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Clinical Trials/NL-OMON40370
NL-OMON40370
Completed
Not Applicable

Pregnancy And Infancy Reduced Stress study - PAIRS study

Vrije Universiteit0 sites560 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Verhoogd risico op stress en stressgerelateerde klachten
Sponsor
Vrije Universiteit
Enrollment
560
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria: The pregnant women should be \>18 years of age, and \<22 weeks pregnant. They should have at least moderate levels of prenatal stress, determined by a score of 22 or higher on the PSS, or a score of 21 or higher on the PRAQ\-R.;Study 2:
  • In order to be eligible to participate in this study, a subject must meet all of the following criteria: For pregnant women see \*Study 1\* above. The non\-pregnant women need to have comparable ages, relevant for matching purposes, and should have at least moderate levels of stress, determined by a score of 22 or higher on the PSS.

Exclusion Criteria

  • A potential subject (pregnant woman) who meets any of the following criteria will be excluded from participation in this study: (1\) chronic medical conditions such as Diabetes, (2\) use of medication which is known to affect cardiovascular stress reactivity measures (e.g., \* blockers), (3\) substance abuse, (4\) insufficient command of the Dutch language required to fill out questionnaires, (5\) a score of 16 or higher on the depression scale of the HADS (cut\-off score for severe depression), and (6\) presence of a history of other severe mental disorders, such as Bipolar disorder or Schizophrenia.;If the partner of the pregnant woman meets any of the following criteria, the couple will be excluded from participation in this study: (1\) presence of a history of other severe mental disorders, such as Bipolar disorder or Schizophrenia, (2\) substance abuse, (3\) insufficient command of the Dutch language required to fill out questionnaires.;Study 2
  • See exclusion criteria women of study 1\.

Outcomes

Primary Outcomes

Not specified

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