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 with smoking cessation. Physical activity trackers (PATs) have been demonstrated to increase PA levels among various populations, as a sole intervention or in combination with behavioral interventions targeting PA. This study aims to examine the feasibility and effect of a cognitive-behavioral therapy (CBT) + Physical Activity Tracker use (Fitbit Versa 3®) for smoking cessation. In this study, an estimated sample of 120 adult smokers of at least 10 cigarettes per day will be randomly allocated to one of the following conditions: 1) CBT for smoking cessation + PAT; 2) CBT for smoking cessation. Mail goals: 1) To examine the feasibility (i.e., adherence, perceived utility, satisfaction) of integrating Fitbit Versa 3® into a CBT for smoking cessation; 2) to examine the effectiveness of CBT for smoking cessation + PAT and CBT for smoking cessation in terms of smoking abstinence rates (point-prevalence and days of continuous abstinence), PA (i.e., steps per day, moderate to vigorous physical activity), physiological outcomes (i.e. sleep quality, quality of life) and mental health outcomes (anxiety and depression symptoms, difficulties in emotional regulation); 3) to examine the association between PA levels and study outcomes
PATs provide information on several objective data related to PA and sleep habits, amongst others. Incipient research has piloted its use for vulnerable populations (e.g., mental health disorders, cancer patients), obtaining satisfactory effects on both feasibility and effectiveness outcomes. In the field of substance use, some studies looked at the effects of PATs on PA but did not evaluate them in a randomized clinical trial. Moreover, increases in PA and improvements in emotional variables may be associated with smoking abstinence, and, arguably, using PAT devices may have an indirect impact on smoking abstinence via these variables. A 6-week protocol will be employed, including group-based cognitive behavioral therapy for smoking cessation treatment and PAT use. Participants will be recruited from the community and will be randomly allocated to the following conditions: 1) CBT for smoking cessation + PATs; 2) CBT for smoking cessation A priori power analysis was conducted using Monte Carlo methods to estimate the statistical power of the generalized estimating equations (GEE) models used to analyze seven-day point-prevalence abstinence rates. Assessment point and treatment condition were included as fixed factors, and age was included as a covariate. Additional subject-level variability was incorporated to approximate within-subject correlation across repeated measurements. Under assumptions of a large effect size for time (approximately OR = 2.0), statistical power reached approximately 0.68 for a sample size of 120 participants, indicating moderate sensitivity to detect longitudinal changes in abstinence outcomes. In the case of PA (i.e., steps per day), a Monte Carlo simulation was conducted for a mixed linear model (MLM) including time and group as fixed effects. Age and baseline PA levels were included as covariates. Power exceeded 0.90 even at sample sizes of approximately 30 participants, so the design is fully powered. R 4.5.3 was used for the power analysis. Analyses will be conducted using the Statistical Package for the Social Sciences (SPSS), R, JASP, and JAMOVI. A set of univariate (i.e., descriptive statistics and frequencies) and multivariate analyses (i.e., t-tests, GEE, and MLM)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
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.
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.
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.
Clinical Unit of Addictive Behaviors
Oviedo, Principality of Asturias, Spain
Acceptability of the activity tracker
Acceptability of the activity tracker is measured using the Participant Experience Questionnaire (PEQ) at the end of treatment. This scale ranges from 10 to 50. A higher score means higher acceptability.
Time frame: End-of-treatment (6-weeks)
Tobacco use
This variable is operationalized as changes in cigarettes/day, carbon monoxide (CO) changes, and self-reported and verified abstinence (i.e., ≤4 ppm).
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Feasibility of treatment and activity tracker use
Feasibility is operationalized as treatment completion, attendance to sessions and adherence to Fitbit Versa 3 use.
Time frame: End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Physical activity
Physical activity (PA) is operationalized as steps per day, plants climbed per day, distance covered per day (kilometers), light physical activity (minutes per day), moderate physical activity (minutes per week), vigorous physical activity (minutes per week), and sedentary time (hours per day). These outcomes will be measured using an adapted version of the International Physical Activity Questionnaire (IPAQ) and Fitbit Versa 3®.
Time frame: In-treatment, from enrollment to end-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Activity tracker perceived utility
Perceived utility with the activity tracker is measured using dichotomous (yes/no) ad-hoc; questions about the utility of the activity tracker for smoking cessation, increasing physical activity, and improving sleep quality.
Time frame: End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Anxiety symptoms
Anxiety symptoms are measured using Generalized Anxiety Disorder-7 (GAD-7). This questionnaire ranges from 0 to 21. Higher punctuation means higher anxiety levels symptoms.
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Depression symptoms
Depression symptoms are measured using the Patient Health Questionnaire-9 (PHQ-9). This questionnaire ranges from 0 to 14. A higher punctuation means higher depression symptom levels.
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Hypothetical demand for cigarettes
CPT (Cigarette purchase task) (Items: Maximum number of cigarettes smoked per day, maximum expenditure in cigarettes per day and maximum expenditure per pack)
Time frame: Enrollment
Emotional dysregulation of negative valence emotions
Emotional dysregulation of negative emotions is measured with the Difficulties in emotion regulation scale-16 (DERS-16). This scale ranges from 16 to 80 points. A higher score means more difficulties in emotion regulation of negative valence emotions.
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Emotional dysregulation of positive valence emotions
Emotional dysregulation of positive emotions is measured with Difficulties in Emotion Regulation Scale-Positive (DERS-P). This scale ranges from 13 to 65. A higher score means more difficulties in emotion regulation of positive valence emotions.
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Delay Discounting
Single and cross-commodity computerized Delay Discounting task of money and tobacco (delay of one day, one week, one month and six month time)
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Suicide ideation
This variable is measured with the Paykel suicide ideation scale (PSS). This scale ranges from 0 to 5 points. Higher punctuation means more severe suicide ideation.
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Life Quality
This variable is measured with the European quality of life- 5 dimensions- 5 levels (EQ-5D-5L). This scale ranges from 5 to 25. A higher score means less life quality (more health-related problems).
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Sleep quality
This variable is measured using The Pittsburgh Sleep Quality Index (PSQI). This scale ranges from 0 to 21 points. A higher score means lower sleep quality. In addition, Fitbit Versa 3 provides a sleep quality punctuation ranging from 0 to 100. A higher punctuation means better sleep quality.
Time frame: In treatment (6 weeks), from Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
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