Back to resultsMother-infant Bonding in the Brain: a Mindfulness-based Intervention
Primary Purpose
Postpartum Depression, Postpartum Anxiety, Parental Stress
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"Mindful with your Baby" group-based therapist-guided intervention
"Mindful with your baby" self-guided online intervention
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Depression focused on measuring Postpartum depression, Postpartum anxiety, Parental stress, Mindfulness, Mindful with your baby, Mother-infant interaction
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
"Mindful with your Baby" group-based therapist-guided intervention (Intervention group)
"Mindful with your baby" self-guided online intervention (Waitlist control group)
Arm Description
Group-based "Mindful with your Baby" therapist-guided intervention via a video-conferencing tool (e.g., Zoom).
The waitlist control group receives an individual self-guided online "Mindful with your baby" intervention after a 10-week waiting period.
Outcomes
Primary Outcome Measures
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.
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.
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.
Change from baseline mother-infant bonding
Assessed with video coding
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05830266
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tilburg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Postpartum Anxiety, Parental Stress
Keywords
Postpartum depression, Postpartum anxiety, Parental stress, Mindfulness, Mindful with your baby, Mother-infant interaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
"Mindful with your Baby" group-based therapist-guided intervention (Intervention group)
Arm Type
Experimental
Arm Description
Group-based "Mindful with your Baby" therapist-guided intervention via a video-conferencing tool (e.g., Zoom).
Arm Title
"Mindful with your baby" self-guided online intervention (Waitlist control group)
Arm Type
Other
Arm Description
The waitlist control group receives an individual self-guided online "Mindful with your baby" intervention after a 10-week waiting period.
Intervention Type
Behavioral
Intervention Name(s)
"Mindful with your Baby" group-based therapist-guided intervention
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
"Mindful with your baby" self-guided online intervention
Intervention Description
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 Measure Information:
Title
Change from baseline postpartum depressive symptoms
Description
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.
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)
Title
Change from baseline postpartum anxiety symptoms
Description
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.
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)
Title
Change from baseline parental stress
Description
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.
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)
Title
Change from baseline mother-infant bonding
Description
Assessed with video coding
Time Frame
Before the intervention (baseline, week 0) and post-intervention (week 8)
Title
Change from baseline neural synchrony between mother and infant (EEG outcome 1)
Description
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.
Time Frame
Before the intervention (baseline, week 0) and post-intervention (week 8)
Title
Change from baseline neural synchrony between mother and infant (EEG outcome 2)
Description
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.
Time Frame
Before the intervention (baseline, week 0) and post-intervention (week 8)
Secondary Outcome Measure Information:
Title
Change from baseline postpartum-specific anxiety
Description
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.
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)
Title
Change from baseline worry
Description
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.
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)
Title
Change from baseline mindfulness skills
Description
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.
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)
Title
Change from baseline self-compassion
Description
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.
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)
Title
Change from baseline bonding
Description
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.
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)
Title
Change from baseline infant temperament
Description
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.
Time Frame
Before the intervention (baseline, week 0), post-intervention (week 8) and after 10-weeks follow-up (week 18)
Title
Change from baseline mindful parenting
Description
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.
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)
Title
Change from baseline parenting self-efficacy
Description
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.
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)
Title
Change from baseline personal goal
Description
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.
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion I van den Heuvel, PhD
Phone
+31134664085
Email
m.i.vdnheuvel@tilburguniversity.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion I van den Heuvel, PhD
Organizational Affiliation
Tilburg University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
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