Developing and testing a smoking cessation app in Arabic language: A pilot randomized trial study protocol

Abstract

Background

Tobacco consumption in the Middle East is very high. Many smoking cessation apps effectively reduce smoking rates, yet few smoking cessation apps are tailored to the region. To date, smoking cessation apps in Arabic are mostly translated from English, with no studies assessing their efficacy. Additionally, these apps often fail to address cultural differences. The purpose of this study is to develop a smoking cessation app in Arabic (iEndSmokin, أنهيت التدخين) and to examine its feasibility and efficacy. The app will incorporate evidence-based 5As, 5Rs, and cognitive behavioral therapy.

Method

In this pilot randomized trial, adults who smoke will be randomized and allocated in a 1:1 ratio to either the app intervention group (using the app) or the control group. Participants in the control arm will attend educational sessions. The intervention will last for 3 months, and participants will be followed for 6 months. A total of 200 adults who smoke willing to quit will be recruited between October and November 2025 (or until recruitment is complete). The study will run from December 2025 to May 2026, with follow-ups at baseline, 1 month, 3 months, and 6 months. Data will be analyzed using an intention-to-treat approach.

Results

The primary outcome will be 30-day point prevalence of smoking abstinence with biochemically confirmed cessation via normal saliva cotinine levels at 3 months. Secondary outcomes include either a 7-day point prevalence abstinence verified by saliva cotinine levels, and a ≥ 20% reduction in smoking rate. Long-term abstinence will be assessed at 6 months’ post-intervention.

Conclusion

Developing a culturally sensitive smoking cessation app to be available for the majority of adults who smoke for free that adhere to clinical guideline is a promising low-cost solution to promote behavioral change. We hypothesize that the iEndSmokin App will be an effective, accessible, and feasible smoking cessation tool for Arabic-speaking populations.

Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT06766227

Keywords

Smoking cessation mHealth cognitive behavioral therapy randomized trial digital health

Introduction

One of the global health threats is the tobacco epidemic. All forms of Tobacco smoking are associated with 8 million deaths, including 1.2 million deaths due to secondhand smoke.^1–3 Male who smoke tobacco account for 36.7% compared to 7.8% for females who smoke. Additionally, low- and middle-income countries account for 80% of global tobacco smoking, which translates into 1.3 billion adults who smoke.³ In Jordan, the smoking rate is skyrocketing. About 41% of adult Jordanians are consuming tobacco, males who smoke account for 65.3% and females for 16.4%.⁴ Secondhand smoke affects up to 79% of all Jordanians. These factors have resulted in high rates of non-communicable diseases, which account for 78% of deaths annually.⁴ Despite the different initiatives to reduce the smoking rate in Jordan - from smoke-free policies, enforcing bans on tobacco advertising, increasing tobacco products taxes, to health promotion and sponsorship^2,5 smoking rates in Jordan remain among the highest in the world.⁶

Advances in artificial intelligence and computer sciences have introduced new innovative solutions in the medical field under the umbrella of digital health. Mobile health (mHealth) apps are widely used to deliver educational material, monitor patients’ health, support clinical diagnosis or decision making, and some apps act as digital therapeutics platforms.⁷These apps help overcome barriers such as location, appointment scheduling, and they reduce the cost of healthcare as many are available for free.⁸ Globally, more than 50 million people use some type of mHealth Apps.⁷ In some low-income countries, smartphone accessibility exceeds access to electricity and clean water. In Jordan, about 90% of the population owns a smartphone,^9–11 and 59.1% of university students have experienced smartphone addiction, and 91.3% have reported using their smartphones for more than four hours per day.¹²

