CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Insomnia Severity
研究概览
简要总结
Several studies have shown that behavioral therapy for chronic pain can be beneficial for chronic pain and that behavioral therapy for insomnia can be beneficial for insomnia. However, seldom do chronic pain patients with insomnia receive a behavioral treatment for insomnia. The purpose of this study is to evaluate whether treatment for insomnia is helpful for pain and whether treatment for pain is helpful for insomnia. It will also assess whether a combined treatment is any more or less effective for pain or for sleep. Finally, the study will assess whether any of these treatments leads to improvements in immune function.
详细描述
The investigators' primary goal is to assess the extent to which three forms of cognitive-behavioral treatment (CBT for insomnia, CBT for pain, and combined insomnia & pain) diminishes insomnia symptoms in patients with chronic pain compared to a group not receiving CBT. This will be evaluated in a randomized trial with before and after evaluations using standard sleep diary measures of sleep continuity.
The investigators' secondary goal is to assess whether treatment responses to any of the interventions are associated with alterations in immune function.
The investigators' tertiary goals are to evaluate whether improved sleep has effects on patient reports of pain severity, frequency, and tolerability as well as on mood and quality of life.
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
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 35-75
- •Chronic non-malignant painful condition of the spine of > 6 months duration
- •Insomnia (> 30 minutes sleep latency and/or wake after sleep onset time for > 3 days/week for > 6 months)
- •Insomnia developed after the onset of the painful condition
- •Preferred sleep phase between 10:00 p.m. and 8:00 am
- •On stable medical regimen for medical and pain conditions (no surgery planned)
- •Willingness to discontinue hypnotic medications
排除标准
- •Unstable medical or psychiatric illness
- •History of seizures
- •Evidence of active illicit substance use or fitting criteria for ethanol (ETOH) abuse or dependence
- •Symptoms suggestive of sleep disorders other than insomnia
- •Polysomnographic data indicating sleep disorders other than insomnia
- •Inadequate language comprehension
- •Fibromyalgia
- •Pregnancy
结局指标
主要结局
Insomnia Severity
时间窗: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.
Pain Severity
时间窗: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
Multidimensional Pain Inventory - Pain Severity SubScale score. The subscale consists of 3 items with a total subscale score ranging from 0-18 with higher values indicating greater pain severity.
IL-6
时间窗: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
Circulating levels of Interleukin-6 (IL-6)from plasma drawn in the morning. Values are presented as picograms per milliliter (pg/mL) and can range from 0 to 500, though tend to be in the range of 0-10. Higher values indicate higher amounts of circulating levels of IL-6, a marker of increased inflammatory processes.
次要结局
- Depression Severity(Pre to Post Treatment Chnage (Over an average of approximately 10 weeks))
研究者
Wilfred Pigeon
Asst Prof
University of Rochester