NCT05023252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 15, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

August 16, 2021

Results QC Date

August 6, 2025

Last Update Submit

November 5, 2025

Conditions

Keywords

Mental health careInformaticsPredictive ModelingBipolar disorderPsychotic DisordersMachine learning

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

Study Arms (1)

mobile application

EXPERIMENTAL

Participants use a mobile application on their smartphone

Other: mobile application

Interventions

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.

Also known as: VetThrive
mobile application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

West Los Angeles, California, 90073-1003, United States

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

SchizophreniaBipolar DisorderPsychotic DisordersStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Results Point of Contact

Title
Alexander Young MD
Organization
Veterans Health Administration, Greater Los Angeles Veterans Healthcare Center

Study Officials

  • Alexander Stehle Young, MD MSHS

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Participants in the trial are enrolled in an intervention group for 9 months
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 26, 2021

Study Start

October 18, 2021

Primary Completion

July 22, 2024

Study Completion

July 22, 2024

Last Updated

November 19, 2025

Results First Posted

October 15, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations