%0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 4 %P e15841 %T Efficacy of a Theory-Based Cognitive Behavioral Technique App-Based Intervention for Patients With Insomnia: Randomized Controlled Trial %A Rajabi Majd,Nilofar %A Broström,Anders %A Ulander,Martin %A Lin,Chung-Ying %A Griffiths,Mark D %A Imani,Vida %A Ahorsu,Daniel Kwasi %A Ohayon,Maurice M %A Pakpour,Amir H %+ Department of Rehabilitation Sciences, Hong Kong Polytechnic University, ST534 Department of Rehabilitation Sciences, Hung Hom, , China (Hong Kong), 852 27666755, cylin36933@gmail.com %K app-based intervention %K cognitive behavioral therapy, insomnia %K sleep hygiene %K theory of planned behavior %D 2020 %7 1.4.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Sleep hygiene is important for maintaining good sleep and reducing insomnia. Objective: This study examined the long-term efficacy of a theory-based app (including cognitive behavioral therapy [CBT], theory of planned behavior [TPB], health action process approach [HAPA], and control theory [CT]) on sleep hygiene among insomnia patients. Methods: The study was a 2-arm single-blind parallel-group randomized controlled trial (RCT). Insomnia patients were randomly assigned to a treatment group that used an app for 6 weeks (ie, CBT for insomnia [CBT-I], n=156) or a control group that received only patient education (PE, n=156) through the app. Outcomes were assessed at baseline and 1 month, 3 months, and 6 months postintervention. Primary outcomes were sleep hygiene, insomnia, and sleep quality. Secondary outcomes included attitudes toward sleep hygiene behavior, perceived behavioral control, behavioral intention, action and coping planning, self-monitoring, behavioral automaticity, and anxiety and depression. Linear mixed models were used to evaluate the magnitude of changes in outcomes between the two groups and across time. Results: Sleep hygiene was improved in the CBT-I group compared with the PE group (P=.02 at 1 month, P=.04 at 3 months, and P=.02 at 6 months) as were sleep quality and severity of insomnia. Mediation analyses suggested that perceived behavioral control on sleep hygiene as specified by TPB along with self-regulatory processes from HAPA and CT mediated the effect of the intervention on outcomes. Conclusions: Health care providers might consider using a CBT-I app to improve sleep among insomnia patients. Trial Registration: ClinicalTrials.gov NCT03605732; https://clinicaltrials.gov/ct2/show/NCT03605732 %M 32234700 %R 10.2196/15841 %U http://www.jmir.org/2020/4/e15841/ %U https://doi.org/10.2196/15841 %U http://www.ncbi.nlm.nih.gov/pubmed/32234700