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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05703412
Acronym
tFOCUS
Enrollment
180
Registered
2023-01-30
Start date
2023-02-14
Completion date
2027-07-31
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Major Depression, Schizophrenia

Keywords

mHealth, psychiatric hospitalization, transitions of care

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.

Interventions

BEHAVIORALTransition-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

BEHAVIORALCheck-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

National Institute of Mental Health (NIMH)
CollaboratorNIH
Brown University
CollaboratorOTHER
Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Brief Psychiatric Rating Scale (BPRS)24 weeksThe 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.

Other

MeasureTime frameDescription
Recovery Assessment Scale (RAS)24 weeksThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026