Feasibility and treatment effect of cognitive behavioral therapy for insomnia in individuals with multiple sclerosis: A pilot randomized controlled trial

Background: At least 40% of individuals with multiple sclerosis (MS) exercise chronic insomnia, and the prevalence is likely higher due to underdiagnosis. Poor sleep quality has been associated with increased fatigue, anxiety, depression, and risk of relapse in individuals with MS. While cognitive behavioral therapy for insomnia (CBT-I) is the recommended treatment for chronic insomnia, the treatment effect of CBT-I in people with MS is unclear. Objective: This pilot randomized control trial (RCT) assessed the feasibility and treatment effect of CBT-I to improve sleep quality and fatigue in individuals with MS with symptoms of insomnia. Methods: Thirty-three individuals with MS (30 females, 3 males; 30 relapsing-remitting; 3 secondary-progressive; 53.0 +/- 9.4 years old) with symptoms of insomnia were randomized into one of three arms: 1. 6-week CBT-I program, 2. 6-week active control, or 3. Single session of sleep education. Participants completed surveys to assess sleep quality, fatigue, sleep self-efficacy, depression, and anxiety. Results: CBT-I in individuals with MS is feasible with high retention and adherence rate. All groups experienced a large magnitude of improvement in insomnia symptoms. The CBT-I and brief education groups experienced a large magnitude of improvement in sleep quality and fatigue. Only the CBT-I group demonstrated a large magnitude of improvement in sleep self-efficacy and depression. Conclusion: This is the first study to prospectively demonstrates that CBT-I is feasible in people with MS and produces promising improvements in insomnia severity, sleep quality, sleep self-efficacy and comorbid symptoms of fatigue, depression, and anxiety. Future studies are needed to determine mechanisms for these improvements and expand the scope of individuals with MS who may benefit from CBT-I. Furthermore, considering the moderate to large improvements experienced by the brief education group and the limited number of CBT-I providers, a stepped-care approach warrants consideration.