Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis
Assessment of the Feasibility of a Web-based CBT-I Intervention to Improve Sleep Quality and Fatigue in Individuals With Multiple Sclerosis
1 other identifier
interventional
44
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Oct 2018
Shorter than P25 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedFirst Posted
Study publicly available on registry
December 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2019
CompletedAugust 28, 2019
January 1, 2019
11 months
October 1, 2018
August 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
change in Insomnia Severity Index (ISI)
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
baseline and week 8
Secondary Outcomes (4)
change in Pittsburgh Sleep Quality Index (PSQI)
baseline and week 8
change in Modified Fatigue Impact Scale (MFIS)
baseline and week 8
change in Fatigue Severity Scale (FSS)
baseline and week 8
change in Multiple Sclerosis Impact Scale (MSIS)
baseline and week 8
Study Arms (2)
cognitive behavioral therapy for insomnia (CBT-I)
EXPERIMENTALParticipants randomized to this arm will participate in a 6-week web-based cognitive behavioral therapy for insomnia (CBT-I) program.
CBT-I + biweekly support
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catherine Siengsukon
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Siengsukon, PT, PhD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 1, 2018
First Posted
December 21, 2018
Study Start
October 1, 2018
Primary Completion
August 20, 2019
Study Completion
August 20, 2019
Last Updated
August 28, 2019
Record last verified: 2019-01