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Yoga as a Complementary Therapy for Smoking Cessation

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by The Miriam Hospital
Sponsor:
Information provided by (Responsible Party):
Beth Bock, Ph.D., The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01809678
First received: March 11, 2013
Last updated: November 11, 2015
Last verified: November 2015
  Purpose
This study examines the efficacy of yoga as a complementary therapy for smoking cessation

Condition Intervention
Tobacco Dependence
Behavioral: Smoking Cessation
Behavioral: Yoga
Other: Wellness

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Yoga as a Complementary Therapy for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Smoking abstinence [ Time Frame: One year ]
    Abstinence from smoking at 1-year post treatment


Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Smoking Cessation
Once weekly program of cognitive-behavioral therapy for smoking cessation
Behavioral: Yoga
Twice weekly program of 1-hour Iyengar yoga classes
Active Comparator: 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
Behavioral: Smoking Cessation
Once weekly program of cognitive-behavioral therapy for smoking cessation
Other: Wellness
Twice weekly program of 1-hour wellness classes on a variety of health topics.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Medical Exclusion Criteria

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809678

Contacts
Contact: Santina Horowitz, BS 401-793-8282 Shorowitz@Lifespan.org
Contact: Ryan Lantini, MA 401-793-8332 Rlantini@lifespan.org

Locations
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Santina Horowitz, BS    401-793-8223    Shorowitz@lifespan.org   
Principal Investigator: Beth Bock, PhD         
Sub-Investigator: Ernestine Jennings, PhD         
Sub-Investigator: Shira Dunsiger, PhD         
Sub-Investigator: Joseph Fava, PhD         
Sponsors and Collaborators
The Miriam Hospital
  More Information

Responsible Party: Beth Bock, Ph.D., Staff Psychologist, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01809678     History of Changes
Other Study ID Numbers: R01AT006948 ( US NIH Grant/Contract Award Number )
Study First Received: March 11, 2013
Last Updated: November 11, 2015

Keywords provided by The Miriam Hospital:
Smoking
Tobacco
Yoga

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2017