Efficacy of Yoga-Based Intervention in Improving Mother-Child Bonding in Maternal Depression

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-45
SponsorAll India Institute of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

• Severe mental health conditions including psychotic features

Active suicidal ideation or infanticidal ideas

Active substance dependence (excluding nicotine)

Unstable medical condition

Trial design

Design model

Parallel

Treatments tested in this trial

  • Add-on Yoga Intervention

    Behavioral

    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.

  • Treatment as Usual(Medication Based)

    Drug

    Medication as per Depression Protocall

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Add-on Yoga InterventionExperimental treatment 2 interventions
Group B: Treatment as Usual (TAU)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

To meaasure in Mother-Infant Bonding

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.

Time frame
Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)
2

To measure the Postnatal Depression

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.

Time frame
Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)
3

To measure the Postpartum Bonding through the Postpartum Bonding Questionnaire (PBQ)

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.

Time frame
Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)

Secondary outcomes

1

To measure peripheral serum oxytocin level

Serum oxytocin measured by ELISA (enzyme-linked immunosorbent assay) from 5 ml venous blood sample collected at each timepoint.

Time frame
Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)
2

To measure peripheral serum cortisol level

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.

Time frame
Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)
3

To assess Event Related Potential (ERP) neural responses to standardised infant facial cues

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.

Time frame
Baseline (Day 0)
4

To assess Functional MRI (fMRI) - maternal brain functional connectivity

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.

Time frame
Baseline (Day 0) and within 2 months of baseline (post-intervention, intervention arm only)

Other outcomes

Locations

This trial has no locations.

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