Mobile Health Program for Mental Illness

Recruiting at 3 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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn about how a digital training platform can enhance implementation and effectiveness of a validated mHealth system, called FOCUS, in people with serious mental illness. The main question this research aims to answer is whether patients obtain similar outcomes to previous FOCUS studies when using FOCUS with clinicians trained on a newly developed digital training platform. Participants will be asked to use the FOCUS smartphone application and receive mobile health coaching from clinicians who have been trained using the digital training platform.

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 data supports the effectiveness of the treatment FOCUS in the Mobile Health Program for Mental Illness?

Research shows that the FOCUS mobile health program is as effective as traditional clinic-based care for serious mental illness, but at half the cost. Participants also found it helpful for managing their conditions using their smartphones. ^{1 2 3 4 5}

Is the Mobile Health Program for Mental Illness safe for humans?

The Mobile Health Program, including versions like FOCUS, has been used safely in studies with people who have serious mental illnesses. In one study, participants received many text messages over 12 weeks, and most completed the program without issues, showing it is generally safe for use. ^{1 4 5 6 7}

How is the FOCUS treatment different from other treatments for mental illness?

FOCUS is unique because it is a smartphone self-management app designed specifically for individuals with serious mental illnesses, allowing them to manage their condition through mobile technology in their daily lives, which is different from traditional in-person therapy or medication. ^{1 8 9 10 11}

Research Team

Dror Ben Zeev, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

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

Augmenting mHealth with human support: Notes from community care of people with serious mental illnesses. [2022]

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

Cost of mHealth Versus Clinic-Based Care for Serious Mental Illness: Same Effects, Half the Price Tag. [2021]

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

Life with FOCUS: A qualitative evaluation of the impact of a smartphone intervention on people with serious mental illness. [2023]

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

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

5. 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]

6. United States 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. [2022]

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

A new paradigm for mental-health quality and safety: are we ready? [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Review of mobile health technology for military mental health. [2017]

10. Ireland pubmed.ncbi.nlm.nih.gov

The prevalence and usage of mobile health applications among mental health patients in Saudi Arabia. [2018]

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

Mobile Phone and Smartphone Use by People With Serious Mental Illness. [2021]