NCT06204705 mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 200 participants in total. It began in 2024-09-10 with a primary completion date of 2027-09-30.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Veteran participants will have a confirmed primary diagnosis of a Bipolar I Disorder, Bipolar II Disorder or Other Specified Bipolar Disorder (i.e., those with major depressive episodes and hypomania that meets all episode criteria but for duration) based on the clinical Interview for DSM-5-Research Version (SCID-5-RV), medical chart review and consensus procedure directed by the PI * All Veteran participants will endorse presence of at least one bipolar episode in the last 12 months based on the interview and/or medical chart information * All Veteran participants will own a smartphone capable of running all study apps * All participants will be age 18 years or older * All participants will be fluent in English * All Veteran participants will be able to demonstrate capacity for consent (see below) and have no active court-appointed legal guardianship precluding ability to provide consent * Focus group participants will be active Minneapolis VAHCS providers and administrators who are either actively engaged in care for Veterans with BD or involved in administrative roles overseeing mental health care of Veterans within Minneapolis VAHCS Exclusion Criteria: * Presence of a major neurocognitive disorder or neurological disorder, such as Alzheimer's dementia, vascular dementia, Parkinson's disease, etc. * Impaired global cognition (MoCA score \< 20 for in-person assessment, or equivalent score on "blind" MoCA for virtual assessments) * Presence of physical conditions preventing use of smartphone apps Lack of capacity to provide informed consent * Age \< 18 years * No exclusion for focus group participants as their VA status employment will be taken to indicate age of majority, intact global cognition, etc.

Contact & Investigator

Frequently Asked Questions

Related Trials

Related Intelligence Guides

In-depth guides covering this condition's trials, eligibility, and what to expect.