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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02441595
Acronym
MBCP
Enrollment
193
Registered
2015-05-12
Start date
2015-01-31
Completion date
2018-08-31
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALMBCP

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.

BEHAVIORALPsychoprophylaxis

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.

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Perceived Stress Scale 14-itemFrom baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months oldA scale measuring perception of stressful experiences during the past month
Parent Child Early Relational AssessmentWhen infant is 12 months oldMeasures infant and primary caregiver attachment

Secondary

MeasureTime frameDescription
Change in Maternal serum levels of Brain Derived Neurotrophic Factor-sfrom baseline to 9 weeks (post-intervention)
Change in Maternal serum levels of Corticotrophin Releasing Hormonefrom baseline to 9 weeks (post-intervention)
Change in Edinburgh Postnatal Depression ScaleFrom baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months oldA 10-item scale measuring anxiety and depression
Change in Positive States of MindsFrom baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months oldA six-item scale measuring different positive emotional and cognitive experiences
Change in Five Facets of MindfulnessFrom baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old29-item scale measuring mindfulness
Labour records1 week after giving birthLabour records will be assessed as regards to labour complications and use of pain relief and labour induction
Infant serum levels of the cytokines interleukin-6 and interleukin-10At age 2-3 daysLevels will be analyzed from dried PKU blood spots
Infant serum levels of Brain Derived Neurotrophic Factor-SAt age 2-3 daysLevels will be analyzed from dried PKU blood spots
Infant serum levels of Corticotrophin Releasing HormoneAt age 2-3 daysLevels will be analyzed from dried PKU blood spots
Infant Heart Rate VariabilityAt age 12 monthsExamined through ECG
Pregnancy InterveiwBaseline measureDeveloped by Prof. Arietta Slade an interview concerning attachment to the expected child and the parents.
Change in Maternal heart rate variabilityfrom baseline to 9 weeks (post-intervention)Examined through ECG
Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10from baseline to 9 weeks (post-intervention)

Other

MeasureTime frameDescription
Qualitative study of perceived experience of MBCP-interventionWhen participants infant is 3-4 months oldIndividual in-depth interviews regarding the participants experiences of MBCP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026