About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cognitive behavioral therapy for insomnia
- Sleep and lifestyle education