A Cognitive Behavioral Stress Intervention for Women Who Smoke
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|ClinicalTrials.gov Identifier: NCT03077945|
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : March 14, 2018
|First Submitted Date ICMJE||February 22, 2017|
|First Posted Date ICMJE||March 13, 2017|
|Last Update Posted Date||March 14, 2018|
|Actual Study Start Date ICMJE||December 1, 2016|
|Actual Primary Completion Date||May 30, 2017 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT03077945 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Changes in smoking behavior at follow-up [ Time Frame: followup phone calls take place one week after the study visit ]
changes in cigarettes smoked or methods of coping with stress or craving will be assessed one week after the study visit is completed
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||A Cognitive Behavioral Stress Intervention for Women Who Smoke|
|Official Title ICMJE||Not Provided|
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.
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.
HRVb has also shown promising evidence on stress outcomes. Utilizing behavioral self-regulation strategies such as heart rate variability biofeedback (HRVb) to increase heart rate variability (HRV) shows promise in coping with stress. HRV is a measure of fluctuation from the mean heart rate, representing the interaction between sympathetic and parasympathetic influences on the cardiac system (Siepmann et al., 2008), and serving as a biomarker of autonomic nervous system functioning (Zucker et al., 2009). HRV biofeedback training aims to improve adaptability to and recovery from fight or flight situations by increasing HRV (Gevirtz, 2013). A single session of HRVb improves adaptability to stress as measured with improved cognitive performance in a lab-induced stress task (Prinsloo et al., 2010). Several weeks of HRVb practice have shown reductions in substance craving (Penzlin et al., 2015; Eddie et al., 2014) and food craving (Meule et al., 2012), although no studies to date have examined the effect of a single session of HRVb practice on cigarette craving.
This study assesses whether combining a cognitive and behavioral approach to improve stress responding in smokers may be especially efficacious. No other study to date has examined examined potential additive benefits of combining both strategies. Combining both cognitive and behavioral self-regulation skills for stress adaptation is consistent with cognitive-behavioral theory upon which evidence-based treatments for Axis I pathology were developed, as behavioral (e.g., HRVb) and cognitive (e.g., reappraisal) approaches to self-management allow the individual to target both internal and external stimuli when coping with stress (Rokke & Rehm, 2001). Beyond psychological effects of stress, the combination of such approaches has implications for informing smoking cessation treatments, as it has been previously noted that current treatments for substance addiction "are failing to address important factors that are active in sustaining [such] pathology, because phenomena that lead to relapse... are mediated by physiological as well as cognitive processes" (Eddie, Vaschillo, Vaschillo, & Lehrer, 2015, p. 266). In order to further improve cessation rates, cognitive reappraisal instruction and HRVb can be incorporated at low cost into standard smoking cessation treatment, which currently consists of pharmacotherapy and smoking cessation counseling according to the Clinical Practice Guideline (Fiore et al., 2008). HRVb technology ranges from free smartphone applications (e.g., Elite HRV) to sophisticated devices available for purchase online (e.g. EmWave), making it an affordable and feasible addition to enhance current smoking cessation treatment.
As no studies to date have explored the effects of HRVb in a single session on smoking craving, this study will be the first to address the potential use of a relatively new technology for its short-term effects on variables that increase lapse risk, such as affect, craving, and stress responding. This pilot study will assess the efficacy of practicing HRVb using a device that is available to the general public that has not been previously tested for its short-term effects on craving. Combining HRVb training prior to a stressful task, followed by cognitive reappraisal during a task, has also never been explored for its additive effects above the use of either strategy alone. Both strategies would allow for a more comprehensive approach to managing stress responding, both cognitively and physiologically. Moreover, promising research on self-regulatory strategies like cognitive reappraisal has not compared it with HRVb to assess relative efficacy in improving stress responding, or in assessing its relative efficacy in improving smoking-related outcomes.
Heart rate variability will be measured as one of the primary outcome measures of this study. As heart rate variability is susceptible to several other environmental and mental factors that affect the sympathetic nervous system, additional measures need to be taken to ensure the validity of the heart rate variability data. As secondary measures, blood pressure and breath carbon monoxide will be recorded. Specifically, the following measures will be used for data collection, all of which are non-invasive:
Instrumentation One of the interventions examined in this study is heart rate variability biofeedback, which involves breathing at a slow and steady rate and receiving feedback from a device about one's heart rate. The EmWave2® HRVb device (HeartMath®, Boulder Creek, Colorado) will be used for HRVb practice and will serve as an additional measure of HRV for the HRVb group. The EmWave2® device trains the user in HRVb and provides readings of HRV, time elapsed, and varying levels of physiological coherence (Edwards, 2014). Repeated use of the device has demonstrated clinically significant improvement in performance on tests of executive functioning associated with emotional dysregulation (O'neill & Findlay, 2014) and statistically significant increases on measures of general health and mindfulness (Edwards, 2014).
Baseline Self-Report Measures After consenting procedures are complete, participants will be directed to a website (Qualtrics) where they will complete a battery of baseline self-report questionnaires. Qualtrics is an online-based, private research company that specializes in data collection. All data entered through Qualtrics will be connected only to participants' unique identifying numbers that will not be associated with any identifying information (e.g., name or contact information). Participants will fill out self-report questionnaires that assess demographic information, smoking history and behavior, clinical symptoms, emotion regulation, and other mental health-related indices. (See Attachment 7 for the study measures.)
Specifically, the following measures will be administered:
The BDI-II includes an item that measures an individual's suicidality. If at any point a participant indicates they are feeling significantly suicidal, a message will pop-up at the end of the survey, informing the study staff of the individual's risk for high suicidality. Study staff will then perform a brief assessment and intervention to determine if further professional attention is required to keep the participant safe. (See "Protection Against Potential Risks" and Appendix 2 for more detailed information.)
