NCT05830266 Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
| NCT ID | NCT05830266 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tilburg University |
| Condition | Postpartum Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2023-07-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Marion I van den Heuvel, PhD
PRINCIPAL INVESTIGATOR
Tilburg University
Frequently Asked Questions
Who can join the NCT05830266 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postpartum Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05830266 currently recruiting?
Yes, NCT05830266 is actively recruiting participants. Contact the research team at m.i.vdnheuvel@tilburguniversity.edu for enrollment information.
Where is the NCT05830266 trial being conducted?
This trial is being conducted at Tilburg, Netherlands.
Who is sponsoring the NCT05830266 clinical trial?
NCT05830266 is sponsored by Tilburg University. The principal investigator is Marion I van den Heuvel, PhD at Tilburg University. The trial plans to enroll 64 participants.
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