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A Randomized Clinical Trial to Assess the Efficacy of a Psychological Treatment to Quit Smoking Assisted with an App: Study Protocol

Author

Listed:
  • Ana López-Durán

    (Smoking and Addictive Disorders Unit, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain
    Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain)

  • Elisardo Becoña

    (Smoking and Addictive Disorders Unit, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain
    Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain)

  • Carmen Senra

    (Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain)

  • Daniel Suárez-Castro

    (Smoking and Addictive Disorders Unit, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain
    Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain)

  • María Barroso-Hurtado

    (Smoking and Addictive Disorders Unit, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain
    Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain)

  • Carmela Martínez-Vispo

    (Smoking and Addictive Disorders Unit, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain
    Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain)

Abstract

Numerous studies have shown the efficacy of smoking cessation interventions. However, some challenges, such as relapse rates, remain. The availability of information technologies (ICTs) offers promising opportunities to address such challenges. The aim of this paper is to describe the protocol followed to assess the efficacy of a face-to-face cognitive–behavioral intervention for smoking cessation using a smartphone application as a complement, compared with a control group. A single blind, two-arm, randomized controlled trial is proposed (NCT04765813). The participants will be smokers over 18 years old, who smoke at least eight cigarettes per day. Participants will be randomized to one of two conditions, using a 1:1 allocation ratio: (1) cognitive–behavioral smoking cessation treatment along with an App with active therapeutic components ( SinHumo App); or (2) cognitive–behavioral treatment along with the use of a control App (without active components). The experimental App will be used during the eight treatment sessions and for 12 months after the end of treatment. The primary outcome measures will be 7-days point-prevalence abstinence at 12-months follow-up. We expect the experimental App to obtain higher abstinence rates at the end of treatment and at one-year post-treatment follow-ups and lower relapse rates, compared to the control App.

Suggested Citation

  • Ana López-Durán & Elisardo Becoña & Carmen Senra & Daniel Suárez-Castro & María Barroso-Hurtado & Carmela Martínez-Vispo, 2022. "A Randomized Clinical Trial to Assess the Efficacy of a Psychological Treatment to Quit Smoking Assisted with an App: Study Protocol," IJERPH, MDPI, vol. 19(15), pages 1-18, August.
    • Handle: RePEc:gam:jijerp:v:19:y:2022:i:15:p:9770-:d:883160
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    References listed on IDEAS

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    1. María Barroso-Hurtado & Daniel Suárez-Castro & Carmela Martínez-Vispo & Elisardo Becoña & Ana López-Durán, 2021. "Smoking Cessation Apps: A Systematic Review of Format, Outcomes, and Features," IJERPH, MDPI, vol. 18(21), pages 1-18, November.
    2. Carmela Martínez-Vispo & Rubén Rodríguez-Cano & Ana López-Durán & Carmen Senra & Elena Fernández del Río & Elisardo Becoña, 2019. "Cognitive-behavioral treatment with behavioral activation for smoking cessation: Randomized controlled trial," PLOS ONE, Public Library of Science, vol. 14(4), pages 1-20, April.
    3. Mikyung Lee & Hyeonkyeong Lee & Youlim Kim & Junghee Kim & Mikyeong Cho & Jaeun Jang & Hyoeun Jang, 2018. "Mobile App-Based Health Promotion Programs: A Systematic Review of the Literature," IJERPH, MDPI, vol. 15(12), pages 1-13, December.
    4. World Health Organization, 2021. "WHO report on the global tobacco epidemic 2021: addressing new and emerging products," University of California at San Francisco, Center for Tobacco Control Research and Education qt0014f8hx, Center for Tobacco Control Research and Education, UC San Francisco.
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