Center M Feasibility and Efficacy Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Emotional Regulation Questionnaire (ERQ)
研究概览
简要总结
The goal of this pilot study is to evaluate the acceptability, feasibility, mechanisms of action, and efficacy of Center M. Center M is a group-based, mindfulness-based Cognitive Behavioral Therapy (CBT) intervention to treat Perinatal Depression (PD).
详细描述
The goal of this pilot study is to evaluate the acceptability, feasibility, mechanisms of action, and efficacy of Center M. Center M is a group-based, mindfulness-based Cognitive Behavioral Therapy (CBT) intervention to treat Perinatal Depression (PD). Pregnant participants will be surveyed at three time points: pre-intervention, post-intervention, and 6-weeks postpartum. Surveys will include self-report measures evaluating depressive symptoms, mindfulness skills, emotion regulation, and participant satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •gestational age at intervention onset between 12 and 30 weeks
- •English fluency
- •no previous experience in a mindfulness-based intervention group
- •ability and willingness to participate in a telehealth intervention
排除标准
- 未提供
研究组 & 干预措施
Center M Intervention
Data from participants in this arm will be compared across pre-intervention, post-intervention, and 6-weeks postpartum. All participants will receive the Center M intervention, which includes group-based Cognitive Behavioral Therapy (CBT) sessions and home practice materials.
干预措施: Center M (Behavioral)
结局指标
主要结局
Emotional Regulation Questionnaire (ERQ)
时间窗: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
10-item self-report measure used to assess one's ability to regulate or manage emotion using cognitive reappraisal and expressive suppression.
Patient Health Questionnaire - 8 (PHQ-8)
时间窗: Measured at pre-intervention (within 1 week before first session), post-intervention (within 1 week after last session), and 6-weeks postpartum
Self-report measure that assesses depressive symptoms over the past two weeks.
Edinburgh Postnatal Depression Scale (EPDS)
时间窗: Measured at pre-intervention (within 1 week before first session), post-intervention (within 1 week after last session), and 6-weeks postpartum
10-item self-report measure used to assess perinatal depression symptomology over the past seven days.
Five Facets of Mindfulness Questionnaire (FFMQ)
时间窗: Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum
39-item self-report measure to assess mindfulness skills.
次要结局
- ERQ Cognitive Reappraisal Subscale(Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum)
- Center M Satisfaction(Post-intervention (within 1 week after last session))
- ERQ Expressive Suppression Subscale(Measured at pre-intervention (within 1 week before first session) and 6-weeks postpartum)
研究者
Ellen Tilden
Principal Investigator
Oregon Health and Science University