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基于电子正念的干预措施(eMBI)改善孕期产妇心理健康的卫生经济学评价——一项随机对照试验(RCT)

Health economic evaluation of an electronic mindfulness-based intervention (eMBI) to improve maternal mental health during pregnancy - a randomized controlled trial (RCT).

作者信息

Hasemann Lena, Elkenkamp Svenja, Müller Mitho, Bauer Armin, Wallwiener Stephanie, Greiner Wolfgang

机构信息

AG 5 - Department of Health Economics and Health Care Management, School of Public Health, Bielefeld University, Universitaetsstrasse 25, 33615, Bielefeld, Germany.

Department of Psychology, Ludwig-Maximilians-University of Munich, Leopoldstrasse 13, 80802, Munich, Germany.

出版信息

Health Econ Rev. 2024 Jul 30;14(1):60. doi: 10.1186/s13561-024-00537-z.

Abstract

BACKGROUND

Anxiety and depression are the most prevalent psychiatric diseases in the peripartum period. They can lead to relevant health consequences for mother and child as well as increased health care resource utilization (HCRU) and related costs. Due to the promising results of mindfulness-based interventions (MBI) and digital health applications in mental health, an electronic MBI on maternal mental health during pregnancy was implemented and assessed in terms of transferability to standard care in Germany. The present study focused the health economic outcomes of the randomized controlled trial (RCT).

METHODS

The analysis, adopting a payer's and a societal perspective, included women of increased emotional distress at < 29 weeks of gestation. We applied inferential statistics (α = 0.05 significance level) to compare the intervention group (IG) and control group (CG) in terms of HCRU and costs. The analysis was primarily based on statutory health insurance claims data which covered the individual observational period of 40 weeks.

RESULTS

Overall, 258 women (IG: 117, CG: 141) were included in the health economic analysis. The results on total health care costs from a payer's perspective indicated higher costs for the IGi compared to the CG (Exp(ß) = 1.096, 95% CI: 1.006-1.194, p = 0.037). However, the estimation was not significant after Bonferroni correction (p < 0.006). Even the analysis from a societal perspective as well as sensitivity analyses did not show significant results.

CONCLUSIONS

In the present study, the eMBI did neither reduced nor significantly increased health care costs. Further research is needed to generate robust evidence on eMBIs for women suffering from peripartum depression and anxiety.

TRIAL REGISTRATION

German Clinical Trials Register: DRKS00017210. Registered on 13 January 2020. Retrospectively registered.

摘要

背景

焦虑和抑郁是围产期最常见的精神疾病。它们会给母婴带来相关的健康后果,还会增加医疗保健资源利用(HCRU)及相关成本。鉴于基于正念的干预措施(MBI)和数字健康应用在心理健康方面取得了令人鼓舞的成果,德国实施了一项关于孕期孕产妇心理健康的电子MBI,并对其向标准护理的可转移性进行了评估。本研究聚焦于随机对照试验(RCT)的健康经济结果。

方法

从支付方和社会角度进行分析,纳入妊娠<29周时情绪困扰加剧的女性。我们应用推断统计学(显著性水平α = 0.05)来比较干预组(IG)和对照组(CG)在HCRU和成本方面的差异。分析主要基于法定医疗保险理赔数据,这些数据涵盖了40周的个体观察期。

结果

总体而言,258名女性(IG组:117名,CG组:141名)被纳入健康经济分析。从支付方角度来看,IG组的总医疗保健成本结果显示高于CG组(Exp(ß)=1.096,95%置信区间:1.006 - 1.194,p = 0.037)。然而,经Bonferroni校正后该估计无统计学意义(p < 0.006)。即使从社会角度进行的分析以及敏感性分析也未显示出显著结果。

结论

在本研究中,电子MBI既未降低也未显著增加医疗保健成本。需要进一步研究以产生关于电子MBI对患有围产期抑郁和焦虑的女性的有力证据。

试验注册

德国临床试验注册中心:DRKS00017210。于2020年1月13日注册。回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ad7/11290259/47a7e6e58294/13561_2024_537_Fig1_HTML.jpg

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