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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parent-Child Relations Depression, Postpartum Stress, Physiological Stress, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MBCP intervention

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.

Group Type EXPERIMENTAL

MBCP

Intervention Type BEHAVIORAL

Eight weekly sessions 2,5 h and homework 30 min/day. Practicing various mindfulness meditations coupled with practical skills and theory of birthing and parenting.

Control condition

Participants in the control condition are being offered a standardized course in psychoprophylaxis.

Group Type ACTIVE_COMPARATOR

Psychoprophylaxis

Intervention Type BEHAVIORAL

Three sessions 3h each, and practices to do at home. Practical skills of relaxation and breathing techniques for labor as well as knowledge of birthing and parenting.

Interventions

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MBCP

Eight weekly sessions 2,5 h and homework 30 min/day. Practicing various mindfulness meditations coupled with practical skills and theory of birthing and parenting.

Intervention Type BEHAVIORAL

Psychoprophylaxis

Three sessions 3h each, and practices to do at home. Practical skills of relaxation and breathing techniques for labor as well as knowledge of birthing and parenting.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No