TUBSIS 2.0 - Tobacco Use Behavioral Support and Intervention System

NCT07568483 | Recruiting

• 1 other identifier: UZH-Psych-EC-2026-25.10.20
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder; Nicotine Dependence; Vaping; Smoking Tobacco

Keywords

smoking tobacco; vaping; web-based intervention; mindfulness; Health Action Process Approach

Outcome Measures

Primary Outcomes (2)

• 7-day point prevalence abstinence

  Self-reported abstinence from smoking/vaping (not having smoked/vaped even one puff in the past 7 days).

  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.

  4 weeks (post-intervention) + 4 weeks (follow-up without intervention)

Secondary Outcomes (4)

• Stage of behavior change

  4 weeks (post-intervention) + 4 weeks

• Mental well-being

  4 weeks (post-intervention) + 4 weeks (follow-up without intervention)

• Nicotine dependence (Fagerström Test for Nicotine Dependence)

  4 weeks (post-intervention) + 4 weeks (follow-up without intervention)

• Nicotine dependence (Electronic Fagerström Test for Nicotine Dependence)

  4 weeks (post-intervention) + 4 weeks (follow-up without intervention)

Study Arms (2)

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.

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.

Interventions

TUBSIS 2.0 BEHAVIORAL

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.

TUBSIS 2.0 Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead
• State Secretariat for Education Research and Innovation, Switzerland: collaborator

Study Sites (1)

The Swiss Research Institute for Public Health and Addiction - ISGF (Schweizer Institut für Sucht- und Gesundheitsforschung)

Zurich, 8005, Switzerland

RECRUITING

Related Links

• Official website of the TUBSIS 2.0 web-based intervention program.

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping; Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Michael Schaub, Prof. Dr. phil.

  Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich

  PRINCIPAL INVESTIGATOR

• Inci Derya Yücel, Dr. phil.

  Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich

  STUDY DIRECTOR

Central Study Contacts

Michael Schaub, Prof. Dr. phil.

CONTACT

+41444481160; michael.schaub@isgf.uzh.ch

Inci Derya Yücel, Dr. phil.

CONTACT

+41444481160; inci.derya.yucel@isgf.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants are aware of their group assignment due to the nature of the behavioral intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. phil.

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 5, 2026
• Study Start: November 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)