Yoga for Women Attempting Smoking Cessation
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking |
Behavioral: yoga Behavioral: cognitive therapy Behavioral: wellness |
Phase 3 |
| 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 |
- smoking cessation: 7-day point prevalence abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Acceptability: recruitment, retention, adherence to protocol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | March 2011 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Cognitive-behavioral smoking cessation with yoga
|
Behavioral: yoga
vinyasa yoga
Behavioral: cognitive therapy
cognitive behavioral therapy once weekly
Behavioral: yoga
vinyasa yoga twice weekly with smoking cessation once weekly
|
|
Active Comparator: 2
smoking cessation with twice weekly wellness program
|
Behavioral: cognitive therapy
cognitive behavioral therapy once weekly
Behavioral: wellness
wellness program with smoking cessation
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
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 by The Miriam Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Beth Bock, The Miriam Hospital |
| ClinicalTrials.gov Identifier: | NCT00492310 History of Changes |
| Other Study ID Numbers: | R21 AT003669-01, R21AT003669-01 |
| Study First Received: | June 25, 2007 |
| Last Updated: | July 19, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by The Miriam Hospital:
|
Smoking tobacco women yoga |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 16, 2013