Yoga for Smoking Cessation Feasibility Study
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Purpose
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 | Intervention |
|---|---|
|
Smoking Cessation |
Behavioral: Yoga Behavioral: Wellness Other: Smoking cessation therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Yoga for Women Attempting Smoking Cessation: An Initial Investigation |
- Recruitment and qualitative feasibility [ Time Frame: 10 week ] [ Designated as safety issue: No ]
- Smoking cessation [ Time Frame: 6 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2007 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders 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
Contacts and Locations| United States, Rhode Island | |
| The Miriam Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| Principal Investigator: | Beth C Bock, PhD | The Miriam Hospital |
More Information
No publications provided
| Responsible Party: | Beth Bock, Ph.D., Professor of Psychiatry & Human Behavior, The Miriam Hospital |
| ClinicalTrials.gov Identifier: | NCT01030068 History of Changes |
| Other Study ID Numbers: | R21AT003669 |
| Study First Received: | December 9, 2009 |
| Last Updated: | October 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Miriam Hospital:
|
Smoking Cessation Yoga Wellness Feasibility Smoking Cessation Therapy |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 16, 2013