Assessment of the Feasibility of a Web-based CBT-I Intervention to Improve Sleep Quality and Fatigue in Individuals With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- change in Insomnia Severity Index (ISI)
研究概览
简要总结
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Cognitive behavioral therapy for insomnia (Behavioral)
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.
干预措施: Cognitive behavioral therapy for insomnia (Behavioral)
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.
干预措施: Cognitive behavioral therapy for insomnia + biweekly support (Behavioral)
结局指标
主要结局
change in Insomnia Severity Index (ISI)
时间窗: baseline and week 8
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
次要结局
- change in Pittsburgh Sleep Quality Index (PSQI)(baseline and week 8)
- change in Fatigue Severity Scale (FSS)(baseline and week 8)
- change in Modified Fatigue Impact Scale (MFIS)(baseline and week 8)
- change in Multiple Sclerosis Impact Scale (MSIS)(baseline and week 8)
研究者
Catherine Siengsukon, PT, PhD
Associate Professor
University of Kansas Medical Center