Clinical trial NCT04765813: Use of a Smartphone Application (App) to Assist a Cognitive-Behavioral Smoking Cessation Treatment
Official title: A Randomized Clinical Trial to Assess the Efficacy of a Psychological Treatment to Quit Smoking Assisted With an App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
First posted: 2021-02-21
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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:

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

Eligibility criteria: 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

Primary outcomes:
measure: Point-prevalence abstinence
timeFrame: 1 year
Secondary outcomes:
measure: Continuous abstinence
timeFrame: 1 year
measure: Reduction of cigarette consumption (cigarettes per day)
timeFrame: 1 year
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Smoking Cessation and Addictive Disorders Unit, Faculty of Psychology, University of Santiago de Compostela
state: A Coruña
Study officials:
affiliation: University of Santiago de Compostela
name: Elisardo Becoña, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.