A proof‐of‐concept assessment showed that women with chronic migraine and insomnia can be reasonably treated with digital cognitive behavioral therapy for insomnia, with data suggesting it may improve both conditions.
Jason C. Ong, PhD, associate professor of neurology, Medical Social Sciences and Psychiatry and Behavioral Sciences, Northwestern Feinberg School of Medicine
Jason C. Ong, PhD
Digital cognitive behavioral therapy for insomnia (dCBT-I) appears to be an acceptable and feasible approach for women with migraine who also have the sleep disorder, with new data suggesting that both conditions may be improved.
The investigators, including Jason C. Ong, PhD, associate professor of neurology, Medical Social Sciences and Psychiatry and Behavioral Sciences, Northwestern Feinberg School of Medicine, noted that the results of this study “indicate that a randomized controlled trial is needed to determine the efficacy of dCBT‐I in chronic migraine patients.”
As insomnia commonly occurs alongside chronic migraine, Ong and colleagues conducted this proof‐of‐concept assessment to explore the feasibility of this non‐pharmacological treatment. It included 42 women with symptoms of both conditions with participants randomized to receive dCBT‐I after 2, 4, or 6 weeks of completing baseline sleep diaries. In total, 83.3% (n = 35) completed the intervention within the 12-week period, and 94.3% (n = 33) reported being satisfied (n = 16) or very satisfied (n = 17) with the treatment.
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The DCBT‐I was analyzed against benchmarks for completion rates of ≥90%, acceptability of ≥80%, and clinically relevant posttreatment changes in insomnia symptoms of ≥50%. The intent-to-treat acceptability rate was 78.6% (n = 33), and the intent-to-treat response rate was 54.8% (n = 23) of the full cohort.
“This proof-of-concept study has highlighted that dCBT‐I could be an appropriate treatment for individuals with chronic migraine and insomnia,” Ong and colleagues wrote. “The results demonstrate that the majority of our benchmarks were met. While our ITT results were less promising, however, this was because of the higher dropout rates prior to treatment. We, therefore, still conclude that dCBT‐I is a feasible treatment for females with chronic migraine and insomnia. A follow‐up randomized controlled trial is appropriate needed to determine the efficacy.”
All told, 65.7% (n = 23) of the completers responded to treatment per the universally accepted criteria for insomnia, defined as a clinically meaningful change from baseline of >7 points on the Insomnia Severity Index (ISI). The mean ISI score was 7.7 points (standard deviation [SD], 4.1), down from baseline average scores of 17.6 (SD, 4) for a mean difference of —9.9 (95% CI, –11.7 to –8). Additionally, 45.7% (n = 16) were classified as remitters, defined as an ISI posttreatment score <8.
Posttreatment, the mean Migraine Disability Assessment (MIDAS) scores were 22.4 (SD, 17.8), reduced from baseline scores of 28.7 (SD, 19.5; mean difference, −6.3; 95% CI, −12.3 to −0.02). Migraine frequency was lowered from 21 (SD, 7.0) headache days per month to 18.4 (SD, 8.7) headache days per month (mean difference, −2.6; 95% CI, −4.58 to −0.7). Severity was also reduced from 6.5 (SD, 1.4) to 5.4 (SD, 1.3) on a 1—10 scale, for a mean difference of 1.1 (95% CI, −1.5 to −0.6).
Notably, 34.3% (n = 12) of the completer group and 28.6% (n = 12) of the full intent-to-treat population reverted from chronic to episodic migraine, a secondary measure of the study.
“Together, our results are promising; demonstrating cognitive behavioral‐based strategies for insomnia is an effective strategy for improving both insomnia and potentially as an adjunct treatment for migraines in this population,” Ong and colleagues wrote. “Furthermore, the results support the evaluation of treatment efficacy through a larger randomized controlled trial without significant adaptations to the digital program.”
An analysis of the dCBT-I content suggested that the majority of individuals enjoyed the program, with the 3 most frequently rated likes were the “content of the program” (n = 17), the “efficacy of the treatment” (n = 12), and the “accessibility/convenience/ease” (n = 12). The most frequently noted dislike was “configurations of the interface/computer program/app” (n = 10), which included comments such as “get an app for android,” or “the constant motion of the animation.”
Crawford MR, Luik AI, Espie CA, et al. Digital Cognitive Behavioral Therapy for Insomnia in Women With Chronic Migraines. Published online February 28, 2020. Accessed March 12, 2020. doi: 10.1111/head.13777