The Effects of a Mindful Yoga Program on Mood Symptoms and Stress for Postpartum Women With Depressive Symptoms: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Edinburgh Postnatal Depression Scale
研究概览
简要总结
This is a parallel-group randomized controlled trial. A total of 198 postpartum women with depressive symptoms (EPDS scores≥8 at baseline) will be recruited and randomized into two groups: 10-week mindful yoga intervention and 10-week psychoeducation program. Clinical assessment of depression, self-report questionnaires and salivary cortisol tests will be performed at baseline, after 10-week intervention, and at 6-month and 12-month follow-ups. The investigators expected that the mindful yoga intervention will reduce depression after 10 weeks compared to psychoeducation. The mindful yoga intervention will further reduce anxiety, stress, improve quality of life and sleep, and steepen diurnal cortisol slopes. These effects will be maintained for at least six months.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postpartum women aged 18-60 years old.
- •The scores of EPDS ≥
- •At least 6 week and up to 1 year after childbirth.
- •Giving birth to a single full-term healthy baby (gestation between 37-41 weeks, body weight > 2.5kg, APGAR score at 5 minutes > 7).
- •Fewer than 10 hours of yoga/Qi gong/Tai Chi or mindfulness/meditation practice in the previous 3 months.
排除标准
- •Severe complications after delivery, or their infants are admitted to NICU.
- •Regular psychiatric follow-up.
- •Currently taking antipsychotic drugs.
- •Known pragnancy, or other contraindications to physical exercise (e.g., wound healing situation) according to the body examination by O&G clinicians at 6 weeks after delivery.
研究组 & 干预措施
Mindful yoga group
The participants in experimental group will receive a 10-week mindfulness-based yoga program, one session per week with 1.5 hours in each session.
干预措施: Mindfulness-based yoga program (Behavioral)
Psychoeducation group
The participants in the psychoeducation group will receive a 10-week psychoeducation program, one session per week with 1.5 hours in each session.
干预措施: Psychoeducation (Other)
结局指标
主要结局
Edinburgh Postnatal Depression Scale
时间窗: Baseline, 10 weeks, 6 months and 1 year follow-ups.
Measures postnatal depression. Each item scores 0-3, and the total score ranges from 0 to 30. Higher score means worse depressive symptoms.
次要结局
- Depression Anxiety Stress Scale-Depression(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
- Depression Anxiety Stress Scale-Anxiety(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
- Depression Anxiety Stress Scale-Stress(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
- Pittsburgh Sleep Quality Index(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
- 36 Item-Short Form Health Survey Questionnaire(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
- Pregnancy Symptom Inventory(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
- Cortisol concentration level(Baseline and 10 weeks (post-intervention).)
- Balance(Baseline and 10 weeks (post-intervention).)
- Five Facet Mindfulness Questionnaire(Baseline, 10 weeks, 6 months and 1 year follow-ups.)
- Physical fitness(Baseline and 10 weeks (post-intervention).)
研究者
LIN Jingxia Jessie
Assistant Professor
The Hong Kong Polytechnic University