NCT06629467

Cognitive Behavioral Treatment with Activity Trackers for Smoking Cessation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: University of Oviedo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Given the high prevalence of deaths per year attributable to tobacco use, improving smoking cessation treatments is an important public health priority Worldwide. It is also known that practicing physical activity (PA) may help smoking cessation. Physical activity trackers have been demonstrated to increase PA levels in different studies with various populations, as a sole intervention or in combination with interventions targeting PA. This study aims to examine the feasibility, effect, and cost-effectiveness of cognitive-behavioral therapy (CBT) + Personalized physical activity (PA) + Physical Activity Tracker use (Fitbit Versa 3®) for smoking cessation. Given the high prevalence of deaths per year attributable to tobacco use, improving smoking cessation treatments is an important public health priority worldwide. In this study, an estimated sample of 128 adult smokers will be randomly allocated to one of the following conditions: 1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3®; 2) CBT for smoking cessation + personalized PA plan. Mail goals: 1) To examine the feasibility (i.e., adherence, perceived utility, satisfaction) of integrating Fitbit Versa 3® into a CBT protocol for smoking cessation; 2) to examine the effectiveness of CBT for smoking cessation + personalized PA plan + Fitbit Versa 3® and CBT for smoking cessation + personalized PA plan in terms of smoking abstinence rates (point-prevalence and days of continuous abstinence), PA (i.e., steps per day, moderate to vigorous physical activity) and mental health outcomes (anxiety and depression symptoms, emotional dysregulation); 3) to examine the cost-effectiveness of CBT for smoking cessation + personalized PA plan + Fitbit Versa 3® vs. CBT for smoking cessation + personalized PA plan in terms of smoking abstinence rates (point-prevalence and days of continuous abstinence), PA (i.e., steps per day, moderate to vigorous physical activity) and mental health outcomes (anxiety and depression symptoms, emotional dysregulation).

Detailed description

Fitbit® wearables devices inform on several objective data related to physical activity and sleep habits, amongst others. Incipient research has piloted its use for vulnerable populations such as emerging adults and clinical patients. In the field of substance use, some studies looked at the effects of activity trackers on physical activity but did not evaluate its effects on other clinically relevant variables, such as smoking abstinence. Increases in activity and improvements in mood are associated with smoking abstinence and, arguably, using Fitbit Versa 3® devices would produce any effect on cigarette smoking via these variables. A 6-week protocol will be employed including a cognitive behavioral therapy-based smoking cessation treatment. Participants will be recruited from the community and will be randomly allocated to the following conditions once an in-person assessment is completed: 1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3®; 2) CBT for smoking cessation + personalized PA plan. According to the power analysis, to detect an effect size of d = 0.5 (medium size effect) with a test power of 0.8 the total number of allocated participants will be 128. This sample size was estimated to be sufficient for the statistical pipeline. Analyses will be conducted using the Statistical Package for the Social Science (SPSS), R Studio, JASP, and JAMOVI. A set of univariate (i.e., descriptive statistics and frequencies) and multivariate analyses (i.e. t-test) will be carried out with regard to participants; characteristics and treatment outcomes. Generalized Estimating Equations (GEE) will be conducted to examine changes in smoking abstinence after controlling for relevant covariates (e.g., nicotine dependence, sex). DATCAP will be used to perform the cost-effectivity

Conditions

• Tobacco Use Cessation
• Physical Activity

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-behavioral therapy for smoking cessation	Treatment components will include psychoeducation on the consequences of tobacco use and the benefits of quitting; therapeutic commitment; self-monitoring of cigarette smoking; brief advice on healthy eating behaviors and sleep hygiene, physiological feedback (based on CO levels), training in self-control strategies, stimulus control, management of craving with alternative activities, diaphragmatic breathing, weekly personalized physical activity objectives, and relapse prevention strategies. The protocol consists of a nicotine fading procedure, which consists of a weekly reduction in nicotine intake of 30% (based on both tobacco brands and the number of cigarettes) from the first to the fifth session.
BEHAVIORAL	Personalized PA plan	The treatment provider will fix an objective (e.g. go for brisk walking for 30 minutes 3 times this week) for each participant every week according to his/her current PA level, time availability, likes, and fitness level.
DEVICE	Fitbit Versa 3	Wearable activity tracker with the functionalities of a watch function, including time, date, calendar, and weather (connection to the internet is required). Physical activity monitoring (steps per day, active minutes per day, plants climbed, heart rate monitoring, time, intensity, caloric expenditure, and exercise type of exercise session), sleep monitoring (sleep time, sleep phases time, sleep quality), stress levels managing and guided breathing application are the main health-related functionalities.

Timeline

• Start date: 2023-05-10
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-10-08
• Last updated: 2024-10-08

Locations

1 site across 1 country: Spain