Bipolar Disorder Clinical Trial
Official title:
Daily Electronic Monitoring of Subjective and Objective Measures of Illness Activity in Bipolar Disorder - The MONARCA II Trial (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes II)
Bipolar disorder is associated with a high risk of relapse and hospitalisation and many
patients do not recover to their previous psychosocial function. Major reasons for poor
outcomes are delayed intervention for prodromal depressive and manic symptoms as well as
decreased adherence with treatment.
Recently, in the MONARCA I trial (NCT01446406), the investigators developed and deployed a
smartphone based self-monitoring system (the MONARCA I system) in a randomized controlled
trial, to test the effect of daily reporting of subjective self-monitoring of depressive and
manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms.
In the MONARCA II trial the investigators will develop and deploy a new version of the
smartphone based monitoring system. The investigators will in a randomized controlled single
blind trial investigate whether daily electronic monitoring of subjective and objective
measures of illness activity using a smartphone based self-monitoring system including
feedback on subjective as well as automatically generated objective data (e.g.social
activity, physical activity etc.) (the MONARCA II system) reduces the severity of depressive
and manic symptoms and improves functioning more than a control group receiving a smartphone.
All patients will be followed for 9 months with outcome assessments at baseline, after 4
weeks, after 3 months, after 6 months and after 9 months.
n/a
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