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Mobile Self-Tracking of Mental Health

Passive Mobile Self-Tracking of Mental Health by Veterans With Serious Mental Illness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05023252
Enrollment
87
Registered
2021-08-26
Start date
2021-10-18
Completion date
2024-07-22
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Post-traumatic Stress Disorder, Schizoaffective Disorder, Schizophrenia

Keywords

Mental health care, Informatics, Predictive Modeling, Bipolar disorder, Psychotic Disorders, Machine learning

Brief summary

Serious mental illnesses require years of monitoring and adjustments in treatment. Stress, substance abuse or reduced medication adherence cause rapid worsening of symptoms, with consequences that include job loss, homelessness, suicide, incarceration, and hospitalization. Treatment visits can be infrequent. Illness exacerbations usually occur with no clinician awareness, leaving little opportunity to make treatment adjustments. Tools are needed that quickly detect illness worsening. At least two thirds of Veterans with serious mental illness use a smartphone. These phones generate data that characterize sociability, activity and sleep. Changes in these are warning signs for relapse. Members of this project developed an app that monitors and transmits these mobile data. This project studies passive mobile sensing that allows Veterans to self-track their activities, sociability and sleep; and studies whether this can be used to track symptoms. The project intends to produce a mobile platform that monitors the clinical status of patients, identifies risk for relapse, and allows early intervention.

Detailed description

Background: Serious mental illnesses are common, disabling, challenging to treat, and require years of monitoring with adjustments in treatments. Stress or reduced medication adherence can lead to rapid worsening in symptoms and functioning with consequences that include relapse, job loss, homelessness, incarceration, hospitalization and suicide. In usual care, clinician visits are infrequent, with intervals ranging from monthly to yearly. Communication between patients and clinicians between visits is challenging and often nonexistent. Patient illness exacerbations and relapses generally occur with little or no clinician awareness in real time, leaving little opportunity to adjust treatments. Significance/Impact: For the large population of Veterans with serious mental illness, tools are needed that passively monitor their mental health status, allowing them to self-track their behaviors, quickly detect worsening of mental health, and support prompt assessment and intervention. At least 60% of Veterans with serious mental illness use a smart phone. These generate data that characterize sociability, activity, and sleep. Changes in these behaviors are warning signs of relapse. Passive self-tracking could be used to identify and predict worsening of illness in real time. Innovation: Passive mobile sensing is a novel approach to illness self-tracking and monitoring. There has been relatively little research on passive self-tracking in serious mental illness, with limited analytics development in this area, and none in VA. Specific Aims: This project studies passive mobile sensing with Veterans in treatment for serious mental illness. 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 illness, these are studied for the first time in VA. Analytics are developed that use passive data to predict behaviors and symptoms. This project responds to the HSR&D priority areas of Mental Health and Healthcare Informatics. The project has these objectives: 1. Conduct user-centered design of passive mobile self-tracking to support Veterans' management of their mental health. 2. Study the feasibility, acceptability and safety of passive self-tracking of mental health that includes feedback of mental health status to the Veteran. 3. Use mobile sensor and phone utilization data to develop individualized estimates of sociability, activities, and sleep as measured by weekly interviews. 4. Study the predictive value of using data on sociability, activities, and sleep to identify exacerbations of psychiatric symptoms. Methodology: Activities can be assessed with data on movement, location, and habits. Sociability can be assessed with data on communication and public interactions. Sleep can be assessed using data on light, sound, movement, and phone use. Investigators on this project developed a functional mobile app that monitors and transmits mobile sensor and utilization data. Focus groups and in-lab usability testing inform further app and intervention development. Mixed methods research study deployment in Veterans who passively self-track their behaviors and psychiatric symptoms. If this project meets intended goals, the VA will have a mobile analytics platform that continuously monitors behaviors and symptoms of patients with serious mental illness.

Interventions

OTHERmobile application

VetThrive is a mobile smartphone application that monitors and transmits mobile sensor and utilization data. This app is deployed in Veteran patients who passively self-track their behaviors and psychiatric symptoms.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Participants in the trial are enrolled in an intervention group for 9 months

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Veteran patient at the Greater Los Angeles Veterans Healthcare Center with a chart diagnosis of serious mental illness, defined as a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder * Risk for symptoms based on having had, during the past year, psychiatric hospitalization, psychiatric emergency care, lived at a crisis program, or more than 6 outpatient visits; and, * Ownership of a smartphone with a data plan

