Tobacco AddictionNCT07001722
Development and Implementation of an Online Psychological Support Program for Tobacco Users
A study testing TÜBSİS Web-based Psycho-education Programme in people with Tobacco Addiction, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Addiction
- What is being tested?
- TÜBSİS Web-based Psycho-education Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jan 2023to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Institute on Drug Abuse, Toxicology and Pharmaceutical Science
Izmir, 35100
About this study
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.
Read more
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
Read the 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.
- Conditions
- Tobacco Addiction
- Being tested
- TÜBSİS Web-based Psycho-education Programme
- Keywords
- TUBSIS, tobacco use, mindfulness, web-based psychoeducation, Health Action Process Approach
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TÜBSİS Web-based Psycho-education ProgrammeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 (%)
Measured: 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
Measured: Up to 12 weeks
Secondary outcomes (2)
Increase in Warwick Edinburgh Mental Well-being Scale score (Warwick-Edinburgh Mental Well-Being Scale - Short Form)
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)
Measured: Up to 12 weeks
Increase in Fagerström Nicotine Dependence Test score (Fagerström Test for Nicotine Dependence)
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)
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start26 Jan 2023
- Primary completion30 Sep 2024
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Tobacco AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention is designed as a psychoeducational support remotely for tobacco user adult individuals. The control group had no intervention.
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University Scientific Research Projects Coordination
- Responsible party
- Principal investigator, Inci Derya YUCEL, Ege University
- Investigators
- Gorkem YARARBAS, Prof. Dr., Principal investigator, Ege University, Institute on Drug Abuse, Toxicology and Pharmaceutical Science, Department of Drug AbuseHur HASSOY, Prof. Dr., Principal investigator, Ege University, Faculty of Medicine, Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001722
- Sponsor's protocol ID
- 23-1.1T/38
- Other IDs
- 28432
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33819318Spears 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.
PubMed 31237242van 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.
PubMed 29387266Thornton 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.
PubMed 28749591Oikonomou 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.
PubMed 27044630Firat 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.
PubMed 33931894Legleye 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.
PubMed 35971293Haug 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.
PubMed 27606700Haug 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.
PubMed 23956024Durmaz 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.
PubMed 30961557Bandura, 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of an Online Psychological Support Program for Tobacco Users
- ClinicalTrials.gov ID
- NCT07001722
- Acronym / sponsor ID
- 23-1.1T/38
- Conditions
- Tobacco Addiction
- Keywords
- TUBSIS, tobacco use, mindfulness, web-based psychoeducation, Health Action Process Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Ege University Scientific Research Projects Coordination
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention is designed as a psychoeducational support remotely for tobacco user adult individuals. The control group had no intervention.
| Arm | Type | Receives |
|---|---|---|
| TÜBSİS Web-based Psycho-education Programme | Experimental | Other: TÜBSİS Web-based Psycho-education ProgrammeThe 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. |
| 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TÜBSİS Web-based Psycho-education ProgrammeThe 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. | Other | TÜBSİS Web-based Psycho-education Programme |
Primary outcome
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)
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 (%)
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
2 secondary outcomes
Increase in Warwick Edinburgh Mental Well-being Scale score (Warwick-Edinburgh Mental Well-Being Scale - Short Form)
Time frame: Up to 12 weeks
Increase in Fagerström Nicotine Dependence Test score (Fagerström Test for Nicotine Dependence)
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- BackgroundSchaub, M.P. (2023). Nikotinabhängigkeit. In: Ebert, D.D., Baumeister, H. (eds) Digitale Gesundheitsinterventionen. Springer, Berlin, Heidelberg.
- Background: PubMed 33819318Cetin 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.
- Background: PubMed 31237242Spears 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.
- Background: PubMed 29387266van 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.
- Background: PubMed 28749591Thornton 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.
- Background: PubMed 27044630Oikonomou 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.
- Background: PubMed 33931894Firat 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.
- Background: PubMed 35971293Legleye 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.
- Background: PubMed 27606700Haug 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.
- Background: PubMed 23956024Haug 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.
- Background: PubMed 30961557Durmaz 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.
- BackgroundBandura, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gorkem YARARBAS, Prof. Dr. principal investigator
Ege University, Institute on Drug Abuse, Toxicology and Pharmaceutical Science, Department of Drug Abuse
Hur HASSOY, Prof. Dr. principal investigator
Ege University, Faculty of Medicine, Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TÜBSİS Web-based Psycho-education Programme in people with Tobacco Addiction, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage of Change Based on the Health Action Process Approach (time frame: Up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07001722, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.