The MONARCA Project (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Bipolar disorder is associated with a high risk of relapse and hospitalisation and many
      patients do not recover to previous psychosocial function. Major reasons for poor outcome are
      delayed intervention for prodromal depressive and manic episodes as well as decreased
      adherence with treatment. Recently, electronic self monitoring of affective symptoms using
      cell phones to prompt patients to respond to weekly text messages has been suggested as an
      easy and cheap way to identify early signs of affective episodes. Nevertheless, so far the
      electronic devises has been rather simple not including a bi-directional feed back loop
      between patients and providers and without electronic data on "objective" measures of the
      affective psychopathology. As part of an ongoing EU research program a software program for
      online electronic self-monitoring using a cell phone is being developed including an
      interactive feed back loop between patients, relatives and clinicians. Electronic
      self-monitoring includes subjective items such as mood, irritability, sleep duration,
      activity, alcohol consumption, medication intake and objective items of speech duration (on
      the cell phone), social activity (numbers of calls and SMS'es at the cell phone) and physical
      activity (acceleration of the cell phone). The present PhD. study will in a randomized
      controlled single blind trial including 60 patients with bipolar disorder allocated to using
      the active cell phone program (intervention group) or to using a cell phone to usual
      communication (control group) during a 6 months study period.

      If the cell phone self-monitoring system is proved effective in preventing mood symptoms and
      improving psychosocial functioning,quality of life etc. in the present study there might be
      basis for extending the use of the system to treatment of patients with bipolar disorder in
      clinical practice in general.
    

Detailed description: 
      The objectives of the study are to investigate in a randomised controlled single blind trial
      whether the use of an online monitoring system in patients suffering from bipolar disorder
      reduces symptoms of affective disorder.

      As part of the clinical assessment in the Mood Disorder clinic, a paper version with daily
      monitoring of subjective items has been in use for four years. Based on an interactive
      process with patients suffering from bipolar disorder, the literature as well as clinical
      experience of the research and clinical group involved in the study we have chosen to monitor
      the following subjective items: mood, activity, irritability, sleep duration, alcohol
      consumption, medication intake. Patients are prompted to evaluate these items every evening.
      In the same way, the following objective items will be collected on all cell phones used in
      the study: speech duration (minutes speech per 24 hours on the cell phone), social activity
      (numbers of calls and SMS'es per 24 hours at the cell phone and acceleration of the cell
      phone).

      A personal homepage for each patient is set op on a server so the patient can connect to the
      homepage with his cell phone using secure codes. By giving informed consent to participate in
      the MONARCA trial patients allow clinicians to connect to the homepage. It is optionally
      whether patients allow relatives (or others) to get access to the homepage. Online programs
      present the monitored subjective items as well as speech duration and number of calls and
      SMS's graphically.

      It is not known whether using a cell phone for electronic monitoring of bipolar disorder the
      way described above improve outcome compared to using a cell phone to usual communication. A
      total of 60 patients with bipolar disorder are randomised (1:1) to using the active cell
      phone program (intervention group) or to using a cell phone to usual communication (control
      group). All randomised patients will receive a cell phone (Android) for use during the study
      period.

      Stratification is done for age (18-30 versus 30-60 years) and prior hospitalisations (none
      versus hospitalisation). Study period: 6 months

      The assessments are done by the PhD.-student who is not involved in the treatment of the
      randomised patients and is blinded versus having received the intervention system or the
      control system. All participants in the study will be examined every month by the PhD student
      for the entire study period. The following will be done: The bipolar diagnosis is confirmed
      by a SCAN interview. Further the following ratings/questionnaires are performed every month
      for 6 months: Hamilton Depression Scale-17 items (HAMD-17), the Young Mania Rating Scale
      (YMRS), psychosocial functioning (FAST), Cohen's Perceived stress scale, quality of life
      (WHOQOL), coping strategies (CISS), Altman Self-rating mania scale, Major Depression
      Inventory (MDI). Assessment of cognitive function (SCIP and Massachusetts General Hospital
      Questionnaire), awakening salivary cortisol, urinary oxidative stress, adherence to
      medication (plasma values of medication) and plasma BDNF are measured at start, half way and
      end of the study.

      All assessment is done single blind, i.e., the assessor (researcher) does not know whether
      the patient is randomized to the intervention group or the control group.

      The outcomes are differences between intervention and control group in:

        -  Primary: depressive and manic symptoms

        -  Secondary: psychosocial functioning, quality of life, perceived stress, coping
           strategies,adherence to medication, cognitive function, awakening salivary cortisol,
           urinary oxidative stress, plasma BDNF, physical activity, self-rated depressive and
           manic symptoms
    

Intervention name(s): MONARCA; NON-MONARCA
Intervention type(s): Device; Device
Intervention description(s): Monitoring affective symptoms entered by the patient every day.; A mobile phone for communication purposes only. No application has been installed.
Other intervention name(s): Electronic self-monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar disorder; Electronic daily monitoring; Affective episodes