Mindfulness intervention for mothers and infants
Mother-infant Bonding in the Brain: Promoting Maternal Mental Health and High-quality Mother-infant Interactions Via a Mindfulness-based Intervention
This study tests if a mindfulness program for mothers and their babies can help reduce postpartum depression and anxiety while strengthening their bond.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Tilburg University Academic / other |
| Locations | 1 site (Tilburg, North Brabant) |
| Trial ID | NCT05830266 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a mindfulness-based intervention called 'Mindful with your Baby' for women experiencing postpartum depression, anxiety, and parental stress. The intervention is designed for mothers with infants aged 5-9 months and aims to enhance the mother-infant bond while reducing mental health issues. Participants will engage in both group-based therapist-guided sessions and self-guided online activities. The study hypothesizes that this approach will improve behavioral interactions and neural synchrony between mothers and their infants.
Who should consider this trial
Good fit: Ideal candidates are Dutch-speaking women aged 18 and older who are experiencing postpartum depression, anxiety, or parental stress after having a baby between 5-9 months old.
Not a fit: Patients with severe psychiatric disorders, substance abuse issues, or those who do not have internet access may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health of postpartum women and strengthen the bond with their infants.
How similar studies have performed: While mindfulness interventions have shown promise in other contexts, this specific approach focusing on mother-infant bonding is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tilburg, North Brabant
- Tilburg University — Tilburg, North Brabant, Netherlands (Recruiting)
Study contacts
- Principal investigator: Marion I van den Heuvel, PhD — Tilburg University
- Study coordinator: Marion I van den Heuvel, PhD
- Email: m.i.vdnheuvel@tilburguniversity.edu
- Phone: +31134664085
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.