- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02441595
Mindfulness Based Childbirth and Parenting Education - RCT of Effects on Parent and Child Health (MBCP)
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Активный компаратор: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Perceived Stress Scale 14-item
Временное ограничение: 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
Временное ограничение: When infant is 12 months old
|
Measures infant and primary caregiver attachment
|
When infant is 12 months old
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Maternal heart rate variability
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: from baseline to 9 weeks (post-intervention)
|
from baseline to 9 weeks (post-intervention)
|
|
|
Change in Maternal serum levels of Corticotrophin Releasing Hormone
Временное ограничение: from baseline to 9 weeks (post-intervention)
|
from baseline to 9 weeks (post-intervention)
|
|
|
Change in Edinburgh Postnatal Depression Scale
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: At age 2-3 days
|
Levels will be analyzed from dried PKU blood spots
|
At age 2-3 days
|
|
Infant Heart Rate Variability
Временное ограничение: At age 12 months
|
Examined through ECG
|
At age 12 months
|
|
Pregnancy Interveiw
Временное ограничение: Baseline measure
|
Developed by Prof. Arietta Slade an interview concerning attachment to the expected child and the parents.
|
Baseline measure
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Qualitative study of perceived experience of MBCP-intervention
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Eva Nissen, Professor, Karolinska Institutet
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- K63103043a
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