Perinatal DepressionNCT07515222
Efficacy of Yoga-Based Intervention in Improving Mother-Child Bonding in Maternal Depression
A study testing Add-on Yoga Intervention and Treatment as Usual(Medication Based) in people with Perinatal Depression and Postpartum Depression, run by All India Institute of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Perinatal Depression, Postpartum Depression, Mother-Infant Bonding Disorder
- What is being tested?
- Add-on Yoga Intervention and Treatment as Usual(Medication Based)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Add-on Yoga Intervention, Treatment as Usual(Medication Based)
- Keywords
- Perinatal depression, Postpartum depression, Mother-infant bonding, Yoga
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Add-on Yoga InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Add-on Yoga Intervention | Experimental | 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. Receives: Behavioral: Add-on Yoga Intervention; Drug: Treatment as Usual(Medication Based) |
| Treatment as Usual (TAU) | Active comparator | Standard pharmacological treatment consisting of antidepressant medication with or without low-dose antipsychotics and/or benzodiazepines, as clinically indicated. No structured yoga intervention. Receives: Drug: Treatment as Usual(Medication Based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)
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.
Measured: 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)
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.
Measured: Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)
Secondary outcomes (4)
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.
Measured: Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)
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.
Measured: 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
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.
Measured: Baseline (Day 0)
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.
Measured: Baseline (Day 0) and within 2 months of baseline (post-intervention, intervention arm only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion14 Apr 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shree Mishra, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515222
- Sponsor's protocol ID
- T/IM-F/24-25/11
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 38397655Reck 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.
PubMed 22261433Field 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.
PubMed 27502816Corrigan 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.
PubMed 35337282Wen 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.
PubMed 28440816
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Yoga-Based Intervention in Improving Mother-Child Bonding in Maternal Depression - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07515222
- Acronym / sponsor ID
- T/IM-F/24-25/11
- Keywords
- Perinatal depression, Postpartum depression, Mother-infant bonding, Yoga
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 14 Apr 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Add-on Yoga Intervention | Experimental | Behavioral: Add-on Yoga Intervention, Drug: Treatment as Usual(Medication Based)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. |
| Treatment as Usual (TAU) | Active comparator | Drug: Treatment as Usual(Medication Based)Standard pharmacological treatment consisting of antidepressant medication with or without low-dose antipsychotics and/or benzodiazepines, as clinically indicated. No structured yoga intervention. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • 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
Key exclusion criteria (6 listed)
- • Severe mental health conditions including psychotic features
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Add-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. | Behavioural | Add-on Yoga Intervention |
| Treatment as Usual(Medication Based)Medication as per Depression Protocall | Drug | Add-on Yoga Intervention, Treatment as Usual (TAU) |
Primary outcome
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.
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.
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 38397655Richards 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.
- Background: PubMed 22261433Reck 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.
- Background: PubMed 27502816Field 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.
- Background: PubMed 35337282Corrigan 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.
- Background: PubMed 28440816Wen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Add-on Yoga Intervention and Treatment as Usual(Medication Based) in people with Perinatal Depression and Postpartum Depression, run by All India Institute of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shree Mishra, MD (8249255952, psych_shree@aiimsbhubaneswar.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To meaasure in Mother-Infant Bonding (time frame: Baseline (Day 0), End of Week 3 (Day 21), End of Week 6 (Day 42)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07515222, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.