mHealth Intervention for Severe Mental Illness

(tFOCUS Trial)

Overseen By Toni Amaral

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Butler Hospital

Disqualifiers: Lack of smartphone, Homelessness, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called Transition-FOCUS, designed to assist individuals with severe mental illness, such as schizophrenia or major mood disorders, in transitioning smoothly from hospital care to outpatient support. The app offers personalized support and connects users with clinicians for continuous care after hospital discharge. Participants will either use the app or receive standard post-discharge care. Individuals hospitalized for psychiatric reasons who plan to continue treatment in the community may be suitable candidates, provided they have a smartphone and stable housing. As an unphased trial, this study presents a unique opportunity to contribute to innovative solutions for mental health care transitions.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as the focus is on using a mobile app to support your care.

What prior data suggests that the Transition-FOCUS mHealth Intervention is safe?

Research shows that the Transition-FOCUS (tFOCUS) app, a mobile health tool, has been used in community settings, although specific safety data was not found in the reviewed sources. The app helps people with serious mental illness by sending daily self-check prompts and providing coping tips.

Although exact safety data is unavailable, testing of tFOCUS elsewhere suggests it is generally well-received. As a mobile app, it does not involve medical procedures or medications, which typically enhances safety. The reviewed sources report no physical harm from using the app. It remains important to consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Transition-FOCUS mHealth Intervention because it offers a novel approach to managing severe mental illness by integrating technology with healthcare. Unlike traditional post-discharge care that relies on follow-up appointments and referrals, this intervention uses a mobile app to deliver personalized, algorithm-driven micro interventions directly to patients. The app also employs ecological momentary assessment (EMA) to monitor patients' conditions in real-time and transmits this data to a clinician dashboard for remote supervision. This innovative method aims to enhance treatment engagement and self-management, providing a more immediate and responsive support system for individuals transitioning from hospital care to everyday life.

What evidence suggests that the Transition-FOCUS mHealth Intervention is effective for severe mental illness?

Research shows that the Transition-FOCUS mHealth app, which participants in this trial will use, helps people with serious mental health issues manage their conditions more effectively. Early studies found that this mobile app smooths the transition from hospital to outpatient care. It sends small, helpful tips based on user input to assist with self-care. The app shares collected information with doctors, enabling them to monitor and support patients remotely. Initial results suggest it works well for conditions like major depression, schizophrenia, and bipolar disorder. This app aims to make care more continuous and connected for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Brandon Gaudiano, PhD

Principal Investigator

Butler Hospital

Ethan Moitra, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with schizophrenia or a major mood disorder.

Ability to speak and read English

I plan to continue mental health treatment after leaving the hospital.

Exclusion Criteria

Lack of smartphone

Homelessness or housing instability that would prevent reliable follow-up

I am being discharged to a place where I will receive long-term care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Transition-FOCUS (tFOCUS) app for post-hospital transition care

24 weeks

Remote monitoring via app

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Check-In
• Transition-FOCUS mHealth Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Transition-FOCUS mHealth Intervention Experimental Treatment 1 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-In Active Control 1 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.

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Published Research Related to This Trial

In a study of 163 participants over 3 months, both mHealth and clinic-based care led to a reduction in the use of in-person services, with mHealth users showing a 9% decrease during the intervention and a 2% decrease afterward.

Participants using mHealth who responded positively to treatment continued to reduce their service use post-intervention, while those who did not respond showed an increase, suggesting that mHealth can be particularly effective for individuals who achieve sustained recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Mobile Health on In-person Service Use Among People With Serious Mental Illness. Ben-Zeev, D., Buck, B., Hallgren, K., et al.[2020]

The smartphone-delivered intervention (FOCUS) demonstrated higher patient engagement, with 90% starting treatment and 56% remaining engaged after eight weeks, compared to 58% and 40% for the clinic-based intervention (WRAP).

Both interventions led to significant improvements in clinical symptoms and recovery, with FOCUS showing notable enhancements in recovery and quality of life at six months, indicating that mHealth can be as effective as traditional treatments for serious mental illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health (mHealth) Versus Clinic-Based Group Intervention for People With Serious Mental Illness: A Randomized Controlled Trial. Ben-Zeev, D., Brian, RM., Jonathan, G., et al.[2022]

The Mobile After-Care Support (MACS) intervention, designed for patients transitioning from inpatient to outpatient care for schizophrenia-spectrum disorders, was found to be feasible and acceptable, with positive usability and satisfaction ratings from participants.

After using MACS for one month, participants showed significant reductions in dysfunctional coping strategies and psychiatric symptoms, indicating that this mobile health intervention could effectively support patients during a critical transition period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Initial Testing of an mHealth Transitions of Care Intervention for Adults with Schizophrenia-Spectrum Disorders Immediately Following a Psychiatric Hospitalization. Moitra, E., Park, HS., Gaudiano, BA.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10960682/

A Hybrid Type 1 trial of a multi-component mHealth ... A randomized controlled trial will be conducted to determine the effectiveness of a multi-component mHealth intervention (tFOCUS) for improving outcomes for ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05703412/effectiveness-of-mhealth-post-discharge-intervention-for-patients-with-severe-mental-illness

Effectiveness of mHealth Post-discharge Intervention for ... The overall aim of this program of research is to improve the continuity of care for patients with serious mental illness (SMI) by ...

3. withpower.com withpower.com/trial/phase-bipolar-disorder-1-2023-b8934

mHealth Intervention for Severe Mental Illness (tFOCUS Trial) ... Transition-FOCUS mHealth Intervention will have tolerable side effects & efficacy for patients with Major Depressive Disorder, Schizophrenia, Bipolar ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424000557

A Hybrid Type 1 trial of a multi-component mHealth ... A randomized controlled trial will be conducted to determine the effectiveness of a multi-component mHealth intervention (tFOCUS) for improving outcomes for ...

5. jmir.org jmir.org/2024/1/e55924/PDF

Characteristics and Outcomes of mHealth Interventions in ... With previous evidence demonstrating how self-management can improve outcomes of people living with severe mental illness [64], this.

6. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.20250164

Implementing mHealth for Schizophrenia in Community ... Intervention outcomes of 274 enrolled patients were psychiatric hospitalization and emergency department (ED) admissions, clinical symptoms, and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10438016/

Life with FOCUS: A qualitative evaluation of the impact ... In this study, we examine how individuals with serious mental illness use a mHealth intervention, FOCUS, to self-manage their illnesses.