Center M: Digital Health Innovation Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Screening Rate
研究概览
简要总结
Center M is a digital health solution to Perinatal Depression (PD) which provides an alternative to Mindfulness Based Cognitive Therapy - Perinatal Depression (MBCT-PD). Center M shifts treatment to a telehealth model, reduces the number of sessions, and transitions home practice materials to a digital format. This study will include a clinical trial in which participants will be randomized to the Center M treatment with smartphone app delivery of homework compared to treatment as usual (TAU).
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Currently pregnant
- •Age 18-50 years
- •Fluent in English
- •Available and able to attend online group scheduled meetings
排除标准
- •Current or past enrollment in a mindfulness-based intervention group
结局指标
主要结局
Screening Rate
时间窗: 6 weeks postpartum
Rates of PD screening in Center M and TAU groups.
PD Symptoms at baseline
时间窗: Initial screening pre-intervention
PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
PD Symptoms post intervention
时间窗: Four weeks post intervention
PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
PD Symptoms postpartum
时间窗: Six weeks postpartum
PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
次要结局
- Participant Satisfaction(Six weeks postpartum)
研究者
Ellen Tilden
Principal Investigator
Oregon Health and Science University