Effectiveness of mHealth Post-discharge Intervention for Patients With Severe Mental Illness
NCT05703412 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2025-06-06
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.
Conditions
Interventions
- BEHAVIORAL
-
Transition-FOCUS mHealth Intervention
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
- BEHAVIORAL
-
Check-In
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.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH -
Brown University
collaborator OTHER -
Butler Hospital
lead OTHER
Principal Investigators
-
Brandon Gaudiano, PhD · Butler Hospital
-
Ethan Moitra, PhD · Brown University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-14
- Primary Completion
- 2027-07-31
- Completion
- 2027-07-31
Countries
- United States
Study Locations
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