Cognitive Behavioral Therapy for Insomnia Shows Promise in Pilot Trial of Epilepsy

Nancy Foldvary-Schaefer, DO, FAAN

New data from a pilot trial (NCT03632889) further supported the use of web-based cognitive behavioral therapy for insomnia (CBTI) in adults with epilepsy and insomnia. Overall, there were no major between-group differences in improvement of insomnia symptoms and other patient-reported outcomes (PROs); however, patients on the Go to Sleep (GTS) CBTI program demonstrated greater change in Insomnia Severity Index (ISI), the primary outcome, than those who received standard sleep hygiene instruction.¹

Presented at the 2024 SLEEP Annual Meeting, held June 1-5, in Houston, Texas, 35 adults with epilepsy and moderate-to-severe insomnia symptoms were randomly assigned to GTS (n = 18) or control (n = 17) for 8 weeks. Led by Nancy Foldvary-Schaefer, DO, FAAN, director of the Sleep Disorders Center and staff in the Epilepsy Center at Cleveland Clinic, both groups received a sleep hygiene handout that is standard of care in the treatment of insomnia, while those in the GTS group also received CBTI.

To date, there are no studies exploring sleep and seizure outcomes with treatment of insomnia in patients with epilepsy. GTS, developed and validated by investigators at Cleveland Clinic, constitutes 6 weeks of therapy based on the principles and methods of CBTI presented as a series of daily lessons, learnable skills, and personalized recommendations supported by graphics, animations, audio, and video. The program includes the basic elements of CBTI including sleep hygiene, sleep restriction, stimulus control, cognitive restructuring, and relaxation training.

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At baseline, all patients had an ISI greater than 15. At the conclusion of the 8-week treatment period, ISI change was greater in GTS than in controls (–9.0 [95% CI, –11.3 to –6.6] vs –5.8 [95% CI, –8.4 to –3.3]; P = .079). Changes in other PROs and total sleep time (TST) were not significant. Coming into the study, the cohort had a mean age of 40.9 (±10.9), 77.1% female, with mean ISI of 21.6 (±3.4), Fatigue Severity Scale (FSS) of 46.3 (±9.5), Epworth Sleepiness Scale (ESS) of 9.6 (±5.9), Patient Health Questionnaire-9 (PHQ) of 12.8 (±5.2), and TST of 6.1 (±1.8) hrs.

Despite no statistically significant differences in PROs or TST, decreases in ISI seen in the GTS group were associated with decreases in ESS (P = .004) and PHQ-9 (P <.001), but not FSS or TST. In total, 11 of the 18 patients in the GTS group completed the 6-module program, with 75% reporting satisfaction and easy accessibility with the audio components and content of the program. Notably, completion of lessons was also associated with a decrease in FSS (P = .031).

In 2017, Foldvary-Schaefer and colleagues published data from an additional pilot study comparing GTS and standard sleep hygiene instruction in patients with Parkinson disease (PD) with insomnia. The trial, which featured 28 patients randomly assigned to CBTI (n = 14) or standard education (n = 14), showed that among completers, the improvement in ISI scores was greater with CBTI as compared with standard education (–7.9 vs –3.5; P = .03). Notably, only 57% (8 of 14) of patients randomized to CBTI completed the study. An intention-to-treat analysis that included all enrolled individuals showed that the change in ISI between groups was not significant (–.4.5 vs –3.3; P = .48), likely due to the high dropout rate in the CBTI group (43%).²

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REFERENCES
1. Mouchati C, Andrews N, Bena J, Morrison S. A computerized cognitive behavioral therapy randomized, controlled, pilot trial for insomnia in epilepsy. Presented at: 2024 SLEEP Annual Meeting; June 1-5; Houston, TX. ABSTRACT 0389
2. Patel S, Ojo O, Genc G, et al. A computerized cognitive behavioral therapy randomized, controlled, pilot trial for insomnia in Parkinson disease. J Clin Mov Disord. 2017;4:16. doi:10.1186/s40734-017-0062-2