Multiple SclerosisNorseMSNCT06113666
A Digital Therapeutic to Improve Insomnia in Multiple Sclerosis: A Randomized Controlled Trial.
A study testing Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) and Digital patient education about insomnia (PE) in people with Multiple Sclerosis and Insomnia, run by St. Olavs Hospital at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Insomnia
- What is being tested?
- Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) and Digital patient education about insomnia (PE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteNorway
- Study dates
- 16 Nov 2023to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in People With Multiple Sclerosis in 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
Read the detailed description
Insomnia is prevalent among individuals with Multiple Sclerosis (MS). Improving sleep is an important therapeutic goal, but there is currently a lack of effective treatment options. Cognitive Behavioral Therapy for Insomnia (CBT-I) has been widely studied in other patient groups and is currently recommended as first- line treatment for chronic insomnia.
Overall, the availability of CBT-I has been limited, as the number of patients in need of treatment far exceeds the number of available therapists. Therefore, fully automated digital adaptations of CBT-I (dCBT-I) have been developed that contain both screening and intervention. Whether this treatment is effective for a clinical sample of patients diagnosed with MS, or if improved sleep can lead to improved daytime functioning in MS, is however, currently unknown.
This is a novel approach to a digital treatment of a common disorder in MS, and that may result in improved implementation of a low-threshold intervention.
Update August 28th, 2024
We aim to increase the target sample size from 260 to 550 to increase the statistical power to detect differences between the intervention group and control group on the secondary outcomes, e.g., fatigue, cognitive functioning, mental health, and movement measures measured with actigraphy. Few treatment options have shown effects on these outcomes for people with MS but are a significant problem for this patient group. Small effects from this trial may have substantial scientific and clinical value and are important to test with adequate statistical power.
Based on previous RCTs investigating the effectiveness of dCBT-I we aim to have a sample size large enough to detect small to moderate effects (Cohen's d = 0.3 til 0.5) on the secondary outcome measures fatigue, cognitive function, mental health and movement measures measured with actigraphy. As the planned RCT involves limited contact between researchers and participants, we have predicted that the study dropout rate will likely reach about 50%. Therefore, we aim to recruit 550 participants, to enable us to retain 275 participants (137 in each treatment arm) at the end of the RCT. For a two-sample t-test with alpha=0.05, this sample size gives a power of 90% of detecting a difference of Cohen's d = 0.40.
- Conditions
- Multiple Sclerosis, Insomnia
- Being tested
- Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I), Digital patient education about insomnia (PE)
- Keywords
- Cognitive Behavioral Therapy for Insomnia, Fatigue, Cognitive performance
- Medical subject headings
- Multiple Sclerosis, Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)Behavioural
Also called Sleep Healthy Using The Internet (SHUTi)
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
Digital patient education about insomnia (PE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital cognitive behavioral therapy for insomnia | Experimental | Behavioral: digital cognitive behavioral therapy (dCBT-I) Receives: Behavioral: Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) |
| Patient Education about insomnia | Active comparator | Behavioral: Digital patient education about insomnia (PE) Receives: Behavioral: Digital patient education about insomnia (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 weeks after randomization
Secondary outcomes (89)
Between-group difference in insomnia severity at week 33 after randomization
While between-group difference on the ISI on week 9 is our primary endpoint, we will also assess between group differences on the ISI at week 33 (six months after post-assessment) and week 61 (one year after post assessment). 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.
Measured: 33 weeks after randomization
Between-group difference in insomnia severity at week 61 after randomization
While between-group difference on the ISI on week 9 is our primary endpoint, we will also assess between group differences on the ISI at week 33 (six months after post-assessment) and week 61 (one year after post assessment). 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.
Measured: 61 weeks after randomization
Prospective daily sleep-wake pattern at week 9 after randomization
Assessed with the Consensus Sleep Dairy (sleep-onset latency [SOL]; wake-time after sleep onset [WASO]; sleep efficiency [SE]; total sleep time [TST]; sleep quality [SQ]), which will be completed by the participant at baseline and each follow-up point for at least 10 out of 14 consecutive days.
Measured: 9 weeks after randomization
Prospective daily sleep-wake pattern at week 33 after randomization
Assessed with the Consensus Sleep Dairy (sleep-onset latency [SOL]; wake-time after sleep onset [WASO]; sleep efficiency [SE]; total sleep time [TST]; sleep quality [SQ]), which will be completed by the participant at baseline and each follow-up point for at least 10 out of 14 consecutive days.
Measured: 33 weeks after randomization
Prospective daily sleep-wake pattern at week 61 after randomization
Assessed with the Consensus Sleep Dairy (sleep-onset latency [SOL]; wake-time after sleep onset [WASO]; sleep efficiency [SE]; total sleep time [TST]; sleep quality [SQ]), which will be completed by the participant at baseline and each follow-up point for at least 10 out of 14 consecutive days.
