Cognitive Behavioral Treatment with Activity Trackers for Smoking Cessation

Not Applicable

Recruiting

• Conditions: Tobacco Use Cessation; Physical Activity
• Interventions: Behavioral: Cognitive-behavioral therapy for smoking cessation; Behavioral: Personalized PA plan; Device: Fitbit Versa 3

• Registration Number: NCT06629467
• Lead Sponsor: University of Oviedo

Brief 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

Study Timeline

• Study Start: 2023-05-10
• Study First Submitted: 2024-07-29
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-07
• Last Update Posted: 2024-10-07
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®.	Cognitive-behavioral therapy for smoking cessation	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).
1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®.	Personalized PA plan	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).
1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®.	Fitbit Versa 3	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).
2) CBT for smoking cessation + personalized PA plan	Cognitive-behavioral therapy for smoking cessation	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®.
2) CBT for smoking cessation + personalized PA plan	Personalized PA plan	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®.

Primary Outcome Measures

Name	Time	Method
Acceptability of the activity tracker	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.
Tobacco use	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).
Feasibility of treatment and activity tracker use	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.
Physical activity	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®.
Activity tracker perceived utility	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 Outcome Measures

Name	Time	Method
Anxiety symptoms	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.
Depression symptoms	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.
Hypothetical demand for cigarettes	Enrollment	CPT (Cigarette purchase task) (Items: Maximum number of cigarettes smoked per day, maximum expenditure in cigarettes per day and maximum expenditure per pack)
Emotional dysregulation of negative valence emotions	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.
Emotional dysregulation of positive valence emotions	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.
Delay Discounting	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)
Suicide ideation	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.
Life Quality	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).
Sleep quality	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.

Trial Locations

Locations (1)

Clinical Unit of Addictive Behaviors; 🇪🇸 Oviedo, Asturias, Spain