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

NARecruitingINTERVENTIONAL
Enrollment

550

Participants

Timeline

Start Date

November 16, 2023

Primary Completion Date

October 30, 2025

Study Completion Date

October 30, 2029

Conditions
Multiple SclerosisInsomnia
Interventions
BEHAVIORAL

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)

dCBT-I during 9 weeks. Multicomponent intervention that includes the following: psychoeducation about sleep, sleep hygiene, sleep restriction therapy, stimulus control and challenging beliefs and perception about sleep. The digital CBT-I that will be utilized in this study is named Sleep Healthy Using The internet (SHUTi). The intervention is fully automated with no contact with health care personnel, it is interactive and adapts to input from the users. It comprises of the same elements included in face-to-face CBT-I, but the user gains access to a new educational, behavioral or cognitive module each week only after completion of digital sleep diaries. dCBT-I can be accessed on computers or hand-held devices

BEHAVIORAL

Digital patient education about insomnia (PE)

Control condition PE during 9 weeks. A digital patient education program that can be accessed on computers or hand-held devices. The information overlaps with that included in the dCBT-I intervention but it does not include any of the interactive features of the dCBT-I intervention and all the information is available from the moment the PE site is opened.

Trial Locations (1)

7044

RECRUITING

St.Olavs Hospital, Trondheim

All Listed Sponsors
lead

St. Olavs Hospital

OTHER