Yoga for Smoking Cessation Feasibility Study

This study has been completed.
Sponsor:
Collaborators:
Rhode Island Hospital
Brown University
Information provided by (Responsible Party):
Beth Bock, Ph.D., The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01030068
First received: December 9, 2009
Last updated: October 6, 2011
Last verified: October 2011

December 9, 2009
October 6, 2011
July 2007
July 2011   (final data collection date for primary outcome measure)
Recruitment and qualitative feasibility [ Time Frame: 10 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01030068 on ClinicalTrials.gov Archive Site
Smoking cessation [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Yoga for Smoking Cessation Feasibility Study
Yoga for Women Attempting Smoking Cessation: An Initial Investigation

The purpose of this study is to test whether it is feasible to provide a smoking cessation program together with a yoga program to help women quit smoking. We anticipate that women will be enthusiastic about the program and that we will be able to recruit and treat women for smoking cessation within the designated time frame.

Cigarette smoking is the leading preventable cause of morbidity and mortality among adults in the United States. Smoking, and quitting smoking may be especially problematic for women. Our prior research has demonstrated that traditional aerobic exercise (e.g., brisk walking, bicycling) improves cessation outcomes among women. Exercise appears to reduce the effects of nicotine withdrawal and improves cessation outcomes by improving mood and reducing weight gain. yoga that shares many of the same properties of the traditional aerobic exercise that has been shown to be an efficacious adjunct to smoking cessation treatment. Moreover, some features of yoga, including a focus on breathing, meditation, stress reduction and enhanced mood are likely to have special relevance to smokers who are trying to quit. Thus, yoga may prove to be a more efficacious complimentary treatment for smoking cessation than traditional aerobic exercise.

The goal of this proposal is to conduct an initial investigation of the efficacy of providing Yoga as an adjunct to cognitive behavioral treatment (CBT) for smoking cessation. Adult women smokers (n=72) will be recruited through newspaper advertisements and will be randomly assigned to either: (1) CBT plus Yoga , or (2) CBT plus contact control. All study participants will be given a sub-maximal exercise stress test to ensure that they are safe to exercise. Yoga sessions will be conducted twice weekly for 12 weeks, and will be lead by certified instructors in yoga. Smoking cessation sessions will be conducted once per week for 12 weeks and will be lead by Masters or PhD level specialists in smoking cessation. Differences in post-treatment (12 week) cessation rates (7-day point prevalence abstinence) will provide data for estimates of effect size between conditions. This effect size estimate is necessary in order to calculate power estimates for a major clinical trial.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Smoking Cessation
  • Behavioral: Yoga
    Yoga twice weekly
  • Behavioral: Wellness
    Health and wellness classes twice weekly
  • Other: Smoking cessation therapy
    Smoking cessation therapy
  • Experimental: Yoga
    Yoga plus smoking cessation
    Interventions:
    • Behavioral: Yoga
    • Other: Smoking cessation therapy
  • Active Comparator: Wellness
    Health & Wellness classes plus smoking cessation therapy
    Interventions:
    • Behavioral: Wellness
    • Other: Smoking cessation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy female smokers
  • ages 18-65
  • smoke 10+ cigarettes a day
  • sedentary (not exercising more than 2 times per week)

Exclusion Criteria:

  • major depression
  • hypertension
  • more than 1 year previous yoga experience
  • current experience with yoga or smoking cessation treatment
Female
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01030068
R21AT003669
No
Beth Bock, Ph.D., The Miriam Hospital
The Miriam Hospital
  • Rhode Island Hospital
  • Brown University
Principal Investigator: Beth C Bock, PhD The Miriam Hospital
The Miriam Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP