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

Postpartum Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830266
• Other study ID #: 222-2022-166
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Tilburg University
• Contact: Marion I van den Heuvel, PhD
• Phone: +31134664085
• Email: m.i.vdnheuvel[@]tilburguniversity.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Parental Stress
• Postpartum Anxiety
• Postpartum Depression

Intervention

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 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.

Locations

Country	Name	City	State
Netherlands	Tilburg University	Tilburg	North Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Tilburg University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Change from baseline mother-infant bonding	Assessed with video coding	Before the intervention (baseline, week 0) and post-intervention (week 8)
Primary	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)
Primary	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	Change from baseline postpartum-specific anxiety	Assessed with the 12-item Postpartum Specific Anxiety Scale - Research Short Form - for global Crises (PSAS-RSF-C). Total scores range from 0 to 36, with higher scores representing greater postpartum-specific anxiety. The PSAS-RSF-C has been validated in 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)
Secondary	Change from baseline worry	Assessed with the 16-item Penn-State Worry Questionnaire (PSWQ). The total score ranges from 16 to 80, with higher scores reflecting a stronger tendency to worry. The PSWQ has been validated in Dutch 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)
Secondary	Change from baseline mindfulness skills	Assessed with the 15-item Three Facet Mindfulness Questionnaire Short Form (TFMQ-SF), consisting of the facets acting with awareness, non-judging and non-reacting. The total score ranges from 0 to 60, with higher scores indicating better mindfulness skills. The validity of the measure is established and indices of internal reliability were found to be adequate.	before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
Secondary	Change from baseline self-compassion	Assessed with the 3-item Self-Compassion Scale (SCS-3), which was derived from the Self-Compassion Scale (SCS) and the Self-Compassion Scale Short Form (SCS-SF). The total scores range from 3 to 15, with higher scores indicating higher levels of 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)
Secondary	Change from baseline bonding	Assessed with the 5-item Pre- and Postnatal Bonding Scale (PPBS). Total scores range from 14 to 56, with higher scores reflecting more positive feelings of bonding. The scale has shown good psychometric properties in Dutch perinatal 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)
Secondary	Change from baseline infant temperament	Assessed with the Infant Behavior Questionnaire - Revised - very short form (IBQ-R-vsf), including the subscales surgency, negative affect and effortful control. Total scores can be calculated over the items that received a numerical response, and range from 0 to 259. Higher scores reflect greater levels of infant temperament. The IBQ-R-vsf has been validated in parent samples.	Before the intervention (baseline, week 0), post-intervention (week 8) and after 10-weeks follow-up (week 18)
Secondary	Change from baseline mindful parenting	Assessed with the 27-item adapted Interpersonal Mindfulness in Parenting Scale (IM-P). Total scores range from 27 to 135, with higher scores indicating greater levels of mindful parenting.	before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
Secondary	Change from baseline parenting self-efficacy	Assessed with the 16-item Maternal Self-Efficacy in the Nurturing Role questionnaire (SENR), of which validity and reliability has been established. Total scores range from 16 to 112, with higher scores representing higher levels of parenting self-efficacy.	before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)
Secondary	Change from baseline personal goal	Assessed with Goal Attainment Scaling (GAS). Before the intervention, mothers are asked to write down an overall goal. They also formulate the situation if things are: worse than at the current moment (-1), according to the current moment (0), a little better than the current moment (+1), much better than the current moment (+2), the best possible outcome (+3). In the next assessments, women will see their previously established goal and scales (-1, 0, +1, +2 and +3). They are asked to indicate what describes their current situation best. Validity and reliability of the GAS have been established.	before the intervention (baseline, week 0), halfway through the intervention (week 4), post-intervention (week 8) and after 10-weeks follow-up (week 18)