Effectiveness of mHealth Post-discharge Intervention for Patients With Severe Mental Illness

Study Overview
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Brief Summary
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The overall aim of this program of research is to improve the continuity of care for patients with serious mental illness (SMI) by supporting a safer and more efficient bridge from hospital to outpatient care using a mobile device-delivered app called Transition-FOCUS (tFOCUS), which has previously been tested in community samples. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, multi-component mHealth intervention.

Official Title
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Effectiveness of a Multi-component mHealth Intervention to Improve Post-hospital Transitions of Care for Patients With SMI

Conditions
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Bipolar Disorder, Major Depression, Schizophrenia

Intervention / Treatment
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* Behavioral: Transition-FOCUS mHealth Intervention
* Behavioral: Check-In


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: psychiatric inpatient/partial hospitalization diagnosis of schizophrenia-spectrum disorder or major mood disorder planned ongoing mental health treatment post-discharge in the community 18 years or older ability to speak and read English Exclusion Criteria: lack of smartphone homelessness or housing instability that would prevent reliable follow-up discharge to a long-term restricted living setting

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transition-FOCUS mHealth Intervention<br>All participants will download the tFOCUS app to their mobile phone. tFOCUS uses EMA to assess variables identified as being salient to treatment engagement and illness self-management. The application delivers algorithm-driven micro interventions to address reported problem(s). Data is transmitted to a clinician dashboard, which can be used for remote monitoring. | Behavioral: Transition-FOCUS mHealth Intervention<br>* tFOCUS integrates evidence-based strategies for self-management of severe mental illness (SMI) into a comprehensive mobile assessment and treatment system that is grounded in theoretical SMI models. The application promotes self-management strategies aimed at improving medication adherence to manage biologically driven psychiatric symptoms, increase social support to reduce the negative impact of social withdrawal, improve sleep hygiene to reduce levels of fatigue, and promote strategies for coping with persistent symptoms. tFOCUS application strategies are linked to participants' specific assessment responses, allowing for a highly personalized self-management intervention experience<br>* Other names: tFOCUS;|
| Active Comparator: Check-In<br>Control participants will receive the currently recommended best practices of post-discharge care, including follow-up appointments, instructions, referrals and a follow-up check in. | Behavioral: Check-In<br>* Check-in includes a discharge and safety plan (with medication instructions, crisis services, etc.), a timely follow-up appointment with a mental health provider, and phone check-ins by case managers immediately following post-discharge for care coordination purposes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Psychiatric Rating Scale (BPRS) | The interviewer-rated Brief Psychiatric Rating Scale is a measure of psychiatric symptom severity. The total score (sum of items) will be used to assess overall severity with scores ranging from 18 to 126 and higher scores indicating greater severity. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, psychiatric hospitalization, transitions of care