mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire-9
研究概览
简要总结
Postpartum depression (PPD) is associated with significant health consequences for mothers and children, and the current COVID-19 pandemic has had a major impact on the mental health of particularly vulnerable populations including pregnant Black and Latina women. There is an urgent need for evidence-based, accessible, and scalable mental health care options for these high-risk, vulnerable women. This study aims to: (a) compare the effectiveness of two digitally-delivered self-paced stress reduction programs in pregnant Black and Latina women at increased risk of PPD; and (b) examine barriers and facilitators to implementation within a large healthcare system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, 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
- •Age ≥18 years
- •Current Kaiser Permanente Permanente Northern California (KPNC) member
- •Pregnant woman receiving prenatal care at KPNC
- •Gestational age <30 weeks
- •Singleton pregnancy
- •Self-identify as Black and/or Latina
- •Moderate to moderately severe depressive symptoms (PHQ-9 score between 10 and 19) and no indication of suicidality
- •Owns a device with internet access
- •English- or Spanish-speaking
排除标准
- •Regular stress reduction practice with a mindfulness component (e.g., meditation or yoga more than twice a week)
- •Acting as gestational carrier/surrogate
研究组 & 干预措施
Intervention
Use of mHealth stress reduction program 'A' app 5-20 min daily for 6 weeks
干预措施: Stress reduction program 'A' (Behavioral)
Active control
Use of mHealth stress reduction program 'B' app 5-20 min daily for 6 weeks
干预措施: Stress reduction program 'B' (Behavioral)
结局指标
主要结局
Patient Health Questionnaire-9
时间窗: 7 weeks postpartum
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Patient Health Questionnaire-9
时间窗: Baseline
Depression scale; total score range of 0-27; higher scores indicate higher depression.
Patient Health Questionnaire-9
时间窗: 6-week follow-up
Depression scale; total score range of 0-27; higher scores indicate higher depression.
次要结局
- Perceived Stress Scale(7 weeks postpartum)
- Generalized Anxiety Disorder 7-item scale(7 weeks postpartum)
- Promis Sleep Disturbance - Short Form 6a(7 weeks postpartum)
- Perceived Stress Scale(Baseline)
- Perceived Stress Scale(6-week follow-up)
- Generalized Anxiety Disorder 7-item scale(Baseline)
- Generalized Anxiety Disorder 7-item scale(6-week follow-up)
- Promis Sleep Disturbance - Short Form 6a(Baseline)
- Promis Sleep Disturbance - Short Form 6a(6-week follow-up)