Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).
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
- •18-65 years old
- •Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines20 and verified by their neurologist
- •Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)
- •Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5
- •≥10 on Insomnia Severity Index
- •English speaking
- •≥31 on modified Telephone Interview of Cognitive Status23
- •Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study
- •Report having access to internet service or a data plan and access to a computer, tablet, or smart phone
排除标准
- •Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
- •>3 on STOP BANG indicating increased risk of sleep apnea
- •Restless legs syndrome as determined by RLS-Diagnosis Index
- •Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised
- •Parasomnia as determined by the Sleep Disorders-Revised
- •Currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia
- •Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
- •Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
- •Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria
- •History of other nervous system disorder such as stroke or Parkinson's disease
- •Currently pregnant or intending to become pregnant in the next 6 months
- •Severe mental illness such as schizophrenia or bipolar disorder
- •Severe neurological or sensory impairments that would interfere significantly with testing
- •Relapse and/or corticosteroid use in the past 8 weeks
- •History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
- •Currently receiving a behavioral sleep health intervention
研究组 & 干预措施
Cognitive behavioral therapy for insomnia
1x/week, 6-week 45-60 min one-one-one manualized program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes time in bed restriction, stimulus control, relaxation strategies, cognitive restructuring, and sleep health promotion education.
干预措施: Cognitive behavioral therapy for insomnia (Behavioral)
Sleep and lifestyle education
1x/week, 6 weekly 45-60 min one-on-one program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes gentle stretching activities for major muscle groups accompanied by sleep and lifestyle education.
干预措施: Sleep and lifestyle education (Behavioral)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: baseline, Week 6, Month 6
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
- Positive Affect and Negative Affect Schedule (PANAS)(baseline, Week 6, Month 6)
- Sleep Self-Efficacy Scale (SESS)(baseline, Week 6, Month 6)
- Modified Fatigue Impact Scale (MFIS)(baseline, Week 6, Month 6)
- Multiple Sclerosis Impact Scale (MSIS-29)(baseline, Week 6, Month 6)
- Pittsburgh Sleep Quality Index (PSQI)(baseline, Week 6, Month 6)
- Actigraphy(baseline, Week 6, Month 6)
- Fatigue Severity Scale (FSS)(baseline, Week 6, Month 6)
- Cognitive Failures Questionnaire (CFQ)(baseline, Week 6, Month 6)
- Epworth Sleepiness Scale (ESS)(baseline, Week 6, Month 6)
- Dysfunctional Beliefs About Sleep(baseline, Week 6, Month 6)
研究者
Catherine Siengsukon, PT, PhD
Professor
University of Kansas Medical Center