Measured: 61 weeks after randomization
Self-reported mental health status at baseline
Assessed with the Outcome Questionnaire - 45.2 (OQ-45.2), a 45 item self-report scale for mental health status, specifically designed for patient progress throughout therapy. It has excellent internal consistency and is highly correlated with well-known outcomes such as the Symptom Checklist 90R, Beck Depression Inventory, The State Trait Inventory, The inventory of interpersonal problems, The Social Adjustment Scale, and the SF-36.34 The scale is scored on a scale of 0 (=never) to 5 (=almost always) giving a range of 0 to 180, with higher scores indicating higher levels of psychopathology. The OQ-45.2 has three validated subscales: symptom distress, interpersonal relations, and social role functioning (perceived level of difficulties in the workplace, school or home duties). Results will be reported for the sum score, and for the three subscales. The OQ-45.2 has an established clinical cut-off value and reliable change index
Measured: Baseline
Self-reported mental health status at week 9 after randomization
Assessed with the Outcome Questionnaire - 45.2 (OQ-45.2), a 45 item self-report scale for mental health status, specifically designed for patient progress throughout therapy. It has excellent internal consistency and is highly correlated with well-known outcomes such as the Symptom Checklist 90R, Beck Depression Inventory, The State Trait Inventory, The inventory of interpersonal problems, The Social Adjustment Scale, and the SF-36.34 The scale is scored on a scale of 0 (=never) to 5 (=almost always) giving a range of 0 to 180, with higher scores indicating higher levels of psychopathology. The OQ-45.2 has three validated subscales: symptom distress, interpersonal relations, and social role functioning (perceived level of difficulties in the workplace, school or home duties). Results will be reported for the sum score, and for the three subscales. The OQ-45.2 has an established clinical cut-off value and reliable change index
Measured: 9 weeks after randomization
Self-reported mental health status at week 33 after randomization
Assessed with the Outcome Questionnaire - 45.2 (OQ-45.2), a 45 item self-report scale for mental health status, specifically designed for patient progress throughout therapy. It has excellent internal consistency and is highly correlated with well-known outcomes such as the Symptom Checklist 90R, Beck Depression Inventory, The State Trait Inventory, The inventory of interpersonal problems, The Social Adjustment Scale, and the SF-36.34 The scale is scored on a scale of 0 (=never) to 5 (=almost always) giving a range of 0 to 180, with higher scores indicating higher levels of psychopathology. The OQ-45.2 has three validated subscales: symptom distress, interpersonal relations, and social role functioning (perceived level of difficulties in the workplace, school or home duties). Results will be reported for the sum score, and for the three subscales. The OQ-45.2 has an established clinical cut-off value and reliable change index
Measured: 33 weeks after randomization
Self-reported mental health status at week 61 after randomization
Assessed with the Outcome Questionnaire - 45.2 (OQ-45.2), a 45 item self-report scale for mental health status, specifically designed for patient progress throughout therapy. It has excellent internal consistency and is highly correlated with well-known outcomes such as the Symptom Checklist 90R, Beck Depression Inventory, The State Trait Inventory, The inventory of interpersonal problems, The Social Adjustment Scale, and the SF-36.34 The scale is scored on a scale of 0 (=never) to 5 (=almost always) giving a range of 0 to 180, with higher scores indicating higher levels of psychopathology. The OQ-45.2 has three validated subscales: symptom distress, interpersonal relations, and social role functioning (perceived level of difficulties in the workplace, school or home duties). Results will be reported for the sum score, and for the three subscales. The OQ-45.2 has an established clinical cut-off value and reliable change index
Measured: 61 weeks after randomization
Anxiety/depression at baseline
Assessed with the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire for non-vegetative symptoms of anxiety and depression on a 0 to 3 likert scale. The sum score can be used as a measure of general psychological distress and is widely used in the community, general practice and psychiatric settings. It has a range of 0 to 42 points with higher scores indicating higher levels of psychological distress.
Measured: Baseline
Anxiety/depression at week 9 after randomization
Assessed with the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire for non-vegetative symptoms of anxiety and depression on a 0 to 3 likert scale. The sum score can be used as a measure of general psychological distress and is widely used in the community, general practice and psychiatric settings. It has a range of 0 to 42 points with higher scores indicating higher levels of psychological distress.
Measured: 9 weeks after randomization
Anxiety/depression at week 33 after randomization
Assessed with the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire for non-vegetative symptoms of anxiety and depression on a 0 to 3 likert scale. The sum score can be used as a measure of general psychological distress and is widely used in the community, general practice and psychiatric settings. It has a range of 0 to 42 points with higher scores indicating higher levels of psychological distress.
Measured: 33 weeks after randomization
Anxiety/depression at week 61 after randomization
Assessed with the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire for non-vegetative symptoms of anxiety and depression on a 0 to 3 likert scale. The sum score can be used as a measure of general psychological distress and is widely used in the community, general practice and psychiatric settings. It has a range of 0 to 42 points with higher scores indicating higher levels of psychological distress.
