Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

7 de agosto de 2018 actualizado 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.

Descripción general del estudio

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

193

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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 activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Perceived Stress Scale 14-item
Periodo de tiempo: 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
Periodo de tiempo: When infant is 12 months old
Measures infant and primary caregiver attachment
When infant is 12 months old

Medidas de resultado secundarias

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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Qualitative study of perceived experience of MBCP-intervention
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Eva Nissen, Professor, Karolinska Institutet

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2015

Finalización primaria (Actual)

1 de enero de 2017

Finalización del estudio (Actual)

1 de agosto de 2018

Fechas de registro del estudio

Enviado por primera vez

4 de mayo de 2015

Primero enviado que cumplió con los criterios de control de calidad

7 de mayo de 2015

Publicado por primera vez (Estimar)

12 de mayo de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de agosto de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

7 de agosto de 2018

Última verificación

1 de agosto de 2018

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre MBCP

3
Suscribir