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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

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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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
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.
Drug: Treatment as Usual(Medication Based)
Medication as per Depression Protocall

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
All India Institute of Medical Sciences

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 14, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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