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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| IT University of Copenhagen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-MONARCA II system | Placebo Comparator | Use of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop. |
|
| The MONARCA II system | Experimental | Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The MONARCA II system | Device | Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Faurholt-Jepsen, MD | Psychiatric Centre Copenhagen, Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Centre Copenhagen, Rigshospitalet | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24679993 | Background | Faurholt-Jepsen M, Frost M, Vinberg M, Christensen EM, Bardram JE, Kessing LV. Smartphone data as objective measures of bipolar disorder symptoms. Psychiatry Res. 2014 Jun 30;217(1-2):124-7. doi: 10.1016/j.psychres.2014.03.009. Epub 2014 Mar 13. | |
| 23883891 | Background | Faurholt-Jepsen M, Vinberg M, Christensen EM, Frost M, Bardram J, Kessing LV. Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder--the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial. BMJ Open. 2013 Jul 24;3(7):e003353. doi: 10.1136/bmjopen-2013-003353. Print 2013. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Non-MONARCA II system | Device | Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system. |
|
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 |
| 32046986 | Derived | Faurholt-Jepsen M, Frost M, Christensen EM, Bardram JE, Vinberg M, Kessing LV. Validity and characteristics of patient-evaluated adherence to medication via smartphones in patients with bipolar disorder: exploratory reanalyses on pooled data from the MONARCA I and II trials. Evid Based Ment Health. 2020 Feb;23(1):2-7. doi: 10.1136/ebmental-2019-300106. |
| 30706154 | Derived | Faurholt-Jepsen M, Frost M, Busk J, Christensen EM, Bardram JE, Vinberg M, Kessing LV. Differences in mood instability in patients with bipolar disorder type I and II: a smartphone-based study. Int J Bipolar Disord. 2019 Feb 1;7(1):5. doi: 10.1186/s40345-019-0141-4. |
| 25420431 | Derived | Faurholt-Jepsen M, Vinberg M, Frost M, Christensen EM, Bardram J, Kessing LV. Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones--the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial. BMC Psychiatry. 2014 Nov 25;14:309. doi: 10.1186/s12888-014-0309-5. |