A pilot randomized trial for smoking cessation app in Arabic language: a study protocol
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1
Faculty of Medicine, Yarmouk University, Jordan
2
Faculty of Medicine, The University of Bergen, Norway
Publication date: 2023-04-27
Popul. Med. 2023;5(Supplement):A627
ABSTRACT
Tobacco consumption in the middle-east region is very high. Many smoking cessation apps show to be effective in reducing smoking rates. To date, smoking cessation apps in Arabic mostly are translated from English. No study tested the apps efficacy of the Arabic version in our region. Moreover, the cultural context is not addressed. The purpose of this study is to develop a smoking cessation app in Arabic (iEndSmokin, انهاء التدخين) and to examine its efficacy. The app will be based on clinically proven behavioral therapy as Cognitive-Behavioral Therapy (CBT) and Acceptance Commitment Therapy (ACT). In this pilot randomized clinical trial, smokers will be randomized and allocated in a 1:1 ratio to app intervention or to the control group. Participants in the control arm will attend educational and motivational sessions. The intervention will last for 6 months and participants will be followed for 12 months. The primary outcome is a 30-point prevalence of smoking abstinence and normal saliva cotinine level at the end of the study. A 50% reduction in the smoking rate will be the secondary outcome. Long-term abstinence will be measured after 12 months. The sample size will be around 200 smokers who are willing to quit. Recruitment will be between April 2023 to May 2023 or until the process is completed. The study will start from June 2023 to December 2023 with 4 follow-up points: 1) baseline, 2) 3 months, 3) 6 months, and 4) 12 months. Data will be analyzed based on intention-to-treat. Our main hypothesis, the iEndSmokin app will be an effective, accessible, and feasible smoking cessation app targeting all Arabic speaking countries. All ethical approval will be obtained from Yarmouk University Institutional Review Board (IRB) prior to app development and recruitment. The study Results will be disseminated via peer-reviewed publication.