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

7. august 2018 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

193

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Aktiv 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Perceived Stress Scale 14-item
Tidsramme: 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
Tidsramme: When infant is 12 months old
Measures infant and primary caregiver attachment
When infant is 12 months old

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Maternal heart rate variability
Tidsramme: 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
Tidsramme: 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
Tidsramme: from baseline to 9 weeks (post-intervention)
from baseline to 9 weeks (post-intervention)
Change in Maternal serum levels of Corticotrophin Releasing Hormone
Tidsramme: from baseline to 9 weeks (post-intervention)
from baseline to 9 weeks (post-intervention)
Change in Edinburgh Postnatal Depression Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At age 2-3 days
Levels will be analyzed from dried PKU blood spots
At age 2-3 days
Infant Heart Rate Variability
Tidsramme: At age 12 months
Examined through ECG
At age 12 months
Pregnancy Interveiw
Tidsramme: Baseline measure
Developed by Prof. Arietta Slade an interview concerning attachment to the expected child and the parents.
Baseline measure

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Qualitative study of perceived experience of MBCP-intervention
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Eva Nissen, Professor, Karolinska Institutet

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2015

Primær fullføring (Faktiske)

1. januar 2017

Studiet fullført (Faktiske)

1. august 2018

Datoer for studieregistrering

Først innsendt

4. mai 2015

Først innsendt som oppfylte QC-kriteriene

7. mai 2015

Først lagt ut (Anslag)

12. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

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