Development and Implementation of an Online Psychological Support Program for Tobacco Users
NCT ID: NCT07001722
Last Updated: 2025-06-03
Study Results
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Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2023-01-26
2025-04-24
Brief Summary
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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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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TÜBSİS Web-based Psycho-education Programme
The intervention group had 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.
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.
Control Group (without intervention)
Participants in the control (as well as intervention 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 control study (during one month).
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Not having given the mid-test or post-test measurement within 3 months from the time of the pre-test in the TÜBSİS Program
18 Years
65 Years
ALL
Yes
Sponsors
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Ege University Scientific Research Projects Coordination
UNKNOWN
Ege University
OTHER
Responsible Party
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Inci Derya YUCEL
Dr. Lecturer
Principal Investigators
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Gorkem YARARBAS, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Ege University, Institute on Drug Abuse, Toxicology and Pharmaceutical Science, Department of Drug Abuse
Hur HASSOY, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Ege University, Faculty of Medicine, Department of Public Health
Locations
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Ege University Institute on Drug Abuse, Toxicology and Pharmaceutical Science
Izmir, , Turkey (Türkiye)
Countries
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References
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Schaub, M.P. (2023). Nikotinabhängigkeit. In: Ebert, D.D., Baumeister, H. (eds) Digitale Gesundheitsinterventionen. Springer, Berlin, Heidelberg.
Cetin MB, Sezgin Y, Akinci S, Bakirarar B. Evaluating the Impacts of Some Etiologically Relevant Factors on Excessive Gingival Display. Int J Periodontics Restorative Dent. 2021 May/June;41(3):e73-e80. doi: 10.11607/prd.5475. Epub 2021 Apr 5.
Spears CA, Abroms LC, Glass CR, Hedeker D, Eriksen MP, Cottrell-Daniels C, Tran BQ, Wetter DW. Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 24;7(6):e13059. doi: 10.2196/13059.
van Emmerik AAP, Berings F, Lancee J. Efficacy of a Mindfulness-Based Mobile Application: a Randomized Waiting-List Controlled Trial. Mindfulness (N Y). 2018;9(1):187-198. doi: 10.1007/s12671-017-0761-7. Epub 2017 Jun 21.
Thornton L, Quinn C, Birrell L, Guillaumier A, Shaw B, Forbes E, Deady M, Kay-Lambkin F. Free smoking cessation mobile apps available in Australia: a quality review and content analysis. Aust N Z J Public Health. 2017 Dec;41(6):625-630. doi: 10.1111/1753-6405.12688. Epub 2017 Jul 27.
Oikonomou MT, Arvanitis M, Sokolove RL. Mindfulness training for smoking cessation: A meta-analysis of randomized-controlled trials. J Health Psychol. 2017 Dec;22(14):1841-1850. doi: 10.1177/1359105316637667. Epub 2016 Apr 4.
Firat M, Demir Gokmen B, Karakurt P. An investigation of smoking habits and mental well-being in healthcare personnel during COVID-19. Perspect Psychiatr Care. 2022 Jan;58(1):108-113. doi: 10.1111/ppc.12819. Epub 2021 Apr 30.
Legleye S, Bricard D, Khlat M. Roles of parental smoking and family structure for the explanation of socio-economic inequalities in adolescent smoking. Addiction. 2023 Jan;118(1):149-159. doi: 10.1111/add.16026. Epub 2022 Aug 26.
Haug S, Paz Castro R, Kowatsch T, Filler A, Dey M, Schaub MP. Efficacy of a web- and text messaging-based intervention to reduce problem drinking in adolescents: Results of a cluster-randomized controlled trial. J Consult Clin Psychol. 2017 Feb;85(2):147-159. doi: 10.1037/ccp0000138. Epub 2016 Sep 8.
Haug S, Schaub MP, Venzin V, Meyer C, John U. Efficacy of a text message-based smoking cessation intervention for young people: a cluster randomized controlled trial. J Med Internet Res. 2013 Aug 16;15(8):e171. doi: 10.2196/jmir.2636.
Durmaz S, Ergin I, Durusoy R, Hassoy H, Caliskan A, Okyay P. WhatsApp embedded in routine service delivery for smoking cessation: effects on abstinence rates in a randomized controlled study. BMC Public Health. 2019 Apr 8;19(1):387. doi: 10.1186/s12889-019-6727-z.
Bandura, A. (1969). Social-learning theory of identificatory processes. In D. A. Goslin (Ed.), Handbook of socialization theory and research (pp. 213-262). Chicago, IL: Rand McNally.
Other Identifiers
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28432
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
23-1.1T/38
Identifier Type: -
Identifier Source: org_study_id
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