Using mobile health technology to predict bipolar disorder episodes in veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.