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一种促进中国精神病患者自我管理的数字系统(优心):一项采用混合方法设计的非随机有效性和可行性研究方案

A Digital System (YouXin) to Facilitate Self-Management by People With Psychosis in China: Protocol for a Nonrandomized Validity and Feasibility Study With a Mixed Methods Design.

作者信息

Zhang Xiaolong, Lewis Shôn, Carter Lesley-Anne, Bucci Sandra

机构信息

Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom.

The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China.

出版信息

JMIR Res Protoc. 2023 Sep 12;12:e45170. doi: 10.2196/45170.

Abstract

BACKGROUND

Psychosis is one of the most disabling mental health conditions and causes significant personal, social, and economic burden. Accurate and timely symptom monitoring is critical to offering prompt and time-sensitive clinical services. Digital health is a promising solution for the barriers encountered by conventional symptom monitoring approaches, including accessibility, the ecological validity of assessments, and recall bias. However, to date, there has been no digital health technology developed to support self-management for people with psychosis in China.

OBJECTIVE

We report the study protocol to evaluate the validity, feasibility, acceptability, usability, and safety of a symptom self-monitoring smartphone app (YouXin; Chinese name ) for people with psychosis in China.

METHODS

This is a nonrandomized validity and feasibility study with a mixed methods design. The study was approved by the University of Manchester and Beijing Anding Hospital Research Ethics Committee. YouXin is a smartphone app designed to facilitate symptom self-monitoring for people with psychosis. YouXin has 2 core functions: active monitoring of symptoms (ie, smartphone survey) and passive monitoring of behavioral activity (ie, passive data collection via embedded smartphone sensors). The development process of YouXin utilized a systematic coproduction approach. A series of coproduction consultation meetings was conducted by the principal researcher with service users and clinicians to maximize the usability and acceptability of the app for end users. Participants with psychosis aged 16 years to 65 years were recruited from Beijing Anding Hospital, Beijing, China. All participants were invited to use the YouXin app to self-monitor symptoms for 4 weeks. At the end of the 4-week follow-up, we invited participants to take part in a qualitative interview to explore the acceptability of the app and trial procedures postintervention.

RESULTS

Recruitment to the study was initiated in August 2022. Of the 47 participants who were approached for the study from August 2022 to October 2022, 41 participants agreed to take part in the study. We excluded 1 of the 41 participants for not meeting the inclusion criteria, leaving a total of 40 participants who began the study. As of December 2022, 40 participants had completed the study, and the recruitment was complete.

CONCLUSIONS

This study is the first to develop and test a symptom self-monitoring app specifically designed for people with psychosis in China. If the study shows the feasibility of YouXin, a potential future direction is to integrate the app into clinical workflows to facilitate digital mental health care for people with psychosis in China. This study will inform improvements to the app, trial procedures, and implementation strategies with this population. Moreover, the findings of this trial could lead to optimization of digital health technologies designed for people with psychosis in China.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45170.

摘要

背景

精神病是最具致残性的心理健康状况之一,会造成重大的个人、社会和经济负担。准确及时的症状监测对于提供及时且具有时效性的临床服务至关重要。数字健康是解决传统症状监测方法所遇到障碍的一个有前景的方案,这些障碍包括可及性、评估的生态效度以及回忆偏倚。然而,迄今为止,中国尚未开发出支持精神病患者自我管理的数字健康技术。

目的

我们报告一项研究方案,以评估一款针对中国精神病患者的症状自我监测智能手机应用程序(“友心”;中文名)的效度、可行性、可接受性、可用性和安全性。

方法

这是一项采用混合方法设计的非随机效度和可行性研究。该研究获得了曼彻斯特大学和北京安定医院研究伦理委员会的批准。“友心”是一款旨在方便精神病患者进行症状自我监测的智能手机应用程序。“友心”有两个核心功能:症状主动监测(即智能手机调查)和行为活动被动监测(即通过嵌入式智能手机传感器进行被动数据收集)。“友心”的开发过程采用了系统协同生产方法。首席研究员与服务使用者和临床医生举行了一系列协同生产咨询会议,以最大限度地提高该应用程序对最终用户的可用性和可接受性。年龄在16岁至65岁之间的精神病患者从中国北京安定医院招募。所有参与者均被邀请使用“友心”应用程序自我监测症状4周。在4周随访结束时,我们邀请参与者参加定性访谈,以探讨干预后该应用程序和试验程序的可接受性。

结果

该研究于2022年8月开始招募。在2022年8月至2022年10月被邀请参与该研究的47名参与者中,41名参与者同意参加研究。我们将41名参与者中的1名因不符合纳入标准而排除,共有40名参与者开始了研究。截至2022年12月,40名参与者完成了研究,招募工作结束。

结论

本研究首次在中国开发并测试了一款专门为精神病患者设计的症状自我监测应用程序。如果该研究证明“友心”具有可行性,未来一个潜在的方向是将该应用程序整合到临床工作流程中,以促进中国精神病患者的数字心理健康护理。本研究将为改进该应用程序、试验程序以及针对这一人群的实施策略提供参考。此外, 本试验的结果可能会优化为中国精神病患者设计的数字健康技术。

国际注册报告识别码(IRRID):DERR1-10.2196/45170。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2992/10523209/a63d8204822e/resprot_v12i1e45170_fig1.jpg

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