Use of a Smartphone Application (App) to Assist a Cognitive-Behavioral Smoking Cessation Treatment

Study Overview
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Brief Summary
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This randomized controlled clinical trial examines the effectiveness of a face-to-face* cognitive-behavioral behavioral treatment to quit smoking enriched with an App. This project aims to innovate in the psychological smoking cessation treatment and increase abstinence rates in the short and long term. * Due to the COVID-19 the face-to-face treatment will be conducted in an online format.

Detailed Description
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Psychological treatment (cognitive-behavioral) is a first-line smoking cessation treatment that has proven its efficacy. However, it is necessary to continue investigating to improve smoking outcomes as abstinence and reduce relapse rates. The use of information technologies (ICTs) in the field of health has grown and developed significantly in recent years. Specifically, mobile applications (Apps), aimed at different health-related aspects (mHealth Apps), are a valuable resource. Its use, as a complement to the face-to-face treatment, could help to increase motivation to quit smoking, treatment adherence, and therapeutic activities compliance. 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: 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) 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

Official Title
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A Randomized Clinical Trial to Assess the Efficacy of a Psychological Treatment to Quit Smoking Assisted With an App

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components
* Behavioral: Cognitive-behavioral treatment to quit smoking along with a control App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older who smoke at least 8 cigarettes per day 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 diagnosis of a severe mental disorder (bipolar disorder and/or psychotic disorder) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT and active smartphone mobile application<br>Participants receive a cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components | Behavioral: Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components<br>* 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).<br>|
| Active Comparator: CBT and control smartphone mobile application<br>Participants receive a cognitive-behavioral treatment to quit smoking along with a control App | Behavioral: Cognitive-behavioral treatment to quit smoking along with a control App<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point-prevalence abstinence | Participants will be considered abstinent if they report abstinence, not even a puff of a cigarette, for ≥7 days at the end of treatment (week 8 since beginning treatment), and prior to follow-up day at 3-, 6-, and 12-months follow-up. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence | Self-reported 30-day point prevalence abstinence at 3-, 6-, and 12-month follow-up | 1 year | 
| Reduction of cigarette consumption (cigarettes per day) | Reduction of cigarette consumption between baseline and each follow-up will be calculated from the number of cigarettes smoked in the past 7 days at the end of treatment (week 8 since beginning treatment) and at 3-, 6-, and 12-months follow-up. | 1 year |