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Yoga for Women Attempting Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00492310
Recruitment Status : Unknown
Verified July 2010 by The Miriam Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 27, 2007
Last Update Posted : July 20, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: yoga Behavioral: cognitive therapy Behavioral: wellness Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : August 2007
Primary Completion Date : February 2010
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. smoking cessation: 7-day point prevalence abstinence [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Acceptability: recruitment, retention, adherence to protocol [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00492310


Locations
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Beth C Bock, PhD The Miriam Hospital
More Information

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: R21AT003669-01 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: July 20, 2010
Last Verified: July 2010

Keywords provided by The Miriam Hospital:
Smoking
tobacco
women
yoga