Mobile Health Program for Mental Illness

Recruiting at 4 trial locations

Overseen By Sue Guarino

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Moving, Discontinuing services, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a smartphone app called FOCUS can help individuals with serious mental illnesses manage their conditions more effectively. The study will evaluate FOCUS's effectiveness when used alongside clinicians trained through a new digital platform. Participants will use the app and receive mobile health coaching. Individuals diagnosed with serious mental illnesses such as schizophrenia or bipolar disorder, who speak English and own a smartphone, may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve mental health management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this digital training platform is safe for use in mental health treatment?

Research shows that the FOCUS mHealth system is easy for people with serious mental illness to use. Studies have found that FOCUS is practical, effective, and engaging for users. Previous research demonstrated that people using FOCUS managed their conditions better without major side effects. This makes FOCUS a promising option for those wanting to manage their mental health with a smartphone app. Overall, evidence suggests that FOCUS is safe for people with serious mental illness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for serious mental illness, which often involve medication or in-person therapy sessions, the FOCUS program is a smartphone application designed to enhance self-management of the illness. Researchers are excited about FOCUS because it provides real-time assessments that are both system-initiated and patient-initiated, allowing individuals to engage with their treatment in their own environment. This unique delivery method not only increases accessibility and convenience but also empowers patients to take an active role in their recovery process.

What evidence suggests that the FOCUS smartphone application is effective for serious mental illness?

Studies have shown that the FOCUS smartphone app, which participants in this trial will use, helps people with serious mental illness manage their conditions better. Research indicates that FOCUS aids in recovery and reduces the severity of mental health symptoms through scheduled check-ins and on-demand support. Previous users found it easy to use and helpful in their daily lives. These findings suggest that FOCUS effectively improves mental health management. ^{1 5 6 7 8}

Who Is on the Research Team?

Dror Ben Zeev, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for English-speaking adults (18+) with a serious mental illness like schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. Participants must have access to a smartphone that supports the FOCUS app.

Inclusion Criteria

English-speaking

I have been diagnosed with a serious mental illness.

Have access to a smartphone that can support FOCUS

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the FOCUS smartphone application and receive mobile health coaching for a 12-week period

12 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for changes in quality of life, psychiatric functioning, depressive symptoms, auditory verbal hallucinations, recovery-oriented thinking, and satisfaction with FOCUS

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FOCUS

Trial Overview The study tests if clinicians trained via a digital platform can effectively use the FOCUS mobile health system to help people with serious mental illnesses. It checks if patients achieve outcomes similar to past studies when using this tech-assisted method.

How Is the Trial Designed?

Group I: FOCUS participants Experimental Treatment 1 Intervention

FOCUS is a smartphone application system designed to improve illness self-management and facilitate recovery in individuals with serious mental illness. It delivers both system initiated (i.e. pre-programmed) and patient initiated (i.e. on demand) real-time assessment to individuals in their own environment.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

The FOCUS smartphone application was supported by mHealth specialists over a 12-week period, focusing on enhancing user engagement and data utilization for individuals with serious mental illnesses.

The experiences shared by the specialists highlight the potential of mHealth interventions to improve care and the need for discussions about the role of technology support in community-based mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmenting mHealth with human support: Notes from community care of people with serious mental illnesses. Jonathan, GK., Pivaral, L., Ben-Zeev, D.[2022]

A study of 249 individuals with serious mental illness found that 86% owned mobile phones, with 60% using smartphones, indicating a significant opportunity to leverage mobile technology for health interventions.

Older individuals and those with persistent psychotic disorders or cognitive deficits were less likely to own smartphones, suggesting that mobile health interventions should be specifically tailored to accommodate these factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone and Smartphone Use by People With Serious Mental Illness. Young, AS., Cohen, AN., Niv, N., et al.[2021]

The development of a Mental Health Quality and Safety Framework involved extensive consultations and thematic analysis, resulting in 32 categories grouped into seven key themes aimed at improving mental health services.

The proposed Framework emphasizes a shift from a centralized approach to a more localized model that includes input from frontline staff, consumers, and carers, which is expected to enhance patient safety, clinical outcomes, and staff morale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new paradigm for mental-health quality and safety: are we ready? Short, B., Marr, C., Wright, M.[2019]

About 46% of participants with depression and/or anxiety in Saudi Arabia reported using one or two health-related mobile applications, indicating a significant interest in digital health tools.

