@Article{info:doi/10.2196/15841, author="Rajabi Majd, Nilofar and Brostr{\"o}m, Anders and Ulander, Martin and Lin, Chung-Ying and Griffiths, Mark D and Imani, Vida and Ahorsu, Daniel Kwasi and Ohayon, Maurice M and Pakpour, Amir H", title="Efficacy of a Theory-Based Cognitive Behavioral Technique App-Based Intervention for Patients With Insomnia: Randomized Controlled Trial", journal="J Med Internet Res", year="2020", month="Apr", day="1", volume="22", number="4", pages="e15841", keywords="app-based intervention; cognitive behavioral therapy, insomnia; sleep hygiene; theory of planned behavior", abstract="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 ", issn="1438-8871", doi="10.2196/15841", url="http://www.jmir.org/2020/4/e15841/", url="https://doi.org/10.2196/15841", url="http://www.ncbi.nlm.nih.gov/pubmed/32234700" }