- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05830266
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
April 9, 2024 updated by: Marion van den Heuvel, Tilburg University
Mother-infant Bonding in the Brain: Promoting Maternal Mental Health and High-quality Mother-infant Interactions Via a Mindfulness-based Intervention
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.
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Estimated)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marion I van den Heuvel, PhD
- Phone Number: +31134664085
- Email: m.i.vdnheuvel@tilburguniversity.edu
Study Locations
-
-
North Brabant
-
Tilburg, North Brabant, Netherlands, 5000 LE
- Recruiting
- Tilburg University
-
Contact:
- Marion I van den Heuvel, PhD
- Phone Number: +31134664085
- Email: m.i.vdnheuvel@tilburguniversity.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: "Mindful with your Baby" group-based therapist-guided intervention (Intervention group)
Group-based "Mindful with your Baby" therapist-guided intervention via a video-conferencing tool (e.g., Zoom).
|
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).
|
Other: "Mindful with your baby" self-guided online intervention (Waitlist control group)
The waitlist control group receives an individual self-guided online "Mindful with your baby" intervention after a 10-week waiting period.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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
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)
|
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
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)
|
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
Time Frame: Before the intervention (baseline, week 0) and post-intervention (week 8)
|
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)
Time Frame: Before the intervention (baseline, week 0) and post-intervention (week 8)
|
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)
Time Frame: Before the intervention (baseline, week 0) and post-intervention (week 8)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marion I van den Heuvel, PhD, Tilburg University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
March 24, 2023
First Submitted That Met QC Criteria
April 13, 2023
First Posted (Actual)
April 26, 2023
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 222-2022-166
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Depression
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
Sage TherapeuticsCompletedSevere Postpartum DepressionUnited States
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
British Columbia Children's HospitalActive, not recruiting
-
University of RochesterMae Stone Goode FoundationCompletedPostpartum Depression | Postpartum AnxietyUnited States
-
Gazi UniversityCompletedPostpartum Depression | Postpartum AdaptationTurkey
-
Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
Clinical Trials on "Mindful with your Baby" group-based therapist-guided intervention
-
Ruya Gul TemelCompletedCerebral PalsyTurkey
-
Haukeland University HospitalThe Research Council of NorwayRecruiting
-
Karolinska InstitutetKarolinska University HospitalActive, not recruiting
-
Chinese University of Hong KongRecruiting
-
University of Castilla-La ManchaBiomedical Research Networking Center on Frailty and Healthy Aging (CIBERFES) and other collaboratorsRecruitingHealthy | Physical Inactivity | Older AdultSpain
-
Sabri HergünerCompletedAutism Spectrum DisorderTurkey
-
Hospital Universitari Vall d'Hebron Research InstituteInstitut Català d'Oncologia ICO Girona; Servicio de Geriatría Complejo Hospitalario... and other collaboratorsEnrolling by invitationLung Cancer | Frail Elderly Syndrome | Prostate Cancer | Older Adults | Gastro-Intestinal CancerAndorra, Spain
-
The University of Texas Health Science Center at...The Rutgers Asian Resource Center for Minority Aging Research (RCMAR)Recruiting
-
University of TorontoThe CIHR Social Research Centre in HIV PreventionCompleted