Using mobile health technology to predict bipolar disorder episodes in veterans
mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders (MEASURE-BD)
This study is testing a smartphone app that helps veterans with bipolar disorder spot early signs of mood episodes so they can get help before things get worse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06204705 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and implement mobile health (mHealth) algorithms that can signal upcoming episodes of bipolar disorder in veterans. By utilizing digital phenotyping and machine learning techniques, the study seeks to continuously monitor veterans' mood and psychosocial functioning in real-time. The goal is to provide early warning signs of manic and depressive episodes, allowing for timely interventions that could prevent severe impairments in daily functioning. The study will involve veterans diagnosed with bipolar disorder who will use smartphone applications to track their symptoms and social participation.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18 and older with a confirmed diagnosis of bipolar disorder who have experienced at least one episode in the past year.
Not a fit: Patients who do not own a smartphone or are not fluent in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of bipolar disorder in veterans by enabling timely interventions and reducing the risk of severe psychosocial impairments.
How similar studies have performed: While the use of mHealth in mental health monitoring is gaining traction, this specific approach to predicting bipolar episodes using machine learning is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Minneapolis, Minnesota
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Snezana Urosevic, PhD — Minneapolis VA Health Care System, Minneapolis, MN
- Study coordinator: Snezana Urosevic, PhD
- Email: Snezana.Urosevic@va.gov
- Phone: (612) 467-3897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.