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Clinical Trials/NL-OMON33601
NL-OMON33601
Withdrawn
Not Applicable

Pregnancy Outcomes after Maternity Intervention for Stressful EmotionS - study(PROMISES) - Maternity intervention for stressful emotions

niversitair Medisch Centrum Groningen0 sites300 target enrollmentTBD

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Withdrawn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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

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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