Recently, many interactive smoking cessation apps have shown their efficacy to aid adults who smoker without professional assistance.¹³ Studies have reported that smoking cessation apps can achieve success rates of up to 27%.¹⁴ In low-to middle-income countries, the range of smoking abstinence based in recent systematic reviews was 11‒40.9% at 6 months.¹⁵ High-quality smoking cessation apps commonly feature educational content, goal setting, progress tracking, personalized tips and advice, skill-building exercises, and community support. However, treatment guidelines for smoking cessation and/or psychological therapeutic models such as cognitive behavior therapy (CBT), acceptance and commitment therapy (ACT), and mindfulness are infrequently or partially addressed in most apps.^16,17 CBT-based smoking-cessation apps are suggested to be more effective.¹⁸ However, adherence to evidence-based guidelines in these apps is low, particularly among commercially available apps.¹⁷ Long-term studies to evaluate apps’ effectiveness and sustainability are scarce.^7,19,20 Studies from low-to middle-income countries have poor quality, involving small sample sizes, weak study designs, and methodological limitations, making their findings not generalizable across different geographic areas.^7,20 Furthermore, smoking cessation apps in Arabic are limited, and no studies have assessed their efficacy.²¹ Although Arabic is widely spoken, with approximately 360.2 native speaker across 22 countries.²² Therefore, developing a smoking cessation app in Arabic holds a significant potential for reducing smoking rates in a cost-effective and accessible manner, ultimately helping to prevent tobacco-related premature deaths.

Specific aims and significance

This study aims to test the feasibility and efficacy of a smoking cessation mobile intervention (iEndSmokin, أنهيت التدخين) in Arabic compared to a control group. More specifically, the research aims are the following:

Aim 1. Is iEndSmokin promote significant abstinence in - adults who smoke after 3 months in comparison to a control group?

Aim 2. Is iEndSmokin reduce significantly daily number of cigarettes in adults who smoke after 3 months in comparison to a control group?

Aim 3. Determine whether iEndSmokin prevent relapses at 6 months?

Materials and methods

Study design

This is a pilot, single-blinded randomized controlled trial (RCT), with two parallel groups, using a pre-test and repeated post-test design. All activities will be conducted at Yarmouk University in Jordan following CONSORT statements. The study is a collaboration between the Faculty of Medicine, the Faculty of Educational Sciences, and the Faculty of Information Technology and Computer Sciences; a multi-disciplinary team including a clinical psychologist, public health, information technologist faculty members and research assistants will be responsible for developing the app and conducting the trial. The trial is registered at ClinicalTrials.gov Identifier: NCT06766227

Ethical consideration

All research activities have been approved by the IRB committee at Yarmouk University (Ethics Code: IRB/2023/19) on January 29, 2023. All participants will be provided with written informed consent prior to enrollment in the study. This research will be conducted ethically and in accordance with the World Medical Association Declaration of Helsinki. Regarding data safety and information confidentiality, all Microsoft forms for screening and baseline survey will be generated using the principal investigator's (PI) account at Yarmouk University which has a business associate agreement with Microsoft 365 suits. Security and privacy settings on the account includes dual authentication to safeguard protected health information (PHI) and other sensitive data in compliance with HIPPA regulations.^23,24 All generated data will be de-identified and stored on the PI personnel computer at Yarmouk University/the Faculty of Medicine which is protected by 24 hours/7 days security service.

Study sample and recruitment

Study participants will be recruited through social media, emails, and flyers distributed all offer the university campus and cafés. Participation will be on voluntary base. Recruitment and screening will be conducted online using Microsoft form, which will be sent to all worker at the university, flyers and e-flyer posted with QR code will be posted on cafés and social media pages.²⁵ All eligible participants will be contacted by our research assistants for further baseline assessments and informed consent will be obtained. The inclusion criteria are: (1) adults who smoke aged 18 years old and above, (2) smoking ≥5 cigarettes a day for the past year,²⁶ (3) owing a smartphone (Android), and (4) expressing willingness to quit smoking. The exclusion criteria are: (1) non-Arabic speakers, (2) conditions interfering with the intervention like blindness or deafness, (3) smoking only hookah, or (4) participation in another smoking cessation program.

