The effect of e-aid cognitive behavioral therapy in treating chronic insomnia disorder: an open-label randomized controlled trial

Objective To investigate the efficacy and compliance of e-aid cognitive behavioral therapy for insomnia (eCBTI) in Chinese patients with chronic insomnia disorder. Methods In a 4-week open-label randomized controlled study, by using the simple random method, 190 patients with chronic insomnia disorder who met the study criteria were divided into the eCBTI group (95 cases) and the waiting-list group (95 cases) by 1∶1. The eCBTI group received 4 weeks of treatment including 5 CBTI core modules. The waiting-list group was evaluated by sleep dairy and insomnia severity index (ISI) at the enrollment and weeks 4. The recovery index was defined by sleep efficiency (SE)>85% and ISI<8 separately. T test was used to compare the sleep parameters between two groups, and χ2 test was used to compare the remission rate. Results Fifty-five patients in eCBTI group and 78 patients of the waiting-list group completed the entire treatment and all of evaluations. After 4 weeks of treatment, the score-reducing rate of following index: sleep efficiency (11.6%±3.9% vs. 2.9%±1.1%, t=4.63, P=0.036), sleep onset latency (-57.0%±-14.7% vs. -19.8%±-8.5%, t=13.44, P 85% was used as the recovery index for insomnia, the recovery rate of eCBTI group was 67.3%, and that of waiting-list group was 26.9% (χ2=21.36, P<0.01). when ISI<8 was used as the recovery index for insomnia, the recovery rate of eCBTI group was 43.6%, and that of waiting-list group was 6.4% (χ2=26.22, P<0.01). Conclusion This study supported that eCBTI had good therapeutic effects on Chinese patients with chronic insomnia disorder, but the treatment compliance should be further improved. Key words: Sleep initiation and maintenance disorders; E-aid cognitive behavioral therapy for insomnia; Randomized controlled trial