Disease: Multiple Sclerosis
Type of study: Interventional trial
Coordinating investigator: Simen B. Saksvik (NTNU)
Study directors: Håvard Kallestad (NTNU) & Lars Bø (HUH/UiB)
Background: Insomnia is prevalent among individuals with multiple sclerosis (MS). Improving sleep is an important therapeutic goal, but there is currently a lack of effective treatment options. Cognitive Behavioural Therapy for Insomnia (CBT-I) has been widely studied in other patient groups and is currently recommended as first-line treatment for chronic insomnia.
Overall, the availability of CBT-I has been limited, as the number of patients in need of treatment far exceeds the number of available therapists. Therefore, fully automated digital adaptations of CBT-I (dCBT-I) have been developed that contain both screening and intervention. Whether this treatment is effective for patients diagnosed with MS, or if improved sleep can lead to reduced daytime fatigue in MS, is however, currently unknown.
The objective of this study is to investigate the efficacy and safety of dCBT-I in patients with MS.
Design: This is a multicentre parallel-group randomised controlled trial of 650 persons with MS with selfreported insomnia allocated 1:1 to either dCBT-I or a digital control-condition consisting of patient education about sleep.
The primary endpoint is to test if dCBT-I is effective in reducing insomnia severity in patients with MS.
Status: Inclusion started in November 2024, and by December 2025, a total of about 630 patients were included. The inclusion will end by March 2026 – and the first results are expected in Q3 2027.
Participating centres
- St. Olav’s Hospital, Trondheim
- Haukeland University Hospital, Bergen
- The Norwegian University of Science and Technology, Trondheim
- The University of Bergen
Funding
- The Norwegian MS Society
- St. Olav’s Hospital, Trondheim
- The Norwegian University of Science and Technology, Trondheim
- The Central Regional Health Authority of Norway
- Haukeland University Hospital, Bergen
- The University of Bergen
- The Foundation DAM