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使用智能手机对双相情感障碍进行每日电子自我监测——MONARCA I试验:一项随机、安慰剂对照、单盲、平行组试验。

Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial.

作者信息

Faurholt-Jepsen M, Frost M, Ritz C, Christensen E M, Jacoby A S, Mikkelsen R L, Knorr U, Bardram J E, Vinberg M, Kessing L V

机构信息

The Copenhagen Clinic for Affective Disorder,Psychiatric Centre Copenhagen,Rigshospitalet,Copenhagen,Denmark.

The Pervasive Interaction Laboratory (PIT Lab),IT University of Copenhagen,Copenhagen,Denmark.

出版信息

Psychol Med. 2015 Oct;45(13):2691-704. doi: 10.1017/S0033291715000410. Epub 2015 Jul 29.

Abstract

BACKGROUND

The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder.

METHOD

A total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18-60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups.

RESULTS

Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval -0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group.

CONCLUSIONS

These results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.

摘要

背景

关于情感障碍和其他精神障碍中电子自我监测的研究数量不断增加,表明患者接受度和依从性较高。然而,双相情感障碍患者中电子自我监测的效果从未在随机对照试验(RCT)中进行过研究。本试验的目的是在一项随机对照试验中研究使用智能手机进行每日电子自我监测是否能减轻双相情感障碍患者的抑郁和躁狂症状。

方法

根据国际疾病分类第10版(ICD - 10)标准,共有78例年龄在18至60岁之间、17项汉密尔顿抑郁量表(HAMD - 17)和杨氏躁狂量表(YMRS)评分≤17的双相情感障碍患者被随机分为两组,一组使用智能手机进行包括临床反馈回路的每日自我监测(干预组),另一组使用智能手机进行正常通信目的(对照组),为期6个月。主要结局是干预组和对照组之间分别使用HAMD - 17和YMRS测量的抑郁和躁狂症状差异。

结果

使用线性混合模型的意向性分析显示,使用智能手机进行每日自我监测对抑郁和躁狂症状均无显著影响。干预组有抑郁症状持续时间更长的趋势(B = 2.02,95%置信区间 - 0.13至4.17,p = 0.066)。在无混合症状患者和同时存在抑郁和躁狂症状患者的亚组分析中,干预组在试验期间抑郁症状明显更多,躁狂症状更少。

结论

这些结果表明,电子自我监测虽然直观且有吸引力,但在作为临床工具实施之前需要进行批判性思考和进一步阐明。

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