Actively Recruiting

Age: 18Years +
All Genders
NCT06204705

mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders

Led by VA Office of Research and Development · Updated on 2026-04-24

200

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

Sponsors

V

VA Office of Research and Development

Lead Sponsor

N

National Center for PTSD

Collaborating Sponsor

AI-Summary

What this Trial Is About

Veterans with bipolar disorders (BD) experience recurrent and seemingly unpredictable periods of severe impairments in psychosocial functioning, such as participation in social roles and activities. Many effective treatments for BD emphasize early detection of bipolar episodes, in order to make necessary treatment adjustments and prevent psychosocial impairments associated with acute mood episodes. Unfortunately, acute mood episodes in BD are also associated with a decrease in a patient's insight into their own symptoms, which can prevent one's ability to self-report first signs of symptoms and functional declines. Moreover, routine care visits for BD are typically too infrequent to capture and effectively monitor day-to-day changes in a patient's mood and functioning. Objective, low-effort, and continuous methods of tracking symptoms and social participation of Veterans with BD in real-time and in-situ are needed to provide early (i.e., days in advance) warning signs of acute bipolar episodes and functional declines, which in turn would enable well-timed interventions to prevent poor psychosocial outcomes. mHealth refers to the use of mobile and wireless devices as part of patient care and offers many potential opportunities for early detection of and intervention for acute mood states in this population. However, these mHealth approaches have not been investigated in Veterans with BD. In a Small Projects in Rehabilitation Research (SPiRE)-funded pilot study, the investigator team established high feasibility and acceptability of one such innovative passive mHealth approach using a smartphone program, or an app, in a small sample of Veterans with BD to track their smartphone's GPS/location. The pilot study used a priori location context ratings of visited places (e.g., a priori ratings on types of activities usually engaged in at a frequently visited location) to derive unobtrusive measures of social participation (e.g., time spent at work-related locations). The goal of this Merit Review proposal is to establish reliable and valid machine-learning algorithms using the same types of mHealth data to prospectively (days in advance) detect declines in social participation and prospective onset of mania and depression in Veterans with BD. This proposal has three aims: Aim 1. To establish a machine learning algorithm using GPS/location data for predicting prospective declines in social participation in Veterans with BD. Aim 2. To establish machine learning algorithms using GPS/location data for predicting prospective acute BD clinical states. The investigators will explore whether adding more burdensome daily self-report and voice diaries' speech analysis features improves the models' precision using statistical indices of prediction precision or accuracy. Aim 3. To explore clinical implementation of the mHealth-based algorithms in treatment of BD. Focus groups of VA providers and administrators will assess feasibility of algorithms' implementation in clinical care.

CONDITIONS

Official Title

mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Veteran with confirmed Bipolar I, Bipolar II, or Other Specified Bipolar Disorder diagnosis based on clinical interview and chart review
  • Experienced at least one bipolar episode in the last 12 months
  • Owns a smartphone capable of running all study apps
  • Age 18 years or older
  • Fluent in English
  • Able to provide informed consent without active court-appointed legal guardianship
  • Focus group participants must be active Minneapolis VA providers or administrators involved in care or oversight of Veterans with BD
Not Eligible

You will not qualify if you...

  • Presence of major neurocognitive or neurological disorders (e.g., Alzheimer's, vascular dementia, Parkinson's)
  • Impaired global cognition (MoCA score below 20 or equivalent on virtual assessment)
  • Physical conditions preventing use of smartphone apps
  • Unable to provide informed consent
  • Under 18 years of age
  • No exclusions for focus group participants based on VA employment status

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States, 55417-2309

Actively Recruiting

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Research Team

S

Snezana Urosevic, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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