Effects of Insomnia Treatment on Metabolism in Patients With Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Metabolomic Assays
研究概览
简要总结
This project will examine changes in metabolism and depressive symptoms after receiving CBT-I in 30 subjects with insomnia disorder and MDD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insomnia Severity Index > 14
- •Meet diagnostic criteria for Insomnia
- •Meet diagnostic criteria for Major Depressive Disorder
- •Either currently taking an SSRI/SNRI or no antidepressant
排除标准
- •BMI > 30
- •Those with unstable medical conditions defined by change in diagnosis or medication in past 2 months
- •Those with clinically significant comorbid psychiatric conditions (e.g., Bipolar disorder)
- •Those with known untreated sleep apnea or other clinically significant sleep disorder other than insomnia
- •Those currently taking medications that affect sleep or metabolism (e.g., stimulants, thyroid meds)
结局指标
主要结局
Metabolomic Assays
时间窗: 2 weeks post-treatment (week 10 on average)
Blood samples will be collected 2 weeks following the completion of CBT-I to examine metabolic markers of response to CBT-I. We will use NMR Spectroscopy to examine serum metabolite changes in patients with insomnia before and after CBT-I, in comparison with therapy control.
Insomnia Severity Index
时间窗: 3 months post-treatment (week 20 on average)
A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs.
次要结局
未报告次要终点