Measured: 61 weeks after randomization
Fatigue at baseline
Assessed with the Chalder Fatigue Questionnaire (CFQ), a 11-item questionnaire for daytime physical and psychological fatigue on a 0 to 3 likert scale (0=less than usual, 3=much more than usual). The scale has a range of 0 to 33 with higher scores indicating higher levels of fatigue. Two additional items assess duration of fatigue (0=less than a week, 4=six months or more) and how much of the time the individual experience fatigue (0=25% of the time, 3=all the time)
Measured: Baseline
Fatigue at week 9 after randomization
Assessed with the Chalder Fatigue Questionnaire (CFQ), a 11-item questionnaire for daytime physical and psychological fatigue on a 0 to 3 likert scale (0=less than usual, 3=much more than usual). The scale has a range of 0 to 33 with higher scores indicating higher levels of fatigue. Two additional items assess duration of fatigue (0=less than a week, 4=six months or more) and how much of the time the individual experience fatigue (0=25% of the time, 3=all the time)
Measured: 9 weeks after randomization
Fatigue at week 33 after randomization
Assessed with the Chalder Fatigue Questionnaire (CFQ), a 11-item questionnaire for daytime physical and psychological fatigue on a 0 to 3 likert scale (0=less than usual, 3=much more than usual). The scale has a range of 0 to 33 with higher scores indicating higher levels of fatigue. Two additional items assess duration of fatigue (0=less than a week, 4=six months or more) and how much of the time the individual experience fatigue (0=25% of the time, 3=all the time)
Measured: 33 weeks after randomization
Fatigue at week 61 after randomization
Assessed with the Chalder Fatigue Questionnaire (CFQ), a 11-item questionnaire for daytime physical and psychological fatigue on a 0 to 3 likert scale (0=less than usual, 3=much more than usual). The scale has a range of 0 to 33 with higher scores indicating higher levels of fatigue. Two additional items assess duration of fatigue (0=less than a week, 4=six months or more) and how much of the time the individual experience fatigue (0=25% of the time, 3=all the time)
Measured: 61 weeks after randomization
Fatigue severity at baseline
Assessed with the Fatigue Severity Scale (FSS), a 9-item questionnaire with statements about physical, social and cognitive effects of fatigue on a 1 to 7 likert scale (1=strongly disagree, 7=strongly agree). Higher total scores indicate higher levels of fatigue.
Measured: Baseline
Fatigue severity at week 9 after randomization
Assessed with the Fatigue Severity Scale (FSS), a 9-item questionnaire with statements about physical, social and cognitive effects of fatigue on a 1 to 7 likert scale (1=strongly disagree, 7=strongly agree). Higher total scores indicate higher levels of fatigue.
Measured: 9 weeks after randomization
Fatigue severity at week 33 after randomization
Assessed with the Fatigue Severity Scale (FSS), a 9-item questionnaire with statements about physical, social and cognitive effects of fatigue on a 1 to 7 likert scale (1=strongly disagree, 7=strongly agree). Higher total scores indicate higher levels of fatigue.
Measured: 33 weeks after randomization
Fatigue severity at week 61 after randomization
Assessed with the Fatigue Severity Scale (FSS), a 9-item questionnaire with statements about physical, social and cognitive effects of fatigue on a 1 to 7 likert scale (1=strongly disagree, 7=strongly agree). Higher total scores indicate higher levels of fatigue.
Measured: 61 weeks after randomization
Cognitive test performance at baseline
Assessed with the home-based cognitive test battery Memoro. At baseline the test battery includes subtests for assessing reaction time, spatial memory, working memory, processing speed, attention and abstract reasoning.
Measured: Baseline
Cognitive test performance at week 9 after randomization
Assessed with the home-based cognitive test battery Memoro. At follow-up the test battery includes the subtests Coding (The Symbol Digit Modalities Test) assessing processing speed and a continuous performance test assessing attention and cognitive control function. Cognitive performance will be assessed with reaction time, number of errors and performance variability (standard deviations of hit reaction times).
Measured: 9 weeks after randomization
Cognitive test performance at week 33 after randomization
Assessed with the home-based cognitive test battery Memoro. At follow-up the test battery includes the subtests Coding (The Symbol Digit Modalities Test) assessing processing speed and a continuous performance test assessing attention and cognitive control function. Cognitive performance will be assessed with reaction time, number of errors and performance variability (standard deviations of hit reaction times).
Measured: 33 weeks after randomization
Cognitive test performance at week 61 after randomization
Assessed with the home-based cognitive test battery Memoro. At follow-up the test battery includes the subtests Coding (The Symbol Digit Modalities Test) assessing processing speed and a continuous performance test assessing attention and cognitive control function. Cognitive performance will be assessed with reaction time, number of errors and performance variability (standard deviations of hit reaction times).
