PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES)

Autor: Judith L Meijer, Tjitte Verbeek, Peter de Jonge, Ronald P. Stolk, Chantal Beijers, Marielle G. van Pampus, A. Dennis Stant, Claudi L H Bockting, Huibert Burger, Johan Ormel
Přispěvatelé: Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology Endocrinology Metabolism, Cancer Center Amsterdam, Adult Psychiatry, APH - Mental Health, Amsterdam Neuroscience - Mood, Anxiety, Psychosis, Stress & Sleep, Clinical Psychology and Experimental Psychopathology, Life Course Epidemiology (LCE), Lifestyle Medicine (LM), Interdisciplinary Centre Psychopathology and Emotion regulation (ICPE), Reproductive Origins of Adult Health and Disease (ROAHD)
Jazyk: angličtina
Rok vydání: 2011
Předmět:
Cost-Benefit Analysis
Emotions
Social Sciences
Medicine (miscellaneous)
Bayley Scales of Infant Development
Study Protocol
Child Development
CHILD
Pregnancy
Surveys and Questionnaires
ANXIETY
Pharmacology (medical)
POSTNATAL DEPRESSION
Netherlands
lcsh:R5-920
Depression
Pregnancy Outcome
Prenatal Care
Health Care Costs
Prenatal Care/economics
Cognitive Behavioral Therapy/economics
Mothers/psychology
PREVALENCE
Treatment Outcome
Research Design
Prenatal Exposure Delayed Effects
Anxiety
Female
medicine.symptom
lcsh:Medicine (General)
Psychosocial
Clinical psychology
medicine.medical_specialty
Pregnancy Complications/diagnosis
Anxiety/psychology
QUESTIONNAIRE
Mothers
Psychological/diagnosis
Child Behavior Disorders
Prenatal care
Stress
MENTAL-DISORDERS
medicine
Stress
Psychological/diagnosis
Humans
COHORT
Affective Symptoms
Psychiatry
METAANALYSIS
PRENATAL EXPOSURE
Psychiatric Status Rating Scales
Cognitive Behavioral Therapy
business.industry
Infant
COGNITIVE THERAPY
medicine.disease
Pregnancy Complications
Edinburgh Postnatal Depression Scale
Infant Behavior
Affective Symptoms/psychology
Antenatal depression
business
Child Behavior Disorders/psychology
Depression/psychology
Stress
Psychological
State-Trait Anxiety Inventory
Zdroj: Trials
Trials, Vol 12, Iss 1, p 157 (2011)
TRIALS
Trials, 12. BioMed Central
TRIALS, 12:157. BMC
ISSN: 1745-6215
Popis: Background 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). Trial Registration Netherlands Trial Register (NTR): NTR2242
Databáze: OpenAIRE
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