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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mobile application | Experimental | Participants use a mobile application on their smartphone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile application | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Passive Self-tracking of Mental Health | Feasibility of passive self-tracking of mental health. The number of participants who completed the study. | 9 months |
| 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. | 9 months |
| 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. | 9 months |
| Acceptability of Passive Self-tracking of Mental Health | Acceptability of passive self-tracking of mental health. The number of participants who completed the study. | 9 months |
| 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. | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Stehle Young, MD MSHS | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073-1003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35930336 | Result | Young AS, Choi A, Cannedy S, Hoffmann L, Levine L, Liang LJ, Medich M, Oberman R, Olmos-Ochoa TT. Passive Mobile Self-tracking of Mental Health by Veterans With Serious Mental Illness: Protocol for a User-Centered Design and Prospective Cohort Study. JMIR Res Protoc. 2022 Aug 5;11(8):e39010. doi: 10.2196/39010. | |
| 37874639 | Result |
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Enrolled participants are provided with mobile monitoring. Mobile monitoring is the only group in this study.
Recruitment was conducted at the Greater Los Angeles VA 10/18/2021 - 6/24/2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | mobile application | Participants use a mobile application on their smartphone that monitors and transmits mobile sensor and utilization data. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Application | Participants use a mobile application on their smartphone that monitors and transmits mobile sensor and utilization data. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 9 months |
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Adverse event data were collected during participant enrollment. The enrollment period for participants was 9 months.
Adverse events were monitoring in all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | mobile application | Participants use a mobile application on their smartphone that monitors and transmits mobile sensor and utilization data. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Young MD | Veterans Health Administration, Greater Los Angeles Veterans Healthcare Center | 310-478-3711 | alexander.young@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2020 | Aug 27, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2023 | Oct 7, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D011618 | Psychotic Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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Participants in the trial are enrolled in an intervention group for 9 months
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|
| 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. | 9 months |
| 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. | 9 months |
| Medich M, Cannedy SL, Hoffmann LC, Chinchilla MY, Pila JM, Chassman SA, Calderon RA, Young AS. Clinician and Patient Perspectives on the Use of Passive Mobile Monitoring and Self-Tracking for Patients With Serious Mental Illness: User-Centered Approach. JMIR Hum Factors. 2023 Oct 24;10:e46909. doi: 10.2196/46909. |
| 38844692 | Result | Lin Z, Weinberger E, Nori-Sarma A, Chinchilla M, Wellenius GA, Jay J. Daily heat and mortality among people experiencing homelessness in 2 urban US counties, 2015-2022. Am J Epidemiol. 2024 Nov 4;193(11):1576-1582. doi: 10.1093/aje/kwae084. |
| 39367388 | Result | Chinchilla M, Lulla A, Agans D, Chassman S, Gabrielian SE, Young AS. Pathways to social integration among homeless-experienced adults with serious mental illness: a qualitative perspective. BMC Health Serv Res. 2024 Oct 4;24(1):1180. doi: 10.1186/s12913-024-11678-6. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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. | Posted | Count of Participants | Participants | 9 months |
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| 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. | Posted | Count of Participants | Participants | 9 months |
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| 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. | Posted | Count of Participants | Participants | 9 months |
|
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| 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. | Posted | Count of Participants | Participants | 9 months |
|
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| 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. | Posted | Count of Participants | Participants | 9 months |
|
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| 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. | Posted | Count of Participants | Participants | 9 months |
|
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| 1 |
| 87 |
| 0 |
| 87 |
| 0 |
| 87 |
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| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |