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Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health (MBCP)
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
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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.
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Actieve vergelijker: Control condition
Participants in the control condition are being offered a standardized course in psychoprophylaxis.
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in Perceived Stress Scale 14-item
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in Maternal heart rate variability
Tijdsspanne: 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)
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Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10
Tijdsspanne: from baseline to 9 weeks (post-intervention)
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from baseline to 9 weeks (post-intervention)
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Change in Maternal serum levels of Brain Derived Neurotrophic Factor-s
Tijdsspanne: from baseline to 9 weeks (post-intervention)
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from baseline to 9 weeks (post-intervention)
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Change in Maternal serum levels of Corticotrophin Releasing Hormone
Tijdsspanne: from baseline to 9 weeks (post-intervention)
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from baseline to 9 weeks (post-intervention)
|
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Change in Edinburgh Postnatal Depression Scale
Tijdsspanne: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
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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
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Change in Positive States of Minds
Tijdsspanne: 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
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Change in Five Facets of Mindfulness
Tijdsspanne: From baseline to 9 weeks (postintervention) and follow-ups when infant is 3, 9 and 12 months old
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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
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Labour records
Tijdsspanne: 1 week after giving birth
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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
Tijdsspanne: 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
Tijdsspanne: 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 Corticotrophin Releasing Hormone
Tijdsspanne: 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 Heart Rate Variability
Tijdsspanne: 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
Tijdsspanne: Baseline measure
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Developed by Prof. Arietta Slade an interview concerning attachment to the expected child and the parents.
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Baseline measure
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Qualitative study of perceived experience of MBCP-intervention
Tijdsspanne: 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
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Eva Nissen, Professor, Karolinska Institutet
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- K63103043a
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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Klinische onderzoeken op MBCP
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University of Wisconsin, MadisonGeschorst
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National Taipei University of Nursing and Health...OnbekendStress, psychisch | Zwangerschap gerelateerd
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BiomatlanteCIC BordeauxOnbekend
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Advanced Medical Solutions Ltd.Nog niet aan het wervenTrauma letsel | Orthopedische aandoening | Letsel aan ledematen
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Nantes University HospitalOnbekend
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BiomatlanteOnbekend