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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2023-05-10 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Frequently Asked Questions
Who can join the NCT06629467 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tobacco Use Cessation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06629467 currently recruiting?
Yes, NCT06629467 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Oviedo to inquire about joining.
Where is the NCT06629467 trial being conducted?
This trial is being conducted at Oviedo, Spain.
Who is sponsoring the NCT06629467 clinical trial?
NCT06629467 is sponsored by University of Oviedo. The trial plans to enroll 128 participants.