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Trial record 39 of 2064 for:    Smoking Cessation

Yoga for Smoking Cessation Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01030068
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : October 7, 2011
Rhode Island Hospital
Brown University
Information provided by (Responsible Party):
Beth Bock, Ph.D., The Miriam Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Yoga Behavioral: Wellness Other: Smoking cessation therapy Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Yoga for Women Attempting Smoking Cessation: An Initial Investigation
Study Start Date : July 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Yoga
Yoga plus smoking cessation
Behavioral: Yoga
Yoga twice weekly

Other: Smoking cessation therapy
Smoking cessation therapy

Active Comparator: Wellness
Health & Wellness classes plus smoking cessation therapy
Behavioral: Wellness
Health and wellness classes twice weekly

Other: Smoking cessation therapy
Smoking cessation therapy

Primary Outcome Measures :
  1. Recruitment and qualitative feasibility [ Time Frame: 10 week ]

Secondary Outcome Measures :
  1. Smoking cessation [ Time Frame: 6 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01030068

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United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Rhode Island Hospital
Brown University
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Principal Investigator: Beth C Bock, PhD The Miriam Hospital

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Responsible Party: Beth Bock, Ph.D., Professor of Psychiatry & Human Behavior, The Miriam Hospital Identifier: NCT01030068     History of Changes
Other Study ID Numbers: R21AT003669 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: October 7, 2011
Last Verified: October 2011
Keywords provided by Beth Bock, Ph.D., The Miriam Hospital:
Smoking Cessation
Smoking Cessation Therapy