Digital cognitive behavioral therapy for insomnia compared with digital patient education about insomnia in people with multiple sclerosis in Norway: study protocol for a randomized controlled trial.

Insomnia is prevalent in multiple sclerosis (MS) and may negatively affect quality of life and brain health. Cognitive behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment, but access is limited due to a shortage of trained therapists. Fully automated digital CBT-I (dCBT-I) has been developed to expand availability. Its effectiveness in MS, and whether improvements in insomnia severity lead to benefits in fatigue, mental health, and cognitive function, remains unknown. This randomized controlled trial will examine the effectiveness of dCBT-I compared with patient education about insomnia (PE) in people with MS. We plan to invite all individuals in the Norwegian MS registry (>90% of people diagnosed with MS in Norway) to the trial with the aim of including 550 participants. Participants will be randomly allocated 1:1 to dCBT-I or PE. Outcomes will be assessed at baseline, 9 weeks, 6 months, and 12 months, with additional health registry data collected 5 years after randomization. The between-group difference in self-reported insomnia severity at 9-weeks is the primary endpoint (intention to treat). Secondary outcomes include between-group differences in fatigue, mental health, cognitive function, sleep and daytime activity with actigraphy, medication use, pain, alcohol use, quality of life, social and work functioning, and resource utilization and whether changes in fatigue, mental health and cognitive function are mediated by changes in insomnia severity. The study protocol is approved by the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (Ref: 623308) and is preregistered at ClinicalTrials.gov (ref: NCT06113666). A Digital Therapeutic to Improve Insomnia in Multiple Sclerosis: A Randomized Controlled Trial. (NorseMS) Sponsor: St.Olavs Hospital, Postboks 3250 Torgården, 7006 Trondheim.