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

Schizophrenia Clinical Trial

— tFOCUS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05703412
• Other study ID #: 2208-001
• Secondary ID: R01MH130496
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: May 2024
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Major Depression
• Schizophrenia

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Butler Hospital	Brown University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recovery Assessment Scale (RAS)	The RAS is a self-report measure of aspects of mental health recovery, including hope and self-determination. The total score (sum of items) will be used and ranges from 22 to 110 with higher scores indicating higher suicidal thoughts and behaviors.	24 weeks
Primary	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