Cognitive behavioral therapy for insomnia for individuals with multiple sclerosis (CALM): A randomized control trial protocol.

UNLABELLED: Insomnia is a common problem for individuals with multiple sclerosis (MS) occurring in at least 40 % of individuals with MS. Sleep disturbances in people with MS have been associated with a reduction in cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. Cognitive behavioral therapy for insomnia (CBT-I), a multicomponent treatment strategy, addresses thoughts and behaviors that can negatively impact sleep and is the recommended treatment for chronic insomnia. CBT-I is shown to be more effective than pharmacological interventions long-term for treating insomnia with improvements remaining up to 10 years following CBT-I. However, there are limited studies that have examined the effect of CBT-I on sleep outcomes and comorbid symptoms in people with MS. The objective of the proposed study is to determine the efficacy of CBT-I delivered via telehealth to improve insomnia symptoms, fatigue, and health-related quality of life in people with MS. CBT-I offers a low-risk, cost-effective, non-pharmacological approach to improving sleep quality, fatigue, and daily functioning in individuals with MS. Targeting insomnia in MS may also reduce disability, enhance quality of life, increase employment rates, and lower healthcare and support costs. Furthermore, understanding factors that impact improvement in outcomes will allow more accurate individualization of insomnia treatment for people with MS.

TRIAL REGISTRATION: The CALM study is registered at: https://clinicaltrials.gov (NCT06428006).