Status:
COMPLETED
Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2019
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03783585
Start Date
October 1 2018
End Date
August 20 2019
Last Update
August 28 2019
Active Locations (1)
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1
Catherine Siengsukon
Kansas City, Kansas, United States, 66160