Abstract
BackgroundThere 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/designWe 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).Trial RegistrationNetherlands Trial Register (NTR): NTR2242
Highlights
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
In the WHO Global Burden of Disease project it was estimated that 50% of all daily adjusted life years (DALY’s) in the 15-44 years old are due to nine psychiatry-related conditions [1]
The magnitude of the effects of maternal anxiety or depression on the child’s psychosocial problems is considerable: it is estimated that up to 22% of the variance in behavioural problems is linked with prenatal anxiety, stress or depression [6]
Summary
The burden of mental disorders is huge and at least comparable to the burden caused by many severe physical diseases. An indirect adverse effect might be another mechanism, because women who suffer from antenatal depression have the tendency to take less good care of themselves (e.g. neglecting personal hygiene, sleeping problems, disturbed drinking and smoking habits, denying prenatal care) These consequences might all influence the development of the foetus [14,15,16,17]. It is too early to implement CBT for depressed or anxious women to prevent psychosocial problems in the offspring This is because in the development of such a preventive strategy, demonstration of the causality and size of the effect of the reduction of symptoms of depression and anxiety on child outcomes is a crucial step, a step that has not been taken to date.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
