Hatha Yoga for Smoking Cessation

December 10, 2015 updated by: Creighton University

Hatha Yoga as an Adjunct to Cognitive Behavioral Therapy for Smoking Cessation

The purpose of this study is to determine whether Hatha Yoga can improve the chances of a successful smoking quit attempt.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

While many smoking cessation interventions have been studied, even the most successful interventions result in less than 40% abstinence from smoking at 6 months. Most people attempt to quit multiple times before maintaining long-term abstinence from tobacco. Research into interventions to improve quit rates and decrease smoking prevalence is a high priority for multiple organizations. Yoga is an attractive non-pharmacological option because it can be used safely during pregnancy and lactation, can be combined with other pharmacologic and non-pharmacologic treatments, and can be continued well past the smoking cessation date to combat withdrawal symptoms and cravings. There is a critical need for innovative and effective methods for tobacco control that focus on both prevention and cessation.

This project will be broken into two stages. The first stage will aim to pilot test yoga techniques for feasibility and acceptability. Recruitment and retention strategies will be tested and participant satisfaction will be evaluated. Preliminary measures of smoking abstinence and withdrawal symptoms will be conducted.

The second stage of this study will be a randomized trial to compare smoking abstinence with cognitive behavioral therapy (CBT), CBT + yoga, or yoga alone.

Study Type

Interventional

Enrollment (Actual)

67

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
    • Nebraska
      • Omaha, Nebraska, United States, 68178
        • Creighton University

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 19 years or older
  • Smoker of 5 or more cigarettes per day
  • Willing and physically able to participate in yoga
  • Not currently practicing Hatha yoga.

Exclusion Criteria:

  • Use of smokeless tobacco

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive behavioral therapy
This group will receive a standardized, 8-session cognitive behavioral therapy course that is offered to the public at our practice.
Behavioral: Cognitive behavioral therapy
8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.
Experimental: Cognitive behavioral therapy + yoga
This group will receive the standardized, 8-session cognitive behavioral therapy course + 8 sessions of Hatha yoga.
Behavioral: Cognitive behavioral therapy
8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.
Behavioral: Hatha yoga
30 minutes of instruction in Hatha yoga will be provided for 8 sessions.
Experimental: Hatha yoga
This group will receive 8 sessions of Hatha yoga and printed materials to assist with their quit attempt
Behavioral: Hatha yoga
30 minutes of instruction in Hatha yoga will be provided for 8 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point prevalence abstinence from smoking
Time Frame: End of intervention (week 7)
Abstinence from smoking as measured by expired carbon monoxide at the end of the 7-week intervention.
End of intervention (week 7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence from smoking
Time Frame: 3 and 6 months
Prolonged abstinence defined as no smoking after the identified "quit date" and point prevalence abstinence (no smoking in the past 7 days) will be measured. Measured by self-report.
3 and 6 months
Change in weight
Time Frame: End of intervention (week 7)
Change in weight from baseline to week 7
End of intervention (week 7)
Signs and symptoms of nicotine withdrawal
Time Frame: Weeks 1-7 during intervention period
Survey will be administered weekly during class sessions
Weeks 1-7 during intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Investigators

  • Principal Investigator: Amy Mayer, OTD, OTR/L, Creighton University

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

  • Burns TL, Mayer AE, Washington-Krauth SM, Walters RW, Arouni AJ. Design and Feasibility of a Hatha Yoga Intervention for Smoking Cessation. Journal of Smoking Cessation 2014; doi:10.1017/jsc.2014.21.

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

August 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 2, 2012

First Submitted That Met QC Criteria

July 2, 2012

First Posted (Estimate)

July 4, 2012

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12-16438/13-16721

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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