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

Not Applicable

• Conditions: Bipolar Disorder; Major Depression; Schizophrenia
• Interventions: Behavioral: Transition-FOCUS mHealth Intervention; Behavioral: Check-In

• Registration Number: NCT05703412
• Lead Sponsor: Butler Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-02-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transition-FOCUS mHealth Intervention	Transition-FOCUS mHealth Intervention	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.
Check-In	Check-In	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.

Primary Outcome Measures

Name	Time	Method
Brief Psychiatric Rating Scale (BPRS)	24 weeks	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.

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States