0389 A Computerized Cognitive Behavioral Therapy Randomized, Controlled, Pilot Trial for Insomnia in Epilepsy

Abstract Introduction Insomnia is the most common sleep-wake complaint in adults with epilepsy (AWE), impacting quality of life and potentially seizure control. Cognitive behavioral therapy for insomnia (CBTI) is the first-line treatment, although often costly and inaccessible. We conducted a Pilot Trial using web-based CBTI for Insomnia in AWE. Methods This randomized controlled trial was conducted at Cleveland Clinic comparing the efficacy of web-based CBTI Go to Sleep (GTS) to controls who received an informational sheet on sleep hygiene. The primary outcome was a change in the Insomnia Severity Index (ISI). Fatigue Severity Scale (FSS), Epworth Sleepiness Scale (ESS), Patient Health Questionnaire-9 (PHQ-9), and self-reported total sleep time (TST) were also evaluated. GTS adherence was measured by % of modules (total of 6) completed. Change in survey scores was assessed using ANOVA tests with Pearson’s correlations between baseline and 8 weeks post-randomization. Results A total of 35 subjects (GTS: N=18; control: N=17) were included; mean age 40.9±10.9, 77.1% female, ISI 21.6±3.4, FSS 46.3±9.5, ESS 9.6±5.9, PHQ-9 12.8±5.2, TST 6.1±1.8 hr. At baseline, all patients had ISI of 15+. At follow-up, 33.3% of GTS and 47.1% of controls had scores of 15+(p=0.88). ISI change was greater in GTS than in controls (-9.0 (-11.3,-6.6) vs. -5.8 (-8.4,-3.3); p=0.079). Changes in other patient-reported outcomes (PROs) and TST between groups were not significant. However, decreases in ISI were associated with decreases in ESS, p=0.004 and PHQ-9, p< 0.001, but not FSS or TST. Eleven (61.1%) of GTS patients completed the 6-module program. 75% reported satisfaction with the audio components and content of the program and found GTS very easy to use. Completion of lessons was associated with a decrease in FSS, p=0.031. Conclusion Comparable improvement in insomnia symptoms and other PROs were observed in AWE engaging in web-based CBTI and sleep hygiene education. Program adherence was good. Despite sample size limitations, these findings support the role of non-pharmacological insomnia treatment in AWE. Support (if any)