Digital Cognitive Behavior Therapy for Insomnia Compared With Digital Patient Education About Insomnia in People With Multiple Sclerosis in Norway
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Between-group difference in insomnia severity at week 9 after randomization
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Between-group difference in insomnia severity at week 9 after randomization
时间窗: 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.
次要结局
- Costs of treatment offered by the public services 61 weeks 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 61 after randomization(61 weeks after randomization)
- Fatigue at week 9 after randomization(9 weeks after randomization)
- Anxiety/depression 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 33 after randomization(33 weeks after randomization)
- Between-group difference in insomnia severity at week 33 after randomization(33 weeks after randomization)
- Fatigue at baseline(Baseline)
- Subjective cognitive disfunction at baseline(Baseline)
- Subjective executive functions at baseline(Baseline)
- Self-reported mental health status at baseline(Baseline)
- Self-reported mental health status at week 33 after randomization(33 weeks after randomization)
- Anxiety/depression at week 61 after randomization(61 weeks after randomization)
- Costs of treatment offered by the public services at baseline(Baseline)
- Fatigue before and after cognitive testing at baseline(Baseline)
- Fatigue before and after cognitive testing at 33 weeks(33 weeks after randomization)
- Self-reported mental health status at week 9 after randomization(9 weeks after randomization)
- Anxiety/depression at week 9 after randomization(9 weeks after randomization)
- Self-reported previous and current physical and mental disorders at baseline(Baseline)
- Fatigue severity at week 33 after randomization(33 weeks after randomization)
- Fatigue severity at week 61 after randomization(61 weeks after randomization)
- Cognitive test performance at week 33 after randomization(33 weeks after randomization)
- Cognitive test performance at week 61 after randomization(61 weeks after randomization)
- Continuous recordings of daytime activity and sleep from baseline to 9 weeks after randomization(From baseline to 9 weeks after randomization.)
- Use of health care services at baseline(Baseline)
- Use of health care services at 61 weeks after randomization(61 weeks after randomization)
- Medication use at baseline(Baseline)
- Self-reported mental health status at week 61 after randomization(61 weeks after randomization)
- Anxiety/depression at baseline(Baseline)
- Fatigue at week 61 after randomization(61 weeks after randomization)
- Cognitive test performance at baseline(Baseline)
- Medication use at 5 years after randomization(5 years after randomization)
- Fatigue at week 33 after randomization(33 weeks after randomization)
- Fatigue severity at baseline(Baseline)
- Fatigue severity at week 9 after randomization(9 weeks after randomization)
- Cognitive test performance at week 9 after randomization(9 weeks after randomization)
- Use of health care services at 5 years after randomization(5 years after randomization)
- Medication use at 61 weeks after randomization(61 weeks after randomization)
- Costs of treatment offered by the public services 5 years after randomization(5 years after randomization)
- Sick leave or in receipt of disability benefits at baseline(Baseline)
- Sick leave or in receipt of disability benefits 61 weeks after randomization(61 weeks after randomization)
- Sick leave or in receipt of disability benefits 5 years after randomization(5 years after randomization)
- Subjective executive functions at 9 weeks after randomization(9 weeks after randomization)
- Information about the MS disease at baseline(Baseline)
- Information about the MS disease at 5 years after randomization(5 years after randomization)
- Fatigue before and after cognitive testing at 9 weeks(9 weeks after randomization)
- Information about the MS disease at week 61 after randomization(61 weeks after randomization)
- Excessive daytime sleepiness at baseline(Baseline)
- Subjective executive functions at 33 weeks after randomization(33 weeks after randomization)
- Subjective executive functions at 61 weeks after randomization(61 weeks after randomization)
- Subjective disability status at baseline(Baseline)
- Perceived performance after cognitive testing at 9 weeks(9 weeks after randomization)
- Perceived performance after cognitive testing at 61 weeks(61 weeks after randomization)
- Insomnia symptoms and severity at baseline(Baseline)
- Fatigue before and after cognitive testing at 61 weeks(61 weeks after randomization)
- Perceived performance after cognitive testing at baseline(Baseline)
- Insomnia symptoms and severity at 33 weeks(33 weeks after randomization)
- Pain map with numeric rating scale at baseline(Baseline)
- Opinion on negative effects of the intervention at 9 weeks(9 weeks after randomization)
- Use of therapeutic techniques at 33 weeks(33 weeks after randomization)
- Self-reported medication usage at baseline(Baseline)
- Self-reported previous treatments for mental disorders at baseline(Baseline)
- Self-reported previous treatments for insomnia at baseline(Baseline)
- Self-reported duration of sleep problems at baseline(Baseline)
- Perceived exertion after cognitive testing at 9 weeks(9 weeks after randomization)
- Perceived exertion after cognitive testing at 33 weeks(33 weeks after randomization)
- Perceived exertion after cognitive testing at 61 weeks(61 weeks after randomization)
- Frequency of alcohol use at baseline(Baseline)
- Frequency of alcohol use at 61 weeks(61 weeks after randomization)
- Perceived performance after cognitive testing at 33 weeks(33 weeks after randomization)
- Perceived exertion after cognitive testing at baseline(Baseline)
- Self reported quality of life at 9 weeks(9 weeks after randomization)
- General health state at 61 weeks(61 weeks after randomization)
- Insomnia symptoms and severity at 9 weeks(9 weeks after randomization)
- Insomnia symptoms and severity at 61 weeks(61 weeks after randomization)
- Frequency of alcohol use at 9 weeks(9 weeks after randomization)
- General health state at baseline(Baseline)
- General health state at 33 weeks(33 weeks after randomization)
- Use of therapeutic techniques at 61 weeks(61 weeks after randomization)
- Self-reported internet and media usage at baseline(Baseline)
- Frequency of alcohol use at 33 weeks(33 weeks after randomization)
- Self reported quality of life at baseline(Baseline)
- Self reported quality of life at 33 weeks(33 weeks after randomization)
- Self reported quality of life at 61 weeks after randomization(61 weeks after randomization)
- General health state at 9 weeks(9 weeks after randomization)
- Opinion on negative effects of the intervention at 61 weeks(61 weeks after randomization)
- Self-reported physical activity at baseline(Baseline)
- Self-reported Body Mass Index (BMI) at baseline(Baseline)