Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629467
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Cognitive Behavioral Treatment with Activity Trackers for Smoking Cessation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cognitive Behavioral Treatment with Activity Trackers for Smoking Cessation
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 ie 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 ie steps per day moderate to vigorous physical activity and mental health outcomes anxiety and depression symptoms emotional dysregulation
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 ie 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 ie 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 ie 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 05 medium size effect with a test power of 08 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 ie descriptive statistics and frequencies and multivariate analyses ie 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 eg nicotine dependence sex DATCAP will be used to perform the cost-effectivity
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 05 medium size effect with a test power of 08 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 ie descriptive statistics and frequencies and multivariate analyses ie 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 eg nicotine dependence sex DATCAP will be used to perform the cost-effectivity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None