Effectiveness Of Brief E-aid Cognitive Behavioral Therapy For Insomnia To Prevent The Development Of Chronic Insomnia From Acute Insomnia:a Multi-center Randomized Controlled Trial

Objectives:To evaluate the effectiveness of a brief e-aid cognitive behavioral therapy for insomnia(eCBTI)program in preventing the transition to chronic insomnia from acute insomnia.In addition,the impacts of brief eCBTI program on insomnia severity,dysfunctional beliefs and attitudes about sleep scale,daytime sleepiness,pre-sleep arousal,sleep reactivity,sleep hygiene and practices,depressive and anxiety symptoms,and quality of life were also examined.Methods:This is a pragmatic two-arm,multi-center and randomized controlled trial.A total of 192 participants(mean[SD]age,35.3[10.9]years;118 women[61.5%])meeting inclusion and exclusion criteria were randomly assigned to eCBTI group(n=95)or control group(n=97).The brief eCBTI consists of 7 consecutive daily sessions with approximately 15 minutes for each session.The sessions included sleep hygiene education,sleep restriction,stimulus control,relaxation audios,cognitive components,information about sleeping medication,and a brief overview.Assessments were conducted online at week 0(baseline),week 2(post-treatment)and week 12(follow-up),respectively.The primary outcome was the incidence of chronic insomnia.The secondary outcomes were the Insomnia Severity Index(ISI),the Dysfunctional Beliefs and Attitudes about Sleep-30 items(DBAS-30),Epworth Sleepiness Scale(ESS),Pre-sleep Arousal Scale(PSAS),Ford Insomnia Response to Stress Test(FIRST),Sleep Hygiene and Practices Scale(SHPS),Hospital Anxiety and Depression Scale(HADS),and Short-Form 12-Item Health Survey version 2(SF-12v2).SPSS26.0 was used for descriptive statistics,t-test,Chi-square test,and Repeated Measures analysis of variance(RM-ANOVA),etc.Main analyses were on an intent-to-treat(ITT)basis,and Per protocol(PP)analysis was used for the consistency test.In ITT analysis,last observation carried forward(LOCF)method was used to impute any missing data.Results:At week 12,the incidence of chronic insomnia was significantly lower(33.3%[28/84]vs 65.8%[50/76],P<0.001)in the eCBTI group compared with control group.Participants in the eCBTI group decreased significantly in ISI scores,ESS scores,PSAS scores,FIRST scores,SHPS scores,HADS-Depression scores,and increased in MCS scores and PCS scores of SF-12v2 over time(ISI:?2=0.055;ESS:?2=0.125;PSAS:?2=0.148,FIRST:?2=0.079;SHPS:?2=0.31 1;HADS-Depression:?2=0.075;SF-12v2 PCS:?2=0.181;SF-12v2 MCS:?2=0.136;overall time-by-group interaction,P?0.001)when compared with Control group.However,the changes in DBAS and HADS-Anxiety did not differ between two groups(time-by-group interaction,P>0.05).Similar results were seen in the per-protocol population.Conclusions:This brief eCBTI program is an effective tool to prevent the chronicity of acute insomnia.In addition,it also improves insomnia severity,daytime sleepiness,pre-sleep arousal,sleep reactivity,sleep hygiene and practices,depressive symptoms,and quality of life in patients with acute insomnia.