Yoga for Women Attempting Smoking Cessation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Yoga for Women Attempting Smoking Cessation: an Initial Investigation

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: yoga
* Behavioral: cognitive therapy
* Behavioral: yoga
* Behavioral: wellness


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cognitive-behavioral smoking cessation with yoga | Behavioral: yoga<br>* vinyasa yoga<br>Behavioral: cognitive therapy<br>* cognitive behavioral therapy once weekly<br>Behavioral: yoga<br>* vinyasa yoga twice weekly with smoking cessation once weekly<br>|
| Active Comparator: 2<br>smoking cessation with twice weekly wellness program | Behavioral: cognitive therapy<br>* cognitive behavioral therapy once weekly<br>Behavioral: wellness<br>* wellness program with smoking cessation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking cessation: 7-day point prevalence abstinence |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability: recruitment, retention, adherence to protocol |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, tobacco, women, yoga