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

Official title

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

Overview

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

• Behavioral Add-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.
• Drug Treatment as Usual(Medication Based)
  Medication as per Depression Protocall

Primary outcome measures

• To meaasure in Mother-Infant Bonding [Time frame: Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)]
• To measure the Postnatal Depression [Time frame: Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)]
• To measure the Postpartum Bonding through the Postpartum Bonding Questionnaire (PBQ) [Time frame: Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)]

Secondary outcome measures (4)

• To measure peripheral serum oxytocin level [Time frame: Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)]
• To measure peripheral serum cortisol level [Time frame: Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)]
• To assess Event Related Potential (ERP) neural responses to standardised infant facial cues [Time frame: Baseline (Day 0)]
• To assess Functional MRI (fMRI) - maternal brain functional connectivity [Time frame: Baseline (Day 0) and within 2 months of baseline (post-intervention, intervention arm only)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Richards MC, Ferrario CA, Yan Y, McDonald NM. The Impact of Postpartum Depression on the Early Mother-Infant Relationship during the COVID-19 Pandemic: Perception versus Reality. Int J Environ Res Public Health. 2024 Jan 31;21(2):164. doi: 10.3390/ijerph21020164. PMID 38397655
• Reck C, Noe D, Gerstenlauer J, Stehle E. Effects of postpartum anxiety disorders and depression on maternal self-confidence. Infant Behav Dev. 2012 Apr;35(2):264-72. doi: 10.1016/j.infbeh.2011.12.005. Epub 2012 Jan 17. PMID 22261433
• Field T. Yoga research review. Complement Ther Clin Pract. 2016 Aug;24:145-61. doi: 10.1016/j.ctcp.2016.06.005. Epub 2016 Jun 16. PMID 27502816
• Corrigan L, Moran P, McGrath N, Eustace-Cook J, Daly D. The characteristics and effectiveness of pregnancy yoga interventions: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2022 Mar 25;22(1):250. doi: 10.1186/s12884-022-04474-9. PMID 35337282
• Wen DJ, Poh JS, Ni SN, Chong YS, Chen H, Kwek K, Shek LP, Gluckman PD, Fortier MV, Meaney MJ, Qiu A. Influences of prenatal and postnatal maternal depression on amygdala volume and microstructure in young children. Transl Psychiatry. 2017 Apr 25;7(4):e1103. doi: 10.1038/tp.2017.74. PMID 28440816

Identifiers

NCT: NCT07515222 · T/IM-F/24-25/11

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