NL-OMON33601WithdrawnNot Applicable
Pregnancy Outcomes after Maternity Intervention for Stressful EmotionS - study(PROMISES) - Maternity intervention for stressful emotions
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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