Mother-infant Bonding in the Brain: Promoting Maternal Mental Health and High-quality Mother-infant Interactions Via a Mindfulness-based Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change from baseline postpartum anxiety symptoms
研究概览
简要总结
The study investigates the effectiveness of the mindfulness-based intervention "Mindful with your Baby" in women with babies between 5-9 months postpartum who experience heightened levels of postpartum depression, anxiety and/or parental stress. The intervention "Mindful with your Baby" is one of the very few interventions for maternal postnatal mental health issues that takes the bond between mother and infant into account. It is hypothesized that the "Mindful with your Baby" intervention will reduce levels of postpartum depression, anxiety and parental stress, and improve mother-infant behavioral interaction and increase neural synchrony between mother and infant brains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women (18+y).
- •First antenatal visit < 12 weeks.
- •Score above cut off on the Edinburgh Postnatal Depression Scale (EPDS), the anxiety subscale of the Symptom Checklist (SCL-90) and/or the Parental Stress Questionnaire (PSQ) at 8-10 weeks postpartum.
- •Dutch-speaking or understanding Dutch.
排除标准
- •Gemelli pregnancy (or higher order pregnancy).
- •Known endocrine disorder before pregnancy (diabetes-I, Rheumatoid arthritis).
- •Severe psychiatric disease (schizophrenia, borderline or bipolar disorder).
- •Drug or alcohol addiction problems.
- •Any other disease resulting in treatment with drugs that are potentially adverse for the fetus and need careful follow-up during pregnancy.
- •No access to the internet.
结局指标
主要结局
Change from baseline postpartum anxiety symptoms
时间窗: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
Assessed with the 10-item anxiety subscale of the Symptom Checklist (SCL-90). The total scores range from 10 to 50 and higher scores reflect more anxiety symptoms. The questionnaire has showed good reliability and validity in non-pregnant samples.
Change from baseline mother-infant bonding
时间窗: Before the intervention (baseline, week 0) and post-intervention (week 8)
Assessed with video coding
Change from baseline neural synchrony between mother and infant (EEG outcome 2)
时间窗: Before the intervention (baseline, week 0) and post-intervention (week 8)
Assessed with dual-EEG, with the Phase Locking Value (PLV) in the alpha band frequency (6-9 Hz) during the still face paradigm. We expect that neural synchrony between mother and infant will increase (more) in the intervention group.
Change from baseline postpartum depressive symptoms
时间窗: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
Assessed with the 10-item Edinburgh Postnatal Depression Scale (EPDS). The EPDS is the most widely used self-rating scale to assess depressive symptoms in the perinatal period. The EPDS total score ranges from 0 to 30, with higher scores indicating more depressive symptoms. The questionnaire has been validated in Dutch postpartum women.
Change from baseline parental stress
时间窗: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
Assessed with the Parental Stress Questionnaire (PSQ, in Dutch: Opvoedingsbelastingvragenlijst), which is based on the Parenting Stress Index. This study uses only the first three subscales related to parenting: parent-child relationship problems, parenting problems and parental role restriction. Total scores range from 19 to 76 with higher scores indicating more parental stress. In order to interpret the level of parental stress experienced, subscale scores are converted into T-scores conform the norms of the child's age (e.g., 0 to 3 years). The questionnaire and subscales have showed good reliability and validity.
Change from baseline neural synchrony between mother and infant (EEG outcome 1)
时间窗: Before the intervention (baseline, week 0) and post-intervention (week 8)
Assessed with dual-EEG, with the Phase Locking Value (PLV) in the alpha band frequency (6-9 Hz) during the free play task. We expect that neural synchrony between mother and infant will increase (more) in the intervention group.
次要结局
- Change from baseline worry(before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18))
- Change from baseline mindfulness skills(before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18))
- Change from baseline postpartum-specific anxiety(before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18))
- Change from baseline infant temperament(Before the intervention (baseline, week 0), post-intervention (week 8) and after 10-weeks follow-up (week 18))
- Change from baseline parenting self-efficacy(before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18))
- Change from baseline personal goal(before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18))
- Change from baseline self-compassion(before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18))
- Change from baseline bonding(before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18))
- Change from baseline mindful parenting(before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18))
研究者
Marion van den Heuvel
Principal Investigator
Tilburg University