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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MBCP
Psychoprophylaxis
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parent-Child Relations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MBCP intervention

    Control condition

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Change in Perceived Stress Scale 14-item
    A scale measuring perception of stressful experiences during the past month
    Parent Child Early Relational Assessment
    Measures infant and primary caregiver attachment

    Secondary Outcome Measures

    Change in Maternal heart rate variability
    Examined through ECG
    Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10
    Change in Maternal serum levels of Brain Derived Neurotrophic Factor-s
    Change in Maternal serum levels of Corticotrophin Releasing Hormone
    Change in Edinburgh Postnatal Depression Scale
    A 10-item scale measuring anxiety and depression
    Change in Positive States of Minds
    A six-item scale measuring different positive emotional and cognitive experiences
    Change in Five Facets of Mindfulness
    29-item scale measuring mindfulness
    Labour records
    Labour 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-10
    Levels will be analyzed from dried PKU blood spots
    Infant serum levels of Brain Derived Neurotrophic Factor-S
    Levels will be analyzed from dried PKU blood spots
    Infant serum levels of Corticotrophin Releasing Hormone
    Levels will be analyzed from dried PKU blood spots
    Infant Heart Rate Variability
    Examined through ECG
    Pregnancy Interveiw
    Developed by Prof. Arietta Slade an interview concerning attachment to the expected child and the parents.

    Full Information

    First Posted
    May 4, 2015
    Last Updated
    August 7, 2018
    Sponsor
    Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02441595
    Brief Title
    Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health
    Acronym
    MBCP
    Official Title
    Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    August 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parent-Child Relations, Depression, Postpartum, Stress, Physiological, Stress, Psychological

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    193 (Actual)

    8. Arms, Groups, and Interventions

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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eva Nissen, Professor
    Organizational Affiliation
    Karolinska Institutet
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31733457
    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.
    Results Reference
    derived
    PubMed Identifier
    30509218
    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.
    Results Reference
    derived

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