{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T15:53:46Z","timestamp":1772553226293,"version":"3.50.1"},"reference-count":90,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T00:00:00Z","timestamp":1761868800000},"content-version":"vor","delay-in-days":303,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,10,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>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 (&amp;gt;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\u00a0weeks, 6\u00a0months, and 12\u00a0months, with additional health registry data collected 5\u00a0years 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).<\/jats:p>\n                  <jats:p>A Digital Therapeutic to Improve Insomnia in Multiple Sclerosis: A Randomized Controlled Trial. (NorseMS) Sponsor: St.Olavs Hospital, Postboks 3250 Torg\u00e5rden, 7006 Trondheim.<\/jats:p>\n                  <jats:p>Statement of Significance Insomnia is common in multiple sclerosis (MS), and has a significant impact on daytime functioning. Fully automated digital Cognitive Behavioral Therapy for Insomnia offers a scalable option that could be deployed in routine MS care. This pragmatic randomized trial is designed to detect effects on insomnia severity in a heterogeneous sample of people with MS and self-reported insomnia, and to test whether improving insomnia leads to benefits in fatigue, mental health, and cognitive function. Data on pain, alcohol use, quality of life, social and work functioning, national registry data, and actigraphy recordings for 90\u00a0days during the intervention phase will also be collected. Findings will directly inform clinical implementation pathways and provide new knowledge about the role of insomnia in MS.<\/jats:p>","DOI":"10.1093\/sleepadvances\/zpaf075","type":"journal-article","created":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T13:36:14Z","timestamp":1761744974000},"source":"Crossref","is-referenced-by-count":1,"title":["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"],"prefix":"10.1093","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4322-3805","authenticated-orcid":false,"given":"Simen Berg","family":"Saksvik","sequence":"first","affiliation":[{"name":"St.Olavs Hospital Department of Research and Development, Trondheim University Hospital , Trondheim ,","place":["Norway"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liv 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Technology , Trondheim ,","place":["Norway"]},{"name":"NorHead, Norwegian Center for Headache Research , Trondheim ,","place":["Norway"]},{"name":"Clinic of Rehabilitation, St. Olavs Hospital , Trondheim ,","place":["Norway"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roshan","family":"das Nair","sequence":"additional","affiliation":[{"name":"Health Department, SINTEF, Trondheim, Norway"},{"name":"School of Medicine, University of Nottingham , Nottingham ,","place":["United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6613-8596","authenticated-orcid":false,"given":"Stian","family":"Lydersen","sequence":"additional","affiliation":[{"name":"Department of Mental Health, Norwegian University of Science and Technology , Trondheim ,","place":["Norway"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julie Grini","family":"Holthe","sequence":"additional","affiliation":[{"name":"St.Olavs Hospital Department of Research and Development, Trondheim University Hospital , Trondheim ,","place":["Norway"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0961-6579","authenticated-orcid":false,"given":"Joar \u00d8veraas","family":"Halvorsen","sequence":"additional","affiliation":[{"name":"Department of Psychology, Norwegian University of Science and Technology , Trondheim ,","place":["Norway"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1972-5901","authenticated-orcid":false,"given":"Gunnar","family":"Morken","sequence":"additional","affiliation":[{"name":"St.Olavs Hospital Department of Research and Development, Trondheim University Hospital , Trondheim ,","place":["Norway"]},{"name":"Department of Mental Health, Norwegian University of Science and Technology , Trondheim ,","place":["Norway"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lee M","family":"Ritterband","sequence":"additional","affiliation":[{"name":"Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia , Charlottesville, VA ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars","family":"B\u00f8","sequence":"additional","affiliation":[{"name":"Department of Neurology, Haukeland University Hospital , Bergen ,","place":["Norway"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9173-942X","authenticated-orcid":false,"given":"H\u00e5vard","family":"Kallestad","sequence":"additional","affiliation":[{"name":"St.Olavs Hospital Department of Research and Development, Trondheim University Hospital , Trondheim ,","place":["Norway"]},{"name":"Department of Mental Health, Norwegian University of Science and Technology , Trondheim 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