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A study of yoga for antenatal depression in Maharastra, India.

A Pragmatic Randomized Controlled Trial to assess the effectiveness and cost-effectiveness of Yoga for Antenatal Depression in Maharashtra, India (PRAGYA). - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073718
Enrollment
336
Registered
2024-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F321- Major depressive disorder, singleepisode, moderate

Interventions

Intervention1: Yoga-Sanskar intervention for antenatal depression: Yoga-Sanskar (YS) intervention for antenatal depression YS is a type of gentle, prenatal yoga-based intervention. It is a practic

Sponsors

DBT-Wellcome Trust India Alliance
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult pregnant women above 18 years of age Gestational age between 12–26 weeks Patient Health Questionnaire-9 (PHQ-9) score of 10 or more Planning to stay in the study area throughout study duration (approximately four months)

Exclusion criteria

Exclusion criteria: Pregnant women advised rest/restriction of physical activities/laborious tasks by their obstetrician due to medical/obstetric problems History of recurrent spontaneous abortions (three or more) History of cervical stitch/encirclage operation History of pre-term labor/premature rupture of members Multiple pregnancy (triplet or more) Receiving treatment for mental health condition like schizophrenia, bipolar disorder Severe depression (score of 20 or above on PHQ-9) Presence of death wish/ suicidal thoughts almost every day (score of 3 on PHQ9 item 9) Inability to communicate in Marathi language Inability to attend in-person yoga sessions

Design outcomes

Primary

MeasureTime frame
Depression during pregnancy is the primary outcome to assess the effectiveness of the intervention. We will assess depression using a culturally adapted and validated Marathi version of PHQ-9.Timepoint: Baseline, 6 weeks post-randomization, three-months post-randomization, post-delivery.

Secondary

MeasureTime frame
Anxiety (measured using the Marathi version of the Generalized Anxiety Disorder-7) Stress (measured usign the Marathi version of the Perceived Stress Scale-14) Quality of Life (measured using EuroQoL 5 Dimensions Score (EQ-5D-5L)) Social Support (measured using Multidimensional Scale for Perceived Social Support). Experience of pregnancy (measured using Pregnancy Experience Scale) Attitude (measured using Attitude towards Yoga practice during pregnancy scale) Awareness (measured using the Marathi version of the Five Facet Mindfulness Questionnaire) Home Practice (measured using a self-report log) Injuries due to yoga (measured using a self-report log) Timepoint: Baseline, three-months post-randomization, and post-delivery

Countries

India

Contacts

Public ContactRahul Shidhaye

Pravara Institute of Medical Sciences

rahul.shidhaye@pmtpims.org07748095634

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026