NCT06434571招募中2 期
Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.
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 guidelines21 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 Telephone Interview of Cognitive Status
- •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
- •If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking < 3 months or dose has changed in past 3 months
- •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
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: baseline, Week 6, Week 12
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
- Epworth Sleepiness Scale (ESS)(baseline, Week 6, Month 6)
- Pittsburgh Sleep Quality Index (PSQI)(baseline, Week 6, Month 6)
- Positive Affect and Negative Affect Schedule (PANAS)(baseline, Week 6, Month 6)
- Dysfunctional Beliefs About Sleep(baseline, Week 6, Month 6)
- Actigraphy(baseline, Week 6, Month 6)
- Multiple Sclerosis Impact Scale (MSIS-29)(baseline, Week 6, Month 6)
- plasma neurofilament light (NfL)(baseline, Week 6, Month 6)
- Modified Fatigue Impact Scale (MFIS)(baseline, Week 6, Month 6)
- Fatigue Severity Scale (FSS)('baseline, Week 6, Month 6)
- Cognitive Failures Questionnaire (CFQ)(baseline, Week 6, Month 6)
- Sleep Self-Efficacy Scale (SESS)(baseline, Week 6, Month 6)
研究者
Catherine Siengsukon, PT, PhD
Professor
University of Kansas Medical Center
研究点 (2)
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