Skip to main content
OpenTrials
Completed

NCT Number: NCT02441595

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

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

Treatment and study plan

MBCP

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.

Psychoprophylaxis

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.

Primary outcomes

  1. Change in Perceived Stress Scale 14-item

    Time frame: 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

  2. Parent Child Early Relational Assessment

    Time frame: When infant is 12 months old

    Measures infant and primary caregiver attachment

Secondary outcomes

  1. Change in Maternal heart rate variability

    Time frame: from baseline to 9 weeks (post-intervention)

    Examined through ECG

  2. Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10

    Time frame: from baseline to 9 weeks (post-intervention)

  3. Change in Maternal serum levels of Brain Derived Neurotrophic Factor-s

    Time frame: from baseline to 9 weeks (post-intervention)

  4. Change in Maternal serum levels of Corticotrophin Releasing Hormone

    Time frame: from baseline to 9 weeks (post-intervention)

  5. Change in Edinburgh Postnatal Depression Scale

    Time frame: 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

  6. Change in Positive States of Minds

    Time frame: 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

  7. Change in Five Facets of Mindfulness

    Time frame: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old

    29-item scale measuring mindfulness

  8. Labour records

    Time frame: 1 week after giving birth

    Labour records will be assessed as regards to labour complications and use of pain relief and labour induction

  9. Infant serum levels of the cytokines interleukin-6 and interleukin-10

    Time frame: At age 2-3 days

    Levels will be analyzed from dried PKU blood spots

  10. Infant serum levels of Brain Derived Neurotrophic Factor-S

    Time frame: At age 2-3 days

    Levels will be analyzed from dried PKU blood spots

  11. Infant serum levels of Corticotrophin Releasing Hormone

    Time frame: At age 2-3 days

    Levels will be analyzed from dried PKU blood spots

  12. Infant Heart Rate Variability

    Time frame: At age 12 months

    Examined through ECG

  13. Pregnancy Interveiw

    Time frame: Baseline measure

    Developed by Prof. Arietta Slade an interview concerning attachment to the expected child and the parents.

Other outcomes

  1. Qualitative study of perceived experience of MBCP-intervention

    Time frame: When participants infant is 3-4 months old

    Individual in-depth interviews regarding the participants experiences of MBCP

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Acronym: MBCP

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 12, 2015
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.