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Recruiting NCT05830266

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

No phase Interventional Postpartum Depression Postpartum Anxiety Parental Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: "Mindful with your Baby" group-based therapist-guided intervention, "Mindful with your baby" self-guided online intervention.
Who it may be relevant to
Registry conditions: Postpartum Depression, Postpartum Anxiety, Parental Stress. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral "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
  • Behavioral "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.

Primary outcome measures

  • Change from baseline postpartum depressive symptoms [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Before the intervention (baseline, week 0) and post-intervention (week 8)]
  • Change from baseline neural synchrony between mother and infant (EEG outcome 1) [Time frame: Before the intervention (baseline, week 0) and post-intervention (week 8)]
  • Change from baseline neural synchrony between mother and infant (EEG outcome 2) [Time frame: Before the intervention (baseline, week 0) and post-intervention (week 8)]
Secondary outcome measures (9)
  • Change from baseline postpartum-specific anxiety [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 infant temperament [Time frame: Before the intervention (baseline, week 0), post-intervention (week 8) and after 10-weeks follow-up (week 18)]
  • Change from baseline mindful parenting [Time frame: 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 parenting self-efficacy [Time frame: 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 personal goal [Time frame: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Tilburg University — Tilburg

Identifiers

NCT: NCT05830266 · 222-2022-166

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