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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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