PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES): study protocol for a randomised controlled trial
Identifieur interne : 000209 ( Ncbi/Curation ); précédent : 000208; suivant : 000210PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES): study protocol for a randomised controlled trial
Auteurs : Judith L. Meijer [Pays-Bas] ; Claudi Lh Bockting [Pays-Bas] ; Chantal Beijers [Pays-Bas] ; Tjitte Verbeek [Pays-Bas] ; A Dennis Stant [Pays-Bas] ; Johan Ormel [Pays-Bas] ; Ronald P. Stolk [Pays-Bas] ; Peter De Jonge [Pays-Bas] ; Mariëlle G. Van Pampus [Pays-Bas] ; Huibert Burger [Pays-Bas]Source :
- Trials [ 1745-6215 ] ; 2011.
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 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).
Netherlands Trial Register (NTR):
Url:
DOI: 10.1186/1745-6215-12-157
PubMed: 21689394
PubMed Central: 3144012
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Van Pampus</name><affiliation wicri:level="1"><nlm:aff id="I4">Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, P.O. Box 95500, 1090 HM Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, P.O. 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Meijer</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author><author><name sortKey="Bockting, Claudi Lh" sort="Bockting, Claudi Lh" uniqKey="Bockting C" first="Claudi Lh" last="Bockting">Claudi Lh Bockting</name><affiliation wicri:level="4"><nlm:aff id="I2">Department of Clinical and Developmental Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical and Developmental Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen</wicri:regionArea><orgName type="university">Université de Groningue</orgName><placeName><settlement type="city">Groningue (ville)</settlement><region>Groningue (province)</region></placeName></affiliation></author><author><name sortKey="Beijers, Chantal" sort="Beijers, Chantal" uniqKey="Beijers C" first="Chantal" last="Beijers">Chantal Beijers</name><affiliation wicri:level="3"><nlm:aff id="I3">Interdisciplinary Centre for Psychiatric Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Interdisciplinary Centre for Psychiatric Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author><author><name sortKey="Verbeek, Tjitte" sort="Verbeek, Tjitte" uniqKey="Verbeek T" first="Tjitte" last="Verbeek">Tjitte Verbeek</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author><author><name sortKey="Stant, A Dennis" sort="Stant, A Dennis" uniqKey="Stant A" first="A Dennis" last="Stant">A Dennis Stant</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author><author><name sortKey="Ormel, Johan" sort="Ormel, Johan" uniqKey="Ormel J" first="Johan" last="Ormel">Johan Ormel</name><affiliation wicri:level="3"><nlm:aff id="I3">Interdisciplinary Centre for Psychiatric Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Interdisciplinary Centre for Psychiatric Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author><author><name sortKey="Stolk, Ronald P" sort="Stolk, Ronald P" uniqKey="Stolk R" first="Ronald P" last="Stolk">Ronald P. Stolk</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author><author><name sortKey="De Jonge, Peter" sort="De Jonge, Peter" uniqKey="De Jonge P" first="Peter" last="De Jonge">Peter De Jonge</name><affiliation wicri:level="3"><nlm:aff id="I3">Interdisciplinary Centre for Psychiatric Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Interdisciplinary Centre for Psychiatric Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author><author><name sortKey="Van Pampus, Marielle G" sort="Van Pampus, Marielle G" uniqKey="Van Pampus M" first="Mariëlle G" last="Van Pampus">Mariëlle G. Van Pampus</name><affiliation wicri:level="1"><nlm:aff id="I4">Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, P.O. Box 95500, 1090 HM Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, P.O. Box 95500, 1090 HM Amsterdam</wicri:regionArea><wicri:noRegion>1090 HM Amsterdam</wicri:noRegion></affiliation></author><author><name sortKey="Burger, Huibert" sort="Burger, Huibert" uniqKey="Burger H" first="Huibert" last="Burger">Huibert Burger</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="I3">Interdisciplinary Centre for Psychiatric Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Interdisciplinary Centre for Psychiatric Epidemiology, University Medical Centre Groningen, Hanzeplein 1, 9700 RB, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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.</p></sec><sec><title>Methods/design</title><p>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%.</p><p>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.</p><p>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.</p><p>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).</p></sec><sec><title>Trial Registration</title><p>Netherlands Trial Register (NTR): <ext-link ext-link-type="uri" xlink:href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2242">NTR2242</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Murray, L" uniqKey="Murray L">L Murray</name></author><author><name sortKey="Fiori Cowley, A" uniqKey="Fiori 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Duvekot</name></author><author><name sortKey="Thornton, Jg" uniqKey="Thornton J">JG Thornton</name></author><author><name sortKey="Scherjon, Sa" uniqKey="Scherjon S">SA Scherjon</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gibbons, Rd" uniqKey="Gibbons R">RD Gibbons</name></author><author><name sortKey="Hedeker, D" uniqKey="Hedeker D">D Hedeker</name></author><author><name sortKey="Elkin, I" uniqKey="Elkin I">I Elkin</name></author><author><name sortKey="Waternaux, C" uniqKey="Waternaux C">C Waternaux</name></author><author><name sortKey="Kraemer, Hc" uniqKey="Kraemer H">HC Kraemer</name></author><author><name sortKey="Greenhouse, Jb" uniqKey="Greenhouse J">JB Greenhouse</name></author><author><name sortKey="Shea, Mt" uniqKey="Shea M">MT Shea</name></author><author><name sortKey="Imber, Sd" uniqKey="Imber S">SD Imber</name></author><author><name sortKey="Sotsky, Sm" uniqKey="Sotsky S">SM Sotsky</name></author><author><name sortKey="Watkins, Jt" uniqKey="Watkins J">JT Watkins</name></author></analytic></biblStruct></listBibl></div1></back></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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