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 |
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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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