NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Digital Therapeutic to Improve Insomnia in Multiple Sclerosis: A Randomized Controlled Trial.

Active Not RecruitingNA

Sponsor: St. Olavs Hospital

Conditions: Multiple Sclerosis, Insomnia

Interventions: Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I), Digital patient education about insomnia (PE)

Countries: Norway

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Trondheim, Norway