NL-OMON33601
Withdrawn
Not Applicable
Pregnancy Outcomes after Maternity Intervention for Stressful EmotionS - study(PROMISES) - Maternity intervention for stressful emotions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- 10037173
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 300
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnant women with a significant level of anxiety (6 item STAI \>\<\=42\) or at least moderate depressive symptoms (Edinburgh Postnatal Depression Scale \>\<\=12\) will be included in the trial.
Exclusion Criteria
- •Women fulfilling one or more of the following criteria will be excluded from participation:
- •1\. Multiple pregnancy. We decided to exclude women with multiple pregnancies 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
- •4\. Substantial physical disease or illegal substance abuse
- •5\. No mastery of the Dutch language
Outcomes
Primary Outcomes
Not specified
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