Clinical trial NCT02441595: Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health
Official title: Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Depression, Postpartum
Stress, Physiological
Stress, Psychological
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 193
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Perceived Stress Scale 14-item
timeFrame: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
measure: Parent Child Early Relational Assessment
timeFrame: When infant is 12 months old
Secondary outcomes:
measure: Change in Maternal heart rate variability
timeFrame: from baseline to 9 weeks (post-intervention)
measure: Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10
timeFrame: from baseline to 9 weeks (post-intervention)
measure: Change in Maternal serum levels of Brain Derived Neurotrophic Factor-s
timeFrame: from baseline to 9 weeks (post-intervention)
measure: Change in Maternal serum levels of Corticotrophin Releasing Hormone
timeFrame: from baseline to 9 weeks (post-intervention)
measure: Change in Edinburgh Postnatal Depression Scale
timeFrame: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
measure: Change in Positive States of Minds
timeFrame: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
measure: Change in Five Facets of Mindfulness
timeFrame: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
measure: Labour records
timeFrame: 1 week after giving birth
measure: Infant serum levels of the cytokines interleukin-6 and interleukin-10
timeFrame: At age 2-3 days
measure: Infant serum levels of Brain Derived Neurotrophic Factor-S
timeFrame: At age 2-3 days
measure: Infant serum levels of Corticotrophin Releasing Hormone
timeFrame: At age 2-3 days
measure: Infant Heart Rate Variability
timeFrame: At age 12 months
measure: Pregnancy Interveiw
timeFrame: Baseline measure
Other outcomes:
measure: Qualitative study of perceived experience of MBCP-intervention
timeFrame: When participants infant is 3-4 months old
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Eva Nissen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lonnberg G, Jonas W, Unternaehrer E, Branstrom R, Nissen E, Niemi M. Effects of a mindfulness based childbirth and parenting program on pregnant women's perceived stress and risk of perinatal depression-Results from a randomized controlled trial. J Affect Disord. 2020 Feb 1;262:133-142. doi: 10.1016/j.jad.2019.10.048. Epub 2019 Oct 30.
citation: Lonnberg G, Nissen E, Niemi M. What is learned from Mindfulness Based Childbirth and Parenting Education? - Participants' experiences. BMC Pregnancy Childbirth. 2018 Dec 3;18(1):466. doi: 10.1186/s12884-018-2098-1.