- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02441595
Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health (MBCP)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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.
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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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Comparador activo: 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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¿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
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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
Periodo de tiempo: 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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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)
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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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
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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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eva Nissen, Professor, Karolinska Institutet
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- K63103043a
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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