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Enrolling by Invitation

NCT Number: NCT05703412

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depression Mental Disorders Mood Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02916, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transition-FOCUS mHealth Intervention

Behavioral

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

Other names: tFOCUS

Check-In

Behavioral

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.

Primary outcomes

  1. Brief Psychiatric Rating Scale (BPRS)

    Time frame: 24 weeks

    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.

Other outcomes

  1. Recovery Assessment Scale (RAS)

    Time frame: 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • Brown University
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: tFOCUS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2023
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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