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

Tilburg University

Status: Enrolling

Conditions: Postpartum Anxiety; Parental Stress; Postpartum Depression

Treatments: Behavioral: "Mindful with your baby" self-guided online intervention; Behavioral: "Mindful with your Baby" group-based therapist-guided intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05830266

222-2022-166

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

"Mindful with your Baby" group-based therapist-guided intervention (Intervention group)

Experimental group

Description:

Group-based "Mindful with your Baby" therapist-guided intervention via a video-conferencing tool (e.g., Zoom).

Treatment:

Behavioral: "Mindful with your Baby" group-based therapist-guided intervention

"Mindful with your baby" self-guided online intervention (Waitlist control group)

Other group

Description:

The waitlist control group receives an individual self-guided online "Mindful with your baby" intervention after a 10-week waiting period.

Treatment:

Behavioral: "Mindful with your baby" self-guided online intervention