Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: Cognitive behavioral therapy for insomniaBehavioral: Cognitive behavioral therapy for insomnia + biweekly support
- Registration Number
- NCT03783585
- Lead Sponsor
- University of Kansas Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cognitive behavioral therapy for insomnia (CBT-I) Cognitive behavioral therapy for insomnia Participants randomized to this arm will participate in a 6-week web-based cognitive behavioral therapy for insomnia (CBT-I) program. CBT-I + biweekly support Cognitive behavioral therapy for insomnia + 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. CBT-I + biweekly support Cognitive behavioral therapy for insomnia 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.
- Primary Outcome Measures
Name Time Method change in Insomnia Severity Index (ISI) baseline and week 8 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
- Secondary Outcome Measures
Name Time Method change in Pittsburgh Sleep Quality Index (PSQI) baseline and week 8 The PSQI is a well-validated and reliable measure of sleep quality and consists of 9 items within 7 sleep categories. The 7 sleep category scores are summed to form a single global score ranging from 0-21. A global score of \>5 reflects poor sleep quality
change in Fatigue Severity Scale (FSS) baseline and week 8 Fatigue Severity Scale (FSS) assesses the impact of fatigue on activities for the week prior and consists of 9 questions. The mean of the 9 scores is calculated with a range of 0-7.
change in Modified Fatigue Impact Scale (MFIS) baseline and week 8 The MFIS consists of 21 items with 3 subscales: physical, cognitive, and psychosocial. The score on the 21 items are scored with a range of 0-84 with a higher score indicating a greater impact of fatigue.
change in Multiple Sclerosis Impact Scale (MSIS) baseline and week 8 MSIS-29 is total of 29 items scale, with subscales of physical (20 items) and psychological (9 items). Responses computed in a range from 0-100, and higher scores indicating a worse quality of life due to physical and physiological impacts of MS.
Trial Locations
- Locations (1)
Catherine Siengsukon
🇺🇸Kansas City, Kansas, United States