TY - JOUR

T1 - The effect of smartphone-based monitoring on illness activity in bipolar disorder

T2 - the MONARCA II randomized controlled single-blinded trial

AU - Faurholt-Jepsen, Maria

AU - Frost, Mads

AU - Christensen, Ellen Margrethe

AU - Bardram, Jakob E.

AU - Vinberg, Maj

AU - Kessing, Lars Vedel

PY - 2020

Y1 - 2020

N2 - BackgroundRecently, the MONARCA I randomized controlled trial (RCT) was the first to investigate the effect of smartphone-based monitoring in bipolar disorder (BD). Findings suggested that smartphone-based monitoring sustained depressive but reduced manic symptoms. The present RCT investigated the effect of a new smartphone-based system on the severity of depressive and manic symptoms in BD.MethodsRandomized controlled single-blind parallel-group trial. Patients with BD, previously treated at The Copenhagen Clinic for Affective Disorder, Denmark and currently treated at community psychiatric centres, private psychiatrists or GPs were randomized to the use of a smartphone-based system or to standard treatment for 9 months. Primary outcomes: Differences in depressive and manic symptoms between the groups.ResultsA total of 129 patients with BD (ICD-10) were included. Intention-to-treat analyses showed no statistically significant effect of smartphone-based monitoring on depressive (B = 0.61, 95% CI â'0.77 to 2.00, p = 0.38) and manic (B = â'0.25, 95% CI â'1.1 to 0.59, p = 0.56) symptoms. The intervention group reported higher quality of life and lower perceived stress compared with the control group. In sub-analyses, the intervention group had higher risk of depressive episodes, but lower risk of manic episodes compared with the control group.ConclusionsThere was no effect of smartphone-based monitoring. In patient-reported outcomes, patients in the intervention group reported improved quality of life and reduced perceived stress. Patients in the intervention group had higher risk of depressive episodes and reduced risk of manic episodes. Despite the widespread use and excitement of electronic monitoring, few studies have investigated possible effects. Further studies are needed.

AB - BackgroundRecently, the MONARCA I randomized controlled trial (RCT) was the first to investigate the effect of smartphone-based monitoring in bipolar disorder (BD). Findings suggested that smartphone-based monitoring sustained depressive but reduced manic symptoms. The present RCT investigated the effect of a new smartphone-based system on the severity of depressive and manic symptoms in BD.MethodsRandomized controlled single-blind parallel-group trial. Patients with BD, previously treated at The Copenhagen Clinic for Affective Disorder, Denmark and currently treated at community psychiatric centres, private psychiatrists or GPs were randomized to the use of a smartphone-based system or to standard treatment for 9 months. Primary outcomes: Differences in depressive and manic symptoms between the groups.ResultsA total of 129 patients with BD (ICD-10) were included. Intention-to-treat analyses showed no statistically significant effect of smartphone-based monitoring on depressive (B = 0.61, 95% CI â'0.77 to 2.00, p = 0.38) and manic (B = â'0.25, 95% CI â'1.1 to 0.59, p = 0.56) symptoms. The intervention group reported higher quality of life and lower perceived stress compared with the control group. In sub-analyses, the intervention group had higher risk of depressive episodes, but lower risk of manic episodes compared with the control group.ConclusionsThere was no effect of smartphone-based monitoring. In patient-reported outcomes, patients in the intervention group reported improved quality of life and reduced perceived stress. Patients in the intervention group had higher risk of depressive episodes and reduced risk of manic episodes. Despite the widespread use and excitement of electronic monitoring, few studies have investigated possible effects. Further studies are needed.

KW - Bipolar disorder

KW - depressive and manic symptoms

KW - illness activity

KW - MONARCA II

KW - randomized controlled trial

KW - smartphone

KW - The Monsenso system

U2 - 10.1017/S0033291719000710

DO - 10.1017/S0033291719000710

M3 - Journal article

C2 - 30944054

AN - SCOPUS:85063890728

VL - 50

SP - 838

EP - 848

JO - Psychological Medicine

JF - Psychological Medicine

SN - 0033-2917

IS - 5

ER -