This trial is active, not recruiting.

Condition smoking
Treatments yoga, cognitive therapy, wellness
Phase phase 3
Sponsor The Miriam Hospital
Collaborator National Center for Complementary and Alternative Medicine (NCCAM)
Start date August 2007
End date February 2010
Trial size 60 participants
Trial identifier NCT00492310, R21 AT003669-01, R21AT003669-01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Cognitive-behavioral smoking cessation with yoga
vinyasa yoga
cognitive therapy
cognitive behavioral therapy once weekly
vinyasa yoga twice weekly with smoking cessation once weekly
(Active Comparator)
smoking cessation with twice weekly wellness program
cognitive therapy
cognitive behavioral therapy once weekly
wellness program with smoking cessation

Primary Outcomes

smoking cessation: 7-day point prevalence abstinence
time frame: 6 months

Secondary Outcomes

Acceptability: recruitment, retention, adherence to protocol
time frame: 12 weeks

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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

Additional Information

Official title Yoga for Women Attempting Smoking Cessation: an Initial Investigation
Principal investigator Beth C Bock, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by The Miriam Hospital.