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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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