A Pragmatic Randomized Controlled Trial to assess the effectiveness and cost-effectiveness of Yoga for Antenatal Depression in Maharashtra, India (PRAGYA).
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- DBT-Wellcome Trust India Alliance
- Enrollment
- 336
- Locations
- 1
- Primary Endpoint
- Depression during pregnancy is the primary
Overview
Brief Summary
| A Pragmatic Randomized Controlled Trial to assess the effectiveness and cost-effectiveness of Yoga for Antenatal Depression in Maharashtra, India (PRAGYA). |
Trial Design:
Pragmatic, single-blind, individual randomized, parallel-group, superiority trial with 1:1 allocation ratio.
Primary Objectives:
-
To assess the effectiveness of the Yoga-Sanskar intervention on the severity of antenatal depression.
-
To assess the cost-effectiveness of the Yoga-Sanskar intervention for antenatal depression
Secondary Objectives:
-
To assess the effectiveness of the Yoga-Sanskar intervention on anxiety, stress, and quality of life (secondary outcomes) during pregnancy.
-
To assess the effectiveness of the Yoga-Sanskar intervention on pregnancy outcomes (preterm labor, type of delivery, birthweight, and post-partum depression).
Hypothesis:
Women with antenatal depression who practice yoga for three months during pregnancy will show greater reduction in the severity of depression measured using the Patient Health Questionnaire-9 compared to women with antenatal depression receiving Enhanced Usual Care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 49.00 Year(s) (—)
- Sex
- Female
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
- •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.
Outcomes
Primary Outcomes
Depression during pregnancy is the primary
Time Frame: Baseline, 6 weeks post-randomization, three-months post-randomization, post-delivery.
outcome to assess the effectiveness of the
Time Frame: Baseline, 6 weeks post-randomization, three-months post-randomization, post-delivery.
intervention. We will assess depression using a
Time Frame: Baseline, 6 weeks post-randomization, three-months post-randomization, post-delivery.
culturally adapted and validated Marathi version
Time Frame: Baseline, 6 weeks post-randomization, three-months post-randomization, post-delivery.
of PHQ-9.
Time Frame: Baseline, 6 weeks post-randomization, three-months post-randomization, post-delivery.
Secondary Outcomes
- Anxiety (measured using the Marathi version of the Generalized Anxiety Disorder-7)
Investigators
Rahul Shidhaye
Pravara Institute of Medical Sciences