Clinical trial NCT05830266: Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
Official title: Mother-infant Bonding in the Brain: Promoting Maternal Mental Health and High-quality Mother-infant Interactions Via a Mindfulness-based Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Postpartum Anxiety
Parental Stress
Keywords: Postpartum depression
Postpartum anxiety
Parental stress
Mindfulness
Mindful with your baby
Mother-infant interaction
Lead sponsor: Tilburg University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline postpartum depressive symptoms
timeFrame: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
measure: Change from baseline postpartum anxiety symptoms
timeFrame: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
measure: Change from baseline parental stress
timeFrame: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
measure: Change from baseline mother-infant bonding
timeFrame: Before the intervention (baseline, week 0) and post-intervention (week 8)
measure: Change from baseline neural synchrony between mother and infant (EEG outcome 1)
timeFrame: Before the intervention (baseline, week 0) and post-intervention (week 8)
measure: Change from baseline neural synchrony between mother and infant (EEG outcome 2)
timeFrame: Before the intervention (baseline, week 0) and post-intervention (week 8)
Secondary outcomes:
measure: Change from baseline postpartum-specific anxiety
timeFrame: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
measure: Change from baseline worry
timeFrame: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
measure: Change from baseline mindfulness skills
timeFrame: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
measure: Change from baseline self-compassion
timeFrame: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
measure: Change from baseline bonding
timeFrame: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
measure: Change from baseline infant temperament
timeFrame: Before the intervention (baseline, week 0), post-intervention (week 8) and after 10-weeks follow-up (week 18)
measure: Change from baseline mindful parenting
timeFrame: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
measure: Change from baseline parenting self-efficacy
timeFrame: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
measure: Change from baseline personal goal
timeFrame: before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: Tilburg University
state: North Brabant
Study officials:
affiliation: Tilburg University
name: Marion I van den Heuvel, PhD
role: PRINCIPAL_INVESTIGATOR
References: