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Completed

NCT Number: NCT07001722

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

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

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Key information

Conditions

Tobacco Addiction Behavior Tobacco Use

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Institute on Drug Abuse, Toxicology and Pharmaceutical Science

Izmir, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for the participants in the study:

  • 18 years of age or older
  • Used tobacco at least once a week for the last one month
  • Being literate in Turkish language
  • Be a student of Ege University or have graduated within the last three months

Exclusion criteria

for the participants in the study:

  • Currently taking any smoking cessation intervention or medical treatment
  • Not having given the mid-test or post-test measurement within 3 months from the time of the pre-test in the TÜBSİS Program

Treatment and study plan

TÜBSİS Web-based Psycho-education Programme

Other

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.

Primary outcomes

  1. Stage of Change Based on the Health Action Process Approach

    Time frame: Up to 12 weeks

    Participants' readiness to quit smoking is classified into one of three stages defined by HAPA model: pre-intender, intender, or actor. Stage classification is based on responses to HAPA Questionnaire.

    Unit of Measure: Stage (categorical: pre-intender, intender, actor)

  2. 7-day point prevalence smoking cessation attempt (i.e. not having smoked a puff of cigarette in the last 7 days)

    Time frame: Up to 12 weeks

    Defined as complete self-reported abstinence from smoking-not even a single puff-for at least the 7 days preceding the follow-up assessment.

    Unit of Measure: Percentage of participants (%)

  3. Daily cigarette consumption amount

    Time frame: Up to 12 weeks

    Daily smokers will report the average number of cigarettes smoked per day. Occasional smokers will report the number of smoking days per month and the average number of cigarettes per smoking day.

    Unit of Measure: Number of cigarettes per day or per month

Secondary outcomes

  1. Increase in Warwick Edinburgh Mental Well-being Scale score (Warwick-Edinburgh Mental Well-Being Scale - Short Form)

    Time frame: Up to 12 weeks

    Participants' mental well-being is assessed using the validated short-form Warwick-Edinburgh Mental Well-Being Scale (WEMWBS-KF). Change in total score from baseline to 12 weeks is evaluated.

    Unit of Measure: Scale score (min. score: 7 points - max. score: 35 points)

  2. Increase in Fagerström Nicotine Dependence Test score (Fagerström Test for Nicotine Dependence)

    Time frame: Up to 12 weeks

    Participants' level of nicotine dependence is assessed using the Fagerström Test for Nicotine Dependence (FNBT). Change in total score from baseline to 12 weeks is evaluated.

    Unit of Measure: Scale score (min. score: 0 point - max. score: 10 points)

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • Ege University Scientific Research Projects Coordination

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 3, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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