Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis
Completed · Not applicable
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT03783585
- Run by
- University of Kansas Medical Center
- People needed
- 44
- Starts
- 2018-10-01
- Expected to finish
- 2019-08-20
- Last updated by the study team
- 2019-08-28
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Catherine Siengsukon — Kansas City, Kansas, United States
Full record on ClinicalTrials.gov
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