Clinical trial NCT06113666: A Digital Therapeutic to Improve Insomnia in Multiple Sclerosis: A Randomized Controlled Trial.
Official title: Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in People With Multiple Sclerosis in Norway
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Insomnia
Keywords: Cognitive Behavioral Therapy for Insomnia
Fatigue
Cognitive performance
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: Between-group difference in insomnia severity at week 9 after randomization
timeFrame: 9 weeks after randomization
Secondary outcomes:
measure: Between-group difference in insomnia severity at week 33 after randomization
timeFrame: 33 weeks after randomization
measure: Between-group difference in insomnia severity at week 61 after randomization
timeFrame: 61 weeks after randomization
measure: Prospective daily sleep-wake pattern at week 9 after randomization
timeFrame: 9 weeks after randomization
measure: Prospective daily sleep-wake pattern at week 33 after randomization
timeFrame: 33 weeks after randomization
measure: Prospective daily sleep-wake pattern at week 61 after randomization
timeFrame: 61 weeks after randomization
measure: Self-reported mental health status at baseline
timeFrame: Baseline
measure: Self-reported mental health status at week 9 after randomization
timeFrame: 9 weeks after randomization
measure: Self-reported mental health status at week 33 after randomization
timeFrame: 33 weeks after randomization
measure: Self-reported mental health status at week 61 after randomization
timeFrame: 61 weeks after randomization
measure: Anxiety/depression at baseline
timeFrame: Baseline
measure: Anxiety/depression at week 9 after randomization
timeFrame: 9 weeks after randomization
measure: Anxiety/depression at week 33 after randomization
timeFrame: 33 weeks after randomization
measure: Anxiety/depression at week 61 after randomization
timeFrame: 61 weeks after randomization
measure: Fatigue at baseline
timeFrame: Baseline
measure: Fatigue at week 9 after randomization
timeFrame: 9 weeks after randomization
measure: Fatigue at week 33 after randomization
timeFrame: 33 weeks after randomization
measure: Fatigue at week 61 after randomization
timeFrame: 61 weeks after randomization
measure: Fatigue severity at baseline
timeFrame: Baseline
measure: Fatigue severity at week 9 after randomization
timeFrame: 9 weeks after randomization
measure: Fatigue severity at week 33 after randomization
timeFrame: 33 weeks after randomization
measure: Fatigue severity at week 61 after randomization
timeFrame: 61 weeks after randomization
measure: Cognitive test performance at baseline
timeFrame: Baseline
measure: Cognitive test performance at week 9 after randomization
timeFrame: 9 weeks after randomization
measure: Cognitive test performance at week 33 after randomization
timeFrame: 33 weeks after randomization
measure: Cognitive test performance at week 61 after randomization
timeFrame: 61 weeks after randomization
measure: Continuous recordings of daytime activity and sleep from baseline to 9 weeks after randomization
timeFrame: From baseline to 9 weeks after randomization.
measure: Use of health care services at baseline
timeFrame: Baseline
measure: Use of health care services at 61 weeks after randomization
timeFrame: 61 weeks after randomization
measure: Use of health care services at 5 years after randomization
timeFrame: 5 years after randomization
measure: Medication use at baseline
timeFrame: Baseline
measure: Medication use at 61 weeks after randomization
timeFrame: 61 weeks after randomization
measure: Medication use at 5 years after randomization
timeFrame: 5 years after randomization
measure: Costs of treatment offered by the public services at baseline
timeFrame: Baseline
measure: Costs of treatment offered by the public services 61 weeks after randomization
timeFrame: 61 weeks after randomization
measure: Costs of treatment offered by the public services 5 years after randomization
timeFrame: 5 years after randomization
measure: Sick leave or in receipt of disability benefits at baseline
timeFrame: Baseline
measure: Sick leave or in receipt of disability benefits 61 weeks after randomization
timeFrame: 61 weeks after randomization
measure: Sick leave or in receipt of disability benefits 5 years after randomization
timeFrame: 5 years after randomization
measure: Information about the MS disease at baseline
timeFrame: Baseline
measure: Information about the MS disease at week 61 after randomization
timeFrame: 61 weeks after randomization
