Effectiveness of mHealth Post-discharge Intervention for Patients With Severe Mental Illness
tFOCUS
Effectiveness of a Multi-component mHealth Intervention to Improve Post-hospital Transitions of Care for Patients With SMI
2 other identifiers
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedStudy Start
First participant enrolled
February 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
June 6, 2025
June 1, 2025
4.5 years
January 19, 2023
June 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (1)
Recovery Assessment Scale (RAS)
24 weeks
Study Arms (2)
Transition-FOCUS mHealth Intervention
EXPERIMENTALAll 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
ACTIVE COMPARATORControl participants will receive the currently recommended best practices of post-discharge care, including follow-up appointments, instructions, referrals and a follow-up check in.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- psychiatric inpatient/partial hospitalization
- diagnosis of schizophrenia-spectrum disorder or major mood disorder
- planned ongoing mental health treatment post-discharge in the community
- years or older
- ability to speak and read English
You may not qualify if:
- lack of smartphone
- homelessness or housing instability that would prevent reliable follow-up
- discharge to a long-term restricted living setting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Butler Hospitallead
- National Institute of Mental Health (NIMH)collaborator
- Brown Universitycollaborator
Study Sites (1)
Butler Hospital
Providence, Rhode Island, 02916, United States
Related Publications (1)
Moitra E, Amaral TM, Benz MB, Cambow S, Elwy AR, Kunicki ZJ, Lu Z, Rafferty NS, Rabasco A, Rossi R, Schatten HT, Gaudiano BA. A Hybrid Type 1 trial of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with serious mental illness: Study protocol. Contemp Clin Trials. 2024 Apr;139:107481. doi: 10.1016/j.cct.2024.107481. Epub 2024 Mar 1.
PMID: 38431134DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brandon Gaudiano, PhD
Butler Hospital
- PRINCIPAL INVESTIGATOR
Ethan Moitra, PhD
Brown University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2023
First Posted
January 30, 2023
Study Start
February 14, 2023
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
June 6, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- De-identified data will be available after the project is completed without time limit.
- Access Criteria
- See guidelines of the NIMH Data Archive.
Data will be uploaded to the NIMH Data Archive.