ArticleSleep advances : a journal of the Sleep Research Society2025
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.
Article in Sleep advances : a journal of the Sleep Research Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06113666 (Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in People With Multiple Sclerosis in Norway), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in People With Multiple Sclerosis in Norway
Who cites it
1 citing paper in PubMed.
- Reflecting on 2025. Anticipating 2026.Sleep advances : a journal of the Sleep Research Society · 2026Article
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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