The primary aim of this research study is to examine the effects of an 8-week yoga program on aspects related to nicotine dependence, stress, and coping during a smoking quit attempt. Guided by initial studies reporting on the effects of yoga on putative mediators of smoking relapse (i.e., cortisol, distress intolerance, withdrawal symptoms), the proposed experiment examines the effects of an 8-week yoga practice on nicotine withdrawal intensity by way of aiding withdrawal characteristics predictive of smoking relapse. The long-term objectives of the proposed line of research are to: (1) inform theoretical models of nicotine withdrawal, (2) guide the development of effective alternative interventions for smokers susceptible to relapse during the critical withdrawal period (i.e., smokers low in distress tolerance), and (3) to help guide behavioral strategies for treating substance addictions broadly.
As the leading cause of preventable death in the US and a major cause for chronic disease/mortality worldwide, smoking represents a major public health issue in need of effective interventions to reduce its burden. The development of such strategies is best directed by basic research on the biobehavioral processes underlying smoking maintenance and relapse. A major predictor of cessation failure is nicotine withdrawal, especially among individuals low in distress tolerance (DT). Reducing nicotine withdrawal-related distress and relapse in low DT smokers may require the regulation of certain hormones involved in the hypothalamic pituitary axis (HPA-axis) (i.e., the human stress response). Regular practice of yoga, a mindfulness-based form of physical activity, emerges as a promising strategy for regulating the HPA-axis, decreasing withdrawal symptoms, and increasing DT, thus promoting smoking cessation success. We will randomly assign 50 smokers (≥10 cigarettes daily) low in DT to either an 8-week yoga intervention \[YOGA\] or a waitlist control \[WL\] prior to undergoing a self-guided quit attempt. We hypothesize participants assigned to the yoga condition (relative to waitlist) will differ on various outcomes assessed throughout the intervention (e.g., quit status, negative affective states, stress, hormonal changes, withdrawal) and, quit day, and throughout the 2-week quit follow-up period. More specifically, we hypothesize that certain typical maladaptive, during-withdrawal changes may be attenuated through YOGA. We also hope to obtain initial effect sizes of the advantage of yoga compared to waitlist for point-prevalent abstinence at two weeks following an unaided quit attempt.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
50
The yoga intervention will be an 8-week program involving two 60-minute sessions each week at a local studio with three locations in Austin. Participants will be instructed to take classes deemed within a moderate-to-vigorous intensity dose. Participants will also be encouraged both by the PI and yoga instructors to complete the entire 60 minutes of yoga, urged to do only what is comfortable and not push themselves beyond their physical limits.
University of Texas at Austin
Austin, Texas, United States
Measurement of Objective Stress through Hormonal Biomarkers (Hair & Salivary Cortisol)
we will collect biological samples of hair and saliva to assess changes in biomarkers in response to yoga, and as a potential mechanism by which yoga may aid in smoking cessation. Saliva samples will be collected with Salivettes (Sarstedt, Rommelsdorf, Germany), plastic vials with cotton dental rolls inside. Participants will complete 2 Salivettes at each of three separate 12-hr collection periods. participants will provide two hair strand samples cut by trained personnel (Gerber et al., 2012; Suave et al., 2007; Meyer \& Novak, 2012). Hair strands are cut close to the scalp from the posterior vertex of the head using surgical scissors.
Time frame: Collected at pre-and-post intervention (Baseline and Quit day, Week 9)
Minnesota Nicotine Withdrawal Scale-Revised
MNWS-R (Hughes \& Hatsukami, 1986) is a validated 15-item self-report measure of withdrawal severity rated on a 5 point Likert scale (0 "none" to 4 "severe") that will establish level of nicotine withdrawal as a major outcome assessed between groups during quit period.
Time frame: post-yoga Week 9 on Quit day and week 10 follow-up
Self reported anxiety sensitivity - Anxiety Sensitivity Scale (ASI).
The 16-item ASI will be employed to assess sensitivity to, and discomfort with, physical anxiety sensations. The ASI (Reiss et al., 1986) as a screening criterion (ASI≥ 20 as indicative of elevated AS) and an outcome measure. The ASI has good internal consistency, test-retest reliability, and excellent convergent validity with other established measures. For the purpose eligibility assessment, this measure will be completed during the Online Prescreen. This measure will also be assessed weekly as a primary outcome assessed between groups.
Time frame: Weekly from pre-to-post intervention (screen, Baseline, weeks 1-10)
carbon monoxide (CO)
Participants will complete carbon monoxide (CO) analysis of breath sample (≥8ppm cutoff; Jarvis et al., 1987) to determine smoking status during ad-libitum phases and to assess smoking quit status during the quit period.
Time frame: Screen, week 0 (baseline), week 9 Quit day, & week 10 follow up
Smoking point-prevalence - timeline follow back calendar
Participants will complete the full timeline follow back calendar (TLFB; past-week) to assess daily point-prevalence of cigarettes both as a screening tool (reflecting ≥ 10 cigarettes/day on average for the past year; and throughout the study period. point prevalence during quit period will be examined between groups and verified with biochemical measurement of lung carbon monoxide (CO)
Time frame: Weeks Screen, 0 (baseline), 1-8 (intervention), 9-10 (quit period)
Five Facet Mindfulness Questionnaire (FFMQ).
