- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02441595
Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health (MBCP)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Perceived Stress Scale 14-item
Délai: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
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A scale measuring perception of stressful experiences during the past month
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From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
|
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Parent Child Early Relational Assessment
Délai: When infant is 12 months old
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Measures infant and primary caregiver attachment
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When infant is 12 months old
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Maternal heart rate variability
Délai: from baseline to 9 weeks (post-intervention)
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Examined through ECG
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from baseline to 9 weeks (post-intervention)
|
|
Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10
Délai: 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
Délai: from baseline to 9 weeks (post-intervention)
|
from baseline to 9 weeks (post-intervention)
|
|
|
Change in Maternal serum levels of Corticotrophin Releasing Hormone
Délai: from baseline to 9 weeks (post-intervention)
|
from baseline to 9 weeks (post-intervention)
|
|
|
Change in Edinburgh Postnatal Depression Scale
Délai: 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
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From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
|
|
Change in Positive States of Minds
Délai: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
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A six-item scale measuring different positive emotional and cognitive experiences
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From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
|
|
Change in Five Facets of Mindfulness
Délai: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
|
29-item scale measuring mindfulness
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From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
|
|
Labour records
Délai: 1 week after giving birth
|
Labour records will be assessed as regards to labour complications and use of pain relief and labour induction
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1 week after giving birth
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Infant serum levels of the cytokines interleukin-6 and interleukin-10
Délai: At age 2-3 days
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Levels will be analyzed from dried PKU blood spots
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At age 2-3 days
|
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Infant serum levels of Brain Derived Neurotrophic Factor-S
Délai: 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
Délai: At age 2-3 days
|
Levels will be analyzed from dried PKU blood spots
|
At age 2-3 days
|
|
Infant Heart Rate Variability
Délai: At age 12 months
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Examined through ECG
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At age 12 months
|
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Pregnancy Interveiw
Délai: Baseline measure
|
Developed by Prof. Arietta Slade an interview concerning attachment to the expected child and the parents.
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Baseline measure
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Qualitative study of perceived experience of MBCP-intervention
Délai: When participants infant is 3-4 months old
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Individual in-depth interviews regarding the participants experiences of MBCP
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When participants infant is 3-4 months old
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Eva Nissen, Professor, Karolinska Institutet
Publications et liens utiles
Publications générales
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- K63103043a
Plan pour les données individuelles des participants (IPD)
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