Pregnancy outcomes after a Maternity Intervention for Stressful Emotions (PROMISES): A randomised controlled trial

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

Research output: Chapter in Book/Report/Conference proceedingChapterAcademicpeer-review

1 Citation (Scopus)

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.

Original languageEnglish
Title of host publicationPerinatal Programming of Neurodevelopment
EditorsMarta Antonelli
PublisherSpringer
Pages443-459
Number of pages17
Volume10
ISBN (Electronic)978-1-4939-1372-5
ISBN (Print)978-1-4939-1371-8
DOIs
Publication statusPublished - 2015

Publication series

NameAdvances in Neurobiology
ISSN (Print)2190-5215

Keywords

  • ANTENATAL CARE
  • Transdiagnostic factor
  • depression
  • Post traumatic stress disorder (PTSD)
  • ANXIETY DISORDERS

Cite this