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Yoga for Smoking Cessation Feasibility Study

This study has been completed.
Sponsor:
Collaborators:
Rhode Island Hospital
Brown University
Information provided by (Responsible Party):
Beth Bock, Ph.D., The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01030068
First received: December 9, 2009
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to test whether it is feasible to provide a smoking cessation program together with a yoga program to help women quit smoking. We anticipate that women will be enthusiastic about the program and that we will be able to recruit and treat women for smoking cessation within the designated time frame.


Condition Intervention
Smoking Cessation
Behavioral: Yoga
Behavioral: Wellness
Other: Smoking cessation therapy

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

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Recruitment and qualitative feasibility [ Time Frame: 10 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking cessation [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga
Yoga plus smoking cessation
Behavioral: Yoga
Yoga twice weekly
Other: Smoking cessation therapy
Smoking cessation therapy
Active Comparator: Wellness
Health & Wellness classes plus smoking cessation therapy
Behavioral: Wellness
Health and wellness classes twice weekly
Other: Smoking cessation therapy
Smoking cessation therapy

Detailed Description:

Cigarette smoking is the leading preventable cause of morbidity and mortality among adults in the United States. Smoking, and quitting smoking may be especially problematic for women. Our prior research has demonstrated that traditional aerobic exercise (e.g., brisk walking, bicycling) improves cessation outcomes among women. Exercise appears to reduce the effects of nicotine withdrawal and improves cessation outcomes by improving mood and reducing weight gain. yoga that shares many of the same properties of the traditional aerobic exercise that has been shown to be an efficacious adjunct to smoking cessation treatment. Moreover, some features of yoga, including a focus on breathing, meditation, stress reduction and enhanced mood are likely to have special relevance to smokers who are trying to quit. Thus, yoga may prove to be a more efficacious complimentary treatment for smoking cessation than traditional aerobic exercise.

The goal of this proposal is to conduct an initial investigation of the efficacy of providing Yoga as an adjunct to cognitive behavioral treatment (CBT) for smoking cessation. Adult women smokers (n=72) will be recruited through newspaper advertisements and will be randomly assigned to either: (1) CBT plus Yoga , or (2) CBT plus contact control. All study participants will be given a sub-maximal exercise stress test to ensure that they are safe to exercise. Yoga sessions will be conducted twice weekly for 12 weeks, and will be lead by certified instructors in yoga. Smoking cessation sessions will be conducted once per week for 12 weeks and will be lead by Masters or PhD level specialists in smoking cessation. Differences in post-treatment (12 week) cessation rates (7-day point prevalence abstinence) will provide data for estimates of effect size between conditions. This effect size estimate is necessary in order to calculate power estimates for a major clinical trial.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy female smokers
  • ages 18-65
  • smoke 10+ cigarettes a day
  • sedentary (not exercising more than 2 times per week)

Exclusion Criteria:

  • major depression
  • hypertension
  • more than 1 year previous yoga experience
  • current experience with yoga or smoking cessation treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030068

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

No publications provided

Responsible Party: Beth Bock, Ph.D., Professor of Psychiatry & Human Behavior, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01030068     History of Changes
Other Study ID Numbers: R21AT003669
Study First Received: December 9, 2009
Last Updated: October 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Smoking Cessation
Yoga
Wellness
Feasibility
Smoking Cessation Therapy

ClinicalTrials.gov processed this record on November 27, 2014