measure: Information about the MS disease at 5 years after randomization
timeFrame: 5 years after randomization
measure: Excessive daytime sleepiness at baseline
timeFrame: Baseline
measure: Subjective cognitive disfunction at baseline
timeFrame: Baseline
measure: Subjective executive functions at baseline
timeFrame: Baseline
measure: Subjective executive functions at 9 weeks after randomization
timeFrame: 9 weeks after randomization
measure: Subjective executive functions at 33 weeks after randomization
timeFrame: 33 weeks after randomization
measure: Subjective executive functions at 61 weeks after randomization
timeFrame: 61 weeks after randomization
measure: Subjective disability status at baseline
timeFrame: Baseline
measure: Fatigue before and after cognitive testing at baseline
timeFrame: Baseline
measure: Fatigue before and after cognitive testing at 9 weeks
timeFrame: 9 weeks after randomization
measure: Fatigue before and after cognitive testing at 33 weeks
timeFrame: 33 weeks after randomization
measure: Fatigue before and after cognitive testing at 61 weeks
timeFrame: 61 weeks after randomization
measure: Perceived performance after cognitive testing at baseline
timeFrame: Baseline
measure: Perceived performance after cognitive testing at 9 weeks
timeFrame: 9 weeks after randomization
measure: Perceived performance after cognitive testing at 33 weeks
timeFrame: 33 weeks after randomization
measure: Perceived performance after cognitive testing at 61 weeks
timeFrame: 61 weeks after randomization
measure: Perceived exertion after cognitive testing at baseline
timeFrame: Baseline
measure: Perceived exertion after cognitive testing at 9 weeks
timeFrame: 9 weeks after randomization
measure: Perceived exertion after cognitive testing at 33 weeks
timeFrame: 33 weeks after randomization
measure: Perceived exertion after cognitive testing at 61 weeks
timeFrame: 61 weeks after randomization
measure: Insomnia symptoms and severity at baseline
timeFrame: Baseline
measure: Insomnia symptoms and severity at 9 weeks
timeFrame: 9 weeks after randomization
measure: Insomnia symptoms and severity at 33 weeks
timeFrame: 33 weeks after randomization
measure: Insomnia symptoms and severity at 61 weeks
timeFrame: 61 weeks after randomization
measure: Pain map with numeric rating scale at baseline
timeFrame: Baseline
measure: Frequency of alcohol use at baseline
timeFrame: Baseline
measure: Frequency of alcohol use at 9 weeks
timeFrame: 9 weeks after randomization
measure: Frequency of alcohol use at 33 weeks
timeFrame: 33 weeks after randomization
measure: Frequency of alcohol use at 61 weeks
timeFrame: 61 weeks after randomization
measure: Self reported quality of life at baseline
timeFrame: Baseline
measure: Self reported quality of life at 9 weeks
timeFrame: 9 weeks after randomization
measure: Self reported quality of life at 33 weeks
timeFrame: 33 weeks after randomization
measure: Self reported quality of life at 61 weeks after randomization
timeFrame: 61 weeks after randomization
measure: General health state at baseline
timeFrame: Baseline
measure: General health state at 9 weeks
timeFrame: 9 weeks after randomization
measure: General health state at 33 weeks
timeFrame: 33 weeks after randomization
measure: General health state at 61 weeks
timeFrame: 61 weeks after randomization
measure: Opinion on negative effects of the intervention at 9 weeks
timeFrame: 9 weeks after randomization
measure: Opinion on negative effects of the intervention at 61 weeks
timeFrame: 61 weeks after randomization
measure: Use of therapeutic techniques at 33 weeks
timeFrame: 33 weeks after randomization
measure: Use of therapeutic techniques at 61 weeks
timeFrame: 61 weeks after randomization
measure: Self-reported medication usage at baseline
timeFrame: Baseline
measure: Self-reported previous and current physical and mental disorders at baseline
timeFrame: Baseline
measure: Self-reported physical activity at baseline
timeFrame: Baseline
measure: Self-reported Body Mass Index (BMI) at baseline
timeFrame: Baseline
measure: Self-reported internet and media usage at baseline
timeFrame: Baseline
measure: Self-reported previous treatments for mental disorders at baseline
timeFrame: Baseline
measure: Self-reported previous treatments for insomnia at baseline
timeFrame: Baseline
measure: Self-reported duration of sleep problems at baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St.Olavs Hospital
Study officials:
affiliation: Senior clinical psychologist and researcher
name: Håvard Kallestad, PhD
role: PRINCIPAL_INVESTIGATOR
References: