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

NCT06204705 | Recruiting

• 1 other identifier: D4800-R
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Veterans; Telemedicine; Digital Phenotyping; Machine Learning

Outcome Measures

Primary Outcomes (4)

• Impaired Social Participation

  To determine presence of impaired social participation, an average of T scores will be calculated from two scales: PROMIS Satisfaction with Participation in Social Roles and PROMIS Ability to Participate in Social Roles and Activities scales. Averaged T scores less than 40 (1 standard deviation below population mean of 50) will be considered as indicators of impaired social participation. The PROMIS scales will be administered biweekly for the duration of 14 weeks of the follow-up.

  Biweekly for 14 weeks

• Modified Hamilton Rating Scale for Depression

  Modified Hamilton Rating Scale for Depression interviews administered biweekly will assess depression symptoms for each week of the 14-week follow-up to assess presence of clinically significant depression (score of 14 or higher) and/or changes in depression severity.

  Weekly for 14 weeks

• Young Mania Rating Scale

  Young Mania Rating Scale interviews administered biweekly will assess manic/hypomanic symptoms for each week of the 14-week follow-up period to determine presence of clinically significant hypomania/mania (scores above 12) and changes in hypomania/mania symptom severity.

  Weekly for 14 weeks

• PROMIS Ability to Participate in Social Roles and Activities

  PROMIS Ability to Participate in Social Roles and Activities is a self-report measure of difficulties with social participation. The raw scores range from 8 to 40 with higher scores indicating greater difficulties with social participation. The raw scores will be transformed into T scores and then average with T score for PROMIS Satisfaction with Participation in Social Roles for each week of the follow-up. These average scores of T score less than 40 will be considered as indicators of impaired social participation during this week.

  Biweekly for 14 weeks

Secondary Outcomes (1)

• DSI Suicidality Subscale

  Biweekly for 14 weeks

Other Outcomes (2)

• VA Clinicians Focus Group Themes

  Once at a half-point of study's data collection (end of Year 2)

• VA Administrators Focus Group Themes

  Once at the end of study's data collection (Year 4)

Study Arms (2)

Veterans with Bipolar Disorders

Veterans with a diagnosis of a bipolar disorder.

VA clinicians and administrators

VA clinicians and administrators who provide or oversee clinical care of Veterans with bipolar disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans with bipolar disorders who receive care at the Minneapolis VA Health Care System. VA providers and administrators who provide care to Veterans with bipolar disorders at the Minneapolis VA Health Care System.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• National Center for PTSD: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Snezana Urosevic, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Snezana Urosevic, PhD

CONTACT

(612) 467-3897; Snezana.Urosevic@va.gov

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 12, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Some supporting information, such as statistical analysis plan, may be shared prior to publication of results in online pre-registration open science websites. IPD and supporting information will be shared from the time of study results publication until 7 years after the publication for valid scientific reasons.
• Access Criteria: PI will share the IPD and supporting information in consultation with local Research office administrators for valid scientific purposes (e.g., validation of results, inclusion in mega-analysis or meta-analysis). PI will utilize VA approved methods at the time for online sharing of this type of information.

Locations

US (1)