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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
146
Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.
Psychiatric Centre Copenhagen, Rigshospitalet
Copenhagen, Denmark
Differences between the groups in depressive and manic symptoms and the number of affective episodes
Differences between the groups in depressive and manic symptoms measured using Hamilton Depression Rating Scale (HDRS) and Young Mania Rating Scale (YMRS) and episodes defined ad HDRS\<= 14 and/or YMRS\<= 14
Time frame: Baseline and up to 9 months
Differences between the groups in smartphone measures
Differences between the groups in: -Automatically generated objective smartphone measures
Time frame: Baseline and up to 9 months
Differences between the groups in number of hospitalizations
Differences between the groups in number of hospitalization
Time frame: Baseline up to 9 months follow up
Differences between the groups in number of contacts to clinicians and emergency rooms
Differences between the groups in number of contacts to clinicians and emergency rooms
Time frame: Baseline up to 9 months follow up
Differences between the groups in functioning
Differences between the groups in functioning measured using the FAST questionnaire
Time frame: Baseline up to 9 months follow up
Differences between the groups in perceived stress
Differences between the groups in perceived stress using the perceived stress questionnaire
Time frame: Baseline up to 9 months
Differences between the groups in quality of life
Differences between the groups in quality of life measured using the WHOQoL questionnaire
Time frame: Baseline up to 9 months follow up
Differences between the groups in self-rated depressive symptoms
Differences between the groups in self-rated depresisve symptoms using the BDI questionnaire
Time frame: Baseline up to 9 months
Differences in self-rated manic symptoms
Differences between the groups in self-rated manic symptoms using the ASRM questionnaire
Time frame: Baseline up to 9 months follow up
Differences between the groups in adherence to medication
Differences between the groups in adherence to medication measured using the questionnaire MARS
Time frame: Baseline up to 9 months follow up
Differences between the groups in recovery
Differences between the groups in recovery using the questionnaire Recovery Assessment Scale (RAS)
Time frame: Baseline up to 9 months follow up
Differences between the groups in empowerment
Differences between the groups in empowerment using the questionnaire Rogers Empowerment scale.
Time frame: baseline up ot 9 months
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