The effect of smartphone-based monitoring on illness activity in bipolar disorder: the MONARCA II randomized controlled single-blinded trial
The effect of smartphone-based monitoring on illness activity in bipolar disorder: the MONARCA II randomized controlled single-blinded trial
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DOI：
10.1017/s0033291719000710
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发表时间：
2020-04-01
影响因子：
6.9
通讯作者：
Kessing, Lars Vedel
中科院分区：
文献类型：
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作者：
Faurholt-Jepsen, Maria;Frost, Mads;Kessing, Lars Vedel
背景最近，MONARCA I随机对照试验（RCT）首次研究了基于智能手机的监测对双相情感障碍（BD）的影响。研究结果表明，基于智能手机的监测持续抑郁，但减少躁狂症状。本RCT研究了一种新的基于智能手机的系统对BD抑郁和躁狂症状严重程度的影响。方法随机对照、单盲、平行分组试验。之前在丹麦丹麦情感障碍诊所接受治疗，目前在社区精神病中心、私人精神科医生或全科医生接受治疗的BD患者被随机分配使用基于智能手机的系统或标准治疗9个月。主要结果：两组之间抑郁和躁狂症状的差异。结果共纳入129例BD患者（ICD-10）。意向治疗分析显示，基于智能手机的监测对抑郁（B = 0.61，95% CI -0.77至2.00，p = 0.38）和躁狂（B =-0.25，95% CI -1.1至0.59，p = 0.56）症状无统计学显著影响。与对照组相比，干预组报告了更高的生活质量和更低的感知压力。在子分析中，与对照组相比，干预组抑郁发作的风险较高，但躁狂发作的风险较低。结论基于智能手机的监测没有影响。在患者报告的结果中，干预组的患者报告生活质量提高，感知压力减少。干预组患者抑郁发作的风险较高，躁狂发作的风险降低。尽管电子监测的广泛使用和兴奋，很少有研究调查可能的影响。需要进一步研究。
Background Recently, 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. Methods Randomized 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. Results A 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 -0.77 to 2.00, p = 0.38) and manic (B = -0.25, 95% CI -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. Conclusions There 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.