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mHealth Intervention for Severe Mental Illness (tFOCUS Trial)

N/A
Waitlist Available
Led By Brandon Gaudiano, PhD
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Summary

This trial aims to use a mobile app to help bridge the gap between hospital and outpatient care for people with mental illness, improving continuity of care.

Who is the study for?
This trial is for adults over 18 who speak and read English, have been hospitalized or in partial hospitalization for schizophrenia-spectrum disorder or major mood disorders like bipolar disorder and depression, and plan to continue mental health treatment after discharge. It's not for those without a smartphone, unstable housing situations, or if they're being discharged to long-term restricted living.
What is being tested?
The study tests the Transition-FOCUS (tFOCUS) mobile app designed to help patients with severe mental illness transition from hospital to outpatient care. The aim is to see if this mHealth intervention can make the change safer and more efficient.
What are the potential side effects?
Since tFOCUS is a mobile app intervention aimed at improving continuity of care rather than a medication, it does not have traditional side effects. However, users may experience stress or anxiety related to technology use or reminders of their condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brief Psychiatric Rating Scale (BPRS)
Other study objectives
Recovery Assessment Scale (RAS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Transition-FOCUS mHealth InterventionExperimental Treatment1 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.
Group II: Check-InActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,356 Total Patients Enrolled
253 Trials studying Schizophrenia
89,744 Patients Enrolled for Schizophrenia
Brown UniversityOTHER
463 Previous Clinical Trials
618,513 Total Patients Enrolled
7 Trials studying Schizophrenia
323 Patients Enrolled for Schizophrenia
Butler HospitalLead Sponsor
130 Previous Clinical Trials
16,313 Total Patients Enrolled
2 Trials studying Schizophrenia
92 Patients Enrolled for Schizophrenia

Media Library

Transition-FOCUS mHealth Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05703412 — N/A
Schizophrenia Research Study Groups: Transition-FOCUS mHealth Intervention, Check-In
Schizophrenia Clinical Trial 2023: Transition-FOCUS mHealth Intervention Highlights & Side Effects. Trial Name: NCT05703412 — N/A
Transition-FOCUS mHealth Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05703412 — N/A
~115 spots leftby Jul 2027
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