The FFMQ (Baer et al., 2006) is a 39-item self-report measure of mindfulness components: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. This will be given across intervention to assess changes in response to the mindfulness-based practice of yoga (i.e., with changes compared between groups).
Time frame: Weekly from baseline to post-yoga (week 9)
Barratt Impulsiveness Scale (BIS) of Trait Impulsivity
BIS-15 (Spinella, 2007) is a 15-item self-report measure of 3 non-overlapping impulsivity components: non-planning, motor impulsivity, and attention impulsivity. As one of the most commonly used measures of impulsivity, it has demonstrated validity and reliability in neuropsychiatric and healthy populations. The 15-item short form of the BIS has shown to retain its 3-factor structure when subject to factor analysis and maintained good reliability and validity (Spinella 2007). screening tool (coupled with the ASI) to select individuals scoring above the community norm for impulsivity (Mean score ≥ 32.6 out of 54), as this smoking population may be especially at risk for reactivity to withdrawal symptoms/withdrawal related relapse.
Time frame: Eligibility Screen
Balloon Analogue Risk Task (BART).
BART is a laboratory-based behavioral measure of risk taking, evidencing sound experimental properties. It has been shown to predict risk-related constructs (e.g., impulsivity, sensation seeking) as well as self-reported real-world risk behaviors in adults and adolescents (Lejuez et al., 2002). Riskiness on the BART has been correlated with occurrence of addictive, health, and safety risk behaviors, indicating that the BART may be a useful clinical assessment tool. Importantly, as smokers have demonstrated greater total riskiness and sensation seeking on the BART, we will administer the task at pre-and-post intervention as a secondary predictor of smoking outcomes in our trial, possibly indicative of greater difficulty quitting related to impulsivity (which may also be aided with yoga, and thus, differences in behavior will be compared between groups).
Time frame: Pre-to-post (at eligibility screen & week 9 visit).
Computerized Delay Discounting Task (DDT).
The Delay Discounting choice task is a valid and reliable computer adaptive procedure developed for the purpose of studying choice behavior and delayed reward (Richards et al., 1999). The program asks the participant to decide between a higher amount of money (e.g., $10) to be received after one of the different delay periods (e.g., 1 day, 1 week) or a smaller amount of money (e.g. $1) to be received immediately. Because scores on DDT appear to be related to smoking status and level of nicotine dependence (Sweitzer et al., 2008) this measure was included both as a secondary screening predictor of smoking cessation success, and to observe possible pre-to-post changes afforded by yoga. Changes in behavior on this task will compared between groups.
Time frame: Pre-to-post (eligibility screen & week 9 visit)
Distress Tolerance Scale (DTS).
The DTS (Simons \& Gaher, 2005), a 15-item self-report measure of physical and psychological distress tolerance, will assess changes in DT; it consists of a 5-point Likert scale with possible ratings ranging from strongly agree to strongly disagree. DTS has high internal consistency (alpha=.82). This will serve as a secondary measurement of distress tolerance, accompanying the ASI, and assessed through between-group changes.
Time frame: Weekly; Baseline (week 0) through week 10 follow up
Mood and Anxiety Symptom Questionnaire (MASQ).
The MASQ is a self-report measure derived from the tripartite model (Watson et al., 1995). It includes 62 items rated on a scale ranging from 1 (not at all) to 5 (extremely) focusing on how much an individual has experienced specific affect symptoms in the past week. Four subscales include: Anxious Arousal, Anhedonic Depression, General Distress: Anxious Symptoms, and General Distress: Depressive symptoms. We will use the MASQ to assess affective changes in response to 12-hour withdrawal. The MASQ has been employed in previous smoking cessation work (e.g., Zvolensky et al., 2009), and therefore, beyond being psychometrically sound, offers a higher degree of comparability across research. Ratings will be compared between-groups
Time frame: Quit day week 9
Fagerstrom Test of Nicotine Dependence (FTND).
The FTND (Heatherton, Kozlowski, Frecker, \& Fagerstrom, 1991) has shown good internal consistency, a single dimension factor structure, and positive relationships with degree of nicotine intake. Dependence status will be assessed at baseline, mid, and post-treatment. This measure will serve to quantify nicotine dependence, which will be used as a covariate in the primary analyses.
Time frame: Week 0, 6, 9
Beck Depression Inventory (BDI).
The BDI (Beck, Mendelson, Mock, \& Erbaugh, 1961) is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms. Individuals will only be eligible with scores of ≤30 on the BDI (scores ≥30 indicate severe depression). The BDI will also be administered throughout the protocol to assess changes in depressive symptoms possibly affected through yoga.
Time frame: Eligibility screen, weeks 0, 6, 9
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