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A Digital Therapeutic to Improve Insomnia in Multiple Sclerosis: A Randomized Controlled Trial. — NorseMS  

Multiple Sclerosis Clinical Trial

Official title:
Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in People With Multiple Sclerosis in Norway

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

Clinical Trial Details
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
View Details
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