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

NCT07001722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-06-03

No results posted yet for this study

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

Conditions

  • Tobacco Addiction

Interventions

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.

Sponsors & Collaborators

  • Ege University Scientific Research Projects Coordination

    collaborator UNKNOWN
  • Ege University

    lead OTHER

Principal Investigators

  • Gorkem YARARBAS, Prof. Dr. · Ege University, Institute on Drug Abuse, Toxicology and Pharmaceutical Science, Department of Drug Abuse

  • Hur HASSOY, Prof. Dr. · Ege University, Faculty of Medicine, Department of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-26
Primary Completion
2024-09-30
Completion
2025-04-24

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07001722 on ClinicalTrials.gov