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

7 de agosto de 2018 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

193

Estágio

  • Não aplicável

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comparador Ativo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Perceived Stress Scale 14-item
Prazo: 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
Prazo: When infant is 12 months old
Measures infant and primary caregiver attachment
When infant is 12 months old

Medidas de resultados secundários

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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Qualitative study of perceived experience of MBCP-intervention
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Eva Nissen, Professor, Karolinska Institutet

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2015

Conclusão Primária (Real)

1 de janeiro de 2017

Conclusão do estudo (Real)

1 de agosto de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

4 de maio de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de maio de 2015

Primeira postagem (Estimativa)

12 de maio de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de agosto de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de agosto de 2018

Última verificação

1 de agosto de 2018

Mais Informações

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