- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07515222
Efficacy of Yoga-Based Intervention in Improving Mother-Child Bonding in Maternal Depression
March 31, 2026 updated by: Shree Mishra, All India Institute of Medical Sciences
Efficacy of Yoga-Based Intervention in Improving Mother-Child Bonding in Maternal Depression - A Randomised Controlled 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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shree Mishra, MD
- Phone Number: 8249255952
- Email: psych_shree@aiimsbhubaneswar.edu.in
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Add-on Yoga Intervention
Structured bedside yoga session of 40 minutes duration, delivered daily for 3 consecutive weeks by a trained yoga instructor, in addition to Treatment as Usual (TAU).
Sessions include: (1) Rotation movements with mindful awareness of imaginary circular movement; (2) Grounding with Beej Mantras or humming sound vibration.
|
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.
Medication as per Depression Protocall
|
|
Active Comparator: Treatment as Usual (TAU)
Standard pharmacological treatment consisting of antidepressant medication with or without low-dose antipsychotics and/or benzodiazepines, as clinically indicated.
No structured yoga intervention.
|
Medication as per Depression Protocall
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To meaasure in Mother-Infant Bonding
Time Frame: 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.
|
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)
|
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.
|
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)
|
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.
|
Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To measure peripheral serum oxytocin level
Time Frame: 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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
Baseline (Day 0) and within 2 months of baseline (post-intervention, intervention arm only)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 15, 2026
Primary Completion (Estimated)
April 14, 2027
Study Completion (Estimated)
May 15, 2027
Study Registration Dates
First Submitted
March 26, 2026
First Submitted That Met QC Criteria
March 31, 2026
First Posted (Actual)
April 7, 2026
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
March 31, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T/IM-F/24-25/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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