NCT06629467 Cognitive Behavioral Treatment with Activity Trackers for Smoking Cessation
| NCT ID | NCT06629467 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oviedo |
| Condition | Tobacco Use Cessation |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2023-05-10 |
| Primary Completion | 2025-12-01 |
Trial Parameters
Eligibility Fast-Check
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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).
Eligibility Criteria
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.