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Completed

NCT Number: NCT06629467

Cognitive Behavioral Treatment With Activity Trackers 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. 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

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Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior Motor Activity Physical Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Unit of Addictive Behaviors

Oviedo, Principality of Asturias, 33003, Spain

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being aged 18 or over.
  • Smoking at least 10 cigarettes per day.

Exclusion criteria

  • Being currently receiving other psychological or pharmacological treatment for smoking cessation.
  • Being diagnosed with substance use disorder or severe psychiatric disorder.
  • Active suicidal ideation.

Treatment and study plan

Cognitive-behavioral therapy for smoking cessation

Behavioral

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.

Personalized PA plan

Behavioral

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.

Fitbit Versa 3

Device

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.

Primary outcomes

  1. Acceptability of the activity tracker

    Time frame: End-of-treatment (6-weeks)

    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.

  2. Tobacco use

    Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

    This variable is operationalized as changes in cigarettes/day, carbon monoxide (CO) changes, and self-reported and verified abstinence (i.e., ≤4 ppm).

  3. Feasibility of treatment and activity tracker use

    Time frame: End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

    Feasibility is operationalized as treatment completion, attendance to sessions and adherence to Fitbit Versa 3 use.

  4. Physical activity

    Time frame: In-treatment, from enrollment to end-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

    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®.

  5. Activity tracker perceived utility

    Time frame: End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

    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.

Secondary outcomes

  1. Anxiety symptoms

    Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

    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.

  2. Depression symptoms

    Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

    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.

  3. Hypothetical demand for cigarettes

    Time frame: Enrollment

    CPT (Cigarette purchase task) (Items: Maximum number of cigarettes smoked per day, maximum expenditure in cigarettes per day and maximum expenditure per pack)

  4. Emotional dysregulation of negative valence emotions

    Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

    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.

  5. Emotional dysregulation of positive valence emotions

    Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

    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.

  6. Delay Discounting

    Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

    Single and cross-commodity computerized Delay Discounting task of money and tobacco (delay of one day, one week, one month and six month time)

  7. Suicide ideation

    Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

    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.

  8. Life Quality

    Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

    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).

  9. Sleep quality

    Time frame: In treatment (6 weeks), from Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

    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.

Sponsors and collaborators

Lead sponsor

University of Oviedo

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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