NCT06113666Active, not recruiting
A Digital Therapeutic to Improve Insomnia in Multiple Sclerosis: A Randomized Controlled Trial.
Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in People With Multiple Sclerosis in Norway
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 550 (estimated)
- First submitted
- 27 Oct 2023
- Start date
- 16 Nov 2023
- Primary completion date
- 10 Feb 2026
- Lead sponsor
- St. Olavs Hospital
- Diseases
- Multiple sclerosis
- NCT number
- NCT06113666
What you commit to
- Study type: Interventional
- Planned participants: 550
- From 16 Nov 2023 to the primary completion date, 10 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently in an attack phase of MS and/or on treatment with steroids,
- Concomitant psychological treatment for sleep problems
Other illness
- Self-reported surgery for heart disease the last two months
Other
- 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')
- Self-reported night shifts in their work schedule,
- Inadequate opportunity to sleep or living in circumstances that prevent modification of sleep pattern (e.g. having an infant residing at home),
- Pregnant in the last two trimesters
- Unable to get into bed or out of bed without human assistance.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Olavs Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.