孕期情绪应激干预后的妊娠结局（PROMISES）：一项随机对照试验

Pregnancy Outcomes After a Maternity Intervention for Stressful Emotions (PROMISES): A Randomised Controlled Trial.

作者信息

Burger Huibert, Bockting Claudi L H, Beijers Chantal, Verbeek Tjitte, Stant A Dennis, Ormel Johan, Stolk Ronald P, de Jonge Peter, van Pampus Mariëlle G, Meijer Judith

机构信息

Department of General Practice, University of Groningen, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands,

出版信息

Adv Neurobiol. 2015;10:443-59. doi: 10.1007/978-1-4939-1372-5_21.

DOI:10.1007/978-1-4939-1372-5_21

PMID:25287553

Abstract

UNLABELLED

There is ample evidence from observational prospective studies that maternal depression or anxiety during pregnancy is a risk factor for adverse psychosocial outcomes in the offspring. However, to date no previous study has demonstrated that treatment of depressive or anxious symptoms in pregnancy actually could prevent psychosocial problems in children. Preventing psychosocial problems in children will eventually bring down the huge public health burden of mental disease. The main objective of this study is to assess the effects of cognitive behavioural therapy in pregnant women with symptoms of anxiety or depression on the child's development as well as behavioural and emotional problems. In addition, we aim to study its effects on the child's development, maternal mental health, and neonatal outcomes, as well as the cost-effectiveness of cognitive behavioural therapy relative to usual care.We will include 300 women with at least moderate levels of anxiety or depression at the end of the first trimester of pregnancy. By including 300 women, we will be able to demonstrate effect sizes of 0.35 or more on the total problems scale of the Child Behaviour Checklist 1.5-5 with alpha 5 % and power (1-beta) 80 %.Women in the intervention arm are offered 10-14 individual cognitive behavioural therapy sessions, 6-10 sessions during pregnancy and 4-8 sessions after delivery (once a week). Women in the control group receive care as usual.Primary outcome is behavioural/emotional problems at 1.5 years of age as assessed by the total problems scale of the Child Behaviour Checklist 1.5-5 years.Secondary outcomes are mental, psychomotor and behavioural development of the child at age 18 months according to the Bayley scales; maternal anxiety and depression during pregnancy and postpartum; and neonatal outcomes such as birth weight, gestational age and Apgar score, health-care consumption and general health status (economic evaluation).

TRIAL REGISTRATION

NTR2242.

摘要

未标注

来自观察性前瞻性研究的大量证据表明，孕期母亲抑郁或焦虑是后代不良心理社会结局的一个风险因素。然而，迄今为止，尚无研究表明孕期治疗抑郁或焦虑症状实际上可以预防儿童的心理社会问题。预防儿童的心理社会问题最终将减轻精神疾病带来的巨大公共卫生负担。本研究的主要目的是评估认知行为疗法对有焦虑或抑郁症状的孕妇的儿童发育以及行为和情绪问题的影响。此外，我们旨在研究其对儿童发育、母亲心理健康和新生儿结局的影响，以及认知行为疗法相对于常规护理的成本效益。

我们将纳入300名在妊娠早期结束时至少有中度焦虑或抑郁水平的女性。纳入300名女性后，我们将能够在α为5%、检验效能（1-β）为80%的情况下，在儿童行为量表1.5 - 5岁的总问题量表上显示出0.35或更大的效应量。

干预组的女性将接受10 - 14次个体认知行为疗法治疗，孕期6 - 10次，产后4 - 8次（每周一次）。对照组的女性接受常规护理。

主要结局是通过儿童行为量表1.5 - 5岁的总问题量表评估的1.5岁时的行为/情绪问题。次要结局是根据贝利量表评估的18个月大儿童的智力、心理运动和行为发育；孕期和产后母亲的焦虑和抑郁；以及新生儿结局，如出生体重、孕周和阿氏评分、医疗保健消费和总体健康状况（经济评估）。