Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis

Study Overview
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Brief Summary
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The purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I) will improve sleep quality, fatigue, and quality of life in individuals with multiple sclerosis (MS) with symptoms of insomnia.

Official Title
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Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia
* Behavioral: Control


Participation Criteria
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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 English speaking Core at least 24 on the Mini-Mental State Exam (MMSE) to indicate reduced risk of dementia Exclusion Criteria: Known untreated sleep disorder (such as sleep apnea or restless leg syndrome) >4 on STOP BANG indicating high risk of sleep apnea Increased risk of restless leg syndrome on Restless Legs Syndrome (RLS) Diagnosis Index Nervous system disorder other than MS Relapse and/or corticosteroid use in past 8 weeks

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>6 weeks of CBT-I. | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will be one-on-one or in a group.<br>|
| Active Comparator: Control<br>6 weeks of stretching and thinking games. | Behavioral: Control<br>* Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will involve stretching and thinking games.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | The ISI consists of 7 questions, each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with a score of ≥ 10 suggesting clinical insomnia. The lower the score the less severe insomnia. | Change from Baseline to Week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI 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 from Baseline to Week 7 | 
| Modified Fatigue Impact Scale (MFIS) | The MFIS assesses the impact of fatigue on daily activities for the month prior. 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 from Baseline to Week 7 | 
| Fatigue Severity Scale (FSS) | The 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 from Baseline to Week 7 | 
| Multiple Sclerosis Impact Scale (MSIS) | Quality of life will be assessed using the Multiple Sclerosis Impact Scale (MSIS-29). 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. | Change from Baseline to Week 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis