Yoga for Smoking Cessation Feasibility Study

Yoga for Women Attempting Smoking Cessation: An Initial Investigation

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Yoga; Other: Smoking cessation therapy; Behavioral: Wellness

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • The Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: Smoking cessation therapy; Smoking cessation therapy; Behavioral: Wellness; Health and wellness classes twice weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recruitment and qualitative feasibility	10 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Smoking cessation	6 month

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: Brown University; Rhode Island Hospital
• Investigators: Principal Investigator: Beth C Bock, PhD, The Miriam Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: December 9, 2009
• First Submitted That Met QC Criteria: December 10, 2009
• First Posted (Estimate): December 11, 2009

Study Record Updates

• Last Update Posted (Estimate): October 7, 2011
• Last Update Submitted That Met QC Criteria: October 6, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Feasibility; Yoga; Smoking Cessation; Wellness; Smoking Cessation Therapy
• Other Study ID Numbers: R21AT003669 (U.S. NIH Grant/Contract)