Department of Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.
Trials. 2011 Jun 20;12:157. doi: 10.1186/1745-6215-12-157.
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.
METHODS/DESIGN: 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 over on the total problems scale of the child behavioural 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 will be 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).
Netherlands Trial Register (NTR): NTR2242.
大量观察性前瞻性研究的证据表明，孕妇在怀孕期间的抑郁或焦虑是后代出现不良心理社会结局的一个危险因素。然而，迄今为止，尚无研究表明治疗妊娠期间的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对有焦虑或抑郁症状的孕妇进行认知行为疗法对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、产妇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。
方法/设计：我们将纳入 300 名至少在妊娠第一期末出现中度以上焦虑或抑郁的女性。通过纳入 300 名女性，我们将能够在儿童行为检查表 1.5-5 岁的总问题量表上显示出 0.35 或以上的效应大小，α 值为 5%，功率（1-β）为 80%。干预组的女性接受 10-14 次个体认知行为治疗，妊娠期间 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 1.5 岁时的行为/情绪问题，通过儿童行为检查表 1.5-5 岁的总问题量表评估。次要结局将是 18 个月时儿童的心理、精神运动和行为发育，根据贝利量表评估，妊娠和产后期间的母亲焦虑和抑郁，以及新生儿结局，如出生体重、胎龄和阿普加评分、医疗保健消费和一般健康状况（经济评估）。
荷兰试验注册（NTR）：NTR2242。
