Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II Trial

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Device: The MONARCA II system
* Device: Non-MONARCA II system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bipolar Disorder according to SCAN interview ≥18 years of age Patients who previously have received a course of treatment at the Clinic for Affective Disorders, Psychiatric Centre Copenhagen, Denmark Exclusion Criteria: Pregnancy Lack of Danish language skills Patients who previously have received and used the MONARCA I system for self-monitoring

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Non-MONARCA II system<br>Use of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop. | Device: Non-MONARCA II system<br>* Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.<br>|
| Experimental: The MONARCA II system<br>Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop | Device: The MONARCA II system<br>* Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop<br>* Other names: Non-MONARCA II system (control group condition);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between the groups in smartphone measures | Differences between the groups in: -Automatically generated objective smartphone measures | Baseline and up to 9 months | 
| Differences between the groups in number of hospitalizations | Differences between the groups in number of hospitalization | 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 | Baseline up to 9 months follow up | 
| Differences between the groups in functioning | Differences between the groups in functioning measured using the FAST questionnaire | 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 | 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 | 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 | Baseline up to 9 months | 
| Differences in self-rated manic symptoms | Differences between the groups in self-rated manic symptoms using the ASRM questionnaire | 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 | 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) | 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. | baseline up ot 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar disorder, Daily electronic monitoring, Smartphones, Subjective and objective smartphone data, Feedback loop