Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 12, 2020
Date Accepted: Oct 9, 2020
Integrating a mobile health device into a community youth mental health team to manage severe mental illness: Protocol for a randomized controlled trial
ABSTRACT
Background:
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 a mHealth device into a community mental health service to enhance management of severe mental illness in young adults.
Objective:
The aim of this study is to examine whether: 1) a mHealth device integrated into a community mental health team can improve outcomes for young adults with severe mental illness, and 2) the device detects periods of mental health vs. deterioration.
Methods:
A randomized controlled trial will allocate up to 126 young adults from community mental health services for up to 6 months to standard case management combined with an integrated mHealth device (physiological information is viewed by both participant and case manager; unWIRED intervention) or an unintegrated mHealth device (participant alone views information; control). Participants will wear the Empatica Embrace2 which continuously measures electrodermal activity and actigraphy (rest and activity). The study also examines whether the Embrace2 can detect periods of mental health vs. deterioration. A variety of measurements will be taken, including physiological data from the Embrace2, participant and case manager self-report, chart reviews and ecological momentary assessments of stress in real time. In addition, participants and case managers will provide qualitative data regarding their experience with the integrated mHealth device which will be thematically analysed.
Results:
The study has received ethical approval at Western Sydney Local Health District. It is due to start in August 2020 and conclude in August 2022.
Conclusions:
The randomized controlled trial 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 the unWIRED intervention will prevent relapse by improving detection of stress and enabling case managers and patients to better engage and respond to symptoms. Clinical Trial: Australia New Zealand Clinical Trials Registry Registration Number: ACTRN12620000642987 https://www.anzctr.org.au/ACTRN12620000642987.aspx
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