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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH130496 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Brown University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transition-FOCUS mHealth Intervention | Experimental | 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. |
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| Check-In | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Gaudiano, PhD | Butler Hospital | Principal Investigator |
| Ethan Moitra, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02916 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38431134 | Derived | Moitra E, Amaral TM, Benz MB, Cambow S, Elwy AR, Kunicki ZJ, Lu Z, Rafferty NS, Rabasco A, Rossi R, Schatten HT, Gaudiano BA. A Hybrid Type 1 trial of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with serious mental illness: Study protocol. Contemp Clin Trials. 2024 Apr;139:107481. doi: 10.1016/j.cct.2024.107481. Epub 2024 Mar 1. |
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Data will be uploaded to the NIMH Data Archive.
De-identified data will be available after the project is completed without time limit.
See guidelines of the NIMH Data Archive.
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
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| 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. |
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| D019967 |
| Schizophrenia Spectrum and Other Psychotic Disorders |