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

7. August 2018 aktualisiert von: Gunilla Lönnberg, Karolinska Institutet
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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

193

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: MBCP intervention
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.
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.
Aktiver Komparator: Control condition
Participants in the control condition are being offered a standardized course in 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Perceived Stress Scale 14-item
Zeitfenster: 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
From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Parent Child Early Relational Assessment
Zeitfenster: When infant is 12 months old
Measures infant and primary caregiver attachment
When infant is 12 months old

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Maternal heart rate variability
Zeitfenster: from baseline to 9 weeks (post-intervention)
Examined through ECG
from baseline to 9 weeks (post-intervention)
Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10
Zeitfenster: from baseline to 9 weeks (post-intervention)
from baseline to 9 weeks (post-intervention)
Change in Maternal serum levels of Brain Derived Neurotrophic Factor-s
Zeitfenster: from baseline to 9 weeks (post-intervention)
from baseline to 9 weeks (post-intervention)
Change in Maternal serum levels of Corticotrophin Releasing Hormone
Zeitfenster: from baseline to 9 weeks (post-intervention)
from baseline to 9 weeks (post-intervention)
Change in Edinburgh Postnatal Depression Scale
Zeitfenster: 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
From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Change in Positive States of Minds
Zeitfenster: 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
From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Change in Five Facets of Mindfulness
Zeitfenster: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
29-item scale measuring mindfulness
From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
Labour records
Zeitfenster: 1 week after giving birth
Labour records will be assessed as regards to labour complications and use of pain relief and labour induction
1 week after giving birth
Infant serum levels of the cytokines interleukin-6 and interleukin-10
Zeitfenster: At age 2-3 days
Levels will be analyzed from dried PKU blood spots
At age 2-3 days
Infant serum levels of Brain Derived Neurotrophic Factor-S
Zeitfenster: At age 2-3 days
Levels will be analyzed from dried PKU blood spots
At age 2-3 days
Infant serum levels of Corticotrophin Releasing Hormone
Zeitfenster: At age 2-3 days
Levels will be analyzed from dried PKU blood spots
At age 2-3 days
Infant Heart Rate Variability
Zeitfenster: At age 12 months
Examined through ECG
At age 12 months
Pregnancy Interveiw
Zeitfenster: Baseline measure
Developed by Prof. Arietta Slade an interview concerning attachment to the expected child and the parents.
Baseline measure

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Qualitative study of perceived experience of MBCP-intervention
Zeitfenster: When participants infant is 3-4 months old
Individual in-depth interviews regarding the participants experiences of MBCP
When participants infant is 3-4 months old

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Eva Nissen, Professor, Karolinska Institutet

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2015

Primärer Abschluss (Tatsächlich)

1. Januar 2017

Studienabschluss (Tatsächlich)

1. August 2018

Studienanmeldedaten

Zuerst eingereicht

4. Mai 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2015

Zuerst gepostet (Schätzen)

12. Mai 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. August 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. August 2018

Zuletzt verifiziert

1. August 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

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