Bipolar Disorder Clinical Trial
Official title:
Electronic Daily Self-monitoring of Subjective and Objective Symptoms in Bipolar Disorder - The MONARCA Project (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes)
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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