Smartphone App for Serious Mental Illness

Overseen By Alexander Stehle Young, MD MSHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Under 18, Conservator, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a smartphone app designed to assist Veterans with serious mental illnesses such as schizophrenia, schizoaffective disorder, or bipolar disorder. The app monitors phone data to track changes in sociability, activity, and sleep, which can indicate a risk of relapse. The goal is to detect worsening symptoms early and enable timely intervention. Veterans who have experienced frequent mental health crises in the past year and own a smartphone with a data plan may be suitable for this trial. As an unphased trial, it offers Veterans the chance to contribute to innovative mental health solutions and potentially benefit from early symptom 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. It seems focused on using a smartphone app to monitor symptoms rather than changing your medication.

What prior data suggests that this mobile application is safe for monitoring serious mental illness?

Research has shown that using smartphone apps to passively monitor individuals with serious mental illnesses is generally safe and well-received. Studies have found that these apps effectively track behaviors and symptoms, and users find them acceptable. No major safety issues have been reported. This technology monitors changes in social interactions, activity levels, and sleep patterns, which can indicate when symptoms might worsen. Importantly, this type of self-monitoring is considered a safe way to help manage mental health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mobile self-tracking apps for serious mental illness because they offer a unique, accessible way to manage symptoms and improve patient engagement. Unlike traditional treatments like medication and therapy that require regular in-person visits, these apps allow individuals to monitor their mental health anywhere, anytime, right from their smartphones. This method empowers users with real-time feedback and data, promoting self-awareness and potentially leading to more personalized care. Additionally, the convenience and privacy of a mobile app may reduce stigma and encourage more people to seek help.

What evidence suggests that this mobile application is effective for serious mental illness?

Research shows that smartphone apps can effectively monitor and support mental health. In this trial, participants will use a mobile application on their smartphones to track their mental health. One study found that a specific app reduced the severity of mental health symptoms and disability while aiding recovery for people with serious mental illnesses. Another study showed that patients found these digital tools useful, especially for managing habits like smoking. Overall, smartphone apps offer an affordable and easy way to track mental health and symptoms. They help identify early signs of relapse, allowing for timely intervention. ^{1 4 5 6 7}

Who Is on the Research Team?

Alexander Stehle Young, MD MSHS

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Are You a Good Fit for This Trial?

This trial is for adult Veterans at the Greater Los Angeles Veterans Healthcare Center diagnosed with serious mental illnesses like schizophrenia, schizoaffective disorder, or bipolar disorder. Participants must have had a risk of symptom exacerbation in the past year and own a smartphone with a data plan.

Inclusion Criteria

You need to have a smartphone with internet access.

I've had significant mental health care needs in the past year.

I have had significant mental health care needs in the past year.

Exclusion Criteria

I am under 18 years old.

I have a legal guardian or representative.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

User-Centered Design

Conduct user-centered design of passive mobile self-tracking to support Veterans' management of their mental health

3 months

Passive Self-Tracking

Participants use a mobile application to passively self-track their behaviors and psychiatric symptoms

9 months

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after the main study period

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Self-Tracking

Trial Overview The study tests an app that uses mobile phone data to monitor sociability, activity, and sleep as indicators of mental health status. It aims to detect early signs of relapse in patients with serious mental illnesses for timely intervention.

How Is the Trial Designed?

Group I: mobile application Experimental Treatment 1 Intervention

Participants use a mobile application on their smartphone

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11815452/

Smartphone apps for mental health: systematic review of ... Smartphone apps offer a potentially cost-effective, available and accessible solution for monitoring, supporting and treating mental health conditions.

2. 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 ...

3. researchprotocols.org researchprotocols.org/2024/1/e58288

Testing the Effectiveness of a Mobile Smartphone App ... App content includes information on mental health, help seeking, mindfulness, and common workplace-related concerns of junior physicians.

4. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.focus.20250014

Smartphone Apps and Digital Tools for Managing ... Patients with serious mental illnesses found these interventions useful, and qualitative data favored the app's approach to normalizing smoking ...

5. pcori.org pcori.org/research-results/2014/comparing-smartphone-program-peer-led-program-help-people-serious-mental-illness-manage-their-symptoms

Comparing a Smartphone Program with a Peer-Led ... The research team compared two programs to help people with SMI manage their symptoms. In the FOCUS program, people used a smartphone app.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05023252

NCT05023252 | Mobile Self-Tracking of Mental Health Data are used for self-tracking of behaviors and symptoms. While passive mobile sensing has been feasible, acceptable and safe in patients with serious mental ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9391975/

Passive Mobile Self-tracking of Mental Health by Veterans ... The aim of this research is to study the feasibility, acceptability, and safety of passive mobile sensing for tracking behaviors and symptoms of patients in ...