Examining Yoga's Effects on Aspects Related to Stress and Smoking Behavior
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Yoga
- Sponsor
- University of Texas at Austin
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Measurement of Objective Stress through Hormonal Biomarkers (Hair & Salivary Cortisol)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Measurement of Objective Stress through Hormonal Biomarkers (Hair & Salivary Cortisol)
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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))
- 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)