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临床试验/NCT03077945
NCT03077945已完成不适用

A Cognitive Behavioral Stress Intervention for Women Who Smoke

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Change in cigarette craving

研究概览

简要总结

  1. PURPOSE OF THE STUDY 1.1 Justification The purpose of the project is to examine the effect of breathing biofeedback and thoughts about stress on performance under stress and cigarette cravings. Smoking rates in the United States have been steadily going down over the past 50 years, and now 16.8% of adults smoke (Centers for Disease Control and Prevention, 2015). Most smokers try to quit, but end up going back to smoking (Garcia-Rodriguez et al., 2013; Piasecki, 2006; Rafful et al., 2013). The reasons people go back to smoking may have something to do with stress in their lives, particularly for women who smoke. This study wants to see if we can reduce temporary stress and lower craving to smoke after stress.

1.2 Description of the Research Project Approximately 60 adult women will participate in the study. Participants must be between 18 and 65 years old, able to read English fluently, and must agree to engage in the research procedures (stress protocol, physiological assessment, breathing training, questionnaires) to participate. People who are taking medications that interfere with physiological assessment are excluded from participating including people with: self-identified substance use problems, self-identified psychosis, morbid obesity (BMI>40), and people who take anti-cholinergic medication, beta blockers, Ritalin, benzodiazepines, tricyclic antidepressants or bupropion, varenicline, antipsychotic medication, or nicotine replacement therapy. People who have a cardiac rhythm abnormality or major neurological problem are also excluded from the study. Also, participants may not participate if they are pregnant or color-blind. Participation is strictly voluntary. 2. PROGRESSION OF THIS STUDY 2.1 Procedures The study visit procedures will take place at the Emotion and Psychopathology Laboratory at Rutgers University, located at the Rutgers Institute for Health, Healthcare Policy, and Aging Research. Participants will first complete some questionnaires and provide some basic information about themselves (demographic information, responses to emotion and stress, and smoking history). Next, participants will engage in a baseline psychophysiological assessment where investigators will examine heart rate, breathing, and blood pressure. Next, investigators will either ask participants to sit quietly for 30 minutes while completing a computer task and watching short videos, or practice a specific deep breathing exercise for 30 minutes. Then participants will do three tasks on a computer. The tasks will ask participants to trace different shapes, answer math problems while receiving feedback about how they're doing, and identify colors and words on a screen. Finally, participants will be asked to sit quietly for 15 minutes before investigators remove the psychophysiological recording equipment. One week after the study visit, investigators will contact participants via phone to ask them some questions about the study visit.

2.2 Duration of the study This study visit will last approximately 3 hours. Length of the visit may vary because each individual may complete procedures at a different pace. The phone call after the study visit will last approximately 10-15 minutes.

详细描述

Objectives Aim 1: Examine the effect of using cognitive reappraisal and HRVb in a single session on stress task performance. Investigators expect that participants assigned to practice both cognitive reappraisal and HRVb will demonstrate greater cognitive performance and persistence on stressful tasks during a laboratory visit in contrast to a control group of female smokers.

Aim 2: Examine the effect of using cognitive reappraisal and HRVb on short-term HRV, craving, and affect. Investigators expect that participants assigned to practice both cognitive reappraisal and HRVb will exhibit the greatest HRV adaptations, and demonstrate less reactive craving and affect by the end of the visit than participants randomized to a control group.

III. Background and Rationale Twenty percent of all deaths in the United States, or more than 480,000 deaths each year, are attributable to smoking (USDHHS, 2014). Cigarette smoking remains the leading preventable cause of death, with 16.8% of adults currently smoking (CDC, 2015) and over 16 million Americans living with a smoking-related disease (USDHHS, 2014). Smoking remains difficult to quit; even with the best available current treatments, quit attempts are successful 35% of the time or less (Garrison & Dugan, 2009). Smoking cessation and relapse to smoking is by far the most frequent path of cigarette use for smokers (Garcia-Rodriguez et al., 2013; Piasecki, 2006; Rafful et al., 2013). Stress has been implicated as a primary mechanism in smoking relapse (McKee et al., 2003; Baer et al., 1989; Cohen & Lichtenstein, 1990), often triggering increases in negative affect (Shiffman, 2005; Shiffman & Waters, 2004) and exposing difficulties in emotion regulation (Farris, Zvolensky, & Schmidt, 2015). Evidence suggests that stress prospectively predicts smoking lapse (Shiffman & Waters, 2004) and lapses triggered by stress progress more quickly to relapse (Shiffman et al., 1996), suggesting deficits in the ability to cope with stress.

In particular, women's smoking habits show trends that are different from men's: reports have shown that women consume more cigarettes than men (Hammond, 2009; Ng et al., 2014) and are less likely to successfully quit smoking than men (Cepeda-Benito et al., 2004; Perkins, 2001; Piper et al., 2010). While stress has been implicated in relapse for all smokers, recent evidence indicates that stress is a principal factor in promoting relapse to smoking in females, in part because women appear to be more strongly predisposed to stress responses (Torres & O'Dell, 2016). It is therefore likely that women are at particular risk for relapse due to stress.

Cognitive reappraisal has demonstrated positive effects on stress responding and smoking-related outcomes. Cognitive reappraisal is the reframing of a situation in order to influence one's emotional response to it (Gross, 1998). Compared with acceptance and suppression, reappraisal as measured by the Emotion Regulation Questionnaire (ERQ; Gross & John, 2003) is associated with overall lower craving and negative affect during craving inductions and stress tasks, as well as improved performance on a cognitive stress task (Szasz, Szentagotai, & Hofmann, 2012). Fucito, Juliano, and Toll (2010) found that frequent reappraisal on the ERQ was cross-sectionally associated with smoking fewer cigarettes. Recent evidence has indicated that reappraising stress-related arousal improves cognitive performance and physiological reactivity (Jamieson et al., 2012; 2013). Evidence thus far suggests that the use of cognitive reappraisal in particular as a self-regulation strategy may have positive implications for smoking behavior, including cigarette craving.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • To be included in the study, participants must report smoking at least 10 cigarettes per day, and agree to complete study procedures, which requires a willingness to practice quitting smoking.
  • They must also provide a breath carbon monoxide sample of at least 15ppm to verify their smoking status.

排除标准

  • Exclusionary criteria include being pregnant or trying to become pregnant
  • Color-blindness
  • Current psychosis, current substance dependence, current body mass index (BMI) of over 40
  • Current diagnosis of a cardiac rhythm abnormality (mitrovalve prolapse, frequent premature ventricular contractions
  • Atrial fibrillation, bundle branch block) or a major neurological problem, history of a myocardial infarction, or past-week use of illicit drugs
  • Nicotine replacement therapy, bupropion, varenicline, anti-cholinergic medications, beta blockers, Ritalin
  • Benzodiazepines
  • Tricyclic antidepressants
  • Antipsychotic medication.

结局指标

主要结局

Change in cigarette craving

时间窗: Total time frame of measurement is 3 hours. The QSU-B will be completed at T=0, T=25, T=75, T=90

Change in self-reported craving to smoke a cigarette as reported in the Questionnaire on Smoking Urges - Brief (QSU-B).

Change in heart rate variability

时间窗: 3 hours

Change in heart rate variability over the course of the study, as recorded on Biopac Acqknowledge software

Performance on a stress task

时间窗: 10-15 minutes

Performance on the color-word Stroop task

次要结局

  • Changes in smoking behavior at follow-up(followup phone calls take place one week after the study visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasmine Omar

Clinical Psychology PhD Candidate

Rutgers, The State University of New Jersey

研究点 (2)

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