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

Recruitingn/aAges 18 Years - anyAllVA Office of Research and Development
NCT06204705 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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