Recruitment will start on October to November 2025 or until the recruitment process is complete. Assuming a 1:1 ratio of intervention to control participants, with an alpha level of 0.05, 80% power, and an expected effect difference of 5%^27,28 between two groups. The required sample size is estimated at 284 participants per group, totaling 568 participants. This calculation is based on a two-tailed test for proportions using free sample size calculator ClinCalc.com. Accounting for a 20% loss to follow-up, the final required sample size increases to 341 participants per group, totaling 682 participants. A pilot feasibility study is planned to assess preliminary outcomes with 200 participants, equally divided between the intervention and control groups (100 participants each).

Randomization

Participants will be stratified based on their nicotine dependence using the Fagerstrom Test into light, moderate, and heavy adults who smoke.²⁹ Participants will be completely randomized into two equal groups: control group or app intervention group. The randomization will be done using Research Randomizer (version 4.0) software by a research assistant who is independent from those collecting or analyzing the data. Multiple precautionary measures will be taken to avoid any possible interaction between groups including: separating participants by place and time (with a 1‒2 day gap). The research assistant for the control group will not perform any tasks related to the intervention group. Different research assistants responsible for collecting the study measures and analyzing the data, and they will be completely blinded for participants’ group allocation.

APP development

The mobile phone app will be developed by our IT research assistants from the Information Technology department / the Faculty of Information Technology and Computer Sciences. The app's features will be aligned with the U.S. preventive services task force (USPSTF) clinical Guidelines for smoking cessation, and CBT.¹⁸ It will also include an individualized plan, daily tracker, videos and messages pop-ups (Figure 1).

Figure 1.

Iendsmokin app prototype: (a) login pages and baseline assessment and (b) CBT phases and exercises.

Development of CBT-based app treatment program

Clinical and Psychological activities will be developed and reviewed by two culturally sensitive clinical psychologists experts with extensive experience in using CBT-based treatment for various mental health problems, including addiction, in clinical settings. This CBT-based app program incorporates cognitive behavioral principles and behavior change techniques to provide personalized smoking cessation support and social skills training. The goal of the program is to reshape smoking-related thoughts, knowledge, and behaviors, ultimately transforming smoking habits into cessation behaviors.³⁰

The CBT program is structured into six levels, targeting key psychological and behavioral domains. It begins with assessing the individual's readiness to quit, identifying personal triggers, and exploring motivations for smoking and quitting. Cognitive restructuring techniques will be used to challenge irrational beliefs about smoking, such as the belief that smoking reduces stress or enhances concentration, through the ABC model (Activating event, Belief, Consequence). Emotional regulation strategies will be introduced to help individuals cope with negative emotions like anger, sadness, and boredom without relying on smoking, including guided imagery and time-jump visualization to assess long-term consequences of continued smoking versus quitting. The program also will incorporate behavioral techniques such as coping cards, aversion exercises, and mirror work to promote self-awareness and resilience. Role-reversal activities and cost-benefit analysis will be used to enhance insight and motivation, while positive self-talk and modeling successful quitters that help to reinforce confidence and behavioral change. Each level will build on the previous one, providing daily tasks, reflective exercises, and practical strategies to support sustainable smoking cessation.

The first two levels will include educational material and exercises that will teach the participants how to use the app, smoking related information, how to set their own plan to quit, and how to follow themselves through their plan. Levels three to four, will include exercises teaching skills to understand smoking stimulus, distraction techniques to stay away from smoking, coping strategies for withdrawal symptoms, cravings, emotions, triggers, and peers’ pressure. Levels five to six will be about how to live a smoke free life, and prevent relapses. Exercises will heavily rely on journaling, goal setting, tracking participants’ behavior, reminders, individualized pop-up messages, quotes and videos.

