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

Primary Purpose

Bipolar Disorder, Major Depression, Schizophrenia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transition-FOCUS mHealth Intervention
Check-In
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring mHealth, psychiatric hospitalization, transitions of care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transition-FOCUS mHealth Intervention

Check-In

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2023
Last Updated
April 24, 2023
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH), Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT05703412
Brief Title
Effectiveness of mHealth Post-discharge Intervention for Patients With Severe Mental Illness
Acronym
tFOCUS
Official Title
Effectiveness of a Multi-component mHealth Intervention to Improve Post-hospital Transitions of Care for Patients With SMI
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
July 31, 2027 (Anticipated)
Study Completion Date
July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH), Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Major Depression, Schizophrenia
Keywords
mHealth, psychiatric hospitalization, transitions of care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transition-FOCUS mHealth Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Check-In
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Transition-FOCUS mHealth Intervention
Other Intervention Name(s)
tFOCUS
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Check-In
Intervention Description
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 Outcome Measure Information:
Title
Brief Psychiatric Rating Scale (BPRS)
Description
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.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Recovery Assessment Scale (RAS)
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Gaudiano, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ethan Moitra, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02916
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be uploaded to the NIMH Data Archive.
IPD Sharing Time Frame
De-identified data will be available after the project is completed without time limit.
IPD Sharing Access Criteria
See guidelines of the NIMH Data Archive.
IPD Sharing URL
https://nda.nih.gov/

Learn more about this trial

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

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