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

Abstract

IntroductionElectronic self-monitoring of affective symptoms using cell phones is suggested as a practical and inexpensive way to monitor illness activity and identify early signs of affective symptoms. It has never been tested in a randomised clinical trial whether electronic self-monitoring improves outcomes in bipolar disorder. We are conducting a trial testing the effect of using a Smartphone for self-monitoring in bipolar disorder.MethodsWe developed the MONARCA application for Android-based Smartphones, allowing patients suffering from bipolar disorder to do daily self-monitoring—including an interactive feedback loop between patients and clinicians through a web-based interface. The effect of the application was tested in a parallel-group, single-blind randomised controlled trial so far including 78 patients suffering from bipolar disorder in the age group 18–60 years who were given the use of a Smartphone with the MONARCA application (intervention group) or to the use of a cell phone without the application (placebo group) during a 6-month study period. The study was carried out from September 2011. The outcomes were changes in affective symptoms (primary), social functioning, perceived stress, self-rated depressive and manic symptoms, quality of life, adherence to medication, stress and cognitive functioning (secondary and tertiary).AnalysisRecruitment is ongoing.EthicsEthical permission has been obtained.DisseminationPositive, neutral and negative findings of the study will be published.Registration detailsThe trial is approved by the Regional Ethics Committee in The Capital Region of Denmark (H-2-2011-056) and The Danish Data Protection Agency (2013-41-1710). The trial is registered at ClinicalTrials.gov as NCT01446406.

Mood instability in bipolar disorder type I versus type II-continuous daily electronic self-monitoring of illness activity using smartphones

“…et al 2009), regular cell phones (Bopp et al 2010) and smartphones (Depp et al 2012;Faurholt-Jepsen et al 2014;Faurholt-Jepsen et al 2013;Depp et al 2015) as tools for the continuous self-monitoring of mood and other items related to the assessment of illness activity in bipolar disorder.…”

Engagement Strategies for Self-Monitoring Symptoms of Bipolar Disorder With Mobile and Wearable Technology: Protocol for a Randomized Controlled Trial (Preprint)

“…Our study app was simple in its design: users can log, review, and visualize their mood. This simplicity ensures study results will generalize to the wealth of mobile and wearable technology developed for BP [12][13][14][15][16][17][18][19], translating into better technology for individuals with BP to monitoring symptoms.…”

“…Smart-phone platforms MONARCA (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes) [18] and PRIORI (Predicting Individual Outcomes for Rapid Intervention) [19] predict mood from patterns of speech and behavior from recorded calls, number of phone calls, and phone call duration. Wearable devices such as activity trackers monitor not only physical activity, but also circadian and sleep rhythms, primary targets of therapies such as sleep deprivation and interpersonal and social rhythm therapy [20,21].…”

Requirements Identification Towards a Design of Adaptive ICTs for Supporting Bipolar Disorder Treatment in Different Healthcare Contexts

“…Recently, the electronic self-monitoring of the affective symptoms of bipolar patients, which involved the use of cell phones to prompt patients to respond to weekly text messages, was proposed as an easy and inexpensive way to monitor and identify early signs of emerging affective episodes so that providers could intervene shortly after the prodromal symptoms appeared [2]. Among these e-mental health technologies, in the MONARCA (MONitoring, treAtment, and pRediCtion of bipolAr Disorder Episodes) project, solutions were developed for the multiparametric long-term monitoring of behavioral and physiological information (i.e., mood/irritability, sleep, speech, and physical activity) relevant to bipolar disorder and for treatment adherence in a bidirectional feedback loop between patients and providers [2].…”

“…Medical treatment may be enhanced by psychoeducation, cognitive behavioural therapy, and peer support practices [2] [3] [4] [5]. Early detection of prodromal depressive and manic episodes and adherence to treatments are essential for preventing the progressive development of the disease [2].…”