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

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Perinatal Programming of Neurodevelopment

Part of the book series: Advances in Neurobiology ((NEUROBIOL,volume 10))

Abstract

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

This work is based on a previously published journal article: Meijer JL, Bockting CL, Beijers C, Verbeek T, Stant AD, Ormel J, Stolk RP, de Jonge P, van Pampus MG, Burger H. PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES): Study protocol for a randomized controlled trial. Trials. 2011 Jun 20;12:157. doi: 10.1186/17457450.1186/174

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Abbreviations

ADHD:

Attention deficit hyperactivity disorder

ALSPAC:

Avon Longitudinal Study of Parents and Children

BSID II:

Bayley Scale of Infant Development

CAU:

Care as usual

CBCL:

Child Behaviour Checklist

CBT:

Cognitive behavioural therapy

C-TRF:

Caregiver–Teacher Report Form

DALY:

Daily adjusted life years

DAS:

Dysfunctional Attitudes Scale

DSM:

Diagnostic and Statistical Manual of Mental Disorders

ECR:

Experiences in Close Relationships Scale

EPDS:

Edinburgh Postnatal Depression Scale

EQ-5D:

EuroQol

HELLP:

Hemolytic anemia, elevated liver enzymes and low platelet count

ITT:

Intention to treat

LDS:

Language Development Survey

MINI:

Mini International Neuropsychiatric Interview

NEO-FFI:

NEO Five Factor Inventory

NEO-PI-R:

Revised NEO Personality Inventory

NLEQ:

Negative Life Events Questionnaire

PROMISES:

PRegnancy Outcomes after Maternity Intervention for Stressful EmotionS

QALY:

Quality-adjusted life years

RCT:

Randomised controlled trial

SCID:

Structured Clinical Interview for DSM-VI Disorders

SSQ:

Social Support Questionnaire

STAI:

State and Trait Anxiety Inventory

TiC-P:

Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness

UCL:

Utrechtse Coping Lijst

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Acknowledgments

This work is supported by a grant from the Netherlands Organization for Health Research and Development (120520013).

Conflicts of Interest

The authors declare no conflicts of interest.

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Authors and Affiliations

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

    Huibert Burger

  2. Department of Clinical and Developmental Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS, Groningen, The Netherlands

    Claudi L. H. Bockting

  3. Department of Psychiatry, University of Groningen, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands

    Huibert Burger, Chantal Beijers, Johan Ormel & Peter de Jonge

  4. Department of Epidemiology, University of Groningen, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands

    Tjitte Verbeek, A. Dennis Stant, Ronald P. Stolk & Judith Meijer

  5. Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

    Mariëlle G. van Pampus

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  1. Huibert Burger
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  2. Claudi L. H. Bockting
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  3. Chantal Beijers
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  4. Tjitte Verbeek
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  6. Johan Ormel
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  7. Ronald P. Stolk
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  8. Peter de Jonge
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  9. Mariëlle G. van Pampus
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  10. Judith Meijer
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Correspondence to Huibert Burger .

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Editors and Affiliations

  1. Facultad de Medicina Inst de Biologia Celular y Neurociecias, Universidad de Buenos Aires, Buenos Aires, Argentina

    Marta C. Antonelli

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Burger, H. et al. (2015). Pregnancy Outcomes After a Maternity Intervention for Stressful Emotions (PROMISES): A Randomised Controlled Trial. In: Antonelli, M. (eds) Perinatal Programming of Neurodevelopment. Advances in Neurobiology, vol 10. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1372-5_21

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