Actively Recruiting
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis
Led by University of Kansas Medical Center · Updated on 2025-07-20
70
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).
CONDITIONS
Official Title
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosis of relapsing-remitting or secondary progressive multiple sclerosis confirmed by a neurologist
- Mild to moderately severe disability (score 6 or less on the Patient Determined Disability Steps scale)
- Difficulty falling asleep, maintaining sleep, or waking too early at least 3 nights per week for 3 months causing distress and functional impact not due to other sleep disorders
- Insomnia Severity Index score of 10 or higher
- English speaking
- Modified Telephone Interview of Cognitive Status score of 31 or higher
- High school diploma or equivalent reading ability
- Access to internet and a computer, tablet, or smartphone
You will not qualify if you...
- Known untreated sleep disorders such as sleep apnea or restless legs syndrome
- STOP BANG score above 3 indicating risk of sleep apnea
- Diagnosis of restless legs syndrome by RLS-Diagnosis Index
- Circadian rhythm sleep-wake disorder
- Parasomnia
- Current use of benzodiazepines, non-benzodiazepines, or melatonin for insomnia
- Severe depression (PHQ-9 score 20 or higher) or suicidal thoughts
- Severe anxiety (GAD-7 score 15 or higher)
- Current or recent (within 2 years) alcohol or drug abuse
- History of other nervous system disorders like stroke or Parkinson's disease
- Currently pregnant or planning pregnancy in next 6 months
- Severe mental illness such as schizophrenia or bipolar disorder
- Severe neurological or sensory impairments affecting testing
- Relapse or corticosteroid use in past 8 weeks
- History of overnight shift work in past 5 years
- Currently receiving behavioral sleep therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
E
Eryen Nelson, MPH
CONTACT
C
Catherine Siengsukon, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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