讨PolarUs应用程序的可行性、影响和参与度。
在本方案发布时，PolarUs应用程序alpha版本的开发已完成。参与者招募已于2022年6月开始。数据收集预计于2022年12月完成。
除了提供关于一种新型应用程序在支持双相情感障碍患者生活质量和自我管理方面的可行性和影响的知识外，本研究还将提供与移动健康应用程序参与度相关的新见解。此外，它将作为双相情感障碍患者、医疗保健提供者和双相情感障碍研究人员之间成功共同设计的案例研究，为未来在移动健康干预开发中使用基于社区的参与性研究框架提供模板。研究结果将用于进一步完善PolarUs应用程序，并为更大规模临床试验的设计提供信息。
国际注册报告识别号（IRRID）：PRR1-10.2196/36213。
