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Study on the development of children, whose mothers were treated for their anxious and/or depressed complaints during pregnancy.


- candidate number7837
- NTR NumberNTR2242
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-mrt-2010
- Secondary IDs120520013 ZonMW
- Public TitleStudy on the development of children, whose mothers were treated for their anxious and/or depressed complaints during pregnancy.
- Scientific TitlePRegnancy Outcomes after Maternity Intervention for Stressful EmotionS.
- ACRONYMPROMISES
- hypothesisThere 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. To date, however, 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.
- Healt Condition(s) or Problem(s) studiedDepression, Anxiety, Cognitive behavior therapy, Pregnancy outcome, Fetal programming, Negative emotions
- Inclusion criteriaHaving at least moderate depression and/or anxiety symptoms during pregnancy.
- Exclusion criteriaWomen fulfilling one or more of the following criteria will be excluded from participation:
1. Multiparae pregnant women. We decided to exclude multiparae pregnant women as they have a markedly increased obstetric risk; inclusion will threaten the homogeneity of the study population and thereby decrease the sensitivity to detect effects;
2. High suicidal risk according to the suicidality subscale score on the MINI (defined as a positive response on the question on concrete suicide plans);
3. Presently receiving psychotherapy at a higher than twice a month rate;
4. Substantial physical disease or illegal substance abuse.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2013
- Target number of participants300
- InterventionsThe cognitive behavioral therapy consists of 10-14 individual sessions, 6-10 sessions during pregnancy and 4-8 sessions after delivery (once a week). The CBT will be conducted by registered psychologists, specialized in conducting CBT.
The first session will focus on the rationale of cognitive behavioral therapy, i.e. the influence of (irrational or dysfunctional) cognitions and attitudes on feelings and behaviors. Additionally, goal setting will be initiated. These therapy goals will be unique for each patient. Subsequent sessions will be targeted at identifying and amending irrational cognitions and attitudes related to pregnancy, delivery, concerns about the (unborn) child and the future family situation. Each session will address specific pregnancy-related cognitions. Additionally, patients will be taught how dysfunctional cognitions and attitudes affect adversely feelings and behaviors. These dysfunctional cognitions and attitudes will be challenged and replaced by functional cognitions and attitudes. After each session, patients will be given home work. For example, patients will be asked to register negative experiences, and accompanying cognitions, feelings and behaviors. Finally, in the last two to four sessions, the newly learned cognitions and attitudes will be consolidated.

The control group will receive care as usual. They will be given the advice to contact their general practitioner, who will provide care towards own insight.
- Primary outcomeBehavioral/emotional problems at age 1.5 as assessed by the total problems scale of the Child Behavior Check List 1.5 – 5 years.
- Secondary outcome1. Mental, psychomotor and behavioral development of the child at age 18 months according to the Bayley scales;
2. Maternal anxiety and depression during pregnancy and 6 weeks postnatal;
3. Maternal attachment style;
4. Neonatal outcomes: birth weight, gestational age and Apgar score;
5. Health care consumption and general health status (economic evaluation).
- Timepoints1. Baseline (12 weeks gestation);
2. 24 weeks of gestation;
3. 36 weeks of gestation;
4. 6 weeks postpartum;
5. 6 months postpartum;
6. 12 months postpartum;
7. 18 months postpartum.
- Trial web sitewww.promises-onderzoek.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. J.L. Meijer
- CONTACT for SCIENTIFIC QUERIESMSc. J.L. Meijer
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryRationale:
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. To date, however, 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.

Objective:
To assess the effects of Cognitive Behavioral Therapy (CBT) in pregnant women with symptoms of anxiety or depression on the child’s behavioral/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 CBT relative to usual care.

Study design:
Randomized controlled trial.

Study population:
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 CBCL 1.5-5 with alpha 5% and power (1-beta) 80%.

Intervention:
10-14 individual CBT sessions, 6-10 sessions during pregnancy and 4-8 sessions after delivery (once a week), or care as usual.

Main study parameters/endpoints:
Primary:
1. Behavioral/emotional problems at age 1.5 as assessed by the total problems scale of the Child Behavior Check List 1.5 – 5 years.
Secondary:
1. Mental, psychomotor and behavioral development of the child at age 18 months according to the Bayley scales;
2. Maternal anxiety and depression during pregnancy and 6 weeks postnatal;
3. Maternal attachment style;
4. Neonatal outcomes: birth weight, gestational age and Apgar score;
5. Health care consumption and general health status (economic evaluation).
- Main changes (audit trail)
- RECORD15-mrt-2010 - 29-mrt-2010


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