Mother-Infant Bonding Disorder, Perinatal Depression, Postpartum Depression
Conditions
Keywords
Perinatal depression, Postpartum depression, Mother-infant bonding, Yoga
Brief summary
Perinatal depression (PND), defined as a depressive episode occurring from the antenatal period through 12 months following childbirth, has a reported prevalence of 12-22%, with higher rates in low- and middle-income countries (LMICs) including India. PND has a multifaceted and detrimental impact on both the mother and the child during a critical window of the child's emotional, cognitive, and physical development. Mother-infant bonding - the affective relationship that develops between a mother and her infant - is significantly impaired by maternal depression. Impaired bonding leads to poor antenatal attachment, earlier cessation of breastfeeding, risk of child maltreatment and neglect, and diminished reciprocal emotional and cognitive growth in the infant. The maternal brain undergoes significant neurobiological adaptations during the perinatal period to facilitate recognition of infant emotional cues, reward-driven bonding experiences, and reciprocal emotional responses. These include changes in oxytocin signalling, cortisol regulation, and functional connectivity of brain regions involved in maternal behaviour. Perinatal depression disrupts these neurobiological processes. Yoga-based interventions offer a safe, cost-effective, culturally acceptable, non-pharmacological approach. Yoga has demonstrated efficacy in improving depression and anxiety in perinatal populations. Its mechanisms include modulation of the HPA axis, reduction of cortisol, enhancement of oxytocin release, and promotion of mindful interoceptive awareness - directly relevant to the neurobiological disruptions in PND. This randomised controlled trial evaluates the efficacy of a structured 3-week bedside yoga intervention as an add-on to treatment as usual in improving mother-infant bonding scores, depression scores, and peripheral oxytocin and cortisol levels in mothers with perinatal depression. The study additionally explores the baseline neural correlates of mother-infant bonding using Event Related Potentials (ERP) and functional MRI (fMRI) of the brain.
Detailed description
BACKGROUND: Perinatal depression affects approximately 12-22% of women globally and up to 22% in India. Despite its prevalence and serious impact on both mother and infant, evidence-based interventions specifically targeting mother-infant bonding impairment - a central and harmful consequence of PND - are limited in low-resource settings. Yoga, an Indian system of mind-body medicine, is safe, low-cost, and widely acceptable. Neurobiological studies suggest yoga modulates HPA axis dysregulation (reducing cortisol, enhancing oxytocin), increases parasympathetic tone, and promotes mindful attunement - mechanisms directly relevant to impaired maternal bonding in PND. INTERVENTION DESCRIPTION: The yoga protocol consists of a 40-minute structured bedside session delivered daily for 3 consecutive weeks by a trained yoga instructor. Sessions comprise: (1) Rotation movements with mindful awareness of imaginary circular movement - promoting embodied awareness and physical grounding (2) Beej Mantra or humming sound vibration - promoting mental grounding and parasympathetic activation Sessions are delivered at bedside to accommodate postpartum mothers, in addition to ongoing Treatment As Usual (TAU). NEUROBIOLOGICAL SUB-STUDY: Baseline ERP and fMRI will be acquired for all cases to characterise neural correlates of mother-infant bonding. Post-intervention fMRI will be acquired within 2 months of baseline to assess neurobiological changes following yoga intervention. CONTROL ARM: Treatment As Usual (TAU) - standard pharmacological management with antidepressants with or without low-dose antipsychotics and/or benzodiazepines, as clinically indicated. ASSESSMENTS: - Mother-Infant Bonding Scale (MIBS) / Postpartum Bonding Questionnaire (PBQ) - Edinburgh Postnatal Depression Scale (EPDS) - Serum oxytocin and cortisol (ELISA) - Event Related Potential (ERP) - standardised infant facial cues paradigm - Functional MRI (fMRI) - maternal brain functional connectivity - Infant development assessment.
Interventions
BEHAVIORALAdd-on Yoga Intervention
40-minute structured bedside yoga protocol delivered daily for 3 weeks. Comprises rotation movements with mindful awareness and Beej Mantra / humming sound grounding. Delivered by trained yoga instructor at bedside to accommodate postpartum mothers.
DRUGTreatment as Usual(Medication Based)
Medication as per Depression Protocall
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Outcome assessors who administer and score rating scales (MIBS, PBQ, EPDS) will be blinded to group allocation. Treating clinicians and participants cannot be blinded given the nature of the yoga intervention.
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* • Mothers aged 19 to 45 years presenting with an index depressive episode with onset either antenatally or within 12 months following childbirth and having a living child aged 0 to 28 months at time of enrolment * Edinburgh Postnatal Depression Scale (EPDS) score of 13 or above3 * Willing to participate and provide written informed consent
Exclusion criteria
* • Severe mental health conditions including psychotic features * Active suicidal ideation or infanticidal ideas * Active substance dependence (excluding nicotine) * Unstable medical condition * Extreme physical limitation precluding yoga participation * Visual or auditory impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To meaasure in Mother-Infant Bonding | Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42) | The Mother-to-Infant Bonding Scale (MIBS) is a short self-report questionnaire (typically 10 items on a 0-3 Likert scale) used to screen for difficulties in the mother-infant bond, with total scores ranging from 0 to 30 (higher scores indicate poorer bonding). A score of 0-3 is generally considered low and reflects relatively normal bonding, while 4 or above is treated as high and suggests clinically meaningful bonding difficulties, with higher values indicating more severe problems. |
| To measure the Postnatal Depression | Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42) | The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire used to screen for postnatal depression, with each item scored 0-3, giving a total range of 0-30 (higher scores indicate more severe depressive symptoms). A score of 0-9 is generally considered low and suggests minimal or no depression, while 10 or above is treated as high and indicates possible depression warranting further clinical assessment; cut-offs of 13 or more are often used to signal more severe or likely depressive illness. |
| To measure the Postpartum Bonding through the Postpartum Bonding Questionnaire (PBQ) | Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42) | The Postpartum Bonding Questionnaire (PBQ) is a 25-item self-report measure used to screen for difficulties in the mother-infant bond, with total scores ranging from 0 (minimum) to 75 (maximum). A score of 0-25 is considered low and within the normal/non-impaired range, 26-39 indicates impaired bonding, and 40 or above suggests severe bonding impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To measure peripheral serum oxytocin level | Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42) | Serum oxytocin measured by ELISA (enzyme-linked immunosorbent assay) from 5 ml venous blood sample collected at each timepoint. |
| To measure peripheral serum cortisol level | Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42) | Serum cortisol measured by ELISA from 5 ml venous blood sample at each timepoint. Cortisol as a biomarker of HPA axis regulation and maternal stress. |
| To assess Event Related Potential (ERP) neural responses to standardised infant facial cues | Baseline (Day 0) | ERP recorded during presentation of standardised infant facial cue paradigm. Components of interest: N170 and P300 amplitudes and latencies reflecting neural processing of infant emotional facial expressions - biomarkers of maternal brain attunement to infant cues. |
| To assess Functional MRI (fMRI) - maternal brain functional connectivity | Baseline (Day 0) and within 2 months of baseline (post-intervention, intervention arm only) | Resting state and task-based fMRI to assess maternal brain functional connectivity in regions associated with bonding and maternal behaviour (medial prefrontal cortex, amygdala, striatum). Pre-post comparison in intervention arm. |
Contacts
CONTACTShree Mishra, MD
Outcome results
None listed