Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention During Pregnancy in Prevention of Post-partum Depression: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 114
- 主要终点
- Anxiety
研究概览
简要总结
This randomized controlled trial aims to evaluate the efficacy of Cognitive Behavioral Therapy for Insomnia in pregnant women. Particularly, this study aim to explore the effect of this intervention in ameliorating insomnia symptoms and in preventing post-partum depression disorder. The experimental intervention is a digital CBT-I and the control intervention group is an assertive communication training. Both interventions include a screening phase and will be delivered in a digital way and will be composed of 5 sessions. Furthermore, both interventions protocol include a baseline, half time and follow up assessments.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnancy
- •Women that not consume nicotine or alcool
- •BMI < 30
- •Women who complains of insomnia or bad sleep quality
排除标准
- •Complicated pregnancy
- •Women who consume nicotine or alcool
结局指标
主要结局
Anxiety
时间窗: Follow up: 6 months post partum
Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
Depression
时间窗: Follow up: 6 months post partum
Depression symptomatology (Edinburgh Postnatal Depression Scale - EPDS). Scoring: \< 8: depression not likely; 9-11: depression possible; 12-13:Fairly high possibility of depression; \> 14 probable depression
次要结局
- Sleep pattern (sleep onset latency; total sleep time; wake after sleep onset; sleep efficiency)(Post intervention: after 5 weeks from the start of intervention)
- insomnia symptoms(Post intervention: after 5 weeks from the start of intervention)
- Emotion regulation(Post intervention: after 5 weeks from the start of intervention)
研究者
Valeria Bacaro
Principal Investigator
University of Rome G. Marconi