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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Having an established diagnosis of Multiple Sclerosis (MS) and being included in the Norwegian MS registry

• Being 18 years or older

• Scoring at least 12 points on the Insomnia Severity Index

• Willing and able to provide written informed consent

Locations
Other Locations
Norway
St.Olavs Hospital
RECRUITING
Trondheim
Contact Information
Primary
Simen Saksvik, PhD
simen.b.saksvik@ntnu.no
+4797542252
Backup
Håvard Kallestad, PhD
havard.kallestad@ntnu.no
+4793027262
Time Frame
Start Date: 2023-11-16
Estimated Completion Date: 2029-10-30
Participants
Target number of participants: 550
Treatments
Experimental: Digital cognitive behavioral therapy for insomnia
Behavioral: digital cognitive behavioral therapy (dCBT-I)
Active_comparator: Patient Education about insomnia
Behavioral: Digital patient education about insomnia (PE)
Related Therapeutic Areas
Sponsors
Leads: St. Olavs Hospital

This content was sourced from clinicaltrials.gov