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

Sponsor
Butler Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05703412
Collaborator
National Institute of Mental Health (NIMH) (NIH), Brown University (Other)
180
Enrollment
1
Location
2
Arms
53.9
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Transition-FOCUS mHealth Intervention
  • Behavioral: Check-In
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of a Multi-component mHealth Intervention to Improve Post-hospital Transitions of Care for Patients With SMI
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2027
Anticipated Study Completion Date :
Jul 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transition-FOCUS mHealth Intervention

All participants will download the tFOCUS app to their mobile phone. tFOCUS uses EMA to assess variables identified as being salient to treatment engagement and illness self-management. The application delivers algorithm-driven micro interventions to address reported problem(s). Data is transmitted to a clinician "dashboard," which can be used for remote monitoring.

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
Other Names:
  • tFOCUS

    		•
    Active Comparator: Check-In

    Control participants will receive the currently recommended best practices of post-discharge care, including follow-up appointments, instructions, referrals and a follow-up check in.

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Brief Psychiatric Rating Scale (BPRS) [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 Outcome Measures

    1. Recovery Assessment Scale (RAS) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Butler Hospital Providence Rhode Island United States 02916

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Brandon Gaudiano, PhD, Butler Hospital
    • Principal Investigator: Ethan Moitra, PhD, Brown University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Butler Hospital
    ClinicalTrials.gov Identifier:
    NCT05703412
    Other Study ID Numbers:
    • 2208-001
    • R01MH130496
    First Posted:
    Jan 30, 2023
    Last Update Posted:
    Jan 30, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Butler Hospital
    mHealth
    psychiatric hospitalization
    transitions of care
    Additional relevant MeSH terms:
    Schizophrenia
    Bipolar Disorder

    Study Results

    No Results Posted as of Jan 30, 2023