Use of a Smartphone Application (App) to Assist a Cognitive-Behavioral Smoking Cessation Treatment
NCT ID: NCT04765813
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
287 participants
INTERVENTIONAL
2021-09-15
2023-11-10
Brief Summary
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\* Due to the COVID-19 the face-to-face treatment will be conducted in an online format.
Detailed Description
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mHealth Apps are becoming highly relevant due to their cost-effectiveness and the added attractiveness for many users. Considering this context, the main aim of the present project is to design and assess the efficacy of a cognitive-behavioral treatment (CBT) for smoking cessation enriched with a Smartphone App.
A randomized clinical trial will be carried out with a sample of 270 treatment-seeking smokers at the Smoking Cessation and Addictive Disorders Unit of the University of Santiago de Compostela. Participants will be randomly assigned to one of the following groups:
1. The experimental group (CBT + App), in which participants will receive a cognitive-behavioral treatment\* to quit smoking along with an App with active therapeutic components during the treatment and 12 months follow-ups period (n = 135)
2. The control group (CBT), in which participants will receive the same cognitive-behavioral treatment\* along with the use of a Control App (without active components) during the treatment (n = 135).
The main hypothesis is that the combination of a cognitive-behavioral psychological treatment to quit smoking and an App with active therapeutic components will obtain higher abstinence rates at the end of treatment and the 12-month follow-up period, compared to the control group
\* Due to the COVID-19, the face-to-face cognitive-behavioral treatment will be conducted in an online format
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CBT and active smartphone mobile application
Participants receive a cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components
Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components
Cognitive-behavioral smoking cessation treatment components will be: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem-solving training, change tobacco-related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs).
Participants will use a smartphone App with therapeutic components during the intervention (8 weeks) and follow-up period (time frame: one year).
CBT and control smartphone mobile application
Participants receive a cognitive-behavioral treatment to quit smoking along with a control App
Cognitive-behavioral treatment to quit smoking along with a control App
Cognitive-behavioral smoking cessation treatment components will be: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem-solving training, change tobacco-related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs).
Participants will use a control smartphone App (only to access session materials) during the intervention period (8 weeks).
Interventions
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Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components
Cognitive-behavioral smoking cessation treatment components will be: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem-solving training, change tobacco-related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs).
Participants will use a smartphone App with therapeutic components during the intervention (8 weeks) and follow-up period (time frame: one year).
Cognitive-behavioral treatment to quit smoking along with a control App
Cognitive-behavioral smoking cessation treatment components will be: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem-solving training, change tobacco-related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs).
Participants will use a control smartphone App (only to access session materials) during the intervention period (8 weeks).
Eligibility Criteria
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Inclusion Criteria
* Desire to participate voluntarily in the treatment offered to quit smoking
* Correctly fill out all the pretreatment assessment questionnaires
* Be able to provide written informed consent
* Currently own a valid email and a smartphone Android or iOS and willing to use it during treatment
Exclusion Criteria
* To have a substance use disorder (alcohol, cannabis, cocaine, heroin), different from a tobacco use disorder
* To smoke rolling snuff, cigars, little cigars, or other tobacco products
* To have participated in an effective psychological treatment to quit smoking during the previous 12 months
* To have received other effective pharmacological treatment to quit smoking in the previous 12 months (nicotine gum or patches, bupropion, varenicline)
* To have a physical pathology involving life-threatening risks for the person who would require immediate intervention in individual format (e.g., recent myocardial infarction, pneumothorax)
* To have a visual impairment that impedes the use of the App
18 Years
ALL
No
Sponsors
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Ministerio de Ciencia e Innovación, Spain
OTHER_GOV
University of Santiago de Compostela
OTHER
Responsible Party
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Elisardo Becoña Iglesias
Professor of Clinical Psychology at the Faculty of Psychology
Principal Investigators
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Elisardo Becoña, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Santiago de Compostela
Locations
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Smoking Cessation and Addictive Disorders Unit, Faculty of Psychology, University of Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Countries
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References
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Lopez-Duran A, Becona E, Senra C, Suarez-Castro D, Barroso-Hurtado M, Martinez-Vispo C. 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.
Lopez-Duran A, Martinez-Vispo C, Barroso-Hurtado M, Suarez-Castro D, Becona E. Incorporating technology in smoking cessation interventions: In-person vs. Video-call formats. Int J Med Inform. 2025 Mar;195:105774. doi: 10.1016/j.ijmedinf.2024.105774. Epub 2024 Dec 24.
Other Identifiers
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PID2019-109400RB-I00
Identifier Type: -
Identifier Source: org_study_id