Byrne Simon, Kotze Beth, Ramos Fabio, Casties Achim, Starling Jean, Harris Anthony
Western Sydney Local Health District Mental Health Service, Sydney, NSW, Australia.
Westmead Institute for Medical Research, Sydney, Australia.
JMIR Res Protoc. 2020 Nov 2;9(11):e19510. doi: 10.2196/19510.
Symptoms of mental illness are often triggered by stress, and individuals with mental illness are sensitive to these effects. The development of mobile health (mHealth) devices allows continuous recording of biometrics associated with activity, sleep, and arousal. Deviations in these measures could indicate a stressed state requiring early intervention. This paper describes a protocol for integrating an mHealth device into a community mental health team to enhance management of severe mental illness in young adults.
The aim of this study is to examine (1) whether an mHealth device integrated into a community mental health team can improve outcomes for young adults with severe mental illness and (2) whether the device detects periods of mental health versus deterioration.
This study examines whether physiological information from an mHealth device prevents mental deterioration when shared with the participant and clinical team versus with the participant alone. A randomized controlled trial (RCT) will allocate 126 young adults from community mental health services for 6 months to standard case management combined with an integrated mHealth device (ie, physiological information is viewed by both participant and case manager: unWIRED intervention) or an unintegrated mHealth device (ie, participant alone self-monitors: control). Participants will wear the Empatica Embrace2 device, which continuously records electrodermal activity and actigraphy (ie, rest and activity). The study also examines whether the Embrace2 can detect periods of mental health versus deterioration. A variety of measurements will be taken, including physiological data from the Embrace2; participant and case manager self-report regarding symptoms, functioning, and quality of life; chart reviews; and ecological momentary assessments of stress in real time. Changes in each participant's Clinical Global Impression Scale scores will be assessed by blinded raters as the primary outcome. In addition, participants and case managers will provide qualitative data regarding their experience with the integrated mHealth device, which will be thematically analyzed.
The study has received ethical approval from the Western Sydney Local Health District Human Research Ethics Committee. It is due to start in October 2020 and conclude in October 2022.
The RCT will provide insight as to whether an integrated mHealth device enables case managers and participants to pre-emptively manage early warning signs and prevent relapse. We anticipate that unWIRED will enhance early intervention by improving detection of stress and allowing case managers and patients to better engage and respond to symptoms.
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000642987; https://www.anzctr.org.au/ACTRN12620000642987.aspx.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/19510.
精神疾病症状常由压力引发，患有精神疾病的个体对这些影响较为敏感。移动健康（mHealth）设备的发展使得与活动、睡眠和觉醒相关的生物特征能够被持续记录。这些指标的偏差可能表明处于需要早期干预的压力状态。本文描述了一项将mHealth设备整合到社区精神卫生团队中以加强对年轻成年人严重精神疾病管理的方案。
本研究的目的是检验（1）整合到社区精神卫生团队中的mHealth设备是否能改善患有严重精神疾病的年轻成年人的治疗效果，以及（2）该设备能否检测出精神健康期与病情恶化期。
本研究考察与参与者单独分享相比，当与参与者及临床团队分享来自mHealth设备的生理信息时，是否能预防精神衰退。一项随机对照试验（RCT）将把126名来自社区精神卫生服务机构的年轻成年人分配到为期6个月的标准病例管理组，其中一组结合整合式mHealth设备（即参与者和病例管理员都能查看生理信息：未连线干预），另一组结合非整合式mHealth设备（即参与者独自进行自我监测：对照组）。参与者将佩戴Empatica Embrace2设备，该设备可持续记录皮肤电活动和活动记录仪数据（即休息和活动情况）。该研究还考察Embrace2能否检测出精神健康期与病情恶化期。将进行多种测量，包括来自Embrace2的生理数据；参与者和病例管理员关于症状、功能和生活质量的自我报告；病历审查；以及实时的压力生态瞬时评估。由不知情的评估者评估每位参与者临床总体印象量表评分的变化作为主要结果。此外，参与者和病例管理员将提供关于他们使用整合式mHealth设备体验的定性数据，并进行主题分析。
该研究已获得西悉尼地方卫生区人类研究伦理委员会的伦理批准。研究定于2020年10月开始，2022年10月结束。
该随机对照试验将提供关于整合式mHealth设备是否能使病例管理员和参与者预先管理早期预警信号并预防复发的见解。我们预计未连线干预将通过改善压力检测并使病例管理员和患者能更好地应对症状来加强早期干预。
澳大利亚新西兰临床试验注册中心（ANZCTR）ACTRN12620000642987；https://www.anzctr.org.au/ACTRN12620000642987.aspx。
国际注册报告识别码（IRRID）：PRR1-10.2196/19510。
