Yoga as a Complementary Therapy for Smoking Cessation

NCT ID: NCT01809678

Last Updated: 2021-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2017-06-30

Brief Summary

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This study examines the efficacy of yoga as a complementary therapy for smoking cessation

Detailed Description

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Despite the existence of effective medications for smoking cessation, approximately 50-80% of smokers attempt to quit without using pharmacotherapy. Efforts to encourage medication use during cessation attempts have met with mixed success. Many do not use medications because of concerns about side effects, contraindications that make medication use inappropriate, and individual preferences for chemical-free quit attempts. This leaves many smokers seeking an effective alternative to assist them in attempting to quit smoking. Each year, over 41% of smokers report failed attempts to quit smoking. Thus, effective non-pharmacological interventions to increase rates of successful cessation are greatly needed.

Our research, and the research of other investigators, has demonstrated that traditional (Western) exercise (e.g., brisk walking, bicycling) improves smokers' ability to successfully quit. Exercise may help smokers quit by reducing concerns regarding post-cessation weight gain, and by reducing nicotine withdrawal and enhancing mood. Recent research suggests that yoga is an acceptable and potentially effective alternative therapy for smoking cessation for several reasons: As a form of exercise, yoga shares many of the same properties as traditional (Western) aerobic exercise in that yoga has been shown to improve mood, physical fitness, weight control, self-image and quality of life in healthy and ill populations. Moreover, features of yoga, including a focus on breathing, mental concentration, meditation, stress reduction and enhanced mood are likely to have special relevance for smokers who are trying to quit. Thus, yoga may be particularly attractive as an alternative for individuals who either cannot use medications, or who choose not to use medications while quitting.

The proposed study will test the efficacy of Yoga as a complementary therapy for smoking cessation using a randomized, controlled study design. Adult smokers will be randomly assigned to either; 1) Yoga, or 2) an equal contact time Control group (CTL) given a health \& wellness program to control for contact time. All participants will be provided (separately by treatment group assignment) with the same cognitive-behavioral Smoking Cessation Counseling (SCC). Smoking abstinence will be measured at the end of treatment (week 8) and at 3, 6 and 12 months follow-up. We hypothesize that abstinence will be significantly higher in the SCC+Yoga group compared to SCC+CTL. We will also test theoretically posited mediators of intervention efficacy (e.g., perceived stress, cognitive/perceptual changes), examine the cost-efficacy of the yoga intervention, and examine the relationship between maintenance of yoga practice during the post-treatment period and smoking status. This study builds on our programmatic line of research developing innovative, theory-driven smoking cessation therapies.

Conditions

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Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Smoking Cessation plus Yoga

Twice weekly, 1-hour yoga classes delivered for 8 weeks combined with once-weekly, 1-hour cognitive-behavioral smoking cessation classes.

Group Type EXPERIMENTAL

Smoking Cessation

Intervention Type BEHAVIORAL

Once weekly program of cognitive-behavioral therapy for smoking cessation

Yoga

Intervention Type BEHAVIORAL

Twice weekly program of 1-hour Iyengar yoga classes

Smoking Cessation plus Wellness

Twice-weekly, 1-hour Wellness classes given on a variety of health topics twice weekly to match schedule of the yoga classes, plus 1-hour per week of cognitive-behavioral smoking cessation

Group Type ACTIVE_COMPARATOR

Smoking Cessation

Intervention Type BEHAVIORAL

Once weekly program of cognitive-behavioral therapy for smoking cessation

Wellness

Intervention Type OTHER

Twice weekly program of 1-hour wellness classes on a variety of health topics.

Interventions

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Smoking Cessation

Once weekly program of cognitive-behavioral therapy for smoking cessation

Intervention Type BEHAVIORAL

Yoga

Twice weekly program of 1-hour Iyengar yoga classes

Intervention Type BEHAVIORAL

Wellness

Twice weekly program of 1-hour wellness classes on a variety of health topics.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older (physician clearance for age \> 65)
* English-speaking
* Currently Healthy
* Smoking smoked 5 or more cigarettes/day
* Must accept randomization procedure
* BMI\< 40
* Will be Living in RI/MA/CT for next year

Exclusion Criteria

* Participated in any Yoga, Tai Chi, Qi Gong or Mindfulness-based therapy program twice in the past month or 10 times within the past year
* MD refused consent or Unable to obtain MD consent
* Unable to attend program due to work or home schedule
* Currently using medications or in active treatment to quit smoking
* Currently or planned participation in research or treatment programs that would interfere with this study
* Presence of health conditions that would make participation in yoga difficult or dangerous


* Cardiovascular disease
* Stroke/TIA
* Chest pain with physical activity
* Current or recent (\< 6 months) cancer treatment
* Uncontrolled Hypertension
* Untreated major depression or hospitalization \< six months
* Bone joint problems
* Liver or Kidney Disease
* Fainting within the past year
* History of seizures
* Balance condition that interferes with ability to exercise
* Respiratory Condition - COPD (e.g., emphysema requiring oxygen)
* Liver Disease
* Kidney Disease
* Other medical condition that would interfere with ability to exercise
* Hypothyroid (not on stable medication for 3 months)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Beth Bock, Ph.D.

Staff Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Thind H, Jennings E, Fava JL, Sillice MA, Becker BM, Hartman SJ, Bock BC. Differences between Men and Women Enrolling in Smoking Cessation Programs Using Yoga as a Complementary Therapy. J Yoga Phys Ther. 2016;6(3):245. doi: 10.4172/2157-7595.1000245. Epub 2016 Jun 15.

Reference Type BACKGROUND
PMID: 27683623 (View on PubMed)

Bock BC, Rosen RK, Fava JL, Gaskins RB, Jennings E, Thind H, Carmody J, Dunsiger SI, Gidron N, Becker BM, Marcus BH. Testing the efficacy of yoga as a complementary therapy for smoking cessation: design and methods of the BreathEasy trial. Contemp Clin Trials. 2014 Jul;38(2):321-32. doi: 10.1016/j.cct.2014.06.003. Epub 2014 Jun 14.

Reference Type BACKGROUND
PMID: 24937018 (View on PubMed)

Bock BC, Dunsiger SI, Rosen RK, Thind H, Jennings E, Fava JL, Becker BM, Carmody J, Marcus BH. Yoga as a Complementary Therapy for Smoking Cessation: Results From BreathEasy, a Randomized Clinical Trial. Nicotine Tob Res. 2019 Oct 26;21(11):1517-1523. doi: 10.1093/ntr/nty212.

Reference Type RESULT
PMID: 30295912 (View on PubMed)

Bock BC, Thind H, Dunsiger S, Fava JL, Jennings E, Becker BM, Marcus BH, Rosen RK, Sillice MA. Who Enrolls in a Quit Smoking Program with Yoga Therapy? Am J Health Behav. 2017 Nov 1;41(6):740-749. doi: 10.5993/AJHB.41.6.8.

Reference Type RESULT
PMID: 29025502 (View on PubMed)

Rosen RK, Thind H, Jennings E, Guthrie KM, Williams DM, Bock BC. "Smoking Does Not Go With Yoga:" A Qualitative Study of Women's Phenomenological Perceptions During Yoga and Smoking Cessation. Int J Yoga Therap. 2016 Jan;26(1):33-41. doi: 10.17761/1531-2054-26.1.33.

Reference Type RESULT
PMID: 27797659 (View on PubMed)

Other Identifiers

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R01AT006948

Identifier Type: NIH

Identifier Source: org_study_id

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