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

Butler Hospital

Status: Invitation-only

Conditions: Major Depression; Schizophrenia; Bipolar Disorder

Treatments: Behavioral: Check-In; Behavioral: Transition-FOCUS mHealth Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05703412

R01MH130496 (U.S. NIH Grant/Contract)

2208-001

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Transition-FOCUS mHealth Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Transition-FOCUS mHealth Intervention

Check-In

Active Comparator group

Description:

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.

Treatment:

Behavioral: Check-In