NCT05596318进行中（未招募）不适用
Efficacy of Digital Cognitive Behavior Therapy for Insomnia for the Prevention of Perinatal Depression
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)
研究概览
简要总结
The goal of this clinical trial is to compare two sleep programs in pregnant people with insomnia. The main questions it aims to answer are:
- What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression?
- Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement?
- Is the effect of digital CBT-I on perinatal depression moderated by baseline depressive symptom severity?
Participants will receive one of two sleep programs - SHE or CBT-I. Both involve six weekly online sessions. Participants will complete surveys and interviews until 1 year postpartum.
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
- Double (Investigator, 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
- •Pregnant 14-28 weeks gestation
- •18 years or older
- •Daily access to a web-enabled computer, smart phone, or tablet
- •Current elevated insomnia symptom severity and insomnia disorder
- •English speaking
排除标准
- •Current major depression
- •Taking or planning to take antidepressant medication (ADM)
- •Other diagnosed or suspected sleep disorder
- •Other psychiatric or medical issues (e.g., bipolar disorder, active suicidality, bed rest)
- •Night shift worker
研究组 & 干预措施
Digital cognitive behavior therapy for insomnia (CBT-I)
Experimental
干预措施: Digital CBT-I (Device)
Digital sleep hygiene education (SHE)
Active Comparator
干预措施: Digital SHE (Device)
结局指标
主要结局
Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)
时间窗: Baseline to 12 months postpartum
This is a binary outcome that measures whether a participant experienced a depressive episode at any point since randomization.
次要结局
- Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Edinburgh Postnatal Depression Scale (EPDS)(Baseline to 12 months postpartum)
- Change in anxiety symptom severity, as assessed by the GAD-7(Baseline to 12 months postpartum)
- Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Patient Health Questionnaire-9 (PHQ-9)(Baseline to 12 months postpartum)
- Change in suicidal ideation severity, as rated by the C-SSRS(Baseline to 12 months postpartum)
- Change in prenatal insomnia symptom severity as a mediator of the effect of digital CBT-I on perinatal depression, as assessed by the ISI(Baseline to 10 weeks post-randomization (mediator))
- Baseline depressive symptom severity as a moderator, as assessed by the EPDS(Baseline)
- Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9(Baseline)
研究者
研究点 (1)
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