Clinical trial NCT02221336: Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar disorder
Daily electronic monitoring
Smartphones
Subjective and objective smartphone data
Feedback loop
Lead sponsor: Psychiatric Centre Rigshospitalet
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: IT University of Copenhagen
First posted: 2014-08-20
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Differences between the groups in depressive and manic symptoms and the number of affective episodes
timeFrame: Baseline and up to 9 months
Secondary outcomes:
measure: Differences between the groups in smartphone measures
timeFrame: Baseline and up to 9 months
measure: Differences between the groups in number of hospitalizations
timeFrame: Baseline up to 9 months follow up
measure: Differences between the groups in number of contacts to clinicians and emergency rooms
timeFrame: Baseline up to 9 months follow up
measure: Differences between the groups in functioning
timeFrame: Baseline up to 9 months follow up
measure: Differences between the groups in perceived stress
timeFrame: Baseline up to 9 months
measure: Differences between the groups in quality of life
timeFrame: Baseline up to 9 months follow up
measure: Differences between the groups in self-rated depressive symptoms
timeFrame: Baseline up to 9 months
measure: Differences in self-rated manic symptoms
timeFrame: Baseline up to 9 months follow up
measure: Differences between the groups in adherence to medication
timeFrame: Baseline up to 9 months follow up
measure: Differences between the groups in recovery
timeFrame: Baseline up to 9 months follow up
measure: Differences between the groups in empowerment
timeFrame: baseline up ot 9 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Psychiatric Centre Copenhagen, Rigshospitalet
Study officials:
affiliation: Psychiatric Centre Copenhagen, Rigshospitalet, Denmark
name: Maria Faurholt-Jepsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.