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Not Yet RecruitingNCT07515222

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

Efficacy of Yoga-Based Intervention in Improving Mother-Child Bonding in Maternal Depression - A Randomised Controlled Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
52 (estimated)
Sponsor
All India Institute of Medical Sciences · Academic / Other
Sex
Female
Age
19 Years – 45 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAdd-on Yoga Intervention40-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

Timeline

Start date
2026-04-15
Primary completion
2027-04-14
Completion
2027-05-15
First posted
2026-04-07
Last updated
2026-04-07

Source: ClinicalTrials.gov record NCT07515222. Inclusion in this directory is not an endorsement.