Sleep Therapy for Insomnia and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change from Baseline Score of the Hamilton Depression Rating Scale at 8 weeks
研究概览
简要总结
In this study we are testing 2 different forms of sleep therapy to help people with insomnia and depression. As part of the study, you receive 1 of these 2 sleep therapies. We want to see how these sleep therapies help insomnia in people with depression.
详细描述
The first group is the sleep hygiene group. If you are assigned to the sleep hygiene group you have 1 session with a clinician to learn about different things you can do to improve your sleep.
The second group is the intensive sleep retraining group. If you are in this group you will spend about 1 day at our sleep lab, starting around your usual bedtime and ending the following day. Over a 20 hour period you will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake you after a few minutes if you fall asleep.
For both groups, after the treatment session, you will complete questionnaires online and talk with a study clinician who will ask you questions about your mood every two weeks for 8 weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experiencing depression
- •Experiencing chronic insomnia
- •Have been taking an antidepressant medication at a stable dose for at least 8 weeks, and willing to stay on a stable dose for the duration of the study. This medication must be prescribed by a doctor at the University of Michigan. OR not taking any antidepressants and you do not plan to start taking any antidepressants over the next 9 weeks.
排除标准
- •Have psychiatric conditions or sleep disorders other than depression or insomnia
- •Have a chronic medical condition that could negatively affect your sleep or mood
- •Are currently receiving treatment for insomnia (such as prescription or over-the-counter medications, or other therapies)
研究组 & 干预措施
Sleep Hygiene Group
Participants assigned to the sleep hygiene group you have 1 session with a clinician to learn about different things they can do to improve their sleep.
干预措施: Sleep Hygiene (Behavioral)
Intensive Sleep Retraining Group
Participants assigned to this group will spend just over 1 day at our sleep lab, starting around your usual bedtime and ending the following day. Over a 20 hour period participants will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake the participant up after a few minutes if they fall asleep.
干预措施: Intensive Sleep Retraining (Behavioral)
结局指标
主要结局
Change from Baseline Score of the Hamilton Depression Rating Scale at 8 weeks
时间窗: 8 weeks after administration of intervention
Clinician-rated depression symptom severity measure
次要结局
- Change from Baseline Score of the Insomnia Severity Index at 8 weeks(8 weeks after administration of intervention)
研究者
Leslie Swanson
Clinical Assistant Professor
University of Michigan