Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
NCT ID: NCT05830266
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2023-07-01
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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"Mindful with your Baby" group-based therapist-guided intervention (Intervention group)
Group-based "Mindful with your Baby" therapist-guided intervention via a video-conferencing tool (e.g., Zoom).
"Mindful with your Baby" group-based therapist-guided intervention
This 8-sessions long intervention is one of very few interventions that actively includes the baby in the therapy sessions. The intervention includes the following sessions: "Becoming aware of the autopilot", "Practice to really look at your baby", "Getting back in touch with yourself", "Responding sensitively to your baby", "Taking care of yourself in the difficult moments", "Distance and proximity: it's both part of it", "Dealing with expectations of yourself and the environment" and "Mindful parenting: trial and error". The intervention is a group-based therapist-guided intervention via a video-conferencing tool (e.g., Zoom).
"Mindful with your baby" self-guided online intervention (Waitlist control group)
The waitlist control group receives an individual self-guided online "Mindful with your baby" intervention after a 10-week waiting period.
"Mindful with your baby" self-guided online intervention
This 8-sessions long intervention includes the following sessions: "Autopilot", "Fresh view", "At home in your body", "Responsive versus reactive parenting", "Kindness to yourself", "Distance and proximity", "Boundaries and taking care of yourself" and "Mindful parenting - day by day". The intervention is an individual self-guided online intervention.
Interventions
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"Mindful with your Baby" group-based therapist-guided intervention
This 8-sessions long intervention is one of very few interventions that actively includes the baby in the therapy sessions. The intervention includes the following sessions: "Becoming aware of the autopilot", "Practice to really look at your baby", "Getting back in touch with yourself", "Responding sensitively to your baby", "Taking care of yourself in the difficult moments", "Distance and proximity: it's both part of it", "Dealing with expectations of yourself and the environment" and "Mindful parenting: trial and error". The intervention is a group-based therapist-guided intervention via a video-conferencing tool (e.g., Zoom).
"Mindful with your baby" self-guided online intervention
This 8-sessions long intervention includes the following sessions: "Autopilot", "Fresh view", "At home in your body", "Responsive versus reactive parenting", "Kindness to yourself", "Distance and proximity", "Boundaries and taking care of yourself" and "Mindful parenting - day by day". The intervention is an individual self-guided online intervention.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Tilburg University
OTHER
Responsible Party
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Marion van den Heuvel
Principal Investigator
Principal Investigators
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Marion I van den Heuvel, PhD
Role: PRINCIPAL_INVESTIGATOR
Tilburg University
Locations
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Tilburg University
Tilburg, North Brabant, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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222-2022-166
Identifier Type: -
Identifier Source: org_study_id
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