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

  • United States
    • 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.
Behavioral: Cognitive Behavioral Therapy for Smoking Cessation
one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation
Behavioral: Yoga
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.
Behavioral: Cognitive Behavioral Therapy for Smoking Cessation
one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation
Behavioral: Health & Wellness
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.

Sponsor

The Miriam Hospital

Collaborators

National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

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.

General Publications

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.

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