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

PRegnancy Outcomes after Maternity Intervention for Stressful EmotionS.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29057
Enrollment
300
Registered
2010-03-15
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

negative emotions fetal programming cognitive behaviour therapy pregnancy outcome negatieve emoties (angst en depressie) prenatale programmering cognitieve gedragstherapie zwangerschapsuitkomst

Interventions

The 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 psychologi

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Having at least moderate depression and/or anxiety symptoms during pregnancy.

Exclusion criteria

Exclusion criteria: Women 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Contacts

Public ContactJ.L. Meijer

Hanzeplein 1

j.l.meijer@epi.umcg.nl+31 (0)50 3611450

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)