Feasibility of Web-based CBT-I Intervention in Individuals With Multip
Assessment of the Feasibility of a Web-based CBT-I Intervention to Improve Sleep Quality and Fatigue in Individuals With Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Cognitive behavioral therapy for insomnia
- Cognitive behavioral therapy for insomnia + biweekly support
What it measured
Main measures
change in Insomnia Severity Index (ISI)
baseline and week 8
Mood and sleep
Other measures (4)
change in Pittsburgh Sleep Quality Index (PSQI)
baseline and week 8
Mood and sleepchange in Modified Fatigue Impact Scale (MFIS)
baseline and week 8
Thinking and memoryFatiguechange in Fatigue Severity Scale (FSS)
baseline and week 8
Fatiguechange in Multiple Sclerosis Impact Scale (MSIS)
baseline and week 8
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 80
Show the full criteria
Inclusion criteria
* 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 criteria
* 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Oct 2018
Main results due
Aug 2019
Finished
Aug 2019