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

NCT07001722 | Completed DMC

• 2 other identifiers: 23-1.1T/3828432
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Conditions

Tobacco Addiction

Keywords

TUBSIS; tobacco use; mindfulness; web-based psychoeducation; Health Action Process Approach

Outcome Measures

Primary Outcomes (3)

• Stage of Change Based on the Health Action Process Approach

  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)

  Up to 12 weeks

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

  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 (%)

  Up to 12 weeks

• Daily cigarette consumption amount

  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

  Up to 12 weeks

Secondary Outcomes (2)

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

  Up to 12 weeks

• Increase in Fagerström Nicotine Dependence Test score (Fagerström Test for Nicotine Dependence)

  Up to 12 weeks

Study Arms (2)

TÜBSİS Web-based Psycho-education Programme

EXPERIMENTAL

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.

Other: TÜBSİS Web-based Psycho-education Programme

Control Group (without intervention)

NO 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).

Interventions

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.

TÜBSİS Web-based Psycho-education Programme

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead
• Ege University Scientific Research Projects Coordination: collaborator

Study Sites (1)

Ege University Institute on Drug Abuse, Toxicology and Pharmaceutical Science

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (12)

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  BACKGROUND

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  PMID: 33819318 BACKGROUND

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  PMID: 31237242 BACKGROUND

• 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.

  PMID: 29387266 BACKGROUND

• 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.

  PMID: 28749591 BACKGROUND

• 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.

  PMID: 27044630 BACKGROUND

• 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.

  PMID: 33931894 BACKGROUND

• 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.

  PMID: 35971293 BACKGROUND

• 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.

  PMID: 27606700 BACKGROUND

• 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.

  PMID: 23956024 BACKGROUND

• 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.

  PMID: 30961557 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Gorkem YARARBAS, Prof. Dr.

  Ege University, Institute on Drug Abuse, Toxicology and Pharmaceutical Science, Department of Drug Abuse

  PRINCIPAL INVESTIGATOR

• Hur HASSOY, Prof. Dr.

  Ege University, Faculty of Medicine, Department of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Lecturer

Model Details: The intervention is designed as a psychoeducational support remotely for tobacco user adult individuals. The control group had no intervention.

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 3, 2025
• Study Start: January 26, 2023
• Primary Completion: September 30, 2024
• Study Completion: April 24, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)