Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health

Not Applicable

Completed

• Conditions: Stress, Physiological; Stress, Psychological; Depression, Postpartum; Parent-Child Relations
• Interventions: Behavioral: Psychoprophylaxis; Behavioral: MBCP

• Registration Number: NCT02441595
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Primary Completion: 2017-01
• Status Verified: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 193

Inclusion Criteria

The study is open to pregnant women in the late second or early third trimester of pregnancy who are screened with a short questionnaire: Those who report high levels of perceived stress, and/or previous mental health issues such as depression/anxiety, and/or childhood neglect are included. Participants must also speak fluent Swedish.

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Exclusion Criteria

Actively psychotic, having previous experience of mindfulness, third wave cognitive behavioral therapies, or related practices.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control condition	Psychoprophylaxis	Participants in the control condition are being offered a standardized course in psychoprophylaxis.
MBCP intervention	MBCP	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.

Primary Outcome Measures

Name	Time	Method
Change in Perceived Stress Scale 14-item	From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old	A scale measuring perception of stressful experiences during the past month
Parent Child Early Relational Assessment	When infant is 12 months old	Measures infant and primary caregiver attachment

Secondary Outcome Measures

Name	Time	Method
Change in Maternal serum levels of Brain Derived Neurotrophic Factor-s	from baseline to 9 weeks (post-intervention)
Pregnancy Interveiw	Baseline measure	Developed by Prof. Arietta Slade an interview concerning attachment to the expected child and the parents.
Infant Heart Rate Variability	At age 12 months	Examined through ECG
Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10	from baseline to 9 weeks (post-intervention)
Change in Maternal serum levels of Corticotrophin Releasing Hormone	from baseline to 9 weeks (post-intervention)
Change in Five Facets of Mindfulness	From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old	29-item scale measuring mindfulness
Infant serum levels of Brain Derived Neurotrophic Factor-S	At age 2-3 days	Levels will be analyzed from dried PKU blood spots
Change in Maternal heart rate variability	from baseline to 9 weeks (post-intervention)	Examined through ECG
Change in Edinburgh Postnatal Depression Scale	From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old	A 10-item scale measuring anxiety and depression
Change in Positive States of Minds	From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old	A six-item scale measuring different positive emotional and cognitive experiences
Infant serum levels of the cytokines interleukin-6 and interleukin-10	At age 2-3 days	Levels will be analyzed from dried PKU blood spots
Infant serum levels of Corticotrophin Releasing Hormone	At age 2-3 days	Levels will be analyzed from dried PKU blood spots
Labour records	1 week after giving birth	Labour records will be assessed as regards to labour complications and use of pain relief and labour induction