- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02441595
Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health (MBCP)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Perceived Stress Scale 14-item
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Maternal heart rate variability
Lasso di tempo: 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)
|
|
Change in Maternal serum levels of cytokines interleukin-6 and interleukin-10
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: from baseline to 9 weeks (post-intervention)
|
from baseline to 9 weeks (post-intervention)
|
|
|
Change in Edinburgh Postnatal Depression Scale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At age 2-3 days
|
Levels will be analyzed from dried PKU blood spots
|
At age 2-3 days
|
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Infant serum levels of Corticotrophin Releasing Hormone
Lasso di tempo: At age 2-3 days
|
Levels will be analyzed from dried PKU blood spots
|
At age 2-3 days
|
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Infant Heart Rate Variability
Lasso di tempo: 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
Lasso di tempo: Baseline measure
|
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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Qualitative study of perceived experience of MBCP-intervention
Lasso di tempo: When participants infant is 3-4 months old
|
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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Eva Nissen, Professor, Karolinska Institutet
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Primo Inserito (Stima)
Aggiornamenti dei record di studio
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Maggiori informazioni
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- K63103043a
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