Yoga-based lifestyle intervention for Antenatal Depression (YOGA-D)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- We will assess the feasibility and acceptability of the Yoga-Sanskar (YS) intervention and the preliminary efficacy of the intervention on depression in pregnant women.
研究概览
简要总结
The overall aim of this pilot randomized controlled trial is to examine the feasibility, acceptability, and preliminary efficacy of Yoga-Sanskar (YS), a yoga-based intervention to improve antenatal depression.
The primary objectives of this pilot randomized trial are:
To estimate participant eligibility, recruitment and retention-in-care and study completion rates.
To assess the feasibility of delivering Yoga-Sanskar intervention and acceptability of this intervention by the participants.
To assess the adherence rate, safety, and preliminary efficacy of Yoga-Sanskar intervention in improving antenatal depression (primary outcome).
The secondary objectives of this pilot randomized trial are:
1. To assess the preliminary efficacy of Yoga-Sanskar intervention on anxiety, stress, and quality of life (secondary outcomes) during pregnancy.
To assess the preliminary efficacy of the intervention on pregnancy outcomes (preterm labor, type of delivery, birthweight, and post-partum depression.
To explore the feasibility of administering all the evaluation tools including the Client Service Receipt Inventory to assess the healthcare and intervention costs.
To explore the feasibility of following up recruited participants four weeks post-delivery.
- To study the psychometric properties of the translated versions of the Pregnancy Experience Scale, Common Symptoms in Pregnancy inventory, Attitude towards Yoga during Pregnancy scale, and the Five Facet Mindfulness Questionnaire-17.
Trial design
Single-blind individual randomized parallel group-controlled pilot trial with 1:1 allocation ratio.
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 Singleton pregnancy 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 one or more spontaneous abortions History of cervical stitch/encirclage operation History of pre-term labor/premature rupture of members Receiving treatment for depression or any other mental health condition Presence of suicidal ideation (score of 3 on PHQ-9 item 9) History of hypertension, heart disease, diabetes (including gestational diabetes), respiratory disease, severe anemia, lower respiratory tract infection Inability to communicate in Marathi language Inability to attend in-person yoga sessions.
结局指标
主要结局
We will assess the feasibility and acceptability of the Yoga-Sanskar (YS) intervention and the preliminary efficacy of the intervention on depression in pregnant women.
时间窗: Baseline, three-months post-randomization, post-delivery
Process data will inform the feasibility of the enrolment, engagement with the intervention, and completion of the intervention. The process indicators are as follows:
时间窗: Baseline, three-months post-randomization, post-delivery
1. Number and proportion of eligible participants enrolled per week in the YS and the EUC arm.
时间窗: Baseline, three-months post-randomization, post-delivery
2. Number and proportion of enrolled participants in the YS arm who attend the first session, three follow-up training sessions, and the final assessment session.
时间窗: Baseline, three-months post-randomization, post-delivery
3. Number and proportion of enrolled participants in both arms who complete the follow-up assessment three months post-randomization.
时间窗: Baseline, three-months post-randomization, post-delivery
Depression during pregnancy is the primary outcome to assess the efficacy of the intervention. We will assess depression using a culturally adapted and validated Marathi version of PHQ-9.
时间窗: Baseline, three-months post-randomization, post-delivery
次要结局
- Anxiety(Stress)
研究者
Rahul Shidhaye
Pravara Institute of Medical Sciences