Measured: 61 weeks after randomization
Continuous recordings of daytime activity and sleep from baseline to 9 weeks after randomization
Sleep and daytime activity will be recorded using actigraphy (GENEactiv Original, Activinsights Ltd, Kimbolton, United Kingdom). This will primarily allow collection of data to assess details of sleep-wake cycles as well as adherence to the intervention. It will also allow assessment of any intervention-related changes in daytime activity patterns and novel use of mathematical modelling.
Measured: From baseline to 9 weeks after randomization.
Use of health care services at baseline
Number of appointments at mental health care clinics, type and timing of treatment and admissions, and date of the first appointment for each patient during the study period from the Norwegian Patient Registry
Measured: Baseline
Use of health care services at 61 weeks after randomization
Number of appointments at mental health care clinics, type and timing of treatment and admissions, and date of the first appointment for each patient during the study period from the Norwegian Patient Registry
Measured: 61 weeks after randomization
Use of health care services at 5 years after randomization
Number of appointments at mental health care clinics, type and timing of treatment and admissions, and date of the first appointment for each patient during the study period from the Norwegian Patient Registry
Measured: 5 years after randomization
Medication use at baseline
Dose, timing, and type of prescribed hypnotic, sedative/anxiolytic, antidepressant and other psychotropic medications and medications used in treatment of MS (According to the WHO Anatomical Therapeutic Chemical Classification System) and changes recorded during the RCT (data from the Norwegian Prescription Database
Measured: Baseline
Medication use at 61 weeks after randomization
Dose, timing, and type of prescribed hypnotic, sedative/anxiolytic, antidepressant and other psychotropic medications and medications used in treatment of MS (According to the WHO Anatomical Therapeutic Chemical Classification System) and changes recorded during the RCT (data from the Norwegian Prescription Database
Measured: 61 weeks after randomization
Medication use at 5 years after randomization
Dose, timing, and type of prescribed hypnotic, sedative/anxiolytic, antidepressant and other psychotropic medications and medications used in treatment of MS (According to the WHO Anatomical Therapeutic Chemical Classification System) and changes recorded during the RCT (data from the Norwegian Prescription Database
Measured: 5 years after randomization
Costs of treatment offered by the public services at baseline
Data from the database named 'Kontroll og Utbetaling av Helserefusjon'
Measured: Baseline
Costs of treatment offered by the public services 61 weeks after randomization
Data from the database named 'Kontroll og Utbetaling av Helserefusjon'
Measured: 61 weeks after randomization
Costs of treatment offered by the public services 5 years after randomization
Data from the database named 'Kontroll og Utbetaling av Helserefusjon'
Measured: 5 years after randomization
Sick leave or in receipt of disability benefits at baseline
Data from the administrative database called Forløpsdatabasen
Measured: Baseline
Sick leave or in receipt of disability benefits 61 weeks after randomization
Data from the administrative database called Forløpsdatabasen
Measured: 61 weeks after randomization
Sick leave or in receipt of disability benefits 5 years after randomization
Data from the administrative database called Forløpsdatabasen
Measured: 5 years after randomization
Information about the MS disease at baseline
Disability status assessed with the Extended Disability Status Scale from the Norwegian MS registry, information about previous and current treatment for MS, previous attack phases, first diagnosis of MS from the Norwegian MS registry.
Measured: Baseline
Information about the MS disease at week 61 after randomization
Disability status assessed with the Extended Disability Status Scale from the Norwegian MS registry, information about previous and current treatment for MS, previous attack phases, first diagnosis of MS from the Norwegian MS registry.
Measured: 61 weeks after randomization
Information about the MS disease at 5 years after randomization
Disability status assessed with the Extended Disability Status Scale from the Norwegian MS registry, information about previous and current treatment for MS, previous attack phases, first diagnosis of MS from the Norwegian MS registry.
Measured: 5 years after randomization
Excessive daytime sleepiness at baseline
Assessed with the Epworth Sleepiness Scale, a eight item questionnaire. The eight items represent real-life situations where the participants must rate their chance of dozing off using a 4-point scale from 0 to 3. Higher scores indicate higher chance of dozing off. Total score indicates the extent of self-reported sleep propensity.
Measured: Baseline
Subjective cognitive disfunction at baseline
Assessed with the Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA), a 16-item self-reported instrument of subjective cognitive dysfunctions including executive function, processing speed, working memory, verbal learning and memory, attention/concentration and mental tracking. Items are rated using a 4-point scale. The higher the score, the more subjective complaints. Although the assessment was initially introduced for use with individuals with bipolar disorders, the rating can be used in other clinical populations
Measured: Baseline
Subjective executive functions at baseline
Assessed with the Behavior Rating Inventory of Executive Function for Adults, a 75 item questionnaire that that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Items are rated on a 3-point scale (Never a problem - sometimes a problem - often a problem).
Measured: Baseline
Subjective executive functions at 9 weeks after randomization
Assessed with the Behavior Rating Inventory of Executive Function for Adults, a 75 item questionnaire that that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Items are rated on a 3-point scale (Never a problem - sometimes a problem - often a problem).
