title: Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial.
abstract: BACKGROUND
  The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder.
  
  
  METHODS
  A total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18-60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups.
  
  
  RESULTS
  Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval -0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group.
  
  
  CONCLUSIONS
  These results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.
authors.affiliation: The Copenhagen Clinic for Affective Disorder,Psychiatric Centre Copenhagen,Rigshospitalet,Copenhagen,Denmark.
authors.forename: M
authors.initials: M
authors.lastname: Faurholt-Jepsen
authors.affiliation: The Pervasive Interaction Laboratory (PIT Lab),IT University of Copenhagen,Copenhagen,Denmark.
authors.forename: M
authors.initials: M
authors.lastname: Frost
authors.affiliation: Department of Basic Sciences and Environment,Faculty of Life Sciences,University of Copenhagen,Copenhagen,Denmark.
authors.forename: C
authors.initials: C
authors.lastname: Ritz
authors.affiliation: The Copenhagen Clinic for Affective Disorder,Psychiatric Centre Copenhagen,Rigshospitalet,Copenhagen,Denmark.
authors.forename: E M
authors.initials: EM
authors.lastname: Christensen
authors.affiliation: The Copenhagen Clinic for Affective Disorder,Psychiatric Centre Copenhagen,Rigshospitalet,Copenhagen,Denmark.
authors.forename: A S
authors.initials: AS
authors.lastname: Jacoby
authors.affiliation: The Copenhagen Clinic for Affective Disorder,Psychiatric Centre Copenhagen,Rigshospitalet,Copenhagen,Denmark.
authors.forename: R L
authors.initials: RL
authors.lastname: Mikkelsen
authors.affiliation: The Copenhagen Clinic for Affective Disorder,Psychiatric Centre Copenhagen,Rigshospitalet,Copenhagen,Denmark.
authors.forename: U
authors.initials: U
authors.lastname: Knorr
authors.affiliation: The Pervasive Interaction Laboratory (PIT Lab),IT University of Copenhagen,Copenhagen,Denmark.
authors.forename: J E
authors.initials: JE
authors.lastname: Bardram
authors.affiliation: The Copenhagen Clinic for Affective Disorder,Psychiatric Centre Copenhagen,Rigshospitalet,Copenhagen,Denmark.
authors.forename: M
authors.initials: M
authors.lastname: Vinberg
authors.affiliation: The Copenhagen Clinic for Affective Disorder,Psychiatric Centre Copenhagen,Rigshospitalet,Copenhagen,Denmark.
authors.forename: L V
authors.initials: LV
authors.lastname: Kessing
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy*; D003863:Depression / Q000175:diagnosis*; D005260:Female; D006801:Humans; D038801:International Classification of Diseases; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D016037:Single-Blind Method; D000068997:Smartphone / Q000295:instrumentation*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents
keywords: Bipolar disorder; electronic self-monitoring; feedback loop; randomized controlled trial; smartphone; the MONARCA I trial