[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564460":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":27,"locations":37,"responsibleParty":61,"collaborators":27,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":27,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":27,"enrollmentInfo":73,"targetDuration":27,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":40,"whyStopped":27,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Oviedo","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®.","EXPERIMENTAL","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.\n\nParticipants in this arm will wear the Fitbit Versa 3® during the treatment (6 weeks).",[13,14,15],"Behavioral: Cognitive-behavioral therapy for smoking cessation","Behavioral: Personalized PA plan","Device: Fitbit Versa 3",{"label":17,"type":18,"description":19,"interventionNames":20},"2) CBT for smoking cessation + personalized PA plan","ACTIVE_COMPARATOR","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®.",[13,14],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","Cognitive-behavioral therapy for smoking cessation","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.",[9,17],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Personalized PA plan","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\u002Fher current PA level, time availability, likes, and fitness level.",[9,17],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"DEVICE","Fitbit Versa 3","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.",[9],[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Clinical Unit of Addictive Behaviors","RECRUITING","Oviedo","Principality of Asturias","33003","Spain","ES",{"type":47,"coordinates":48},"Point",[49,50],-5.84476,43.36029,{"lat":50,"lon":49},[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Roberto Secades","CONTACT","985104189","+34","grupoca@uniovi.es",{"name":60,"role":55,"phone":27,"phoneExt":27,"email":27},"Roberto Secades-Villa, PhD",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Alba González-Roz, PhD","Professor, PhD","100564460","cognitive-behavioral-treatment-with-activity-trackers-for-smoking-cessation-100564460",false,"NCT06629467","Cognitive Behavioral Treatment with Activity Trackers for Smoking Cessation","Inclusion Criteria:\n\n* Being aged 18 or over.\n* Smoking at least 10 cigarettes per day.\n\nExclusion Criteria:\n\n* Being currently receiving other psychological or pharmacological treatment for smoking cessation.\n* Being diagnosed with substance use disorder or severe psychiatric disorder.\n* Active suicidal ideation.","ALL","18 Years",{"count":74,"type":75},128,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.\n\nThis 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.\n\nIn 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.\n\nMail 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).",[81,82],"Tobacco Use Cessation","Physical Activity",[84,85,86,87],"Tobacco","Physical activity","Activity tracker","Cognitive-behavioral therapy","2024-10-04",{"date":90,"type":91},"2024-10-08","ACTUAL",{"date":93,"type":91},"2023-05-10",{"date":95,"type":75},"2025-12-01",{"name":5,"class":6},1]