Measured: 9 weeks after randomization
Subjective executive functions at 33 weeks after randomization
Assessed with the Behavior Rating Inventory of Executive Function for Adults, a 75 item questionnaire that that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Items are rated on a 3-point scale (Never a problem - sometimes a problem - often a problem).
Measured: 33 weeks after randomization
Subjective executive functions at 61 weeks after randomization
Assessed with the Behavior Rating Inventory of Executive Function for Adults, a 75 item questionnaire that that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Items are rated on a 3-point scale (Never a problem - sometimes a problem - often a problem).
Measured: 61 weeks after randomization
Subjective disability status at baseline
Assessed with the Patient-Determined Disease Steps (PDDS), a questionnaire where the participants are asked to choose one out of nine alternatives that bests describes their current disability status
Measured: Baseline
Fatigue before and after cognitive testing at baseline
Feelings of state fatigue assessed with a single question (i.e "How much fatigue do you feel right now"). The participants are asked to rate their feelings of fatigue on a 4-point scale from 0=no fatigue, to 4=severe fatigue right before cognitive testing and immediately after cognitive testing.
Measured: Baseline
Fatigue before and after cognitive testing at 9 weeks
Feelings of state fatigue assessed with a single question (i.e "How much fatigue do you feel right now"). The participants are asked to rate their feelings of fatigue on a 4-point scale from 0=no fatigue, to 4=severe fatigue right before cognitive testing and immediately after cognitive testing.
Measured: 9 weeks after randomization
Fatigue before and after cognitive testing at 33 weeks
Feelings of state fatigue assessed with a single question (i.e "How much fatigue do you feel right now"). The participants are asked to rate their feelings of fatigue on a 4-point scale from 0=no fatigue, to 4=severe fatigue right before cognitive testing and immediately after cognitive testing.
Measured: 33 weeks after randomization
Fatigue before and after cognitive testing at 61 weeks
Feelings of state fatigue assessed with a single question (i.e "How much fatigue do you feel right now"). The participants are asked to rate their feelings of fatigue on a 4-point scale from 0=no fatigue, to 4=severe fatigue right before cognitive testing and immediately after cognitive testing.
Measured: 61 weeks after randomization
Perceived performance after cognitive testing at baseline
Perceived performance after cognitive testing will be assessed with a single question (i.e. How did you feel like you performed on the test?) rated on a 10-point scale (1=very bad, 10=very good performance)
Measured: Baseline
Perceived performance after cognitive testing at 9 weeks
Perceived performance after cognitive testing will be assessed with a single question (i.e. How did you feel like you performed on the test?) rated on a 10-point scale (1=very bad, 10=very good performance)
Measured: 9 weeks after randomization
Perceived performance after cognitive testing at 33 weeks
Perceived performance after cognitive testing will be assessed with a single question (i.e. How did you feel like you performed on the test?) rated on a 10-point scale (1=very bad, 10=very good performance)
Measured: 33 weeks after randomization
Perceived performance after cognitive testing at 61 weeks
Perceived performance after cognitive testing will be assessed with a single question (i.e. How did you feel like you performed on the test?) rated on a 10-point scale (1=very bad, 10=very good performance)
Measured: 61 weeks after randomization
Perceived exertion after cognitive testing at baseline
Perceived exertion after cognitive testing will be assessed with a single question (i.e. How much exertion did you feel during the test?) rated on a 10-point scale (1=no exertion at all, 10=very much exertion)
Measured: Baseline
Perceived exertion after cognitive testing at 9 weeks
Perceived exertion after cognitive testing will be assessed with a single question (i.e. How much exertion did you feel during the test?) rated on a 10-point scale (1=no exertion at all, 10=very much exertion)
Measured: 9 weeks after randomization
Perceived exertion after cognitive testing at 33 weeks
Perceived exertion after cognitive testing will be assessed with a single question (i.e. How much exertion did you feel during the test?) rated on a 10-point scale (1=no exertion at all, 10=very much exertion)
Measured: 33 weeks after randomization
Perceived exertion after cognitive testing at 61 weeks
Perceived exertion after cognitive testing will be assessed with a single question (i.e. How much exertion did you feel during the test?) rated on a 10-point scale (1=no exertion at all, 10=very much exertion)
Measured: 61 weeks after randomization
Insomnia symptoms and severity at baseline
Assessed with the Bergen Insomnia Scale (BIS). BIS comprises six items that assesses symptoms of insomnia based on the insomnia criteria found in the Diagnostic and Statistical Manual of Mental Disorders-IVTR (American Psychiatric Association).
Measured: Baseline
Insomnia symptoms and severity at 9 weeks
Assessed with the Bergen Insomnia Scale (BIS). BIS comprises six items that assesses symptoms of insomnia based on the insomnia criteria found in the Diagnostic and Statistical Manual of Mental Disorders-IVTR (American Psychiatric Association).
