Online Prenatal Trial in Mindfulness Sleep Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The aim of this study is to assess an online mindfulness intervention for pregnant women (6 weeks) for the treatment of insomnia and prevention of depression relapse in pregnancy. This mindfulness intervention will also be compared with an online intervention (6 weeks) consisting only of education about insomnia in pregnancy. The principal hypothesis is that the mindfulness intervention will be more effective than the education-only intervention.
详细描述
The aim of this study is to assess an online mindfulness intervention for pregnant women (6 weeks) for the treatment of insomnia and prevention of depression relapse in pregnancy.
There will be two groups:
- An online mindfulness intervention for pregnant women (6 weeks) that focuses on behaviors to overcome sleep difficulties in pregnancy.
- An online control group that will receive information about sleep in pregnancy (6 weeks).
Each group will be composed of 25 participants with a total sample of 50. The principal hypothesis is that the mindfulness intervention will be more effective than sleep education in the improvement of sleep and depression symptoms during pregnancy.
The differences between the intervention and control group will be analyzed. The acceptability and usability of online content will also be assessed.
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
- Single (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
- •Viable pregnancy in second trimester (up to 28 weeks gestation); 2) prior diagnosis of depression currently in remission (score < 3 on the Patient Health Questionnaire (PHQ-2) depression screening questionnaire); 3) subjective report of insomnia (score > 7 on the Insomnia Severity Index); 4) age 18 or older; 5) access to an Internet-enabled smartphone, tablet, or computer; and 6) English fluency. Participants will not be excluded from participation if they are currently receiving psychotropic medications or psychotherapy.
排除标准
- •Known severe congenital fetal anomalies, fetal demise, or expected neonatal death; 2) diagnosis of major depressive disorder within past 2 months; 3) other significant psychiatric illness requiring treatment; 4) current hospitalization; 5) prior diagnosis of obstructive sleep apnea or restless leg syndrome; 6) positive self-report screen for restless leg syndrome; 7) regular mindfulness or meditative practice (at least weekly); and 8) regular night-shift work.
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Enrollment to intervention completion (6 weeks)
Self-rating of overall sleep quality and disturbances using 7 sleep components. Total scores range from 0 to 21, with higher scores indicating worse sleep quality. PSQI global \>5 is highly sensitive and specific for distinguishing good and poor sleepers. A lower PSQI score is a better outcome.
次要结局
- Sleep efficiency(Enrollment to intervention completion (6 weeks))
- Total wake time(Enrollment to intervention completion (6 weeks))
- Total sleep time(Enrollment to intervention completion (6 weeks))
- PROMIS Sleep-Related Impairment Short Form(Enrollment to intervention completion (6 weeks))
- PROMIS Fatigue Short Form(Enrollment to intervention completion (6 weeks))
- Neuro-QOL Positive Affect and Well-Being Short Form(Enrollment to intervention completion (6 weeks))
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form(Enrollment to intervention completion (6 weeks))
- Edinburgh Postnatal Depression Scale (EPDS)(Enrollment to intervention completion (6 weeks))
- PROMIS Depression Short Form(Enrollment to intervention completion (6 weeks))
- PROMIS Anxiety Short Form(Enrollment to intervention completion (6 weeks))
- Short Form (36) Health Survey(Enrollment to intervention completion (6 weeks))
- Intervention adherence(Intervention completion (6 weeks))
- Meditation adherence(Intervention completion (6 weeks))
- Intervention acceptability(Intervention completion (6 weeks))
研究者
Ira Kantrowitz-Gordon
Assistant Professor
University of Washington