Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

TUBSIS 2.0 - Tobacco Use Behavioral Support and Intervention System (TUBSIS_2_0)

torstai 30. huhtikuuta 2026 päivittänyt: Michael Schaub, University of Zurich

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.

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

406

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Tutki yhteystietojen varmuuskopiointi

Opiskelupaikat

      • Zurich, Sveitsi, 8005
        • Rekrytointi
        • The Swiss Research Institute for Public Health and Addiction - ISGF (Schweizer Institut für Sucht- und Gesundheitsforschung)
        • Ottaa yhteyttä:
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
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.
Ei väliintuloa: Waitlist Control
Participants are assigned to a waitlist control group and receive access to the intervention after a defined follow-up period.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
7-day point prevalence abstinence
Aikaikkuna: 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).
4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Cigarette/vapor consumption
Aikaikkuna: 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 weeks (post-intervention) + 4 weeks (follow-up without intervention)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Stage of behavior change
Aikaikkuna: 4 weeks (post-intervention) + 4 weeks
Change in stage of behavior change according to the Health Action Process Approach (pre-intender, intender, actor).
4 weeks (post-intervention) + 4 weeks
Mental well-being
Aikaikkuna: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)

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)
Nicotine dependence (Fagerström Test for Nicotine Dependence)
Aikaikkuna: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)

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)
Nicotine dependence (Electronic Fagerström Test for Nicotine Dependence)
Aikaikkuna: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)

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)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Tutkijat

  • Päätutkija: Michael Schaub, Prof. Dr. phil., Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich
  • Opintojohtaja: Inci Derya Yücel, Dr. phil., Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Lauantai 15. marraskuuta 2025

Ensisijainen valmistuminen (Arvioitu)

Tiistai 30. kesäkuuta 2026

Opintojen valmistuminen (Arvioitu)

Maanantai 31. elokuuta 2026

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 22. huhtikuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 30. huhtikuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Tiistai 5. toukokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 5. toukokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 30. huhtikuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. huhtikuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

Individual participant data will not be shared due to data protection regulations and the sensitive nature of the collected data.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa