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

NCT05830266 | Recruiting

• 1 other identifier: 222-2022-166
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression; Postpartum Anxiety; Parental Stress

Keywords

Postpartum depression; Postpartum anxiety; Parental stress; Mindfulness; Mindful with your baby; Mother-infant interaction

Outcome Measures

Primary Outcomes (6)

• Change from baseline postpartum depressive symptoms

  Assessed with the 10-item Edinburgh Postnatal Depression Scale (EPDS). The EPDS is the most widely used self-rating scale to assess depressive symptoms in the perinatal period. The EPDS total score ranges from 0 to 30, with higher scores indicating more depressive symptoms. The questionnaire has been validated in Dutch postpartum women.

  before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)

• Change from baseline postpartum anxiety symptoms

  Assessed with the 10-item anxiety subscale of the Symptom Checklist (SCL-90). The total scores range from 10 to 50 and higher scores reflect more anxiety symptoms. The questionnaire has showed good reliability and validity in non-pregnant samples.

  before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)

• Change from baseline parental stress

  Assessed with the Parental Stress Questionnaire (PSQ, in Dutch: Opvoedingsbelastingvragenlijst), which is based on the Parenting Stress Index. This study uses only the first three subscales related to parenting: parent-child relationship problems, parenting problems and parental role restriction. Total scores range from 19 to 76 with higher scores indicating more parental stress. In order to interpret the level of parental stress experienced, subscale scores are converted into T-scores conform the norms of the child's age (e.g., 0 to 3 years). The questionnaire and subscales have showed good reliability and validity.

  before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)

• Change from baseline mother-infant bonding

  Assessed with video coding

  Before the intervention (baseline, week 0) and post-intervention (week 8)

• Change from baseline neural synchrony between mother and infant (EEG outcome 1)

  Assessed with dual-EEG, with the Phase Locking Value (PLV) in the alpha band frequency (6-9 Hz) during the free play task. We expect that neural synchrony between mother and infant will increase (more) in the intervention group.

  Before the intervention (baseline, week 0) and post-intervention (week 8)

• Change from baseline neural synchrony between mother and infant (EEG outcome 2)

  Assessed with dual-EEG, with the Phase Locking Value (PLV) in the alpha band frequency (6-9 Hz) during the still face paradigm. We expect that neural synchrony between mother and infant will increase (more) in the intervention group.

  Before the intervention (baseline, week 0) and post-intervention (week 8)

Secondary Outcomes (9)

• Change from baseline postpartum-specific anxiety

  before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)

• Change from baseline worry

  before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)

• Change from baseline mindfulness skills

  before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)

• Change from baseline self-compassion

  before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)

• Change from baseline bonding

  before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)

Study Arms (2)

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

EXPERIMENTAL

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

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

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

OTHER

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

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

Interventions

"Mindful with your Baby" group-based therapist-guided intervention BEHAVIORAL

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" group-based therapist-guided intervention (Intervention group)

"Mindful with your baby" self-guided online intervention BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tilburg University: lead

Study Sites (1)

Tilburg University

Tilburg, North Brabant, 5000 LE, Netherlands

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Marion I van den Heuvel, PhD

  Tilburg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion I van den Heuvel, PhD

CONTACT

+31134664085; m.i.vdnheuvel@tilburguniversity.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 26, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)