Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT06113666
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.
Study:
NCT06113666
Study Brief:
Protocol Section:
NCT06113666