RecruitingNCT06204705

mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders (MEASURE-BD)

Sponsor: VA Office of Research and Development

Trial Details

ConditionBipolar Disorder
StatusRecruiting
Participants200
Est. Completion30 Sept 2027
Last Updated24 Apr 2026

Primary Outcome

Impaired Social Participation; Modified Hamilton Rating Scale for Depression; Young Mania Rating Scale; PROMIS Ability to Participate in Social Roles and Activities

Eligibility Criteria

Inclusion 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.

Trial Sites

Countries

United States
View Registry Entry

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