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Integrating a mobile health device into a community youth mental health team to manage severe mental illness: A randomized controlled trial

A randomized controlled trial examining the effects of a mobile health device integrated into a community mental health team on illness severity and treatment response in young adults with severe mental illness

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000642987
Acronym
unWIRED-RCT
Enrollment
50
Registered
2020-06-01
Start date
2021-01-29
Completion date
2022-09-30
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Symptoms of mental illness are often triggered by stress and individuals with mental illness are sensitive to these effects. This study uses a mobile health device to monitor physiological signs of stress in youths with severe mental illness, as reflected by changes in their activity and arousal. Participants from community mental health services will be allocated to standard case management combined with an integrated mHealth device (information is viewed by both participant and case manager) or an unintegrated mHealth device (participant alone views information; control). We hypothesize that participants and case managers using the integrated mHealth device will be better able to engage and respond to early signs of mental deterioration.

Interventions

Standard case management augmented by a integrated mobile Health device (unWIRED intervention): Participants will receive case management for their mental illness through a community mental health service, as well as wearing the Embrace2 mobile Health (mHealth) device. Case management involves an assessment followed by combinations of medication-based and/or psychosocial treatments. Participants are assigned a core case manager, however, their treatment is managed within a mental health team. Fr

Standard case management augmented by a integrated mobile Health device (unWIRED intervention): Participants will receive case management for their mental illness through a community mental health service, as well as wearing the Embrace2 mobile Health (mHealth) device. Case management involves an assessment followed by combinations of medication-based and/or psychosocial treatments. Participants are assigned a core case manager, however, their treatment is managed within a mental health team. Frequency of contact with the mental health service varies based on clinical necessity, typically weekly to monthly contact. Contact with the mental health service can be through phone calls, face to face meetings at the community health center or home visits if required. In addition to receiving standard case management, a mHealth device will continuously record the participant's physiological measurements including actigraphy (rest and activity) and electrodermal activity (EDA). The Embrace2 mHealth device will be worn on the wrist for up to 6 months during the trial. The participants will have access to activity-based information which will be transmitted to their mobile phone. These measurements will be relayed to health service computers and displayed on dashboards for the treating case manager to view. The dashboard will provide a visualization of the participant's EDA and activity over a 24-hour period. Based on this information, case managers and/or participants may choose to alter their management plan. For example, periods of high arousal and/or poor sleep may indicate a need for a medication change or a more assertive intervention. Physiological information relayed to both the case manager and participant will be regularly reviewed and discussed during clinical team meetings.

Sponsors

Western Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria: 1. Current community mental health service patient 2. Aged 16-25 years 3. Confirmed diagnosis of serious mental illness, such as schizophrenia spectrum disorders, bipolar, major depressive disorder, anxiety and/or personality disorder 4. Capacity to consent to the study

Exclusion criteria

Exclusion criteria: 1. Non-English speaking 2. Greater than mild developmental disability 3. Inability to comply with either the requirements of informed consent or the treatment protocol

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026