Pregnancy And Infancy Reduced Stress (PAIRS)study.

Recruiting

Conditions: Participants have at least moderate levels of stress and/or pregnancy related anxietyStress
pregnancy related anxietyStress
zwangerschapsgerelateerde angst

Registration Number: NL-OMON21785

Lead Sponsor: Faculty of Psychology & Education,Dept. of Developmental Psychology,VU University, Van der Boechorststraat 1, 1081BT Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 480

Inclusion Criteria

Study 1:

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 (mean score derived from Cohen & Janicki-Deverts, 2012), or a score of 21 or higher on the PRAQ-R (mean score derived from unpublished data from the Generations2 study of VU university).

Exclusion Criteria

Study 1:

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., betablockers), (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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study 1:<br /><br>(a) Perceived stress, anxiety and well-being (pregnant women and their partners) assessed by means of self-report on validated questionnaires; stress physiology of parameters of the autonomic nervous system (e.g. heart rate, heart rate variability, pre-ejection period, respiratory sinus arrhythmia, skin conductance responses) as measured by basal functioning and by responses to a standardized stress task; (b) Medical complications during pregnancy; birth outcomes for the mother and child with regard to: gestational age, birth weight, APGAR scores (1-5 minutes), method of delivery, complications; (c) Infant behaviour and development: sleep patterns, feeding patterns, crying, infant temperament, motor and mental development.

Secondary Outcome Measures

Name	Time	Method
Study 2:<br /><br>HRV biofeedback parameters (e.g. heart rate, heart rate variability, RSA); perceived stress, anxiety and well-being assessed by means of self-report on validated questionnaires; diverted attention