Measured: 9 weeks after randomization
Insomnia symptoms and severity at 33 weeks
Assessed with the Bergen Insomnia Scale (BIS). BIS comprises six items that assesses symptoms of insomnia based on the insomnia criteria found in the Diagnostic and Statistical Manual of Mental Disorders-IVTR (American Psychiatric Association).
Measured: 33 weeks after randomization
Insomnia symptoms and severity at 61 weeks
Assessed with the Bergen Insomnia Scale (BIS). BIS comprises six items that assesses symptoms of insomnia based on the insomnia criteria found in the Diagnostic and Statistical Manual of Mental Disorders-IVTR (American Psychiatric Association).
Measured: 61 weeks after randomization
Pain map with numeric rating scale at baseline
Presence of pain beyond everyday mundane pain, that have lasted longer than 3 months will be assessed with a single yes/no question. Location of pain will be assessed with a pain map, and levels of pain will be assessed with a 11-point numeric rating scale (0 = no pain to 10= severe pain.)
Measured: Baseline
Frequency of alcohol use at baseline
Assessed with the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), a three-item self-report questionnaire assessing frequency of alcohol use (0=never, 4=four times each week or more), number of units typical for a drinking day (0=1-2 units, 4=10 or more units), and frequency of binge-drinking (0=never, 4=daily or almost daily). It is a short-version of the 10-item AUDIT developed by the World Health Organization
Measured: Baseline
Frequency of alcohol use at 9 weeks
Assessed with the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), a three-item self-report questionnaire assessing frequency of alcohol use (0=never, 4=four times each week or more), number of units typical for a drinking day (0=1-2 units, 4=10 or more units), and frequency of binge-drinking (0=never, 4=daily or almost daily). It is a short-version of the 10-item AUDIT developed by the World Health Organization
Measured: 9 weeks after randomization
Frequency of alcohol use at 33 weeks
Assessed with the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), a three-item self-report questionnaire assessing frequency of alcohol use (0=never, 4=four times each week or more), number of units typical for a drinking day (0=1-2 units, 4=10 or more units), and frequency of binge-drinking (0=never, 4=daily or almost daily). It is a short-version of the 10-item AUDIT developed by the World Health Organization
Measured: 33 weeks after randomization
Frequency of alcohol use at 61 weeks
Assessed with the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), a three-item self-report questionnaire assessing frequency of alcohol use (0=never, 4=four times each week or more), number of units typical for a drinking day (0=1-2 units, 4=10 or more units), and frequency of binge-drinking (0=never, 4=daily or almost daily). It is a short-version of the 10-item AUDIT developed by the World Health Organization
Measured: 61 weeks after randomization
Self reported quality of life at baseline
Assessed with the 12-Item Short Form Survey (SF-12). SF-12 The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life, and is a measure of quality of life. The SF-12 is a shortened version of the SF-36.
Measured: Baseline
Self reported quality of life at 9 weeks
Assessed with the 12-Item Short Form Survey (SF-12). SF-12 The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life, and is a measure of quality of life. The SF-12 is a shortened version of the SF-36.
Measured: 9 weeks after randomization
Self reported quality of life at 33 weeks
Assessed with the 12-Item Short Form Survey (SF-12). SF-12 The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life, and is a measure of quality of life. The SF-12 is a shortened version of the SF-36.
Measured: 33 weeks after randomization
Self reported quality of life at 61 weeks after randomization
Assessed with the 12-Item Short Form Survey (SF-12). SF-12 The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life, and is a measure of quality of life. The SF-12 is a shortened version of the SF-36.
Measured: 61 weeks after randomization
General health state at baseline
Assessed with Euroqol-5D, a 5-item self-report questionnaire for general health state on a 0 to 5 likert scale. It measures levels of problems with walking, performing self-care, doing usual activities, pain/discomfort, and anxiety/depression. It is widely used across Europe in assessments of health resources utilization as it allows measurement of Quality Adjusted Life Years (QALYs) in individuals presenting with a wide range of physical and mental disorders
Measured: Baseline
General health state at 9 weeks
Assessed with Euroqol-5D, a 5-item self-report questionnaire for general health state on a 0 to 5 likert scale. It measures levels of problems with walking, performing self-care, doing usual activities, pain/discomfort, and anxiety/depression. It is widely used across Europe in assessments of health resources utilization as it allows measurement of Quality Adjusted Life Years (QALYs) in individuals presenting with a wide range of physical and mental disorders
Measured: 9 weeks after randomization
General health state at 33 weeks
Assessed with Euroqol-5D, a 5-item self-report questionnaire for general health state on a 0 to 5 likert scale. It measures levels of problems with walking, performing self-care, doing usual activities, pain/discomfort, and anxiety/depression. It is widely used across Europe in assessments of health resources utilization as it allows measurement of Quality Adjusted Life Years (QALYs) in individuals presenting with a wide range of physical and mental disorders
Measured: 33 weeks after randomization
General health state at 61 weeks
Assessed with Euroqol-5D, a 5-item self-report questionnaire for general health state on a 0 to 5 likert scale. It measures levels of problems with walking, performing self-care, doing usual activities, pain/discomfort, and anxiety/depression. It is widely used across Europe in assessments of health resources utilization as it allows measurement of Quality Adjusted Life Years (QALYs) in individuals presenting with a wide range of physical and mental disorders
