Examining Yoga's Effects on Aspects Related to Stress and Smoking Behavior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measurement of Objective Stress through Hormonal Biomarkers (Hair & Salivary Cortisol)
研究概览
简要总结
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.
详细描述
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.
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 (Outcomes Assessor)
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
- 是
入选标准
- •Female only patients ages 18-65 capable of providing informed consent
- •Daily smoker for at least one year.
- •Currently smoke an average of at least 10 cigarettes per day.
- •Sedentary as defined by moderate-intensity exercise less than 2 days/wk for at least 30 minutes each
- •Written physician approval/medical clearance to participate in an exercise/yoga protocol.
- •Report motivation to quit smoking of at least 5 on a 10-point Likert-type scale - -Express interest in making a serious, unassisted quit attempt in the next month-
- •Have not decreased number of cigarettes smoked in the past 6 months
排除标准
- •Use of other tobacco products
- •Severe obesity (BMI ≥ 40)
- •Currently pregnant or plans to become pregnant
- •Diagnosis of a schizophrenia or bipolar-spectrum disorder
- •Currently suicidal or suicide high-risk or severe depression
- •Use of corticosteroid medications
- •Change in medication doses for past 6-months for psychotropic drugs
- •Receiving concurrent psychotherapy
研究组 & 干预措施
Yoga
This will involve participating in at least two 60-minute Vinyasa yoga sessions each week for eight weeks (weeks 1-8). This will begin the week following a baseline laboratory appointment. These sessions will be conducted at a local Austin studio that has numerous locations in the area.
干预措施: Yoga (Behavioral)
Waitlist
If randomized to this group, participants will complete weekly assessments only and not yoga during their time in the study. Following full completion of the study (i.e., after week 10), participants will be compensated with a voucher for 2 free months of yoga.
结局指标
主要结局
Measurement of Objective Stress through Hormonal Biomarkers (Hair & Salivary Cortisol)
时间窗: Collected at pre-and-post intervention (Baseline and Quit day, Week 9)
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.
Minnesota Nicotine Withdrawal Scale-Revised
时间窗: post-yoga Week 9 on Quit day and week 10 follow-up
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.
次要结局
- Self reported anxiety sensitivity - Anxiety Sensitivity Scale (ASI).(Weekly from pre-to-post intervention (screen, Baseline, weeks 1-10))
- Smoking point-prevalence - timeline follow back calendar(Weeks Screen, 0 (baseline), 1-8 (intervention), 9-10 (quit period))
- Barratt Impulsiveness Scale (BIS) of Trait Impulsivity(Eligibility Screen)
- Distress Tolerance Scale (DTS).(Weekly; Baseline (week 0) through week 10 follow up)
- carbon monoxide (CO)(Screen, week 0 (baseline), week 9 Quit day, & week 10 follow up)
- Computerized Delay Discounting Task (DDT).(Pre-to-post (eligibility screen & week 9 visit))
- Balloon Analogue Risk Task (BART).(Pre-to-post (at eligibility screen & week 9 visit).)
- Fagerstrom Test of Nicotine Dependence (FTND).(Week 0, 6, 9)
- Mood and Anxiety Symptom Questionnaire (MASQ).(Quit day week 9)
- Beck Depression Inventory (BDI).(Eligibility screen, weeks 0, 6, 9)
- Five Facet Mindfulness Questionnaire (FFMQ).(Weekly from baseline to post-yoga (week 9))