Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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).
Sponsor: University of Kansas Medical Center
You may qualify if…
- ✓ 18-65 years old
- ✓ Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines20 and verified by their neurologist
- ✓ Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)
- ✓ Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5
- ✓ ≥10 on Insomnia Severity Index
- ✓ English speaking
- ✓ ≥31 on modified Telephone Interview of Cognitive Status23
- ✓ Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study
You may not qualify if…
- ✕ Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
- ✕ \>3 on STOP BANG indicating increased risk of sleep apnea
- ✕ Restless legs syndrome as determined by RLS-Diagnosis Index
- ✕ Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised
- ✕ Parasomnia as determined by the Sleep Disorders-Revised
- ✕ Currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia
- ✕ Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
- ✕ Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
Where it's recruiting
Kansas City
Source: ClinicalTrials.gov · NCT06428006 · last updated 2026-06-12