Smoking Clinical Trial - Use of a Smartphone Application (App) to Assist a

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Smoking

Clinical Trial Details

NCT number	NCT04765813
Study type	Interventional
Source	University of Santiago de Compostela
Contact
Status	Completed
Phase	N/A
Start date	September 15, 2021
Completion date	November 10, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms