Tobacco Use DisorderTUBSIS_2_0NCT07568483
TUBSIS 2.0 - Tobacco Use Behavioral Support and Intervention System
A study testing TUBSIS 2.0 in people with Tobacco Use Disorder and Nicotine Dependence, run by University of Zurich at 1 site in Switzerland.
Trial summary
Background: Tobacco smoking and vaping remains public health concern, with many adults continuing to experience difficulties accessing appropriate support for smoking cessation in Switzerland and Türkiye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder, Nicotine Dependence, Vaping
- What is being tested?
- TUBSIS 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Nov 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years or older
- Smoking status:
- Smoked on ≥1 day in the past 30 days, and/or Smoked at least 100 cigarettes in lifetime
- Internet access: Stable internet connection and access to a smartphone, tablet, or computer during interaction of the TUBSIS 2.0 web-based platform.
- Language: Sufficient reading and listening comprehension in the study language (German, English or Turkish)
- Contact: Valid email address and phone number (optional) for study communication, reminders and incentive payments
- Consent: Provided electronic informed consent on TUBSIS 2.0 web-based platform which is developed and administrated by ISGF.
- Study procedures: Agreement to randomization (intervention or control) and completion of study assessments at four time points (baseline, mid-intervention, post-intervention and 8-week follow-up)
Who cannot join
- Individuals who do not meet the inclusion criteria are excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
The Swiss Research Institute for Public Health and Addiction - ISGF (Schweizer Institut für Sucht- und Gesundheitsforschung)
Zurich, 8005
Michael Schaub, Prof. Dr. phil., Sci. Director, +41 44 448 11 60, michael.schaub@isgf.uzh.ch
Inci Derya Yücel, Dr. phil., +41 44 448 11 60, inci.derya.yucel@isgf.uzh.ch
About this study
Official title: Effectiveness of an Internet-based, Self-help, Asynchronized Behavioral Therapy With Mindfulness Approach for Adults With Tobacco Smoking or Vaping to Support Adults in Reducing Tobacco Smoking and Vaping in Switzerland and Türkiye
Background:
Tobacco smoking and vaping remains public health concern, with many adults continuing to experience difficulties accessing appropriate support for smoking cessation in Switzerland and Türkiye. Structural barriers, including stigma related to attempting to quit, limited financial and time resources, low awareness of the health risks associated with tobacco smoking- and vaping-reduce engagement with traditional services. TUBSIS 2.0 aims to address these access inequities by providing a fully remote, anonymous and free internet-based program tailored to diverse adult populations in both countries.
Read more
Objectives:
The "TUBSIS 2.0: An Adaptation Study of Tobacco Addiction Support Programme - TUBSIS for Tobacco Users in Switzerland and Türkiye" project aims to support readiness to reduce or quit tobacco smoking/vaping, improve well-being and self-compassion and strengthen health-related behaviors. The intervention targets German-, English-, and Turkish-speaking adults and includes mindfulness-based strategies for quitting or reducing tobacco smoking and vaping. Motivation to cease tobacco smoking/vaping varies considerably across the lifespan. Younger individuals may perceive smoking/vaping cessation as unnecessary, often due to limited awareness of long-term health risks or a sense of invulnerability. In later adulthood, although addiction tends to be more deeply established, many individuals hesitate to attempt cessation because of concerns about the psychological and behavioral challenges associated with the process. It is therefore essential to provide individuals with support that helps them understand the cessation process, prepare for the challenges that can be expected and identify strategies that align with their psychological needs. Such strategies may include stress management and self-compassion practices that can be utilized before, during and after cessation attempts. TUBSIS 2.0 offers structured and accessible guidance to support this preparation by providing a clear, evidence-based pathway for individuals at different stages of readiness to change.
Methods:
TUBSIS 2.0 is a web-based, individual and asynchronous program consisting of eight modules delivered over four weeks. A total of 406 participants will be recruited and randomly assigned to either the intervention or control group. Data are collected anonymously at four measurement points (baseline, mid-term, post-term and 8-week follow-up) from participants. The program focuses on supporting participants' reducing or quitting tobacco smoking or vaping; to increase their readiness for smoking/vaping cessation, mental well-being, self-compassion and stress management with mindfulness strategies.
Within the Health Action Process Approach (HAPA), the process of behaviour change is conceptualised as a dynamic, non-linear process that progresses through motivational and volitional phases. TUBSIS 2.0 has been adapted to reflect this structure by integrating phase-specific components. These components include modules that enhance risk awareness and outcome expectancies, planning and self-regulation tools to support action initiation and mindfulness-based strategies that are embedded throughout all phases to strengthen self-efficacy and coping. By addressing these shifting needs across the change process, the programme provides a responsive and theory-driven pathway for reducing/quitting tobacco smoking or vaping.
Relevance:
TUBSIS 2.0 is highly relevant to public health priorities, as it provides a cost-effective, scalable and environmentally sustainable intervention that eliminates barriers commonly associated with traditional cessation services. By requiring no travel, printed materials or in-person appointments, the programme offers equitable access to adults across all age groups, genders and diverse migrant communities in Switzerland and Türkiye. Its multilingual and culturally adapted structure addresses significant service gaps for populations that are underserved or hesitant to seek conventional support. By reducing tobacco smoking- or vaping-related harm and facilitating early behavioural change, TUBSIS 2.0 has the potential to decrease long-term healthcare costs while expanding access to evidence-based digital prevention tools.
Read the detailed description
TUBSIS 2.0 is a culturally adapted, digital psychoeducation and behavior change intervention that integrates principles from the Health Action Process Approach (HAPA), mindfulness, and self-compassion. The program aims to support participants in increasing mental well-being, enhancing self-regulation, and facilitating progression through stages of behavior change related to tobacco use.
The intervention consists of eight structured modules delivered over a four-week period. Each module includes brief psychoeducational content, guided exercises, and reflective components targeting awareness of smoking behavior, coping with cravings, stress management, and goal setting. Participants are encouraged to engage with the modules flexibly and at their own pace.
Participants are randomly assigned to either an intervention group or a control group. The intervention group receives immediate access to the TUBSIS 2.0 program, while the control group is placed on a waitlist and receives access after a defined follow-up period.
Data are collected at multiple time points, including baseline, mid-intervention, post-intervention, and follow-up assessments. Primary outcomes include changes in stage of behavior change, tobacco consumption patterns, and point prevalence abstinence. Secondary outcomes include mental well-being and nicotine dependence.
The study is conducted fully online, and participation is voluntary and anonymous. The design aims to minimize participant burden by using short modules and brief assessments while maintaining methodological rigor.
- Conditions
- Tobacco Use Disorder, Nicotine Dependence, Vaping, Smoking Tobacco
- Being tested
- TUBSIS 2.0
- Keywords
- smoking tobacco, vaping, web-based intervention, mindfulness, Health Action Process Approach
- Medical subject headings
- Tobacco Use Disorder, Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUBSIS 2.0Behavioural
A web-based, asynchronous behavioral intervention program integrating psychoeducation, mindfulness, and behavior change techniques to support tobacco and e-cigarette use reduction. The program consists of structured modules delivered over a four-week period and includes exercises targeting self-regulation, craving management, and motivation for behavior change.
| Study group | Role | What they receive |
|---|---|---|
| TUBSIS 2.0 Intervention | Experimental | Participants receive immediate access to the TUBSIS 2.0 web-based behavioral intervention program designed to support "smoking tobacco use or vaping reduction" through psychoeducation, mindfulness and behavior change techniques. Receives: Behavioral: TUBSIS 2.0 |
| Waitlist Control | No intervention | Participants are assigned to a waitlist control group and receive access to the intervention after a defined follow-up period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence
Self-reported abstinence from smoking/vaping (not having smoked/vaped even one puff in the past 7 days).
Measured: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Cigarette/vapor consumption
Change in cigarette/vapor consumption measured as number of cigarettes smoked or vaping per day for daily smokers and frequency and quantity of smoking for occasional smokers.
Measured: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Secondary outcomes (4)
Stage of behavior change
Change in stage of behavior change according to the Health Action Process Approach (pre-intender, intender, actor).
Measured: 4 weeks (post-intervention) + 4 weeks
Mental well-being
Change in mental well-being measured using the Warwick-Edinburgh Mental Well-Being Scale - Short Form.
Scores range from 7 to 35, with higher scores indicating better mental well-being.
Measured: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Nicotine dependence (Fagerström Test for Nicotine Dependence)
Change in nicotine dependence measured using the Fagerström Test for Nicotine Dependence.
Scores range from 0 to 10, with higher scores indicating higher nicotine dependence.
Measured: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Nicotine dependence (Electronic Fagerström Test for Nicotine Dependence)
Change in nicotine dependence measured using the Electronic Fagerström Test for Nicotine Dependence.
Scores range from 0 to 10, with higher scores indicating higher nicotine dependence.
Measured: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start15 Nov 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into an intervention group receiving immediate access to the TUBSIS 2.0 program and a waitlist control group receiving access after a follow-up period.
- Masking
- None (open label)
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- State Secretariat for Education Research and Innovation, Switzerland
- Responsible party
- Principal investigator, Michael Schaub, University of Zurich
- Investigators
- Michael Schaub, Prof. Dr. phil., Principal investigator, Swiss Research Institute for Public Health and Addiction - ISGF, University of ZurichInci Derya Yücel, Dr. phil., Study director, Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568483
- Sponsor's protocol ID
- UZH-Psych-EC-2026-25.10.20
- Acronym
- TUBSIS_2_0
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to data protection regulations and the sensitive nature of the collected data.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Internet-based, Self-help, Asynchronized Behavioral Therapy With Mindfulness Approach for Adults With Tobacco Smoking or Vaping to Support Adults in Reducing Tobacco Smoking and Vaping in Switzerland and Türkiye
- ClinicalTrials.gov ID
- NCT07568483
- Acronym / sponsor ID
- TUBSIS_2_0 / UZH-Psych-EC-2026-25.10.20
- Conditions
- Tobacco Use Disorder, Nicotine Dependence, Vaping, Smoking Tobacco
- Keywords
- smoking tobacco, vaping, web-based intervention, mindfulness, Health Action Process Approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- State Secretariat for Education Research and Innovation, Switzerland
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 5 May 2026 (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.
Background:
Tobacco smoking and vaping remains public health concern, with many adults continuing to experience difficulties accessing appropriate support for smoking cessation in Switzerland and Türkiye. Structural barriers, including stigma related to attempting to quit, limited financial and time resources, low awareness of the health risks associated with tobacco smoking- and vaping-reduce engagement with traditional services. TUBSIS 2.0 aims to address these access inequities by providing a fully remote, anonymous and free internet-based program tailored to diverse adult populations in both countries.
Objectives:
The "TUBSIS 2.0: An Adaptation Study of Tobacco Addiction Support Programme - TUBSIS for Tobacco Users in Switzerland and Türkiye" project aims to support readiness to reduce or quit tobacco smoking/vaping, improve well-being and self-compassion and strengthen health-related behaviors. The intervention targets German-, English-, and Turkish-speaking adults and includes mindfulness-based strategies for quitting or reducing tobacco smoking and vaping. Motivation to cease tobacco smoking/vaping varies considerably across the lifespan. Younger individuals may perceive smoking/vaping cessation as unnecessary, often due to limited awareness of long-term health risks or a sense of invulnerability. In later adulthood, although addiction tends to be more deeply established, many individuals hesitate to attempt cessation because of concerns about the psychological and behavioral challenges associated with the process. It is therefore essential to provide individuals with support that helps them understand the cessation process, prepare for the challenges that can be expected and identify strategies that align with their psychological needs. Such strategies may include stress management and self-compassion practices that can be utilized before, during and after cessation attempts. TUBSIS 2.0 offers structured and accessible guidance to support this preparation by providing a clear, evidence-based pathway for individuals at different stages of readiness to change.
Methods:
TUBSIS 2.0 is a web-based, individual and asynchronous program consisting of eight modules delivered over four weeks. A total of 406 participants will be recruited and randomly assigned to either the intervention or control group. Data are collected anonymously at four measurement points (baseline, mid-term, post-term and 8-week follow-up) from participants. The program focuses on supporting participants' reducing or quitting tobacco smoking or vaping; to increase their readiness for smoking/vaping cessation, mental well-being, self-compassion and stress management with mindfulness strategies.
Within the Health Action Process Approach (HAPA), the process of behaviour change is conceptualised as a dynamic, non-linear process that progresses through motivational and volitional phases. TUBSIS 2.0 has been adapted to reflect this structure by integrating phase-specific components. These components include modules that enhance risk awareness and outcome expectancies, planning and self-regulation tools to support action initiation and mindfulness-based strategies that are embedded throughout all phases to strengthen self-efficacy and coping. By addressing these shifting needs across the change process, the programme provides a responsive and theory-driven pathway for reducing/quitting tobacco smoking or vaping.
