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

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 2026 → Jan 2027
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Record History

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  1. Primary completion pushed from Jul 2026 to Jan 2027 Show 4 more changesShow less
    • Study completion pushed from Sep 2026 to Mar 2027
    • Interventions: "Mindful with your Baby" group-based therapist-guided intervention (Behavioral), "Mindful with your baby" self-guided online intervention… to "Mindful with your Baby" group-based therapist-guided intervention (Behavioral), "Mindful with your baby" self-guided online intervention…
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 9 of 9 entries
  2. Primary completion date: Jul 2025 to Jul 2026
    • Study completion date: Sep 2025 to Sep 2026
    v4
  3. Primary completion date: May 2024 to Jul 2025
    • Study completion date: Aug 2024 to Sep 2025
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2023 to Jul 1, 2023
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Tilburg University
9 trials monitored
See 3 trials at risk
Anxiety
3,284 trials monitored
See 154 trials at risk
Depression
3,069 trials monitored
See 170 trials at risk
Postpartum Depression
199 trials monitored
See 10 trials at risk
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.
Trial Details
NCT Number NCT05830266
Lead Sponsor Tilburg University
Conditions
(from sponsor)		 Postpartum Depression, Postpartum Anxiety, Parental Stress
Related terms Depression, Postpartum
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov