NCT07568483 TUBSIS 2.0 - Tobacco Use Behavioral Support and Intervention System
| NCT ID | NCT07568483 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Tobacco Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 406 participants |
| Start Date | 2025-11-15 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 406 participants in total. It began in 2025-11-15 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Individuals who do not meet the inclusion criteria are excluded.
Contact & Investigator
Michael Schaub, Prof. Dr. phil.
PRINCIPAL INVESTIGATOR
Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich
Frequently Asked Questions
Who can join the NCT07568483 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tobacco Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07568483 currently recruiting?
Yes, NCT07568483 is actively recruiting participants. Contact the research team at michael.schaub@isgf.uzh.ch for enrollment information.
Where is the NCT07568483 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT07568483 clinical trial?
NCT07568483 is sponsored by University of Zurich. The principal investigator is Michael Schaub, Prof. Dr. phil. at Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich. The trial plans to enroll 406 participants.