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| Tracking Information | |||||||||
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| First Received Date † | June 25, 2007 | ||||||||
| Last Updated Date | April 23, 2009 | ||||||||
| Start Date † | August 2007 | ||||||||
| Current Primary Outcome Measures † |
smoking cessation: 7-day point prevalence abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00492310 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
Acceptability: recruitment, retention, adherence to protocol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title † | Yoga for Women Attempting Smoking Cessation | ||||||||
| Official Title † | Yoga for Women Attempting Smoking Cessation: an Initial Investigation | ||||||||
| Brief Summary | The purpose of this study is to examine the feasibility, acceptability and initial effectiveness of adding yoga to a traditional, group-based treatment for smoking cessation for women smokers. |
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| Detailed Description | Smoking is the leading preventable cause of morbidity and mortality among women in the US. Quitting smoking may be especially problematic for women. As a form of exercise, yoga shares many of the same properties as traditional (Western) aerobic exercise which our previous research has shown to be an effective addition to smoking cessation. Yoga may also offer other benefits that may make it an especially effective complimentary treatment for women who are attempting to quit smoking. In this study we will recruit two cohorts of 30 women smokers and provide cognitive-behavioral therapy for smoking cessation once weekly for 12 weeks. In addition, participants will be randomly assigned them to receive either; (1) Yoga or (2) a Wellness program (contact-control), twice weekly during the program. All participants will be assessed for changes in smoking behavior, psychosocial variables relevant to smoking cessation and other psychological constructs that may act as mechanisms of action (mediators) of yoga and smoking cessation. These variables include; weight concerns, perceived stress, mindfulness, self-esteem, quality of life and group cohesion. Interviews will be used to collect qualitative data at the end of each cohort. The proposed study is designed to provide information necessary to establish several research fundamentals necessary to support a full scale efficacy trial. These include: 1) establishing intervention feasibility and acceptability in the target population, 2) piloting recruitment and retention procedures and identifying barriers to participation, 3) obtaining qualitative feedback from participants to enhance treatment content and/or design, 4) establishing anticipated effect size estimates, and 5) identifying likely mechanisms of action that may be responsible for intervention efficacy. |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment | ||||||||
| Condition † | Smoking | ||||||||
| Intervention † |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 60 | ||||||||
| Estimated Completion Date | July 2009 | ||||||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria: Female, Age 18-65, Cigarette smoking 10 or more per day for more than 1 year, sedentary (not exercising more than 2 days per week) Exclusion Criteria: Major depression, Hypertension, Current yoga practice, Current mind/body therapies |
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| Gender | Female | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00492310 | ||||||||
| Responsible Party | Beth Bock, The Miriam Hospital | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | National Center for Complementary and Alternative Medicine (NCCAM) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||||||
| Verification Date | April 2009 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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