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Clinical Trial Summary

The goal of this randomized controlled trial is to test the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) compared with digital patient education about insomnia for people with Multiple Sclerosis (MS). The main questions it aims to answer are whether dCBT-I is effective in reducing insomnia severity in people with MS, whether dCBT-I is effective in reducing daytime fatigue, psychological distress, cognitive problems, medication use (hypnotic, sedative/anxiolytic and antidepressant), resource utilization and if these changes are mediated by improvements in insomnia severity and whether dCBT-I is feasible for people with MS


Clinical Trial Description

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 Behavioral 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 a clinical sample of patients diagnosed with MS, or if improved sleep can lead to improved daytime functioning in MS, is however, currently unknown. This is a novel approach to a digital treatment of a common disorder in MS, and that may result in improved implementation of a low-threshold intervention. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06113666
Study type Interventional
Source St. Olavs Hospital
Contact Simen Saksvik, PhD
Phone +4797542252
Email simen.b.saksvik@ntnu.no
Status Recruiting
Phase N/A
Start date November 16, 2023
Completion date October 30, 2029

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