Cognitive and Emotional Skills to Aid Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Prolonged abstinence (PA)
研究概览
简要总结
Cigarette smoking is a leading cause of morbidity and mortality in the United States. Among individuals who engage in smoking cessation treatment, attrition rates remain high. Many smokers experience difficulties in regulating their emotions, which reduces their ability to benefit from standard interventions and leads to increased smoking behaviors. In addition, cognitive deficits (e.g., reduced working memory capacity) may prevent smokers from applying information from interventions, making smart choices about the benefits and risks of smoking, and resisting smoking advertisements.
This study will test whether adding a working memory training and motivational enhancement component to a standard, evidence-based cognitive behavioral therapy-based smoking cessation program (SCP) can improve treatment adherence and successful quit rates. This study will compare 5 sessions of SCP with an additional wellness-focused component (control intervention) to SCP incorporating motivational enhancement and working memory training ("enhanced" intervention). Participants will be adult smokers recruited from the greater Boston community who are interested in quitting smoking. This study will determine the efficacy, acceptability, and feasibility of the enhanced intervention.
详细描述
This study is targeting adult smokers in the greater Boston community who are interested in entering smoking cessation treatment. This study will employ a block randomization of 74 smoking participants to one of two intervention conditions: (1) a control condition offering the 5-session standard, smoking cessation program (SCP) plus a wellness component, (2) a treatment condition offering the 5-session SCP, a motivational enhancement component, and working memory training.
Research assessments will consist of participant self-reports of smoking behavior and proximal smoking measures (e.g., cravings) as well as self-report of personality characteristics (e.g., sensation seeking) associated with risk behaviors. CO exhalations will also be evaluated to confirm non-smoking status. Subjects will wear a wrist worn wearable sensor to monitor their physiological data and physical activity. The sensors will measure heart rate, inter-beat interval, electrodermal activity, skin temperature and acceleration signal arising from body movement. Once the data is collected, it will be statistically analyzed and machine learning techniques used to determine if specific physiological and behavioral markers precede smoking behavior (ex fidgeting). In addition, each participant's intervention session attendance and engagement will be recorded by the therapist. Participants in both conditions will make their quit attempt prior to the 5th and final intervention session, and will be invited to return for a follow-up visit at 1 week, 2 weeks, and 1 month after completing the final session, at which time their smoking status and related outcomes will be re-assessed.
Participants who miss more than 50% of intervention sessions will be considered off-protocol, but will remain in the study.
Participants will be randomly assigned to 1 of 2 study conditions. Each intervention is to be delivered over five consecutive weeks. Interventions will be led by Master's- or Doctoral-level study clinicians with ongoing supervision from Dr. Otto. For the working memory training component of the enhanced treatment condition, a computerized training program will be utilized.
All interventions will be delivered in groups with variable group size (1-8 members). Each of the study interventions is to be delivered once per week over five consecutive weeks. Therapy components of the sessions will be 60 minutes in length. Sessions may last, in total, up to 2.5 hours. Between intervention sessions, participants will also be asked to complete homework to practice skills learned during each session.
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
- •adults aged 18 or older, current smoker interested in participating in smoking cessation treatment
排除标准
- •Non-English speaking (operationalized as the inability to read and understand the consent form and converse in spoken English), pregnancy
研究组 & 干预措施
Enhanced Intervention (CBT+working memory training)
A standard, manualized cognitive behavioral therapy-based intervention for individuals interested in quitting smoking plus computerized working memory training
干预措施: Enhanced Intervention Condition (Other)
Control Intervention Condition
Participants will receive a manualized cognitive behavioral therapy-based intervention
干预措施: Enhanced Intervention Condition (Other)
结局指标
主要结局
Prolonged abstinence (PA)
时间窗: As informed by assessments from endpoint to final follow-up.
Prolonged abstinence is defined as 7 or more consecutive days of smoking or smoking at least 1 cigarette over the 2 consecutive weeks prior to the assessment.
Smoking Status
时间窗: 9 weeks.
Smoking status will be assessed at baseline and each of the follow-up assessments using point-prevalence abstinence (PPA) measures verified with carbon monoxide and saliva cotinine.
次要结局
- Behavioral/emotional markers preceding smoking behavior(Assessed for the first week of study participation)
- Center for Epidemiological Study - Depression Scale (CES-D)(Assessed at baseline)
- Working Memory Capacity(Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7)
- Distress Tolerance--Behavioral(Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7))
- Perceived Locus of Causality(Assessed at baseline)
- Carbon monoxide (CO) testing(Assessed at baseline, weeks 1-5, 1-week, 2-week, and 1-month follow-up assessments)
- Distress Tolerance--Perceived(Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7))
- Pittsburgh Sleep Quality Index (PSQI)(Assessed at baseline)
- Positive and Negative Affect Schedule(Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7)
- Demographic Questionnaire(Assessed at baseline)
- Delay Discounting(Assessed at baseline and post-quit week 1)
- Self-efficacy(Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7))
- Treatment Adherence(9 weeks (throughout study completion).)
- Executive Function(Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7)
- Satisfaction(Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7)
- Readiness to Change(Assessed at baseline, week 4/study visit 4, and week 2 follow-up/study visit 7)
- Treatment Acceptability(9 weeks (throughout study completion).)
研究者
Michael Otto
Investigator
Boston University Charles River Campus