The MONARCA Project (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes)

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.

Conditions

• Bipolar Disorder

Interventions

DEVICE

MONARCA

Monitoring affective symptoms entered by the patient every day.

DEVICE

NON-MONARCA

A mobile phone for communication purposes only. No application has been installed.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• IT University of Copenhagen

  collaborator OTHER

• The European Union, 7.th Frame program

  collaborator UNKNOWN

• Psychiatric Centre Rigshospitalet

  lead OTHER

Principal Investigators

• Maria Faurholt-Jepsen, MD · Department of psychiatry, Copenhagen, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2014-08-31

Completion

2014-08-31

Countries

• Denmark

Study Locations