Cognitive Behavioral Treatment With Activity Trackers for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Acceptability of the activity tracker
研究概览
简要总结
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 with smoking cessation. Physical activity trackers (PATs) have been demonstrated to increase PA levels among various populations, as a sole intervention or in combination with behavioral interventions targeting PA.
This study aims to examine the feasibility and effect of a cognitive-behavioral therapy (CBT) + Physical Activity Tracker use (Fitbit Versa 3®) for smoking cessation.
In this study, an estimated sample of 120 adult smokers of at least 10 cigarettes per day will be randomly allocated to one of the following conditions: 1) CBT for smoking cessation + PAT; 2) CBT for smoking cessation.
Mail goals: 1) To examine the feasibility (i.e., adherence, perceived utility, satisfaction) of integrating Fitbit Versa 3® into a CBT for smoking cessation; 2) to examine the effectiveness of CBT for smoking cessation + PAT and CBT for smoking cessation in terms of smoking abstinence rates (point-prevalence and days of continuous abstinence), PA (i.e., steps per day, moderate to vigorous physical activity), physiological outcomes (i.e. sleep quality, quality of life) and mental health outcomes (anxiety and depression symptoms, difficulties in emotional regulation); 3) to examine the association between PA levels and study outcomes
详细描述
PATs provide information on several objective data related to PA and sleep habits, amongst others. Incipient research has piloted its use for vulnerable populations (e.g., mental health disorders, cancer patients), obtaining satisfactory effects on both feasibility and effectiveness outcomes. In the field of substance use, some studies looked at the effects of PATs on PA but did not evaluate them in a randomized clinical trial. Moreover, increases in PA and improvements in emotional variables may be associated with smoking abstinence, and, arguably, using PAT devices may have an indirect impact on smoking abstinence via these variables.
A 6-week protocol will be employed, including group-based cognitive behavioral therapy for smoking cessation treatment and PAT use. Participants will be recruited from the community and will be randomly allocated to the following conditions: 1) CBT for smoking cessation + PATs; 2) CBT for smoking cessation
A priori power analysis was conducted using Monte Carlo methods to estimate the statistical power of the generalized estimating equations (GEE) models used to analyze seven-day point-prevalence abstinence rates. Assessment point and treatment condition were included as fixed factors, and age was included as a covariate. Additional subject-level variability was incorporated to approximate within-subject correlation across repeated measurements. Under assumptions of a large effect size for time (approximately OR = 2.0), statistical power reached approximately 0.68 for a sample size of 120 participants, indicating moderate sensitivity to detect longitudinal changes in abstinence outcomes. In the case of PA (i.e., steps per day), a Monte Carlo simulation was conducted for a mixed linear model (MLM) including time and group as fixed effects. Age and baseline PA levels were included as covariates. Power exceeded 0.90 even at sample sizes of approximately 30 participants, so the design is fully powered. R 4.5.3 was used for the power analysis.
Analyses will be conducted using the Statistical Package for the Social Sciences (SPSS), R, JASP, and JAMOVI. A set of univariate (i.e., descriptive statistics and frequencies) and multivariate analyses (i.e., t-tests, GEE, and MLM)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being aged 18 or over.
- •Smoking at least 10 cigarettes per day.
排除标准
- •Being currently receiving other psychological or pharmacological treatment for smoking cessation.
- •Being diagnosed with substance use disorder or severe psychiatric disorder.
- •Active suicidal ideation.
研究组 & 干预措施
1) CBT for smoking cessation + personalized PA plan + 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).
干预措施: Cognitive-behavioral therapy for smoking cessation (Behavioral)
1) CBT for smoking cessation + personalized PA plan + 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).
干预措施: Personalized PA plan (Behavioral)
1) CBT for smoking cessation + personalized PA plan + 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).
干预措施: Fitbit Versa 3 (Device)
2) CBT for smoking cessation + 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®.
干预措施: Cognitive-behavioral therapy for smoking cessation (Behavioral)
2) CBT for smoking cessation + 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®.
干预措施: Personalized PA plan (Behavioral)
结局指标
主要结局
Acceptability of the activity tracker
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Anxiety symptoms(From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.)
- Depression symptoms(From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.)
- Hypothetical demand for cigarettes(Enrollment)
- Emotional dysregulation of negative valence emotions(From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.)
- Emotional dysregulation of positive valence emotions(From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.)
- Delay Discounting(From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.)
- Suicide ideation(From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.)
- Life Quality(From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.)
- Sleep quality(In treatment (6 weeks), from Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.)
研究者
Alba González-Roz, PhD
Professor, PhD
University of Oviedo