Efficacy of a Prenatal Yoga Intervention for Antenatal Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Quick Inventory of Depression Symptoms - Clinician Rating
研究概览
简要总结
This NICHD-funded RCT will enroll up to 178 depressed pregnant women, randomly assigning them to one of 2 intervention conditions: (1) a gentle prenatal yoga program (PYP), or (2) a series of educational workshops focused on perinatal health, the Mom and Baby Wellness Workshop (MBWW), each condition lasting 9 weeks. The investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.
详细描述
In this randomized controlled trial, eligible women will be randomly assigned to either a 9-week Prenatal Yoga Program (PYP) vs. a 9-week health education control group, the Mother-Baby Wellness Workshop (MBWW). Follow up assessments will take place at multiple points during the study. The primary study outcome will be severity of prenatal depression assessed by a blind interviewer. The investigators will examine relevant secondary outcomes (self-reported depression, anxiety, functioning, & pain; pre-term birth) and potential mediators (inflammation, mindfulness/non-judgment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy singleton pregnancy, 12-27 weeks gestation
- •Medically cleared for moderate exercise
- •Depression symptoms in moderate range. Participants must have an Quick Inventory of Depressive Symptoms (QIDS; [119]) score between 8-20
- •English-speaking
- •Aged 18 or older
排除标准
- •New or unstable depression treatment
- •Currently a regular yoga practitioner
- •Bipolar disorder, schizophrenia, psychotic depression, chronic psychosis
- •Current hazardous drug or alcohol use
- •Acute suicidality
结局指标
主要结局
Quick Inventory of Depression Symptoms - Clinician Rating
时间窗: Baseline to 9-week end point
Clinician-rated depression severity
次要结局
- State-Trait Anxiety Inventory(Baseline to 9-week endpoint)
- Edinburgh Postnatal Depression Screen(Baseline to 9-week endpoint)
- Pittsburgh Sleep Quality Index(Baseline to 9-week endpoint)
- Maternal & Neonatal Outcomes Checklist (MNOC)(30 days postpartum)