Qualitative evaluation for app cultural appropriateness

To assess the cultural appropriateness of the app content, a qualitative study will be conducted involving 10 adults who smoke recruited through purposive sampling to ensure diversity in age, gender, and smoking behavior. Semi-structured interviews will be used to gather in-depth feedback on the app's language, themes, visuals, and relevance to local cultural norms and beliefs about smoking and cessation. Participants will be asked to use the app for a set period before the interviews, during which they will reflect on the content's clarity, relatability, and cultural sensitivity. Interviews will be audio-recorded, transcribed, and thematically analyzed to identify common perceptions, culturally specific concerns, and suggestions for adaptation. The findings will guide revisions to enhance the app's cultural relevance and effectiveness. Participants in qualitative evaluation will not be re-included in the main study.

Intervention group

The smoking cessation app will be downloaded and explained to all intervention arm participants after 2-week run-in period and the completion of the baseline assessment. The app will deliver both mandatory evidence-based, guideline-informed smoking cessation content and optional resources such as quitting benefits and practical tips. The app will help adults who smoke to choose to stop either immediately or progressively, monitor their smoking status and progress, receive tips to overcome craving, and prevent relapses during the trial. Key App features will be developed based on clinical guidelines proven to reduce smoking rates by 20% in clinical setting³¹ and psychological interventions shown to be effective.¹⁹ All app content will be evidence-based; based on clinical guidelines and intervention proven in medical literature to be effective. Clinical guidelines used are the “Treating tobacco use and dependence” (“2008 update”),³² and USPSTF prevention guidelines.³³ Psychological exercises will be based on CBT which has been shown to reduce smoking rates.³⁰ The app will provide electronic educational contents, tips, and exercises in written or video-recorded forms. Daily tracker for smoking status will be measured via a daily question pop-up as a notification on the phone. Participants can review their abstinence progress in graphical format.³⁴ Similarly, craving symptoms and mood changes will be monitored.

For the 5-As framework (Ask, Advise, Assess, Assist, Arrange) the app will systematically collects information on smoking behavior (Ask), provides evidence-based personalized messages emphasizing the benefits of cessation (Advise), evaluates the user's readiness to quit using validated motivational scales (Assess), delivers tailored CBT-based interventions and coping strategies (Assist), and ensures ongoing support through automated reminders, progress monitoring, and scheduled follow-ups (Arrange). For the 5-Rs Framework (Relevance, Risks, Rewards, Roadblocks, Repetition) the app will provide cultural sensitive contents align with individual health priorities (Relevance), interactive trackers and visualizations estimate individual risk of smoking-related diseases, emphasizing both short- and long-term health consequences (Risks), reinforces intrinsic and extrinsic benefits of quitting through achievement badges after each session completion (Rewards), identifies and addresses potential barriers to cessation using impeded in CBT program (Roadblocks), and employs repeated delivery of motivational messages and relapse-prevention strategies across multiple sessions (Repetition).

CBT features in our app will include videos for motivation, overcome smoking triggers, addiction and withdrawal symptoms, management of negative affect like stress and anger, cope with cravings ex. Distraction strategies, prevent relapsing by building resilience.³⁵ These features will appear as sequential levels; advanced levels can’t be accessed until the participant finish all the previous level exercises. Accordingly, informational SMS containing motivational messages, tips and strategies will appear as daily notification. Rewards will be presented as electronic badges and further features availability. Participants who will not use the APP for three consecutive days will get an auto-reminder and phone pop-up message to increase compliance with the APP.

Control group

Three educational sessions will be provided to the control group one session each month for the first three months of the study. The first session will take place after 2 week run in period following the randomization. All sessions will take place at the Yarmouk University campus or virtually via Zoom in Arabic by trained research assistant in smoking cessation education and counseling. The first session will provide educational information on the risks of smoking health, reasons to quit, and methods for quitting. The remaining two sessions will focus on follow-up, covering skills and strategies for managing withdrawal symptoms and tips for preventing relapse.

