Digital therapy to improve insomnia in people with Multiple Sclerosis
Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in People With Multiple Sclerosis in Norway
This study is testing a digital therapy for insomnia to see if it can help people with Multiple Sclerosis feel less tired and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT06113666 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) compared to digital patient education for individuals with Multiple Sclerosis (MS). The study will assess whether dCBT-I can reduce insomnia severity, daytime fatigue, psychological distress, and cognitive problems, while also examining its feasibility for MS patients. By increasing the sample size to 550, the trial seeks to enhance the statistical power to detect meaningful differences in secondary outcomes related to fatigue and cognitive functioning. This innovative approach addresses the lack of effective insomnia treatments available for MS patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of Multiple Sclerosis and insomnia severity as indicated by the Insomnia Severity Index.
Not a fit: Patients with self-reported sleep apnea, recent heart surgery, or those currently experiencing an MS attack may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall functioning for patients with Multiple Sclerosis.
How similar studies have performed: While cognitive behavioral therapy for insomnia has shown success in other populations, this digital adaptation for MS patients is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Trondheim
- St.Olavs Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Håvard Kallestad, PhD — Senior clinical psychologist and researcher
- Study coordinator: Simen Saksvik, PhD
- Email: simen.b.saksvik@ntnu.no
- Phone: +4797542252
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.