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Life sciences · Interventional Study
ClinicalTrials.gov · October 15, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05830266). This is a study registration, not published results. Lead sponsor: Tilburg University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 64 participants (ESTIMATED). Conditions: Postpartum Depression, Postpartum Anxiety, Parental Stress. Interventions: BEHAVIORAL: "Mindful with your Baby" group-based therapist-guided intervention; BEHAVIORAL: "Mindful with your baby" self-guided online intervention. Primary outcome measures: Change from baseline postpartum depressive symptoms , 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 , 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 , 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 , Before the intervention (baseline, week 0) and post-intervention (week 8); Change from baseline neural synchrony between mother and infant (EEG outcome 1) , Before the intervention (baseline, week 0) and post-intervention (week 8); Change from baseline neural synchrony between mother and infant (EEG outcome 2) , Before the intervention (baseline, week 0) and post-intervention (week 8). Brief summary: 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.