Yoga for Women Attempting Smoking Cessation

Smoking Clinical Trial

Official title:

Yoga for Women Attempting Smoking Cessation: an Initial Investigation

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00492310
• Other study ID #: R21AT003669-01
• Secondary ID: R21AT003669-01
• Status: Unknown status
• Phase: Phase 3
• First received: June 25, 2007
• Last updated: July 19, 2010
• Start date: August 2007
• Est. completion date: March 2011

Study information

• Verified date: July 2010
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: March 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• yoga
vinyasa yoga
• cognitive therapy
cognitive behavioral therapy once weekly
• yoga
vinyasa yoga twice weekly with smoking cessation once weekly
• wellness
wellness program with smoking cessation

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking cessation: 7-day point prevalence abstinence		6 months
Secondary	Acceptability: recruitment, retention, adherence to protocol		12 weeks