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

Ana López-Durán; Elisardo Becoña; Carmen Senra; Daniel Suárez-Castro; María Barroso-Hurtado; Carmela Martínez-Vispo

doi:10.3390/ijerph19159770

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

Int J Environ Res Public Health. 2022 Aug 8;19(15):9770. doi: 10.3390/ijerph19159770.

Authors

Ana López-Durán^{1

2}, Elisardo Becoña^{1

2}, Carmen Senra², Daniel Suárez-Castro^{1

2}, María Barroso-Hurtado^{1

2}, Carmela Martínez-Vispo^{1

2}

Affiliations

¹ Smoking and Addictive Disorders Unit, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.
² 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.

Keywords: randomized controlled trial; relapse prevention; smartphone app; smoking cessation.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Humans
Mobile Applications*
Randomized Controlled Trials as Topic
Recurrence
Single-Blind Method
Smokers / psychology
Smoking Cessation* / methods

Associated data

ClinicalTrials.gov/NCT04765813

Grants and funding

This research was supported by the Spanish Ministerio de Ciencia e Innovación (Project PID2019-109400RB-100) and co-financed by FEDER (European Regional Development Fund). The Spanish Ministerio de Ciencia e Innovación had no role in the study design, collection, analysis or interpretation of the data, writing the manuscript, or the decision to submit the paper for publication.