A Digital Therapeutic to Improve Insomnia in Multiple Sclerosis: A Ran
Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in People With Multiple Sclerosis in Norway
What it found
No result yet.
What was tested
Treatment tested
- Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
Compared with
- Digital patient education about insomnia (PE)
What it measured
Main measures
Between-group difference in insomnia severity at week 9 after randomization
9 weeks after randomization
Mood and sleep
Other measures (89)
Between-group difference in insomnia severity at week 33 after randomization
33 weeks after randomization
Mood and sleepBetween-group difference in insomnia severity at week 61 after randomization
61 weeks after randomization
Mood and sleepProspective daily sleep-wake pattern at week 9 after randomization
9 weeks after randomization
Myelin repairMood and sleepProspective daily sleep-wake pattern at week 33 after randomization
33 weeks after randomization
Myelin repairMood and sleepProspective daily sleep-wake pattern at week 61 after randomization
61 weeks after randomization
Myelin repairMood and sleepSelf-reported mental health status at baseline
Baseline
Mood and sleepQuality of life (reported by participants)Self-reported mental health status at week 9 after randomization
9 weeks after randomization
Mood and sleepQuality of life (reported by participants)Self-reported mental health status at week 33 after randomization
33 weeks after randomization
Mood and sleepQuality of life (reported by participants)Self-reported mental health status at week 61 after randomization
61 weeks after randomization
Mood and sleepQuality of life (reported by participants)Anxiety/depression at baseline
Baseline
Mood and sleep
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
1. Having an established diagnosis of Multiple Sclerosis (MS) and being included in the Norwegian MS registry 2. Being 18 years or older 3. Scoring at least 12 points on the Insomnia Severity Index 4. Willing and able to provide written informed consent
Exclusion criteria
1. Self-reported symptoms of sleep apnea: Positive endorsement of a screening question for sleep apnoea (the item asks if they 'usually or everyday snore and stop breathing and have difficulties staying awake during the day') 2. Self-reported surgery for heart disease the last two months 3. Currently in an attack phase of MS and/or on treatment with steroids, 4. Self-reported night shifts in their work schedule, 5. Inadequate opportunity to sleep or living in circumstances that prevent modification of sleep pattern (e.g. having an infant residing at home), 6. Pregnant in the last two trimesters 7. Unable to get into bed or out of bed without human assistance. 8. Concomitant psychological treatment for sleep problems
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
Papers
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History
Started
Nov 2023
Main results due
Feb 2026
Finished
Jun 2031