NCT03216889已完成不适用
Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I) will improve sleep quality, fatigue, and quality of life in individuals with multiple sclerosis (MS) with symptoms of insomnia.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS by physician
- •Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 6 months,
- •≥10 on Insomnia Severity Index
- •English speaking
- •Core at least 24 on the Mini-Mental State Exam (MMSE) to indicate reduced risk of dementia
排除标准
- •Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
- •>4 on STOP BANG indicating high risk of sleep apnea
- •Increased risk of restless leg syndrome on Restless Legs Syndrome (RLS) Diagnosis Index
- •Nervous system disorder other than MS
- •Relapse and/or corticosteroid use in past 8 weeks
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Change from Baseline to Week 7
The ISI consists of 7 questions, each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with a score of ≥ 10 suggesting clinical insomnia. The lower the score the less severe insomnia.
次要结局
- Fatigue Severity Scale (FSS)(Change from Baseline to Week 7)
- Pittsburgh Sleep Quality Index (PSQI)(Change from Baseline to Week 7)
- Modified Fatigue Impact Scale (MFIS)(Change from Baseline to Week 7)
- Multiple Sclerosis Impact Scale (MSIS)(Change from Baseline to Week 7)
研究者
研究点 (2)
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