Stress, Psychological Clinical Trial
Official title:
Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health
The purpose of this study is to explore if an intervention using Mindfulness Based Childbirth and Parenting education (MBCP) targeted to stressed pregnant women is effective in: 1) reducing prenatal stress, 2) preventing perinatal maternal mental ill-health, 3) preparing the mother for labor and 4) promoting positive infant-caregiver attachment.
Sample: Pregnant women experiencing high levels of stress, and/or who previously have had
periods of depression or anxiety, and/or who have had some childhood neglect, will be
eligible for the study. A sample of 170 mothers and their partners recruited from antenatal
clinics in Stockholm will be asked to participate. The participants in the study will be
randomized to either treatment or control intervention. The study uses an experimental design
with assessments at baseline and post-intervention as well as follow-ups at 3, 9 and 15
months post-partum. The intervention involves eight 2.5 h weekly group sessions in which
exercises in mindfulness are practiced and associated theory is taught to increase
metacognition, emotional regulation and body awareness. Participants in the control condition
are being offered a standardized course in psychoprophylaxis.
Measurements - parental outcomes PSYCHOLOGICAL FUNCTIONING - 10 item Perceived Stress Scale
[10]. Edinburgh Postnatal Depression Scale [11]. Positive States of Minds [12].
INTERVENTION ADHERENCE - Questions to assess intervention adherence. PHYSIOLOGICAL
ASSESSMENTS - Heart Rate Variability (HRV) will be examined through ECG. The investigators
hypothesize that the intervention will increase HRV in the pregnant women, thus providing an
objective measure of stress. The investigators will test if women who receive the
intervention during pregnancy have lower serum levels of the cytokines interleukin-6 and
interleukin-10, Brain Derived Neurotrophic Factor-s, and Corticotrophin Releasing Hormone
compared to the control group - physiological components that influence the fetus and are
associated with immune response, hypothalamic-pituitary-adrenal axis functions,
stress-related mood disorders and preterm delivery [13-16].
LABOUR - Labour records will be gathered from all participants.
Measurements - infants PHYSIOLOGICAL ASSESSMENTS - Heart Rate Variability (HRV) examined
through ECG at 15 months of age. The investigators hypothesize that increased maternal HRV in
the pregnancy will be associated with increased infant HRV. The investigators will also test
if infants whose mothers have received the intervention have lower serum levels of the
cytokines interleukin-6 and interleukin-10, Brain Derived Neurotrophic Factor-S, and
Corticotrophin Releasing Hor-mone: Levels will be analyzed from PKU blood spots, routinely
collected 3-4 days after birth.
INFANT SOCIAL AND EMOTIONAL FUNCTIONING - The attachment style of the infants will be
assessed at age 15 months, using the standard Parent-Child Early Relational Assessment
developed by Clark [17].
Data analysis: Appropriate methods will be applied to describe the sample. Hypothesis will be
tested by multivariate repeated measures analysis of covariance (MANCOVA) with perceived
stress as the primary outcome.
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