Cognitive Behavioral Treatment with Activity Trackers for Smoking Cessation

University of Oviedo

Status: Enrolling

Conditions: Physical Activity; Tobacco Use Cessation

Treatments: Device: Fitbit Versa 3; Behavioral: Cognitive-behavioral therapy for smoking cessation; Behavioral: Personalized PA plan

Study type: Interventional

Funder types: Other

Identifiers

NCT06629467

SV-PA-21-AYUD/2021/50884.

Details and patient eligibility

About

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).

Full 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

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®.

Experimental group

Description:

The intervention will be delivered in groups (maximum 4 participants) for a total of 6 weeks. Sessions (1.5 hours) will take place once per week. Personalized PA objectives will be set during the treatment. Participants in this arm will wear the Fitbit Versa 3® during the treatment (6 weeks).

Treatment:

Behavioral: Personalized PA plan

Behavioral: Cognitive-behavioral therapy for smoking cessation

Device: Fitbit Versa 3

2) CBT for smoking cessation + personalized PA plan

Active Comparator group

Description:

This intervention include the same components as described above. The exception will be that participants will not be requested to wear the Fitbit Versa 3®.

Treatment:

Behavioral: Personalized PA plan

Behavioral: Cognitive-behavioral therapy for smoking cessation