Yoga for Men Attempting Smoking Cessation
February 4, 2014 updated by: The Miriam Hospital
Complementary Treatments for Smoking Cessation
The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a quit-smoking program that combines behavioral therapy with either yoga, or a health & wellness program that serves as a contact control.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Men enrolled in this pilot will be provided with 8 weeks of cognitive-behavioral therapy for smoking cessation and either 1) a twice-weekly program of yoga, or 2) a health & wellness program that serves as a control for number of contacts and subject burden between study conditions.
Qualitative data from open ended surveys and interviews is used to supplement survey data to enhance the investigators understanding of study outcomes.
Participant accrual and retention rates, acceptance of randomization, and compliance with study protocols will be examined along with perceptions and beliefs about yoga and its relationship to quitting smoking specifically, and health in general.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- The Miriam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- male
- age 18 -65
- daily smoker, 5 or more cigarettes/day
- generally healthy
- able to exercise safely
Exclusion Criteria:
- female
- hypertension
- current or recent history of medication use for major depression
- participation in yoga classes within the past year
- current or >1 year prior experience with mind/body therapies
- currently participating in regular exercise classes
- currently enrolled in quit smoking program
- currently using quit smoking medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga
One-hour sessions of twice weekly yoga for 8 weeks.
|
one hour weekly for 8 weeks.
Cognitive behavioral therapy for smoking cessation
One hour, twice weekly for 8 weeks of vinyasa yoga
|
|
Active Comparator: Health & Wellness
8 week program of health & wellness classes, materials and handouts.
Topics included healthy eating, cancer prevention and cardiovascular disease prevention.
|
one hour weekly for 8 weeks.
Cognitive behavioral therapy for smoking cessation
Lectures, handouts and printed materials on general health and wellness topics including healthy eating, cancer prevention and cardiovascular disease prevention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking abstinence
Time Frame: 7 days
|
7-day point prevalence abstinence was measured at 8 weeks, 3 and 6 months follow up
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
February 3, 2014
First Submitted That Met QC Criteria
February 4, 2014
First Posted (Estimate)
February 5, 2014
Study Record Updates
Last Update Posted (Estimate)
February 5, 2014
Last Update Submitted That Met QC Criteria
February 4, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AT003669-02S1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.