TY - JOUR

T1 - Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones- the MONARCA II trial protocol

T2 - a randomized controlled single-blind parallel-group trial

AU - Faurholt-Jepsen, Maria

AU - Vinberg, Maj

AU - Frost, Mads

AU - Christensen, Ellen Margrethe

AU - Bardram, Jakob

AU - Kessing, Lars Vedel

PY - 2014

Y1 - 2014

N2 - BACKGROUND: Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed.METHODS: The MONARCA II trial uses a randomized controlled single-blind parallel-group design. Patients with bipolar disorder according to ICD-10 who previously have been treated at the Copenhagen Clinic for Affective Disorder, Denmark are included and randomized to either daily use of the Monsenso system including an feedback loop between patients and clinicians (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for a 9-month trial period. The trial was started in September 2014 and recruitment is ongoing. The outcomes are: differences in depressive and manic symptoms; rate of depressive and manic episodes (primary); automatically generated objective data on measures of illness activity; number of days hospitalized; psychosocial functioning (secondary); perceived stress; quality of life; self-rated depressive symptoms; self-rated manic symptoms; recovery; empowerment and adherence to medication (tertiary) between the intervention group and the control group during the trial. Ethical permission has been obtained. Positive, neutral and negative findings will be published.DISCUSSION: If the system is effective in reducing depressive and/or manic symptoms (and other symptoms of bipolar disorder) and the rate of episodes, there will be basis for extending the use to the treatment of bipolar disorder in general and in larger scale.TRIAL REGISTRATION: ClinicalTrials.gov NCT02221336. Registered 26th of September 2014.

AB - BACKGROUND: Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed.METHODS: The MONARCA II trial uses a randomized controlled single-blind parallel-group design. Patients with bipolar disorder according to ICD-10 who previously have been treated at the Copenhagen Clinic for Affective Disorder, Denmark are included and randomized to either daily use of the Monsenso system including an feedback loop between patients and clinicians (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for a 9-month trial period. The trial was started in September 2014 and recruitment is ongoing. The outcomes are: differences in depressive and manic symptoms; rate of depressive and manic episodes (primary); automatically generated objective data on measures of illness activity; number of days hospitalized; psychosocial functioning (secondary); perceived stress; quality of life; self-rated depressive symptoms; self-rated manic symptoms; recovery; empowerment and adherence to medication (tertiary) between the intervention group and the control group during the trial. Ethical permission has been obtained. Positive, neutral and negative findings will be published.DISCUSSION: If the system is effective in reducing depressive and/or manic symptoms (and other symptoms of bipolar disorder) and the rate of episodes, there will be basis for extending the use to the treatment of bipolar disorder in general and in larger scale.TRIAL REGISTRATION: ClinicalTrials.gov NCT02221336. Registered 26th of September 2014.

U2 - 10.1186/s12888-014-0309-5

DO - 10.1186/s12888-014-0309-5

M3 - Journal article

C2 - 25420431

VL - 14

SP - 1

EP - 12

JO - B M C Psychiatry

JF - B M C Psychiatry

SN - 1471-244X

IS - 11

M1 - 309

ER -