Exclusion criteria

* Under age 18 * Has a conservator/legally authorized representative

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Passive Self-tracking of Mental Health9 monthsFeasibility of passive self-tracking of mental health. The number of participants who completed the study.
Estimates of Sociability9 monthsUse mobile sensor and phone utilization data to develop individualized estimates of sociability. There was an effort to calculate an estimate of sociability for each participant. Some participants had insufficient data collected to calculate an estimate. The intent is to determine the number of participants for whom this outcome can be estimated. The investigators report here on the number of participants for whom an estimate of sociability could be successfully calculated.
Identify Exacerbations of Psychiatric Symptoms9 monthsStudy the predictive value of using data on sociability, activities, and sleep to identify exacerbations of psychiatric symptoms. There was an effort to calculate identify exacerbations of psychiatric symptoms for each participant. Some participants had insufficient data collected to identify exacerbations. The intent is to determine the number of participants for whom this outcome can be estimated. The investigators report here on the number of participants for whom exacerbations of psychiatric symptoms could be successfully calculated.
Acceptability of Passive Self-tracking of Mental Health9 monthsAcceptability of passive self-tracking of mental health. The number of participants who completed the study.
Safety of Passive Self-tracking of Mental Health9 monthsSafety of passive self-tracking of mental health. The number of participants with a serious adverse event.
Estimates of Activities9 monthsUse mobile sensor and phone utilization data to develop individualized estimates of activities. There was an effort to calculate an estimate of activity for each participant. Some participants had insufficient data collected to calculate an estimate. The intent is to determine the number of participants for whom this outcome can be estimated. The investigators report on the number of participants for whom an estimate of activity could be successfully calculated.
Estimates of Sleep9 monthsUse mobile sensor and phone utilization data to develop individualized estimates of sleep. There was an effort to calculate an estimate of sleep for each participant. Some participants had insufficient data collected to calculate an estimate. The intent is to determine the number of participants for whom this outcome can be estimated. The investigators report here on the number of participants for whom an estimate of sleep could be successfully calculated.

Countries

United States

Participant flow

Recruitment details

Recruitment was conducted at the Greater Los Angeles VA 10/18/2021 - 6/24/2024.

Pre-assignment details

Enrolled participants are provided with mobile monitoring. Mobile monitoring is the only group in this study.

Participants by arm

ArmCount
Mobile Application
Participants use a mobile application on their smartphone that monitors and transmits mobile sensor and utilization data.
87
Total87

Baseline characteristics

CharacteristicMobile Application
Age, Continuous53.7 years
STANDARD_DEVIATION 13.6
Ethnicity (NIH/OMB)
Hispanic or Latino
22 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
64 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
7 Participants
Race (NIH/OMB)
Black or African American
38 Participants
Race (NIH/OMB)
More than one race
3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants
Race (NIH/OMB)
White
29 Participants
Sex: Female, Male
Female
16 Participants
Sex: Female, Male
Male
71 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
1 / 87
other
Total, other adverse events
0 / 87
serious
Total, serious adverse events
0 / 87

Outcome results

Primary

Acceptability of Passive Self-tracking of Mental Health

Acceptability of passive self-tracking of mental health. The number of participants who completed the study.

Time frame: 9 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mobile applicationAcceptability of Passive Self-tracking of Mental Health58 Participants
Primary

Estimates of Activities

Use mobile sensor and phone utilization data to develop individualized estimates of activities. There was an effort to calculate an estimate of activity for each participant. Some participants had insufficient data collected to calculate an estimate. The intent is to determine the number of participants for whom this outcome can be estimated. The investigators report on the number of participants for whom an estimate of activity could be successfully calculated.

Time frame: 9 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mobile applicationEstimates of Activities85 Participants
Primary

Estimates of Sleep

Use mobile sensor and phone utilization data to develop individualized estimates of sleep. There was an effort to calculate an estimate of sleep for each participant. Some participants had insufficient data collected to calculate an estimate. The intent is to determine the number of participants for whom this outcome can be estimated. The investigators report here on the number of participants for whom an estimate of sleep could be successfully calculated.

Time frame: 9 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mobile applicationEstimates of Sleep85 Participants
Primary

Estimates of Sociability

Use mobile sensor and phone utilization data to develop individualized estimates of sociability. There was an effort to calculate an estimate of sociability for each participant. Some participants had insufficient data collected to calculate an estimate. The intent is to determine the number of participants for whom this outcome can be estimated. The investigators report here on the number of participants for whom an estimate of sociability could be successfully calculated.

Time frame: 9 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mobile applicationEstimates of Sociability73 Participants
Primary

Feasibility of Passive Self-tracking of Mental Health

Feasibility of passive self-tracking of mental health. The number of participants who completed the study.

Time frame: 9 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mobile applicationFeasibility of Passive Self-tracking of Mental Health58 Participants
Primary

Identify Exacerbations of Psychiatric Symptoms

Study the predictive value of using data on sociability, activities, and sleep to identify exacerbations of psychiatric symptoms. There was an effort to calculate identify exacerbations of psychiatric symptoms for each participant. Some participants had insufficient data collected to identify exacerbations. The intent is to determine the number of participants for whom this outcome can be estimated. The investigators report here on the number of participants for whom exacerbations of psychiatric symptoms could be successfully calculated.

Time frame: 9 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mobile applicationIdentify Exacerbations of Psychiatric Symptoms85 Participants
Primary

Safety of Passive Self-tracking of Mental Health

Safety of passive self-tracking of mental health. The number of participants with a serious adverse event.

Time frame: 9 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mobile applicationSafety of Passive Self-tracking of Mental Health0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026