Follow-Up scheme

Follow-up will include both survey methods and biochemical verification using salivary cotinine level. For trial integrity, the follow-up data will be collected by research assistant blinded to participants’ group allocation, and outside the intervention app at each follow up point. In order to increase retention rate, email and telephone reminders will be sent for participants 1 week, 1 day, and 1 h before each follow-up appointment. All Follow-up appointments will be held at Yarmouk University campus. There will be 2‒4 weeks run-in period after screening to obtain informed consent, complete the baseline assessment, and conduct randomization. There will be four follow-up time points (1) baseline, (2) 1 month, (3) 3 months, and (4) 6 months.

Data collection and study measures

The following participants surveys’ will be collected at each follow-up time point (Table 1). In addition, automated app utilization data will be retrieved at 3-months (end of trial) and 6-months (follow-up). The main outcome measure will be self-reported 7-day and 30-day abstinence point prevalence data, verified by salivary cotinine level, which serve as a biochemical marker for tobacco abstinence. Demographic data will include age, gender, education, household income, residence (Urban, Sub-Urban, Rural), number of family members, number of smoking people at home, number of smoking friends, medical history. A detailed smoking history (age started smoking, type of tobacco products used, Fagerstrom scale for smoking dependence,³⁶ number of previous attempts to quit, and methods used to quit smoking).

Table 1.

Follow-up time points and data collection surveys schedule.

Measure	Screening	Baseline	1 month	3 month	6 month
Recruitment and eligibility	X
Demographics		X
Daily number of cigarette smokes		X	X	X	X
Fagerstrom test		X	X	X	X
Tobacco use		X
Smoking history		X
Mars				X	X
7-Point prevalence			X	X	X
30-Point prevalence			X	X	X
Cotinine level		X		X	X

Measurements

The primary end-point of the study will be at 3-months. The main outcome is 30-point abstinence prevalence, confirmed by normal salivary cotinine level. A successful quit event is defined as follows: Participants reported 30 consecutive days’ abstinence from smoking and all forms of nicotine/tobacco products (including cigarettes, hookah, e-cigarettes, HEETS, cigars, gums, etc.), and normal salivary level of cotinine (accounting for second-hand smoking levels). The salivary cotinine level test is sensitive for nicotine exposure within 48‒72 h. Samples can be stored for up to three months without compromising the validity of the test.^37–39 Many smoking cessation studies define abstinence using: Self-report + salivary cotinine <10 ng/mL following the kit manufacture instructions and cutoffs. The secondary outcomes will include: a 7-point abstinence prevalence confirmed by normal salivary level of cotinine, and a ≥ 20% reduction in smoking rate. Prolonged abstinence will be assessed at 6-months to assess relapse rate.⁴⁰

Smoking status will be assessed using the self-reported response to the question “When was the last time you smoked, or even tried, a cigarette?” Responses choices were “Earlier today,” “24 h ago,” “2‒7 days ago,” “8‒30 days ago,” and “Over 30 days ago.” Participants who responded “Over 30 days ago” were considered abstinent for the 30-day point prevalence abstinence outcome and those who responded “8‒30 days ago” and “Over 30 days ago” were considered abstinent for the 7-day point prevalence abstinence outcome. Regarding other tobacco product use, participants were asked about e-cigarette use (“In the last 30 days, how often did you use any kind of e-cigarette or vaping?”) and other tobacco use (“In the last 30 days, how often did you use any other tobacco products such as chewing tobacco, hookahs, HEETS, cigars, pipes?”). Responses for both items ranged from “Not at all” to “At least daily.” Participants who responded “Not at all” were considered abstinent.

Participants app satisfaction and feedback will be assessed using Mobile App Rating Scale (MARS) scale. App utility data (using hours and the most consumed feature/s) and direct questioning about compliance (“Overall, about how many times per week did you use the strategies taught in your assigned app?” and “How useful was your assigned app's quit plan?” in 5-point semantic deferential scale from strongly disagree to strongly agree) will be used to adjust for participants’ adherence to app. APP satisfaction will be assessed with two questions; “Overall, how satisfied are you with your assigned app?,” “Would you recommend your assigned application to a friend?” Response choices for all items ranged from “Not at all” (1) to “Very much” (5) and were dichotomized at a threshold of “Somewhat” (3) or higher.⁴¹

Data analysis

Our primary hypothesis is that smoking app will have a significantly higher 30-point abstinence rate at 3-months post randomization compared to control group. All-forms of tobacco abstinence will be categorized into three groups: abstinence, reduced smoking rate, current adult who smoke. For group comparisons on the primary and secondary endpoints, logistic regression will be used to calculate odds ratio (OR) with 95% confidence interval, adjusting for possible confounders. All models will be analyzed based on intention to treat. All models will follow the intention-to-treat principle. Multiple imputation by chained equations (MICE) will be used to handle missing data.⁴² Those who lost follow-up will be coded as adults who smoke. Baseline characteristics of the participants’ will be compared by chi-square (χ²) test for categorical variables and ANOVA F-test or Mann‒Whitney U test for continuous variables. The Statistical Package for Social Sciences (SPSS Version 25.0, SPSS Inc., 255 Chicago, IL, USA) software for Windows will be used for all analysis.

Discussion

Our app represents a personalized and culturally tailored approach to addressing tobacco use among Arabic-speaking populations through the development and testing of the iEndSmokin mobile app. Utilizing a RCT design, the project significantly contributes to the existing body of literature by addressing the critical gap in evidence-based, low-cost and culturally relevant digital interventions in the Middle East. The integration of the evidence-based 5As and 5Rs frameworks, and CBT methodologies underscores the rigorous methodological innovation employed in this intervention.

Several innovative methodological elements strengthen this study. First, the stratification of participants by nicotine dependence (light, moderate, heavy adults who smokes) using the Fagerstrom Test ensures balanced groups, enhancing internal validity. Additionally, the intervention's alignment with evidence-based practices, particularly CBT, is crucial given its efficacy in smoking cessation globally. The systematic incorporation of psychological constructs like cognitive restructuring, emotional regulation, and behavioral modification techniques such as journaling, role-reversal activities, and aversion exercises reflects a comprehensive behavioral intervention design rarely seen in region-specific digital applications. The app's cultural sensitive design and content, developed explicitly for Arabic speakers rather than adapted from an English version, addresses previously reported limitations of low adherence and cultural irrelevance in existing mHealth apps. The study also demonstrates rigorous methodological robustness through its use of objective biochemical validation measures, specifically cotinine levels, to verify self-reported abstinence. Moreover, the app's feasibility and usability will be evaluated systematically through the MARS, providing valuable insights for future iterations of the intervention.

Conclusion

The iEndSmokin app represents an innovative, evidence-based, and culturally tailored intervention designed to address the high prevalence of smoking among Arabic-speaking populations. This study aims to fill a critical gap in smoking cessation strategies in the Middle East by integrating CBT methodologies, adherence to clinical guidelines, and culturally specific digital features. If proven effective, the iEndSmokin app could offer a scalable, accessible, and cost-effective tool for reducing tobacco use and related morbidity and mortality in the region.

Footnotes

Acknowledgments

We appreciate the support from the smoking cessation research team, the faculty of medicine, the faculty of education, the faculty of information technology and computer sciences, and Yarmouk University for their support.

ORCID iDs

Ola Soudah

Hasan Khasawneh

Ethical approval

Ethical approval was granted by the institutional review board of the Yarmouk University (IRB/2023/19). All participants provided written informed consent prior to enrolment in the study. This research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki.

Author contributions

Ola Soudah contributed to fund acquisition, conceptualization, resources, supervision, writing, and review and editing. Mo’men Aldalal’ah contributed to conceptualization, resources, visualization, methodology and writing. Alameen Alsabbah contributed to methodology and writing. Hasan Khasawneh contributed to visualization and resources. Obada Khayyat contributed to methodology. Ahmad F. Klaib contributed to supervision and software. Sondos Alrefai contributed to creation of CBT program and methodology. Mu'ayyad Megdadi contributed to creation of CBT program and validation.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by Yarmouk University [grant number 23-2023].

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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