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

NCT06113666 | Active Not Recruiting DMC

• 1 other identifier: 623308
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis; Insomnia

Keywords

Cognitive Behavioral Therapy for Insomnia; Fatigue; Cognitive performance

Outcome Measures

Primary Outcomes (1)

• Between-group difference in insomnia severity at week 9 after randomization

  Assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire for the severity of insomnia symptoms the last 14 days. Each item is rated on a 0 to 4 rating scale with higher scores indicating more severe symptoms. The ISI has good psychometric properties and is validated for online use. Range is 0-28 with higher values represent higher levels of insomnia symptom severity.

  9 weeks after randomization

Secondary Outcomes (89)

• Between-group difference in insomnia severity at week 33 after randomization

  33 weeks after randomization

• Between-group difference in insomnia severity at week 61 after randomization

  61 weeks after randomization

• Prospective daily sleep-wake pattern at week 9 after randomization

  9 weeks after randomization

• Prospective daily sleep-wake pattern at week 33 after randomization

  33 weeks after randomization

• Prospective daily sleep-wake pattern at week 61 after randomization

  61 weeks after randomization

Study Arms (2)

Digital cognitive behavioral therapy for insomnia

EXPERIMENTAL

Behavioral: digital cognitive behavioral therapy (dCBT-I)

Behavioral: Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)

Patient Education about insomnia

ACTIVE COMPARATOR

Behavioral: Digital patient education about insomnia (PE)

Behavioral: Digital patient education about insomnia (PE)

Interventions

Digital patient education about insomnia (PE) BEHAVIORAL

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.

Patient Education about insomnia

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) BEHAVIORAL

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

Also known as: Sleep Healthy Using The Internet (SHUTi)

Digital cognitive behavioral therapy for insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 surgery for heart disease the last two months
• Currently in an attack phase of MS and/or on treatment with steroids,
• 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.
• Concomitant psychological treatment for sleep problems

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

St.Olavs Hospital

Trondheim, 7044, Norway

Location

Related Publications (1)

• Saksvik SB, Ronhovde LM, Ytrehus-Lynum K, Langsrud K, Olsen A, das Nair R, Lydersen S, Holthe JG, Halvorsen JO, Morken G, Ritterband LM, Bo L, Kallestad H. Digital cognitive behavioral therapy for insomnia compared with digital patient education about insomnia in people with multiple sclerosis in Norway: study protocol for a randomized controlled trial. Sleep Adv. 2025 Oct 31;6(4):zpaf075. doi: 10.1093/sleepadvances/zpaf075. eCollection 2025.

  PMID: 41278218 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Sleep Initiation and Maintenance Disorders; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Håvard Kallestad, PhD

  Senior clinical psychologist and researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The participants are in theory blinded to which group they are allocated to. However, it is not possible to blind completely as it is easy for the patients to see if they are receiving active, interactive treatment or are allocated into the control group with patient education.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: November 16, 2023
• Primary Completion: February 10, 2026
• Study Completion (Estimated): June 30, 2031
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)