Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis
NCT ID: NCT03783585
Last Updated: 2019-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2018-10-01
2019-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Cognitive behavioral therapy for insomnia
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.
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.
Cognitive behavioral therapy for insomnia
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.
Cognitive behavioral therapy for insomnia + biweekly support
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.
Interventions
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Cognitive behavioral therapy for insomnia
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.
Cognitive behavioral therapy for insomnia + biweekly support
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* \>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.
18 Years
80 Years
ALL
No
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Catherine Siengsukon, PT, PhD
Associate Professor
Principal Investigators
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Catherine Siengsukon, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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Catherine Siengsukon
Kansas City, Kansas, United States
Countries
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Other Identifiers
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STUDY00142464
Identifier Type: -
Identifier Source: org_study_id
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