Mother-infant Bonding in the Brain: a Mindfulness-based Intervention

Официальное название

Mother-infant Bonding in the Brain: Promoting Maternal Mental Health and High-quality Mother-infant Interactions Via a Mindfulness-based Intervention

Обзор

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.

Вмешательства

• Поведенческое "Mindful with your Baby" group-based therapist-guided intervention
  This 8-sessions long intervention is one of very few interventions that actively includes the baby in the therapy sessions. The intervention includes the following sessions: "Becoming aware of the autopilot", "Practice to really look at your baby", "Getting back in touch with yourself", "Responding sensitively to your baby", "Taking care of yourself in the difficult moments", "Distance and proximity: it's both part of it", "Dealing with expectations of yourself and the environment" and "Mindful
• Поведенческое "Mindful with your baby" self-guided online intervention
  This 8-sessions long intervention includes the following sessions: "Autopilot", "Fresh view", "At home in your body", "Responsive versus reactive parenting", "Kindness to yourself", "Distance and proximity", "Boundaries and taking care of yourself" and "Mindful parenting - day by day". The intervention is an individual self-guided online intervention.

Первичные конечные точки

• Change from baseline postpartum depressive symptoms [Срок оценки: 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 anxiety symptoms [Срок оценки: 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 parental stress [Срок оценки: 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 mother-infant bonding [Срок оценки: Before the intervention (baseline, week 0) and post-intervention (week 8)]
• Change from baseline neural synchrony between mother and infant (EEG outcome 1) [Срок оценки: Before the intervention (baseline, week 0) and post-intervention (week 8)]
• Change from baseline neural synchrony between mother and infant (EEG outcome 2) [Срок оценки: Before the intervention (baseline, week 0) and post-intervention (week 8)]

Вторичные конечные точки (9)

• Change from baseline postpartum-specific anxiety [Срок оценки: 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 worry [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Before the intervention (baseline, week 0), post-intervention (week 8) and after 10-weeks follow-up (week 18)]
• Change from baseline mindful parenting [Срок оценки: 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 parenting self-efficacy [Срок оценки: 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 [Срок оценки: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Gemelli pregnancy (or higher order pregnancy).
• Known endocrine disorder before pregnancy (diabetes-I, Rheumatoid arthritis).
• Severe psychiatric disease (schizophrenia, borderline or bipolar disorder).
• HIV.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Tilburg University — Tilburg

Идентификаторы

NCT: NCT05830266 · 222-2022-166

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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