Measured: 61 weeks after randomization
Opinion on negative effects of the intervention at 9 weeks
Assessed with the Negative Effects Questionnaire (NEQ), a self-report measure that contains 20 items that are scored on a five-point Likert-scale (rated 0-4) where higher scores indicate higher levels of negative effects. After each item, the individual is asked whether they consider the effect to be caused by the intervention received or caused by other circumstances (yes/no), as well as one open-ended question
Measured: 9 weeks after randomization
Opinion on negative effects of the intervention at 61 weeks
Assessed with the Negative Effects Questionnaire (NEQ), a self-report measure that contains 20 items that are scored on a five-point Likert-scale (rated 0-4) where higher scores indicate higher levels of negative effects. After each item, the individual is asked whether they consider the effect to be caused by the intervention received or caused by other circumstances (yes/no), as well as one open-ended question
Measured: 61 weeks after randomization
Use of therapeutic techniques at 33 weeks
Assessed with the Use of Sleep Strategies (USS), a six item self-report questionnaire developed to measure how often individuals use six different therapeutic techniques (keep a stable rise time, refrain from sleeping during daytime, use the bed and bedroom only for sleeping, practiced sleep restriction, practiced stimulus control) and their perception of its utility. The techniques are integral to CBT-I but are also described in sleep psychoeducation or hygiene programmes
Measured: 33 weeks after randomization
Use of therapeutic techniques at 61 weeks
Assessed with the Use of Sleep Strategies (USS), a six item self-report questionnaire developed to measure how often individuals use six different therapeutic techniques (keep a stable rise time, refrain from sleeping during daytime, use the bed and bedroom only for sleeping, practiced sleep restriction, practiced stimulus control) and their perception of its utility. The techniques are integral to CBT-I but are also described in sleep psychoeducation or hygiene programmes
Measured: 61 weeks after randomization
Self-reported medication usage at baseline
Dose, timing, and type of prescribed and unsubscribed medications
Measured: Baseline
Self-reported previous and current physical and mental disorders at baseline
Assessed by checking of a list of 20 common medical conditions, and 9 common mental disorders
Measured: Baseline
Self-reported physical activity at baseline
Number of physical activities per week at moderate and/or strenuous intensity, and duration of the activities
Measured: Baseline
Self-reported Body Mass Index (BMI) at baseline
One question assessing height and one question assessing weight
Measured: Baseline
Self-reported internet and media usage at baseline
Familiarity with use of the internet at baseline and electronic media use (five items) over time. These ratings will be used in subsidiary analyses as for example, how baseline skills in using the internet may affect engagement with internet interventions.
Measured: Baseline
Self-reported previous treatments for mental disorders at baseline
Number of previous treatments, number of prescribed medications for mental disorders
Measured: Baseline
Self-reported previous treatments for insomnia at baseline
Number of previous treatments, number of prescribed medications for insomnia
Measured: Baseline
Self-reported duration of sleep problems at baseline
One item assessing for how long the current sleep problem have lasted in years and months
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start16 Nov 2023
- Primary completion10 Feb 2026
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Håvard Kallestad, PhD, Principal investigator, Senior clinical psychologist and researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113666
- Sponsor's protocol ID
- 623308
- Acronym
- NorseMS
- Status last verified
- Mar 2026
- First submitted
- 27 Oct 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41278218
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in People With Multiple Sclerosis in Norway
- ClinicalTrials.gov ID
- NCT06113666
- Acronym / sponsor ID
- NorseMS / 623308
- Conditions
- Multiple Sclerosis, Insomnia
- Keywords
- Cognitive Behavioral Therapy for Insomnia, Fatigue, Cognitive performance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Insomnia is prevalent among individuals with Multiple Sclerosis (MS). Improving sleep is an important therapeutic goal, but there is currently a lack of effective treatment options. Cognitive Behavioral Therapy for Insomnia (CBT-I) has been widely studied in other patient groups and is currently recommended as first- line treatment for chronic insomnia.
Overall, the availability of CBT-I has been limited, as the number of patients in need of treatment far exceeds the number of available therapists. Therefore, fully automated digital adaptations of CBT-I (dCBT-I) have been developed that contain both screening and intervention. Whether this treatment is effective for a clinical sample of patients diagnosed with MS, or if improved sleep can lead to improved daytime functioning in MS, is however, currently unknown.
This is a novel approach to a digital treatment of a common disorder in MS, and that may result in improved implementation of a low-threshold intervention.
Update August 28th, 2024
We aim to increase the target sample size from 260 to 550 to increase the statistical power to detect differences between the intervention group and control group on the secondary outcomes, e.g., fatigue, cognitive functioning, mental health, and movement measures measured with actigraphy. Few treatment options have shown effects on these outcomes for people with MS but are a significant problem for this patient group. Small effects from this trial may have substantial scientific and clinical value and are important to test with adequate statistical power.
