title: 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: BACKGROUND
  Electronic 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.
  
  
  METHODS
  We 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).
  
  
  METHODS
  Recruitment is ongoing.
  
  
  METHODS
  Ethical permission has been obtained.
  
  
  RESULTS
  Positive, neutral and negative findings of the study will be published.
  
  
  BACKGROUND
  The 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.
authors.affiliation: Clinic for Affective Disorders, Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Maria
authors.initials: M
authors.lastname: Faurholt-Jepsen
authors.forename: Maj
authors.initials: M
authors.lastname: Vinberg
authors.forename: Ellen Margrethe
authors.initials: EM
authors.lastname: Christensen
authors.forename: Mads
authors.initials: M
authors.lastname: Frost
authors.forename: Jakob
authors.initials: J
authors.lastname: Bardram
authors.forename: Lars Vedel
authors.initials: LV
authors.lastname: Kessing
keywords: Medical Education & Training; Mental Health