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

180 Participants Needed

Trial Summary

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 data supports the effectiveness of the Check-In, Transition-FOCUS mHealth Intervention treatment for severe mental illness?

Research shows that a similar mHealth intervention, MACS, was effective in reducing psychiatric symptoms and improving coping strategies in patients with schizophrenia-spectrum disorders after hospital discharge. This suggests that mHealth interventions can be beneficial for people with severe mental illness by providing timely support and reducing the risk of relapse. ^{1 2 3 4 5}

Is the mHealth Intervention for Severe Mental Illness safe for humans?

The research articles reviewed do not provide specific safety data for the mHealth Intervention for Severe Mental Illness, including Check-In and Transition-FOCUS mHealth Intervention. They focus on feasibility, user needs, and barriers rather than safety outcomes. ^{2 3 5 6 7}

How is the Transition-FOCUS mHealth Intervention treatment different from other treatments for severe mental illness?

The Transition-FOCUS mHealth Intervention is unique because it uses mobile phone technology to deliver mental health care, making it more accessible and convenient for people with severe mental illness. Unlike traditional treatments that require in-person visits, this approach allows for remote monitoring and support, which can help improve daily functioning and recovery. ^{2 3 4 7 8}

What is the purpose of this trial?

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.

Research Team

Brandon Gaudiano, PhD

Principal Investigator

Butler Hospital

Ethan Moitra, PhD

Principal Investigator

Brown University

Eligibility Criteria

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.

Psychiatric inpatient/partial hospitalization

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Systematic Literature Review of Text Messaging Interventions to Promote Medication Adherence Among People With Serious Mental Illness. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Mobile Phones as a Medium of Mental Health Care Service Delivery: Perspectives and Barriers among Patients with Severe Mental Illness. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Mobile Health (mHealth) Versus Clinic-Based Group Intervention for People With Serious Mental Illness: A Randomized Controlled Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Mobile Health on In-person Service Use Among People With Serious Mental Illness. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

Use of an Interactive Obesity Treatment Approach in Individuals With Severe Mental Illness: Feasibility, Acceptability, and Proposed Engagement Criteria. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Use of mobile technology in a community mental health setting. [2022]

8. England pubmed.ncbi.nlm.nih.gov

mHealth technology to assess, monitor and treat daily functioning difficulties in people with severe mental illness: A systematic review. [2021]