Based on previous RCTs investigating the effectiveness of dCBT-I we aim to have a sample size large enough to detect small to moderate effects (Cohen's d = 0.3 til 0.5) on the secondary outcome measures fatigue, cognitive function, mental health and movement measures measured with actigraphy. As the planned RCT involves limited contact between researchers and participants, we have predicted that the study dropout rate will likely reach about 50%. Therefore, we aim to recruit 550 participants, to enable us to retain 275 participants (137 in each treatment arm) at the end of the RCT. For a two-sample t-test with alpha=0.05, this sample size gives a power of 90% of detecting a difference of Cohen's d = 0.40.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital cognitive behavioral therapy for insomnia | Experimental | Behavioral: Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)Behavioral: digital cognitive behavioral therapy (dCBT-I) |
| Patient Education about insomnia | Active comparator | Behavioral: Digital patient education about insomnia (PE)Behavioral: Digital patient education about insomnia (PE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)Also: Sleep Healthy Using The Internet (SHUTi)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 | Behavioural | Digital cognitive behavioral therapy for insomnia |
| 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. | Behavioural | Patient Education about insomnia |
Primary outcome
Between-group difference in insomnia severity at week 9 after randomization
Time frame: 9 weeks 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.
89 secondary outcomes
Between-group difference in insomnia severity at week 33 after randomization
Time frame: 33 weeks after randomization
Between-group difference in insomnia severity at week 61 after randomization
Time frame: 61 weeks after randomization
Prospective daily sleep-wake pattern at week 9 after randomization
Time frame: 9 weeks after randomization
Prospective daily sleep-wake pattern at week 33 after randomization
Time frame: 33 weeks after randomization
Prospective daily sleep-wake pattern at week 61 after randomization
Time frame: 61 weeks after randomization
Self-reported mental health status at baseline
Time frame: Baseline
Self-reported mental health status at week 9 after randomization
Time frame: 9 weeks after randomization
Self-reported mental health status at week 33 after randomization
Time frame: 33 weeks after randomization
Self-reported mental health status at week 61 after randomization
Time frame: 61 weeks after randomization
Anxiety/depression at baseline
Time frame: Baseline
Anxiety/depression at week 9 after randomization
Time frame: 9 weeks after randomization
Anxiety/depression at week 33 after randomization
Time frame: 33 weeks after randomization
Anxiety/depression at week 61 after randomization
Time frame: 61 weeks after randomization
Fatigue at baseline
Time frame: Baseline
Fatigue at week 9 after randomization
Time frame: 9 weeks after randomization
Fatigue at week 33 after randomization
Time frame: 33 weeks after randomization
Fatigue at week 61 after randomization
Time frame: 61 weeks after randomization
Fatigue severity at baseline
Time frame: Baseline
Fatigue severity at week 9 after randomization
Time frame: 9 weeks after randomization
Fatigue severity at week 33 after randomization
Time frame: 33 weeks after randomization
Fatigue severity at week 61 after randomization
Time frame: 61 weeks after randomization
Cognitive test performance at baseline
Time frame: Baseline
Cognitive test performance at week 9 after randomization
Time frame: 9 weeks after randomization
Cognitive test performance at week 33 after randomization
Time frame: 33 weeks after randomization
Cognitive test performance at week 61 after randomization
Time frame: 61 weeks after randomization
Continuous recordings of daytime activity and sleep from baseline to 9 weeks after randomization
Time frame: From baseline to 9 weeks after randomization.
Use of health care services at baseline
Time frame: Baseline
Use of health care services at 61 weeks after randomization
Time frame: 61 weeks after randomization
Use of health care services at 5 years after randomization
Time frame: 5 years after randomization
Medication use at baseline
Time frame: Baseline
Medication use at 61 weeks after randomization
Time frame: 61 weeks after randomization
Medication use at 5 years after randomization
Time frame: 5 years after randomization
Costs of treatment offered by the public services at baseline
Time frame: Baseline
Costs of treatment offered by the public services 61 weeks after randomization
Time frame: 61 weeks after randomization
Costs of treatment offered by the public services 5 years after randomization
Time frame: 5 years after randomization
Sick leave or in receipt of disability benefits at baseline
Time frame: Baseline
Sick leave or in receipt of disability benefits 61 weeks after randomization
Time frame: 61 weeks after randomization
Sick leave or in receipt of disability benefits 5 years after randomization
Time frame: 5 years after randomization
Information about the MS disease at baseline
Time frame: Baseline
Information about the MS disease at week 61 after randomization
Time frame: 61 weeks after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 41278218Saksvik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Håvard Kallestad, PhD principal investigator
Senior clinical psychologist and researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) and Digital patient education about insomnia (PE) in people with Multiple Sclerosis and Insomnia, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group difference in insomnia severity at week 9 after randomization (time frame: 9 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06113666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.