|The following article is part of conference coverage from the 2018 American Psychiatric Association (APA) Annual Meeting in New York, New York. Psychiatry Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in psychiatry. Check back for the latest news from APA 2018.|
NEW YORK — Results from the MONARCA II trial (Monitoring, Treatment and Prediction of Bipolar Disorder Episodes) showed that a smartphone-based monitoring system consisting of a clinical feedback loop between clinicians and patients with bipolar disorder did not have a clinically significant effect on patients’ level of depressive and manic symptoms.1 These findings were presented at the American Psychiatric Association 2018 Annual Meeting, held May 5 to 9, 2018, in New York City.
This trial was conducted after the MONARCA I trial, in which patients using the smartphone feedback system had more sustained depressive symptoms but fewer manic symptoms during the 6-month trial period.2
The MONARCA II trial (a randomized controlled single-blind parallel-group trial) included 129 patients (58.9% [n=76] women) with a mean age of 42.4 years (standard deviation, 12.2) with bipolar disorder (International Statistical Classification of Diseases and Related Health Problems, 10th Revision) from the Copenhagen Affective Disorder Research Center at the Psychiatric Center in Copenhagen, Denmark. The trial ran from September 2014 to January 2018; follow-up was 9 months.
The intervention group used a smartphone-based self-monitoring tool daily. The tool included a clinical feedback loop on subjective and objective smartphone data (the Monsenso system). The intervention group also had standard treatment.
The control group used a smartphone for normal communication purposes in addition to standard treatment.
The primary outcomes assessed were the differences in clinically assessed depressive and manic symptoms, as well as the rate of depressive and manic episodes. Secondary outcomes included psychosocial functioning, perceived stress, quality of life, self-rated depressive and manic symptoms, recovery, empowerment, and adherence to medication.
The researchers found no differences in clinically assessed depressive symptoms (unadjusted analysis: HDRS-17 differences, 0.67 [95% CI, −0.70 to 2.1; P =.33]; adjusted analysis: HDRS-17 differences, 0.61 [95% CI, −0.77 to 2.00; P =.35]) and manic symptoms (unadjusted analysis: YMRS differences, −0.24 [95% CI, −1.1 to 0.60; P =.57]; adjusted analysis: YMRS differences, −0.25 [95% CI, −1.1 to 0.59; P =.56]) between the intervention group and the control group.
“Overall, the trial was negative with no clinically significant effect of the smartphone-based system on the level of depressive and manic symptoms,” the researchers wrote. “More [randomized controlled trials] investigating the effect of smartphone-based treatment in bipolar disorder are needed.” They noted that they are currently conducting 2 randomized controlled trials examining the effect of smartphone-based treatment on unipolar disorder and bipolar disorder rate of readmissions.3
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1. Faurholt-Jepsen M, Frost M, Christensen EM, Bardram JE, Vinberg M, Kessing LV. Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones: The MONARCA II trial. American Psychiatric Association (APA) 2018 Annual Meeting; May 5-9, 2018; New York City. Poster 40.
2. Faurholt-Jepsen M, Vinberg M, Christensen EM, Frost M, Bardram J, Kessing LV. Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder—the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial [published online July 24, 2013]. BMJ Open. doi: 10.1136/bmjopen-2013-003353
3. Faurholt-Jespen M, Frost M, Martiny K, et al. Reducing the rate and duration of Re-ADMISsions among patients with unipolar disorder and bipolar disorder using smartphone-based monitoring and treatment – the RADMIS trials: study protocol for two randomized controlled trials [published June 15, 2017]. BMC. doi: 10.1186/s13063-017-2015-3