Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis
2019年8月26日 更新者：Catherine Siengsukon, PT, PhD、University of Kansas Medical Center
Assessment of the Feasibility of a Web-based CBT-I Intervention to Improve Sleep Quality and Fatigue in Individuals With Multiple Sclerosis
Forty individuals with multiple sclerosis (MS) will be randomly assigned to a 6-week web-based cognitive behavior therapy for insomnia intervention (wCBT-I) or to wCBT-I plus biweekly support meetings with research personnel via phone or video.
Questionnaires will be used to assess sleep quality, fatigue, and satisfaction.
Recruitment, retention, attrition, adherence, and safety information will also be collected.
This study is significant because addressing insomnia symptoms through CBT-I could be a low-cost, low-risk, non-pharmacological options for improving sleep quality and MS symptoms in individuals with MS.
This study is innovative because CBT-I has never been delivered via a web-based application to individuals with MS which may increase access to services.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
44
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Kansas
-
Kansas City、Kansas、美国、66160
- Catherine Siengsukon
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18-80 years old
- 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 (ISI)
- English speaking
- reports access to internet service and phone
- has a high school diploma to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study.
Exclusion Criteria:
- known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
- >3 on STOP BANG indicating risk of sleep apnea
- increased risk of restless leg syndrome
- nervous system disorder other than MS
- relapse and/or corticosteroid use in past 8 weeks
- score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorse any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
- performs shift-work.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：cognitive behavioral therapy for insomnia (CBT-I)
Participants randomized to this arm will participate in a 6-week web-based cognitive behavioral therapy for insomnia (CBT-I) program.
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The web-based CBT-I program is a 6-week interactive, online program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, and cognitive restructuring.
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实验性的：CBT-I + biweekly support
Participants randomized to this arm will participate in a 6-week web-based CBT-I program.
In addition, biweekly support consisting of one-on-one, semi-structured, online video-chat sessions (via HIPAA-compliant Zoom) or phone calls will be conducted every other week.
|
The web-based CBT-I program is a 6-week interactive, online program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, and cognitive restructuring.
Individuals randomized into the CBT-I + biweekly support will participate in CBT-I as described as well as a biweekly phone call or video call with research personnel for motivational interviewing.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change in Insomnia Severity Index (ISI)
大体时间：baseline and week 8
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The ISI is a valid and reliable measure of sleep difficulties and consists of 7 questions each rated on a 0-4 scale.
The range of scores on the ISI is 0-28, with ≥10 suggesting clinical insomnia
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baseline and week 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change in Pittsburgh Sleep Quality Index (PSQI)
大体时间：baseline and week 8
|
The PSQI is a well-validated and reliable measure of sleep quality and consists of 9 items within 7 sleep categories.
The 7 sleep category scores are summed to form a single global score ranging from 0-21.
A global score of >5 reflects poor sleep quality
|
baseline and week 8
|
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change in Modified Fatigue Impact Scale (MFIS)
大体时间：baseline and week 8
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The MFIS consists of 21 items with 3 subscales: physical, cognitive, and psychosocial.
The score on the 21 items are scored with a range of 0-84 with a higher score indicating a greater impact of fatigue.
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baseline and week 8
|
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change in Fatigue Severity Scale (FSS)
大体时间：baseline and week 8
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Fatigue Severity Scale (FSS) assesses the impact of fatigue on activities for the week prior and consists of 9 questions.
The mean of the 9 scores is calculated with a range of 0-7.
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baseline and week 8
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change in Multiple Sclerosis Impact Scale (MSIS)
大体时间：baseline and week 8
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MSIS-29 is total of 29 items scale, with subscales of physical (20 items) and psychological (9 items).
Responses computed in a range from 0-100, and higher scores indicating a worse quality of life due to physical and physiological impacts of MS.
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baseline and week 8
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年10月1日
初级完成 (实际的)
2019年8月20日
研究完成 (实际的)
2019年8月20日
研究注册日期
首次提交
2018年10月1日
首先提交符合 QC 标准的
2018年12月18日
首次发布 (实际的)
2018年12月21日
研究记录更新
最后更新发布 (实际的)
2019年8月28日
上次提交的符合 QC 标准的更新
2019年8月26日
最后验证
2019年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY00142464
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.