Additional Self-Report Measures At multiple points throughout the study, additional self-report measures will be used to assess smoking craving and affect, which are the subjective outcomes of the study.
Finally, several subscales of the Stress Appraisal Measure (SAM; Peacock & Wong, 1989) will be used as a manipulation check for the cognitive restructuring intervention. The SAM has demonstrated reliability and good internal consistency of its subscales (Carpenter, 2016).
Computer Stress Tasks Participants will first have ten minutes to complete a Mirror Tracing Task (MTT; Quinn, Brandon, & Copeland, 1996) that measures persistence on a stressful task, which is associated with nicotine dependence treatment outcome (Brandon et al., 2003) and can distinguish cigarette smokers from non-smokers (Quinn et al., 1996). The MTT involves tracing three shapes displayed on a computer screen, using the mouse of the computer screen. A buzzing sound indicates whether the shape is being traced incorrectly. As the primary purpose of this task in the study is to induce stress, participants will be instructed to complete the task without the option of termination for ten minutes.
Second, participants will complete the validated Montreal Imaging Stress Task (MIST; Dedovic et al., 2005) which involves mental arithmetic with negative feedback from the investigator, who will be a female member of study staff. The MIST was specifically designed for eliciting psychosocial stress when participant movement is restricted and has demonstrated effects on biological indices of stress, including cortisol (Dedovic et al., 2005) and brain areas associated with the limbic system (Dedovic et al., 2009) and HPA axis (Zschucke et al., 2015).
Third, a computerized Stroop task (Stroop, 1935) will be implemented to induce mental stress. The Stoop task is a well-known and validated measure of mental stress and cognitive performance that involves reading words and identifying colors on a computer screen.
e. Detailed study procedures Interested participants will complete a phone interview for eligibility. Participants referred from the Tobacco Dependence Program will have provided a breath carbon monoxide sample meeting eligibility criteria, which is at least 15ppm. Participants recruited from other sources will be asked to provide a breath sample during a 5-minute visit to the laboratory in order to confirm smoking status at least one day prior to the scheduled study visit.
Eligible participants will be scheduled for a 2.5-hour visit and asked to refrain from alcohol, tobacco, or e-cigarette use for 12 hours prior to their appointment time. The study visit will consist of a breath CO test to confirm tobacco abstinence in the past 12 hours (indicated by a breath CO level of less than 10ppm. Evidence shows that daily smokers who have not yet smoked the first cigarette of the day exhibit expired CO levels between 9 and 11ppm (Adan, Prat, & Sanchez-Turet, 2004). Interested participants who are not CO-eligible will be rescheduled for another study visit day. CO confirmation of study eligibility will be followed by the informed consent process, and finally the completion of a baseline questionnaire packet (detailed below). They will also be instrumented with the BioPac psychophysiology stations by a trained female study staff member. They will then be asked to conduct a baseline psychophysiological assessment for 10 minutes, which is done in order to provide a comparison for the effects of the interventions and stress tasks.
Participants will be randomized to one of two conditions, blocked by age and level of motivation to quit smoking in the next 30 days. Participants ages 18-39 will be randomized separately from participants ages 40-65. Blocking randomization by age group will reduce age confounds within the sample of adult women, as age is correlated with smoking behavior and heart rate variability (Zhang, 2007). Motivation to quit smoking in the next 30 days, on a scale of 1-10, will be assessed in the initial phone interview to block randomization by level of motivation to quit (1-5 versus 6-10). Participants will be randomly assigned to one of two study conditions reflecting the presence or absence of the interventions: 1) HRVb and cognitive reappraisal instructions, or 2) Sitting quietly while engaging in a neutral control task and no reappraisal instructions. HRVb will involve paced breathing as guided by a moving light on a portable biofeedback device (described below). The neutral control tasks will involve pressing a computer key whenever a shape appears on the computer screen, which will occur approximately every minute. To maintain a neutral control condition for 30 minutes, a neutral nature video will supplement the task to prevent significant participant boredom or frustration.
Cognitive reappraisal instructions will explain the function of the stress response as an adaptation to effectively overcome challenges, following an example by Jamieson, Nock, and Mendes (2012). Remaining study visit procedures are detailed in Figure 1.
Debriefing Following the completion of computer tasks, 15 minute recovery period, and removal of psychophysiological recording equipment, participants will be debriefed about the study and its purposes. They also will be provided with a Debriefing/Resources Sheet with information and contact information about mental health. Participants will then be compensated for their participation.
The study staff member will review the Resources Sheet with the individual and provide the participant with a physical copy to take home with them. The Resource Sheet (attachment 9) will include information on resources specific to Rutgers and central New Jersey.
Protections Against Potential Risks Every effort will be made to minimize any risks associated with participation. Our procedures are generally non-invasive and pose little to no physical risk to the participants. As such, the risks involved with participation in this study are minor, though there are a few concerns.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomized to the intervention or control condition, blocked by age and level of motivation to quit smoking.Masking: Single (Participant)
Primary Purpose: Basic Science
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date ICMJE||May 30, 2017|
|Actual Primary Completion Date||May 30, 2017 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years to 65 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT03077945|
|Other Study ID Numbers ICMJE||16-782M|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||Yasmine Omar, Rutgers, The State University of New Jersey|
|Study Sponsor ICMJE||Rutgers, The State University of New Jersey|
|PRS Account||Rutgers, The State University of New Jersey|
|Verification Date||March 2018|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP