Smoking Cessation App. in Arabic

NCT ID: NCT06766227

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-12-01

Brief Summary

Smoking remains a significant global health challenge, causing over 8 million deaths annually, with the burden predominantly in low- and middle-income countries. Jordan experiences some of the highest smoking rates worldwide, contributing to substantial health risks and premature mortality. Despite the prevalence of mobile health (mHealth) applications for smoking cessation, few have supported the Arabic language and none have been evaluated for their efficacy. Our main goal is to develop a culture-sensitive mHealth app in Arabic for smoking cessation and test its efficacy.

Detailed Description

Jordan's smoking rates remain among the highest globally despite various initiatives such as smoke-free policies, advertising bans, increased tobacco taxes, and health promotion programs. Mobile health (mHealth) apps have proven effective in delivering education, monitoring health, supporting diagnoses, and acting as therapeutic platforms, overcoming barriers like location, scheduling, and cost. In Jordan, 90% of the population owns smartphones. High-quality apps typically include features like education, goal-setting, progress tracking, skill-building exercises, and community support. Smoking cessation apps' success rates reached up to 27%, where abstinence rates range from 11% to 40.9% within six months.

Treatment guidelines for smoking cessation and/or Psychological therapeutic models such as cognitive behavior therapy (CBT), acceptance commitment therapy (ACT), and mindfulness were infrequently or partially addressed in most Apps. CBT-based smoking-cessation apps are suggested to be more effective. However, adherence to evidence-based guidelines in these apps is low including most commercially available apps. Long-term studies to evaluate App effectiveness and sustainability are scarce. Smoking cessation Apps studies from low-middle-income countries had poor quality, including small sample size, weak designs, and methodological problems, and can't be generalizable across different geographic areas. There is a limited number of smoking cessation Apps in Arabic with no studies testing their efficacy. The Arabic language is widespread, there are about 360.2 people Arabic is their native language encompassing 22 countries. Therefore, the smoking cessation App in Arabic shows an exciting promise for lowering smoking rates at a low cost and convenient setting and thereby preventing tobacco-related premature deaths.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

App Group

The smoking cessation app will be downloaded and explained to all intervention arm participants after a 2-week run-in period and baseline assessment completion. The smoking cessation app will help smokers set a plan, know how to stop either immediately or progressively, monitor their smoking status and progression, give them tips to overcome cravings, prevent relapses, and aid their mood changes during the cessation trial. The app will provide electronic content, tips, and exercises in written or video-recorded forms. All app content will be evidence-based; based on clinical guidelines and interventions proven in medical literature to be effective. Clinical guidelines used are the "Treating Tobacco Use and Dependence ("2008 update"), and the WHO guidelines. Psychological exercises will be based on CBT which has been shown to reduce smoking rate.

Group Type: EXPERIMENTAL

iEndSmokin App

Intervention Type: BEHAVIORAL

Mobile Health App that includes educational material and psychological programs based on CBT.

Education Group

Three sessions will be provided to the control group one each week for the first month of the study. The first session will take place after a 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 a trained research assistant for smoking cessation counseling. The sessions will be educational sessions about smoking health risks, why you should stop, how to stop, and skills and strategies for dealing with withdrawal symptoms.

Group Type: ACTIVE_COMPARATOR

Educational Session

Intervention Type: BEHAVIORAL

It will include lectures and distribution of educational material about smoking health risks and strategies to quit.

Interventions

iEndSmokin App

Mobile Health App that includes educational material and psychological programs based on CBT.

Intervention Type: BEHAVIORAL

Educational Session

It will include lectures and distribution of educational material about smoking health risks and strategies to quit.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

• Study participants will be students attending Yarmouk University recruited through emails and flyers distributed to all offer the University's Faculties. Participation will be on a voluntary base. Only students who fulfill the following criteria will be invited to participate in the study. The inclusion criteria are: 1) a Yarmouk University student, 2) aged 18 years old and above, 3) smoked ≥5 cigarettes a day for the past year (25), 4) have a smartphone (iOS or Android), and 4) express willingness to quit smoking.

Exclusion Criteria:

• The exclusion criteria are: 1) non-Arabic speaker, 2) have certain conditions that interfere with the intervention like blindness or deafness, 3) have clinical depression or mental illness, 4) smoke only hookah, or 5) participate in another smoking cessation program.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yarmouk University

OTHER

Sponsor Role: lead

Responsible Party

Ola Ali Soudah

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yarmouk University

Irbid, , Jordan

Countries

Jordan

Facility Contacts

Ola Soudah, PhD

Role: primary

ola.soudah@yu.edu.jo

00962799602620

References

Soudah O, Aldalal'ah M, Alsabbah A, Khasawneh H, Khayyat O, Klaib AF, Alrefai S, Megdadi M. Developing and testing a smoking cessation app in Arabic language: A pilot randomized trial study protocol. Digit Health. 2025 Sep 12;11:20552076251378436. doi: 10.1177/20552076251378436. eCollection 2025 Jan-Dec.

Reference Type: DERIVED

PMID: 40949668 (View on PubMed)

Other Identifiers

23-2023

Identifier Type: -

Identifier Source: org_study_id