NCT03216889
Completed
Not Applicable
Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis
ConditionsInsomnia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- University of Kansas Medical Center
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Insomnia Severity Index (ISI)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Insomnia Severity Index (ISI)
Time Frame: Change from Baseline to Week 7
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.
Secondary Outcomes
- Fatigue Severity Scale (FSS)(Change from Baseline to Week 7)
- Pittsburgh Sleep Quality Index (PSQI)(Change from Baseline to Week 7)
- Modified Fatigue Impact Scale (MFIS)(Change from Baseline to Week 7)
- Multiple Sclerosis Impact Scale (MSIS)(Change from Baseline to Week 7)
Study Sites (1)
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