An interventional study of "Mindful with your Baby" group-based therapist-guided intervention and "Mindful with your baby" self-guided online intervention in Postpartum Depression, Postpartum Anxiety and Parental Stress, sponsored by Tilburg University. Recruiting at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Tilburg University · Not applicable, Interventional, and Treatment
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.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 64 is below the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Tilburg University is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group-based "Mindful with your Baby" therapist-guided intervention via a video-conferencing tool (e.g., Zoom).
Behavioral: "Mindful with your Baby" group-based therapist-guided intervention
The waitlist control group receives an individual self-guided online "Mindful with your baby" intervention after a 10-week waiting period.
Behavioral: "Mindful with your baby" self-guided online 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).
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.
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.
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
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)
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.
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
Assessed with video coding
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)
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)
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.
Time frame: Before the intervention (baseline, week 0) and post-intervention (week 8)
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.
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
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)
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.
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
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)
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.
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
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)
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.
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
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)
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.
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)
Started Jul 2023 (actual). Primary completion is estimated for Jan 2027, 42 months after the start.
Of 256 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 42 months is above that.
Counting every sponsor, half of 262 studies reached it within 23 months; a quarter within 11 and three quarters within 36.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: primary completion Jul 2026 → Jan 2027 and completion Sep 2026 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tilburg University