Efficacy of a theory-based cognitive behavioral technique app-based intervention for patients with insomnia: Randomized controlled trial

Nilofar Rajabi MAjd, Anders Broström, MArtin Ulander, Chung Ying Lin (Corresponding Author), MArk D. Griffiths, Vid Imani, Daniel Kwasi Ahorsu, MAurice M. Ohayon, Amir H. Pakpour

Research output: Journal article publicationJournal articleAcademic researchpeer-review

10 Citations (Scopus)


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.

Original languageEnglish
Article numbere15841
JournalJournal of Medical Internet Research
Issue number4
Publication statusPublished - 1 Apr 2020


  • App-based intervention
  • Cognitive behavioral, therapy, insomnia
  • Sleep hygiene
  • Theory of planned behavior

ASJC Scopus subject areas

  • Health Informatics

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