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AKTIBIPO-VALIDATION: A Study to Validate Benefits of Mindpax System in Managing Bipolar Disorder

National Institute of Mental Health, Czech Republic · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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bipolar-disorderna
The aim of the AKTIBIPO VALIDATION study is to evaluate the effect of the Mindpax monitoring and microeducation system in patients with bipolar disorder (BD). Up to 130 participants (BD patients) who participated previously in the observational AKTIBIPO study, as well as new patients (DeNovo) will be enrolled for a follow-up period of 12 months. All participants will wear the wrist actigraphy device and use the Mindpax mobile application on their mobile phone. Through the application, the patients will fill in the weekly mood self assessment questionnaire (ASERT) and receive evidence-based health microeducations aimed at understanding the bipolar disorder and associated risk factors. Apart from general psychoeducation, the participants will receive additional individualized targeted health microeducation when the system detects deviation from individual patterns of mood, activity and sleep. The outcomes will evaluate the subjective and objective impact of system usage on self-reported and clinical outcomes.
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