Clinical trial NCT07001722: Development and Implementation of an Online Psychological Support Program for Tobacco Users
Official title: Development and Implementation of an Online Psychological Support Program for Tobacco Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Addiction
Keywords: TUBSIS
tobacco use
mindfulness
web-based psychoeducation
Health Action Process Approach
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Ege University Scientific Research Projects Coordination
First posted: 2025-06-03
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention is designed as a psychoeducational support remotely for tobacco user adult individuals. The control group had no intervention.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Stage of Change Based on the Health Action Process Approach
timeFrame: Up to 12 weeks
measure: 7-day point prevalence smoking cessation attempt (i.e. not having smoked a puff of cigarette in the last 7 days)
timeFrame: Up to 12 weeks
measure: Daily cigarette consumption amount
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Increase in Warwick Edinburgh Mental Well-being Scale score (Warwick-Edinburgh Mental Well-Being Scale - Short Form)
timeFrame: Up to 12 weeks
measure: Increase in Fagerström Nicotine Dependence Test score (Fagerström Test for Nicotine Dependence)
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University Institute on Drug Abuse, Toxicology and Pharmaceutical Science
Study officials:
affiliation: Ege University, Institute on Drug Abuse, Toxicology and Pharmaceutical Science, Department of Drug Abuse
name: Gorkem YARARBAS, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University, Faculty of Medicine, Department of Public Health
name: Hur HASSOY, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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