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

2026年4月30日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

406

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

      • Zurich、スイス、8005
        • 募集
        • The Swiss Research Institute for Public Health and Addiction - ISGF (Schweizer Institut für Sucht- und Gesundheitsforschung)
        • コンタクト:
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
介入なし:Waitlist Control
Participants are assigned to a waitlist control group and receive access to the intervention after a defined follow-up period.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
7-day point prevalence abstinence
時間枠: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
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Stage of behavior change
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Michael Schaub, Prof. Dr. phil.、Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich
  • スタディディレクター:Inci Derya Yücel, Dr. phil.、Swiss Research Institute for Public Health and Addiction - ISGF, University of Zurich

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年11月15日

一次修了 (推定)

2026年6月30日

研究の完了 (推定)

2026年8月31日

試験登録日

最初に提出

2026年4月22日

QC基準を満たした最初の提出物

2026年4月30日

最初の投稿 (実際)

2026年5月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月5日

QC基準を満たした最後の更新が送信されました

2026年4月30日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

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米国FDA規制医薬品の研究

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米国FDA規制機器製品の研究

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