Using the Sleepio intervention resulted in significantly greater improvement in insomnia symptoms, as well as almost all other outcomes assessed, in women who were pregnant with insomnia.
Jennifer N. Felder, PhD, assistant professor of psychiatry, UCSF Weill Institute for Neurosciences
Jennifer N. Felder, PhD
In a trial of more than 200 patients, digital cognitive behavioral therapy (CBT) was deemed effective, safe, and acceptable by investigators as an intervention for insomnia symptoms in pregnant women.
Additionally, the insomnia therapy, which consisted of 6 weekly, 20-minute sessions, appears to be scalable to a larger population of patients. Those randomized to digital CBT (n = 105) experienced significantly greater improvement in insomnia symptoms, as measured by the total score on the 7-item syndromal measure Insomnia Severity Index (ISI), compared to those who received standard treatment (n = 103), for a difference of −0.36 (95% CI, −0.48 to −0.23; χ2, 29.8; P <.001; d = −1.03).
As well, the differences from baseline to postintervention for all secondary outcomes, with the exception of sleep duration, were statistically significant for those in the CBT group.
“Given the widespread nature of insomnia in pregnancy, the scalability of this intervention, its low-risk profile, and its demonstrated efficacy, digital CBT-I has great promise as a treatment for insomnia in pregnant women,” first author Jennifer N. Felder, PhD, assistant professor of psychiatry, UCSF Weill Institute for Neurosciences, and colleagues wrote.
The intervention, Sleepio, was developed by Big Health, delivered through a website or iOS app. Its content is based on CBT-Insomnia manuals and includes 5 main components: sleep restriction, stimulus control, cognitive therapy, relaxation techniques, and sleep hygiene and education. It is interactive and includes an animated digital therapist.
Standard care consisted of a range of treatments, including sleep, pain, and antidepressant medications, alternative therapy or herbal supplements, psychotherapy or counseling, and support groups.
““Medications frequently prescribed for insomnia in the general population, such as benzodiazepines and zolpidem, are associated with an increased risk of spontaneous abortion, low birth weight, preterm birth, small size for gestational age, and cesarean delivery,” Felder and colleagues wrote. “Pregnant women prefer nonpharmacological treatments for insomnia, and our research indicates that digital CBT-Insomnia treatment is an effective and safe intervention for reducing insomnia symptoms.”
In total, the study included 208 participants who were a mean of 33.6 years of age with a mean gestational age of 17.6 weeks at baseline. Of the CBT cohort, 68 women (64.8%) completed all 6 of the sessions, taking a mean of 7.97 (standard deviation, 2.08) weeks to complete the 6 sessions. A total of 33 women (31.4%) returned to the program for refresher sessions after completing the initial 6 sessions, and 7 (6.7%) never logged in to the digital CBT-I program for unknown reasons.
In total, 2000 women were assessed for the study, of which 1762 did not meet eligibility criteria, mostly due to being >28 weeks pregnant (n = 463), not having an insomnia case or have elevated insomnia symptoms (n = 371), and improper racial identification post-modification of the intervention (n = 488). The high number of women completing the eligibility survey, Felder and colleagues wrote, “revealed that pregnant women are highly interested in an intervention that may improve sleep.”
Ultimately, the main outcome of insomnia symptom severity decreased by 0.59 for the intervention group compared to 0.23 for the standard treatment group. The secondary outcomes included sleep efficiency, sleep duration, global sleep quality, insomnia caseness, depressive symptom severity, and anxiety symptom severity.
The CBT group experienced a gain in sleep efficiency of 0.84, compared to 0.08 for the standard change group (95% CI, 0.39—1.14; P = .001). Similar results were seen for the intervention group compared to standard of care for global sleep quality (—0.31 vs. –0.02; 95% CI, –0.37 to –0.21; P <.001), insomnia caseness (—0.26 vs. –0.02; 95% CI, –0.35 to –0.12; P <.001). Sleep duration, the only non-significantly different outcome, was improved by 0.03 for the CBT group, compared to 0.002 for the standard of care group (95% CI, −0.002 to 0.67; P = .07).
Notably, depressive symptom severity (—0.22 vs. –0.01; 95% CI, –0.30 to –0.11; P <.001), and anxiety symptom severity (—0.19 vs. –0.002; 95% CI, –0.26 to –0.10; P <.001) were both significantly improved for those in the CBT group.
“Participants entered this study with mild depressive and anxiety symptoms, and it seems that research is needed to evaluate whether CBT-Insomnia is effective for treating or preventing perinatal depression or anxiety in those with elevated symptom severity,” Felder et al. detailed. “It is possible that a treatment that improves depressive and anxiety symptoms indirectly may be a less stigmatized entry point for improving perinatal mental health.”
Felder JN, Epel ES, Neuhaus J, Krystal AD, Prather AA. Efficacy of digital cognitive behavioral therapy for the treatment of insomnia symptoms among pregnant women: A randomized clinical trial. JAMA Psychiatry. Published online January 22, 2020. doi: 10.1001/jamapsychiatry.2019.4491.