Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of the Feasibility of a Web-based CBT-I Intervention to Improve Sleep Quality and Fatigue in Individuals With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy for insomnia
* Behavioral: Cognitive behavioral therapy for insomnia + biweekly support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cognitive behavioral therapy for insomnia (CBT-I)<br>Participants randomized to this arm will participate in a 6-week web-based cognitive behavioral therapy for insomnia (CBT-I) program. | Behavioral: Cognitive behavioral therapy for insomnia<br>* 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.<br>|
| Experimental: CBT-I + biweekly support<br>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. | Behavioral: Cognitive behavioral therapy for insomnia<br>* 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.<br>Behavioral: Cognitive behavioral therapy for insomnia + biweekly support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Pittsburgh Sleep Quality Index (PSQI) | 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 | baseline and week 8 | 
| change in Modified Fatigue Impact Scale (MFIS) | 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. | baseline and week 8 | 
| change in Fatigue Severity Scale (FSS) | 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. | baseline and week 8 | 
| change in Multiple Sclerosis Impact Scale (MSIS) | 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. | baseline and week 8 |