Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Yoga for Women Attempting Smoking Cessation
This study is not yet open for participant recruitment.
Verified by National Center for Complementary and Alternative Medicine (NCCAM), June 2007
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00492310
  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
Smoking
Behavioral: yoga
Behavioral: cognitive therapy

MedlinePlus related topics: Quitting Smoking Smoking
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Yoga for Women Attempting Smoking Cessation: an Initial Investigation

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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

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

Estimated Enrollment: 60
Study Start Date: August 2007
Estimated Study Completion Date: April 2009
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492310

Contacts
Contact: Beth C Bock, PhD 401-793-8020 bbock@lifespan.org
Contact: Bess H Marcus, PhD Bess_Marcus@Brown.edu

Locations
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Investigators
Principal Investigator: Beth C Bock, PhD The Miriam Hospital
  More Information

Study ID Numbers: R21 AT003669-1
Study First Received: June 25, 2007
Last Updated: June 25, 2007
ClinicalTrials.gov Identifier: NCT00492310  
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Smoking
tobacco
women
yoga

Study placed in the following topic categories:
Smoking

Additional relevant MeSH terms:
Habits

ClinicalTrials.gov processed this record on January 16, 2009