A Pragmatic Randomized Controlled Trial to assess the effectiveness and cost-effectiveness of Yoga for Antenatal Depression in Maharashtra, India (PRAGYA).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Depression during pregnancy is the primary
研究概览
简要总结
| 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Depression during pregnancy is the primary
时间窗: Baseline, 6 weeks post-randomization, three-months post-randomization, post-delivery.
outcome to assess the effectiveness of the
时间窗: Baseline, 6 weeks post-randomization, three-months post-randomization, post-delivery.
intervention. We will assess depression using a
时间窗: Baseline, 6 weeks post-randomization, three-months post-randomization, post-delivery.
culturally adapted and validated Marathi version
时间窗: Baseline, 6 weeks post-randomization, three-months post-randomization, post-delivery.
of PHQ-9.
时间窗: Baseline, 6 weeks post-randomization, three-months post-randomization, post-delivery.
次要结局
- Anxiety (measured using the Marathi version of the Generalized Anxiety Disorder-7)
研究者
Rahul Shidhaye
Pravara Institute of Medical Sciences