Status:
RECRUITING
mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
National Center for PTSD
University of Wisconsin, Madison
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
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. M...
Detailed Description
Veterans with bipolar disorders (BD) experience recurrent and seemingly unpredictable periods of severe impairments in psychosocial functioning, which lead to poor outcomes over their lifetime, such a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06204705
Start Date
September 10 2024
End Date
September 30 2027
Last Update
August 28 2025
Active Locations (1)
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1
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309