Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Comparative effectiveness between PUMAS and CBTI on acute insomnia effects.
研究概览
简要总结
Nearly half of women develop insomnia during pregnancy, which is associated with increased risk for developing perinatal depression. The purpose of this research is to evaluate the implementability and effectiveness of a mindfulness-based therapy for insomnia relative to cognitive-behavioral therapy for insomnia in pregnant women with insomnia and comorbid depression. The investigators aim to examine whether a mindfulness-based intervention effectiveness reduces symptoms of insomnia and comorbid depression.
详细描述
The investigators will conduct a pilot hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) wherein 100 pregnant women with DSM-5 insomnia disorder and comorbid depression (Edinburgh Postnatal Depression Scale ≥ 10) are randomized to a mindfulness-based intervention--Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)--or Cognitive Behavioral Therapy for Insomnia (CBTI). Patients will be recruited from women's health clinics across Henry Ford Health in Metro Detroit including underserved women, serving as real-world implementation. Per clinic operations since the pandemic, therapies will be via telemedicine to meet patient expectations. Study outcomes will be assessed before and after treatment, then across the first postpartum year.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy, gestational week 14-
- •DSM-5 Insomnia Disorder (acute or chronic).
- •Insomnia Severity Index (ISI) score ≥
- •Edinburgh Postnatal Depression Scale (EPDS) score ≥
- •Ensure adequate sleep opportunity.
- •Age ≥ 18, English-speaking.
- •Reliable internet access (treatment, assessments)
排除标准
- •High risk pregnancy (age >40y, pre-eclampsia, any condition deemed serious risk to mother/fetus; hypertension and diabetes allowed).
- •Active suicidal intent (ideation is allowed).
- •Night or rotating shift work.
- •Epworth Sleepiness Scale>15 (Excessive sleepiness)
- •Health condition unsafe for sleep restriction (bipolar, epilepsy, etc.).
结局指标
主要结局
Comparative effectiveness between PUMAS and CBTI on acute insomnia effects.
时间窗: The investigators will examine change in ISI scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.
The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated in a perinatal sample. The ISI scores range from 0-28 with higher scores indicating greater insomnia severity.
Comparative effectiveness between PUMAS and CBTI on postpartum insomnia effects.
时间窗: The investigators will examine changes in ISI scores across the first postnatal year, which will be assessed at 3, 6, 9, and 12 months postpartum..
The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated in a perinatal sample. The ISI scores range from 0-28 with higher scores indicating greater insomnia severity.
次要结局
- Comparative effectiveness between PUMAS and CBTI on acute depression effects.(The investigators will examine change in EPDS scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.)
- Comparative effectiveness between PUMAS and CBTI on postpartum depression effects.(The investigators will examine changes in EPDS scores across the first postnatal year, which will be assessed at 3, 6, 9, and 12 months postpartum.)
- Comparative effectiveness between PUMAS and CBTI on acute cognitive arousal effects.(The investigators will examine change in PSASC scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.)
- Comparative effectiveness between PUMAS and CBTI on postpartum cognitive arousal effects.(The investigators will examine changes in PSASC scores across the first postnatal year, which will be assessed at 3, 6, 9, and 12 months postpartum.)
研究者
David Kalmbach
Assistant Scientist
Henry Ford Health System