Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Digital Therapeutic to Improve Insomnia in Multiple Sclerosis: A Randomized Controlled Trial.
Sponsor: St. Olavs Hospital
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
Official title: Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in People With Multiple Sclerosis in Norway
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
550
Start Date
2023-11-16
Completion Date
2031-06-30
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
dCBT-I during 9 weeks. Multicomponent intervention that includes the following: psychoeducation about sleep, sleep hygiene, sleep restriction therapy, stimulus control and challenging beliefs and perception about sleep. The digital CBT-I that will be utilized in this study is named Sleep Healthy Using The internet (SHUTi). The intervention is fully automated with no contact with health care personnel, it is interactive and adapts to input from the users. It comprises of the same elements included in face-to-face CBT-I, but the user gains access to a new educational, behavioral or cognitive module each week only after completion of digital sleep diaries. dCBT-I can be accessed on computers or hand-held devices
Digital patient education about insomnia (PE)
Control condition PE during 9 weeks. A digital patient education program that can be accessed on computers or hand-held devices. The information overlaps with that included in the dCBT-I intervention but it does not include any of the interactive features of the dCBT-I intervention and all the information is available from the moment the PE site is opened.
Locations (1)
St.Olavs Hospital
Trondheim, Norway