Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II Trial
NCT ID: NCT02221336
Last Updated: 2018-04-06
Study Results
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Basic Information
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COMPLETED
NA
146 participants
INTERVENTIONAL
2014-09-30
2018-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Non-MONARCA II system
Use of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop.
Non-MONARCA II system
Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.
The MONARCA II system
Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
The MONARCA II system
Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
Interventions
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The MONARCA II system
Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
Non-MONARCA II system
Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥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
* Lack of Danish language skills
* Patients who previously have received and used the MONARCA I system for self-monitoring
18 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
IT University of Copenhagen
OTHER
Psychiatric Centre Rigshospitalet
OTHER
Responsible Party
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Maria Faurholt-Jepsen
Principal Investigator, MD and PhD student
Principal Investigators
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Maria Faurholt-Jepsen, MD
Role: PRINCIPAL_INVESTIGATOR
Psychiatric Centre Copenhagen, Rigshospitalet, Denmark
Locations
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Psychiatric Centre Copenhagen, Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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H-2-2014-059
Identifier Type: -
Identifier Source: org_study_id
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