- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07568483
TUBSIS 2.0 - Tobacco Use Behavioral Support and Intervention System (TUBSIS_2_0)
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.
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michael Schaub, Prof. Dr. phil.
- Número de teléfono: +41444481160
- Correo electrónico: michael.schaub@isgf.uzh.ch
Copia de seguridad de contactos de estudio
- Nombre: Inci Derya Yücel, Dr. phil.
- Número de teléfono: +41444481160
- Correo electrónico: inci.derya.yucel@isgf.uzh.ch
Ubicaciones de estudio
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Zurich, Suiza, 8005
- Reclutamiento
- The Swiss Research Institute for Public Health and Addiction - ISGF (Schweizer Institut für Sucht- und Gesundheitsforschung)
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Contacto:
- Michael Schaub, Prof. Dr. phil., Sci. Director
- Número de teléfono: +41 44 448 11 60
- Correo electrónico: michael.schaub@isgf.uzh.ch
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Contacto:
- Inci Derya Yücel, Dr. phil.
- Número de teléfono: +41 44 448 11 60
- Correo electrónico: inci.derya.yucel@isgf.uzh.ch
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: TUBSIS 2.0 Intervention
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.
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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.
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Sin intervención: Waitlist Control
Participants are assigned to a waitlist control group and receive access to the intervention after a defined follow-up period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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7-day point prevalence abstinence
Periodo de tiempo: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
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Self-reported abstinence from smoking/vaping (not having smoked/vaped even one puff in the past 7 days).
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4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
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Cigarette/vapor consumption
Periodo de tiempo: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
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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.
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4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Stage of behavior change
Periodo de tiempo: 4 weeks (post-intervention) + 4 weeks
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Change in stage of behavior change according to the Health Action Process Approach (pre-intender, intender, actor).
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4 weeks (post-intervention) + 4 weeks
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Mental well-being
Periodo de tiempo: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
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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. |
4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
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Nicotine dependence (Fagerström Test for Nicotine Dependence)
Periodo de tiempo: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
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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. |
4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
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Nicotine dependence (Electronic Fagerström Test for Nicotine Dependence)
Periodo de tiempo: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
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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. |
4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael Schaub, Prof. Dr. phil., Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich
- Director de estudio: Inci Derya Yücel, Dr. phil., Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UZH-Psych-EC-2026-25.10.20
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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