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OptiMUM研究:对有既往分娩后创伤后应激障碍的孕妇及有分娩恐惧的孕妇进行眼动脱敏再处理疗法:一项多中心随机对照试验的设计

The OptiMUM-study: EMDR therapy in pregnant women with posttraumatic stress disorder after previous childbirth and pregnant women with fear of childbirth: design of a multicentre randomized controlled trial.

作者信息

Baas M A M, Stramrood C A I, Dijksman L M, de Jongh A, van Pampus M G

机构信息

Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis , Amsterdam , the Netherlands.

Department of Obstetrics and Gynaecology, University Medical Centre Utrecht , Utrecht , the Netherlands.

出版信息

Eur J Psychotraumatol. 2017 Feb 24;8(1):1293315. doi: 10.1080/20008198.2017.1293315. eCollection 2017.

DOI:10.1080/20008198.2017.1293315
PMID:28348720
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5345578/
Abstract

: Approximately 3% of women develop posttraumatic stress disorder (PTSD) after giving birth, and 7.5% of pregnant women show a pathological fear of childbirth (FoC). FoC or childbirth-related PTSD during (a subsequent) pregnancy can lead to a request for an elective caesarean section as well as adverse obstetrical and neonatal outcomes. For PTSD in general, and several subtypes of specific phobia, eye movement desensitization and reprocessing (EMDR) therapy has been proven effective, but little is known about the effects of applying EMDR during pregnancy. : To describe the protocol of the OptiMUM-study. The main aim of the study is to determine whether EMDR therapy is an effective and safe treatment for pregnant women with childbirth-related PTSD or FoC. In addition, the cost-effectiveness of this approach will be analysed. : The single-blind OptiMUM-study consists of two two-armed randomized controlled trials (RCTs) with overlapping design. In several hospitals and community midwifery practices in Amsterdam, the Netherlands, all eligible pregnant women with a gestational age between eight and 20 weeks will be administered the Wijma delivery expectations questionnaire (WDEQ) to asses FoC. Multiparous women will also receive the PTSD checklist for DSM-5 (PCL-5) to screen for possible PTSD. The clinician administered PTSD scale (CAPS-5) will be used for assessing PTSD according to DSM-5 in women scoring above the PCL-5 cut-off value. Fifty women with childbirth-related PTSD and 120 women with FoC will be randomly allocated to either EMDR therapy carried out by a psychologist or care-as-usual. Women currently undergoing psychological treatment or women younger than 18 years will not be included. Primary outcome measures are severity of childbirth-related PTSD or FoC symptoms. Secondary outcomes are percentage of PTSD diagnoses, percentage caesarean sections, subjective childbirth experience, obstetrical and neonatal complications, and health care costs. : The results are meant to provide more insight about the safety and possible effectiveness of EMDR therapy during pregnancy for women with PTSD or FoC. : This study is the first RCT studying efficacy and safety of EMDR in pregnant women with PTSD after childbirth or Fear of Childbirth.

摘要

约3%的女性在产后会患上创伤后应激障碍(PTSD),7.5%的孕妇表现出对分娩的病理性恐惧(FoC)。孕期(后续)出现的FoC或与分娩相关的PTSD会导致产妇要求进行选择性剖宫产,并引发不良的产科和新生儿结局。对于一般的PTSD以及特定恐惧症的几种亚型,眼动脱敏再处理(EMDR)疗法已被证明有效,但对于在孕期应用EMDR的效果却知之甚少。:描述OptiMUM研究的方案。该研究的主要目的是确定EMDR疗法对患有与分娩相关PTSD或FoC的孕妇是否为一种有效且安全的治疗方法。此外,还将分析这种方法的成本效益。:单盲的OptiMUM研究由两项双臂随机对照试验(RCT)组成,采用重叠设计。在荷兰阿姆斯特丹的几家医院和社区助产机构,所有孕周在8至20周的符合条件的孕妇将接受维伊玛分娩期望问卷(WDEQ)以评估FoC。经产妇还将接受《精神疾病诊断与统计手册》第5版(DSM - 5)的PTSD检查表(PCL - 5)以筛查可能的PTSD。对于PCL - 5得分高于临界值的女性,将使用临床医生实施的PTSD量表(CAPS - 5)根据DSM - 5评估PTSD。50名患有与分娩相关PTSD的女性和120名患有FoC的女性将被随机分配至由心理学家实施的EMDR疗法组或常规护理组。目前正在接受心理治疗的女性或年龄小于18岁的女性将不被纳入。主要结局指标是与分娩相关的PTSD或FoC症状的严重程度。次要结局包括PTSD诊断的百分比、剖宫产的百分比、主观分娩体验、产科和新生儿并发症以及医疗保健成本。:研究结果旨在为孕期EMDR疗法对患有PTSD或FoC的女性的安全性和可能的有效性提供更多见解。:本研究是第一项研究EMDR对产后患有PTSD或分娩恐惧的孕妇的疗效和安全性的随机对照试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efa9/5345578/6be48bcf25a1/zept_a_1293315_f0002_c.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efa9/5345578/450c61b2f4f4/zept_a_1293315_f0001_c.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efa9/5345578/6be48bcf25a1/zept_a_1293315_f0002_c.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efa9/5345578/450c61b2f4f4/zept_a_1293315_f0001_c.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efa9/5345578/6be48bcf25a1/zept_a_1293315_f0002_c.jpg

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