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

Stress, Psychological Clinical Trial

— MBCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441595
• Other study ID #: K63103043a
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: August 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative study of perceived experience of MBCP-intervention	Individual in-depth interviews regarding the participants experiences of MBCP	When participants infant is 3-4 months old
Primary	Change in Perceived Stress Scale 14-item	A scale measuring perception of stressful experiences during the past month	From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Primary	Parent Child Early Relational Assessment	Measures infant and primary caregiver attachment	When infant is 12 months old
Secondary	Change in Maternal heart rate variability	Examined through ECG	from baseline to 9 weeks (post-intervention)
Secondary	Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10		from baseline to 9 weeks (post-intervention)
Secondary	Change in Maternal serum levels of Brain Derived Neurotrophic Factor-s		from baseline to 9 weeks (post-intervention)
Secondary	Change in Maternal serum levels of Corticotrophin Releasing Hormone		from baseline to 9 weeks (post-intervention)
Secondary	Change in Edinburgh Postnatal Depression Scale	A 10-item scale measuring anxiety and depression	From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Secondary	Change in Positive States of Minds	A six-item scale measuring different positive emotional and cognitive experiences	From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Secondary	Change in Five Facets of Mindfulness	29-item scale measuring mindfulness	From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Secondary	Labour records	Labour records will be assessed as regards to labour complications and use of pain relief and labour induction	1 week after giving birth
Secondary	Infant serum levels of the cytokines interleukin-6 and interleukin-10	Levels will be analyzed from dried PKU blood spots	At age 2-3 days
Secondary	Infant serum levels of Brain Derived Neurotrophic Factor-S	Levels will be analyzed from dried PKU blood spots	At age 2-3 days
Secondary	Infant serum levels of Corticotrophin Releasing Hormone	Levels will be analyzed from dried PKU blood spots	At age 2-3 days
Secondary	Infant Heart Rate Variability	Examined through ECG	At age 12 months
Secondary	Pregnancy Interveiw	Developed by Prof. Arietta Slade an interview concerning attachment to the expected child and the parents.	Baseline measure