Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Mindfulness intervention for mothers and infants

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

Run by Tilburg University · NCT05830266 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment64 (estimated)
SponsorTilburg University
Academic / other
Locations1 site (Tilburg, North Brabant)
StatusRecruiting
StartedJuly 1, 2023
Main results expectedJanuary 2027
Study endsMarch 2027
Registry record updatedOctober 15, 2026
Trial IDNCT05830266 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While mindfulness interventions have shown promise in other contexts, this specific approach focusing on mother-infant bonding is relatively novel.

Who can join: the full rules

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 it's running

  • Tilburg University
    Tilburg, North Brabant, Netherlands
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.