NCT07001722

Development and Implementation of an Online Psychological Support Program for Tobacco Users

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Ege University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Introduction: Tobacco use is the most prevalent and preventable public health problem in the world, responsible for 8 million deaths worldwide annually. Objective: The aim of this study was to develop and implement a remote, asynchronous, eight-module psychoeducation programme (Tobacco Addiction Support System (TÜBSİS) = Tobacco Addiction Psychological Support Programme) based on mindfulness psychological intervention with a web-based, online platform-supported application for male and female individuals over the age of 18 with tobacco use. The TÜBSİS Programme, which is an individual intervention, was applied to male and female tobacco users at a university via a web platform. Method: In this randomised controlled study, data collection from the participants in the intervention group was carried out through the web-based platform of the TÜBSİS Programme. Data collection from the participants in the control group was carried out via Google Forms and Google E-mail (Gmail). The participants were asked questions including the intervention variables three times in total, at the beginning, after two weeks and after four weeks. The participants in the intervention and control groups were asked about sociodemographic characteristics and tobacco use characteristics at baseline. Health Action Process Approach (HAPA) Model Change Question Form, Warwick Edinburgh Mental Well-Being Scale, Fagerström Nicotine Dependence Test and Informed Consent Form were applied to both groups at the beginning, in the middle and at the end of the intervention study. Intervention Variable '4-week TÜBSİS Tobacco Addiction Psychoeducation Programme' and 'Control Variables' Sociodemographic Characteristics (Age, Gender, Education level, Student status (being a student or not and level of education), Regular employment status (present/absent), Marital status, Having children, Perceived monthly income level, Father's education level, Living environment), Tobacco Use Characteristics (Age at the time of first smoking attempt, Past (pre-survey) smoking cessation attempt and number of attempts). The primary outcomes evaluated completed-8 modules of follow-up during the TÜBSİS Programme are as follows: 'Stage of change according to the HAPA Model (pre-intender stage, intender stage, actor stage)', "7-day point prevalence smoking cessation attempt (i.e. not having smoked a puff of cigarette in the last 7 days)", "Daily cigarette consumption amount (number of cigarettes smoked in a typical day for daily smokers, number of days smoked in a month and number of cigarettes smoked in a typical smoking day for occasional smokers)". Secondary outcomes were 'Increase in Warwick Edinburgh Mental Well-being Scale score' and 'Increase in Fagerström Nicotine Dependence Test score'. All statistical analyses were performed using SPSS version 25 software. Keywords: tobacco use, mindfulness, web-based psychoeducation, Health Action Process Approach

Detailed description

Tobacco addiction is not only a behavioral challenge but also a neurobiological and psychosocial condition requiring tailored interventions beyond simple awareness efforts. Digital interventions-particularly those grounded in psychological theory and structured learning-have shown growing promise in addressing addictive behaviors in accessible and scalable formats. The TÜBSİS Programme was developed as a structured psychoeducational tool incorporating principles of mindfulness and behavior change, aiming to strengthen psychological resources such as self-regulation, motivation, and resilience in tobacco users. While the program was digitally delivered, its design emphasized individual reflection, staged goal-setting, and emotional regulation skills to facilitate both cognitive and behavioral disengagement from tobacco use. Each module of TÜBSİS was designed to align with the core constructs of the Health Action Process Approach (HAPA), such as risk perception, action self-efficacy, planning, and maintenance self-efficacy. Participants were guided through these constructs in a phased format, enabling a personalized change trajectory based on their psychological readiness and behavioral intentions. In addition to the behavior change model, mindfulness strategies were embedded throughout the program, including attentional control exercises, present-moment awareness tasks, and cognitive reframing components. These were introduced progressively across modules to avoid cognitive overload and to allow integration into daily life routines. Assessments used in this study were not only intended to track behavioral change but also to understand the interplay between tobacco dependence and psychological well-being. The Warwick Edinburgh Mental Well-Being Scale and the Fagerström Test provided quantitative indices of mental health status and addiction severity, allowing for multidimensional evaluation. Given the asynchronous format, the study emphasized user engagement and retention. Platform analytics and module completion rates were monitored to interpret efficacy within the context of adherence.

Conditions

• Tobacco Addiction

Interventions

Type	Name	Description
OTHER	TÜBSİS Web-based Psycho-education Programme	The theoretical infrastructure of the TÜBSİS Program, which consists of a total of 8 modules lasting 1 month, is supported by the integration of two different frameworks: Mindfulness Approach and HAPA Health Action Approach. While the progress process in the TÜBSİS Program was created with the HAPA Model, the module contents of it were created within the framework of the Mindfulness Approach. Each participant receives reminder emails during this asynchronous and distance learning process and can open each new module at least 3 days later. Participants in the intervention (as well as control group) were asked about sociodemographic and tobacco use characteristics at baseline. Health Action Process Approach (HAPA) Model Change Question Form, Warwick Edinburgh Mental Well-Being Scale, Fagerström Nicotine Dependence Test and Informed Consent Form were administered to the intervention group at the beginning, in the middle and at the end of the intervention study.

Timeline

• Start date: 2023-01-26
• Primary completion: 2024-09-30
• Completion: 2025-04-24
• First posted: 2025-06-03
• Last updated: 2025-06-03

Locations

1 site across 1 country: Turkey (Türkiye)