Integrating a Mobile Health Device Into a Community Youth Mental Health Team to Manage Severe Mental Illness: Protocol for a Randomized Controlled Trial
Authors: Byrne Simon , Kotze Beth , Ramos Fabio , Casties Achim , Starling Jean , Harris Anthony 
Published: October 2020

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 an mHealth device into a community mental health team to enhance management of severe mental illness in young adults.

Objective
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.

Methods
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.

Results
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.

Conclusions
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.

Trial Registration
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000642987; https://www.anzctr.org.au/ACTRN12620000642987.aspx

International Registered Report Identifier (IRRID)
PRR1-10.2196/19510