Relevance:
TUBSIS 2.0 is highly relevant to public health priorities, as it provides a cost-effective, scalable and environmentally sustainable intervention that eliminates barriers commonly associated with traditional cessation services. By requiring no travel, printed materials or in-person appointments, the programme offers equitable access to adults across all age groups, genders and diverse migrant communities in Switzerland and Türkiye. Its multilingual and culturally adapted structure addresses significant service gaps for populations that are underserved or hesitant to seek conventional support. By reducing tobacco smoking- or vaping-related harm and facilitating early behavioural change, TUBSIS 2.0 has the potential to decrease long-term healthcare costs while expanding access to evidence-based digital prevention tools.
Detailed description
TUBSIS 2.0 is a culturally adapted, digital psychoeducation and behavior change intervention that integrates principles from the Health Action Process Approach (HAPA), mindfulness, and self-compassion. The program aims to support participants in increasing mental well-being, enhancing self-regulation, and facilitating progression through stages of behavior change related to tobacco use.
The intervention consists of eight structured modules delivered over a four-week period. Each module includes brief psychoeducational content, guided exercises, and reflective components targeting awareness of smoking behavior, coping with cravings, stress management, and goal setting. Participants are encouraged to engage with the modules flexibly and at their own pace.
Participants are randomly assigned to either an intervention group or a control group. The intervention group receives immediate access to the TUBSIS 2.0 program, while the control group is placed on a waitlist and receives access after a defined follow-up period.
Data are collected at multiple time points, including baseline, mid-intervention, post-intervention, and follow-up assessments. Primary outcomes include changes in stage of behavior change, tobacco consumption patterns, and point prevalence abstinence. Secondary outcomes include mental well-being and nicotine dependence.
The study is conducted fully online, and participation is voluntary and anonymous. The design aims to minimize participant burden by using short modules and brief assessments while maintaining methodological rigor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized into an intervention group receiving immediate access to the TUBSIS 2.0 program and a waitlist control group receiving access after a follow-up period.
| Arm | Type | Receives |
|---|---|---|
| TUBSIS 2.0 Intervention | Experimental | Behavioral: TUBSIS 2.0Participants receive immediate access to the TUBSIS 2.0 web-based behavioral intervention program designed to support "smoking tobacco use or vaping reduction" through psychoeducation, mindfulness and behavior change techniques. |
| Waitlist Control | No intervention | –Participants are assigned to a waitlist control group and receive access to the intervention after a defined follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18 years or older
- Smoking status:
- Smoked on ≥1 day in the past 30 days, and/or Smoked at least 100 cigarettes in lifetime
- Internet access: Stable internet connection and access to a smartphone, tablet, or computer during interaction of the TUBSIS 2.0 web-based platform.
- Language: Sufficient reading and listening comprehension in the study language (German, English or Turkish)
Key exclusion criteria (1 listed)
- Individuals who do not meet the inclusion criteria are excluded.
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 |
|---|---|---|
| TUBSIS 2.0A web-based, asynchronous behavioral intervention program integrating psychoeducation, mindfulness, and behavior change techniques to support tobacco and e-cigarette use reduction. The program consists of structured modules delivered over a four-week period and includes exercises targeting self-regulation, craving management, and motivation for behavior change. | Behavioural | TUBSIS 2.0 Intervention |
Primary outcome
7-day point prevalence abstinence
Time frame: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Self-reported abstinence from smoking/vaping (not having smoked/vaped even one puff in the past 7 days).
Cigarette/vapor consumption
Time frame: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Change in cigarette/vapor consumption measured as number of cigarettes smoked or vaping per day for daily smokers and frequency and quantity of smoking for occasional smokers.
4 secondary outcomes
Stage of behavior change
Time frame: 4 weeks (post-intervention) + 4 weeks
Mental well-being
Time frame: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Nicotine dependence (Fagerström Test for Nicotine Dependence)
Time frame: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Nicotine dependence (Electronic Fagerström Test for Nicotine Dependence)
Time frame: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Official website of the TUBSIS 2.0 web-based intervention program.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to data protection regulations and the sensitive nature of the collected data.
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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.
Michael Schaub, Prof. Dr. phil. principal investigator
Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich
Inci Derya Yücel, Dr. phil. study director
Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TUBSIS 2.0 in people with Tobacco Use Disorder and Nicotine Dependence, run by University of Zurich at 1 site in Switzerland.
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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Schaub, Prof. Dr. phil. (+41444481160, michael.schaub@isgf.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence abstinence (time frame: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.