A strong 64% of participants expressed a desire to use mobile apps to track their mental health, highlighting the potential for mobile health applications to enhance mental health management in the region.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence and usage of mobile health applications among mental health patients in Saudi Arabia. Atallah, N., Khalifa, M., El Metwally, A., et al.[2018]

Participants with serious mental illness found the mHealth intervention FOCUS helpful for daily symptom management and self-awareness, indicating its practical utility in their illness management.

The intervention positively influenced participants' recovery processes by fostering acceptance of symptoms and motivation, suggesting that mHealth tools can be tailored to support individuals at different stages of recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life with FOCUS: A qualitative evaluation of the impact of a smartphone intervention on people with serious mental illness. Jonathan, G., Carpenter-Song, EA., Brian, RM., et al.[2023]

The Mobile Assessment and Treatment for Schizophrenia (MATS) program, which used text messaging over 12 weeks, significantly improved medication adherence and social interactions, particularly for individuals living independently.

Participants also experienced a notable reduction in the severity of auditory hallucinations, indicating that low-intensity interventions like MATS can effectively enhance outcomes for higher functioning individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Assessment and Treatment for Schizophrenia (MATS): a pilot trial of an interactive text-messaging intervention for medication adherence, socialization, and auditory hallucinations. Granholm, E., Ben-Zeev, D., Link, PC., et al.[2022]

Mobile health (mHealth) approaches are becoming increasingly feasible and acceptable for individuals with mental health issues, highlighting the need for collaboration among policymakers, researchers, and the private sector to enhance access to these resources.

The Lifeline Assistance Program serves as a successful model for expanding access to mobile technology, which could be adapted to include mHealth resources, potentially benefiting low-income individuals with severe mental illness who are in need of mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health for All: Public-Private Partnerships Can Create a New Mental Health Landscape. Ben-Zeev, D.[2020]

Mobile Health (mHealth) technologies can significantly improve access to and quality of mental health care for military veterans and their families, addressing critical challenges in mental health provision.

Key considerations for developing effective mHealth solutions include ensuring safety, privacy, and evidence-based practices, as well as focusing on user-friendliness and compliance with regulations to enhance adoption and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of mobile health technology for military mental health. Shore, JH., Aldag, M., McVeigh, FL., et al.[2017]

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 smartphone-delivered mHealth intervention (FOCUS) costs significantly less to implement than the clinic-based group intervention (WRAP), with average annual costs of $40,439 for FOCUS compared to $78,212 for WRAP.

Both interventions produced comparable clinical outcomes, demonstrating that mHealth can be a cost-effective alternative to traditional treatment methods for serious mental illness, costing about half as much per client.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost of mHealth Versus Clinic-Based Care for Serious Mental Illness: Same Effects, Half the Price Tag. Ben-Zeev, D., Razzano, LA., Pashka, NJ., et al.[2021]

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]

Citations

1. 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.

2. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.201800063

Mobile Health (mHealth) Versus Clinic-Based Group ... FOCUS (25,33,34) is a multimodal, smartphone-delivered intervention for people with serious mental illness that includes three components: FOCUS ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8663659/

A Smartphone Intervention for People With Serious Mental ... This study found that a novel smartphone app, CORE, proved to be usable, acceptable, and effective in improving recovery and reducing the severity of ...

4. tacticahealth.com tacticahealth.com/our-work/focus-mhealth-app/

Focus Mental Illness - Health, Research - Android app, iOS ... Focus takes an evidence-based mHealth approach to support the rehabilitation of individuals with psychiatric conditions, through access to perspective ...

5. jmir.org jmir.org/2021/11/e29201/

A Smartphone Intervention for People With Serious Mental ... CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4357360/

A Smartphone System for Self-Management of Schizophrenia Our research team set out to create an mHealth intervention that would be suitable for, and usable by, individuals with serious mental illness. In the current ...

7. mental.jmir.org mental.jmir.org/2022/1/e26049

FOCUS mHealth Intervention for Veterans With Serious ... Mobile health (mHealth) has been demonstrated to be feasible, acceptable, effective, and engaging among individuals with SMIs in community ...

8. mh4mh.org mh4mh.org/media2

mHealth for Mental Health Media Researchers are developing mobile apps to assess and treat patients who have severe mental illness.