# Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder—the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes)
Maria Faurholt-Jepsen, Maj Vinberg, Ellen Margrethe Christensen, Mads Frost, Jakob Bardram, Lars Vedel Kessing
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[[Bipolar Disorder]]
6 Months study. Give patients with bipolar disorder smartphone for passive tracking, and subjective feedback. (EMA)
Hypothesis - Electronic monitoring, including a feedback loop between patient and clinicians reduce severity of depression and manic symptoms and stress and increases social functioning, quality of life, adherence of medication and cognitive functioning
## What EMA do they ask?
- Every evening, ask to enter
- Mood
- -3 to +3 (depressive to manic)
- Sleep duration
- Medicine - yes or no.
- Activity level - -3 to 3
- Irritability Yes or no
- Mixed mood Yes or no
- Cognitive problems Yes or no
- Alcohol consumption (number of units per day)
- Stress (0 - 5)
- Menstruation (yes or no)
- Early relapse sign (yes or no)
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## Objective (passive tracking)
- Speech duration (mins of calls on phone)
- Social activities - incoming/outcoming calls and text
- Physical activities - Accelerometer
- Physical movement - accelerometer
Design
- a nurse from the service attached, and call the patients
- Control group nurse no access to data
Threshold to call patient
- -2 or +2 mood change for 2 days
- Sleep patter 1hr more or less for 3 days
- Medication not taking
- Mixed mood registered for >3 days
After 4 weeks, they discussed, to adjust the threshold, with patients and caregiver, identify early earning signs etc..
every month, affective symptoms clinical rated using HDRS and YMRS
Also collect biological samples