Cognitive Behavioral Treatment with Activity Trackers for Smoking Cessation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oviedo
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being aged 18 or over.
Smoking at least 10 cigarettes per day.
Disqualifiers
Being currently receiving other psychological or pharmacological treatment for smoking cessation.
Being diagnosed with substance use disorder or severe psychiatric disorder.
Active suicidal ideation.
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive-behavioral therapy for smoking cessation
BehavioralTreatment 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.
Personalized PA plan
BehavioralThe 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.
Fitbit Versa 3
DeviceWearable 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.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: 1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®.Experimental treatment 3 interventions
Group B: 2) CBT for smoking cessation + personalized PA planActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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)2
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.3
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.4
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.Secondary outcomes
1
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.2
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.3
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
Enrollment4
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.Sponsors and contacts
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Source ClinicalTrials.gov